In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products.

They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth.

Subhi shares his personal journey in podcasting, the impact of consistent content production, and the importance of lifelong learning.

They also dive into the intricacies of combination product definitions, regulatory pathways, and trends, offering listeners a well-rounded view of the current state and future potential of this evolving industry.

• [00:02] – Introduction of Subhi Saadeh and his background in combination products.
• [03:45] – The origin story of the Combinate Podcast and its impact on Subhi’s career.
• [12:32] – Overview of combination products and regulatory differences between the US and EU.
• [18:50] – Common misconceptions in drug-device integration.
• [28:10] – The evolving landscape of combination products and industry growth.
• [34:22] – Balancing technical and business aspects in MedTech.
• [46:15] – Notable episodes and guests from the Combinate Podcast.
• [56:30] – Final thoughts on lifelong learning and producing valuable content.

• Subhi Saadeh: "If I want to be a master at my craft, I need to be producing something in a way that is consistent."
• Etienne Nichols: "Teaching others is one of the best ways to instill that knowledge into yourself."
• Subhi Saadeh: "Drugs and devices aren’t as different as people think; it’s how they measure product quality that varies."

• Combinate Podcast: let’s combinate.com
• Subhi Saadeh’s LinkedIn Profile: Connect with Subhi
• FDA Regulatory Guidelines for Combination Products: Important for understanding the regulatory landscape.
• Book Reference: Quality is Free by Philip Crosby - A must-read for quality management professionals.
• Book Reference: Bottle of Lifes by Katherine Eban
• Etienne Nichols’ LinkedIn Profile:

Explore the essential role of quality management in small medical device companies with Vernon Baker, a seasoned engineer. Learn about core QMS activities, regulatory intelligence, effective communication with top management, and key skills for aspiring quality managers. Gain valuable insights on supplier management, risk assessment, and regulatory compliance for startups and growing medical device firms.

In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Listeners will gain valuable insights into maintaining compliance and continuous improvement in the MedTech industry, as well as practical advice for navigating ISO 13485 certification.

• 00:00 - 02:00 - Introduction by Etienne Nichols
• 02:00 - 05:30 - Introduction to HTD Health and their focus
• 05:30 - 10:45 - Discussion on the importance of ISO 13485 certification
• 10:45 - 14:30 - Steps and preparations for achieving ISO 13485 certification
• 14:30 - 20:00 - Benefits and features of using Greenlight Guru’s eQMS
• 20:00 - 25:00 - Challenges and changes faced during the certification process
• 25:00 - 30:00 - Practical tips for preparing for an ISO 13485 audit
• 30:00 - 35:00 - Continuous improvement and future goals for HTD Health
• 35:00 - 40:00 - Closing thoughts and advice from Weonika Michaluk and Zach Markin

1. Weronika Michaluk: "Do a proper gap analysis and also think whether you have enough knowledge internally... it will make your life easier to reach out to a partner or consultant."
2. Zach Markin: "In services, there’s not one ideal agile, but the right flavor of agile for the work that needs to be done."
3. Weronika Michaluk: "Using Greenlight Guru made our lives easier, especially in managing traceability and ensuring compliance."

1. Gap Analysis: Conduct a thorough gap analysis to understand current capabilities and areas needing improvement.
2. Internal Expertise: Ensure you have the necessary internal expertise or consult with experienced partners.
3. Continuous Improvement: Regularly update and improve your processes to maintain compliance and efficiency.

• ISO 13485 Certification: Learn about the ISO 13485 standard for medical devices
• Visit Greenlight Guru for eQMS software solutions
• HTD Health
• Weronika Michaluk on LinkedIn
• Zack Markin on LinkedIn
• Connect with Etienne Nichols on LinkedIn.

ISO 13485: An international standard that outlines the requirements for a quality management system specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements related to medical devices.

QMS (Quality Management System): A structured system of procedures and processes covering all aspects of design, manufacturing, and distribution to ensure products meet regulatory standards and customer expectations.

CAPA (Corrective and Preventive Action): A process within a QMS to investigate and correct the root causes of identified issues and prevent their recurrence.

What MedTech innovation are you most excited about?

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What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.

With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.

• Fundraising: Figure out who you want to raise capital from, what should be in your pitch deck, and what questions will investors ask about problems/solutions.
• When trying to raise money, startups need to know that there are three types of investors—good, neutral, and bad. Sometimes, bad investors are hard to spot.
• When considering acquiring a company, some of the top things strategics look at is how you capture more clients, build your team, incorporate a quality management system (QMS), and handle regulatory challenges.
• If you are selling products to a hospital system, you will need to check three things—physician/clinician (especially nurses) ownership, patient improvement, and economic benefit.
• Build, develop, and invest in your team by finding people who complement your weaknesses. Don’t be afraid to fractionalize. One of the most important thing you can do for your company is to find advisors, partners, and mentors with large professional networks.
• When people are raising money, unless you are raising from a high net worth individual or angel group, be strategic with who you want to raise money. Venture Capitalists have a responsibility to spend (invest) their money just like you have a responsibility to raise it.
• Clients need to understand that regulatory fits into their business, clinical, reimbursement, and commercialization strategies—all those things work together and overlap, so make sure to ask the right questions to the right expert.

“The #1 thing we try to tell all of our startups when they’re going out to raise money is there’s three types of investors. There’s good, neutral, and bad. You really want to avoid bad.”

“For those first few investors, you want to find a good investor. Someone who’s going to bring something else to the table. Fill a knowledge or network gap that you don’t have. Understand what your mission is for the company and how they are going to support it.”

“We talk to a lot of investors and a lot of entrepreneurs, and the one thing we’ve learned is that there is more than one way to raise money. However, there are patterns.”

 “Regulatory fits into your business strategy, fits into your clinical strategy, fits into your commercialization strategy—all those things work together and overlap.”

Duane Mancini on LinkedIn

Project Medtech

Project Medtech Podcast

Etienne Nichols on...

The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.

Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.

• Sterilization validations/revalidations take a lot of money ($40,000-80,000) and a long time (16-20 weeks) to complete.
• Don’t underestimate labeling - 40% of FDA recalls are due to labeling. Make sure your CM has good labeling controls.
• Over a third of all package validations fail the lab test for transit. The biggest reason why companies fail packaging validation is not understanding the various shipping modes and their related testing.
• ISO’s 11607 standard has two parts: Part 1 is about designing the package; Part 2 is validating the package. Also, there is a guidance document due to the complexity of the packaging process.
• The criteria for filing a 510(k) and steps related to packaging include validating that the seals are good from a sterile barrier standpoint and the product is good and has not changed over time because of transit testing or aging.
• From a design standpoint, document how the package has been designed and meets customers’ needs. Recently, the FDA added user testing to the standard for sterile transfer.
• Feasibility testing of prototypes and samples of vibration, drops, and humidity should be conducted to prevent potential problems. Ask engineers about product changes and the risks for redesign of packaging to know if the package will fail or pass.

“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.” 

“Over a third of all package validations failed at the lab for transit. It’s staggering.” 

“Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.” 

“One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”

“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”

Jeff Barrett on LinkedIn

J-Pac Medical

Etienne Nichols on LinkedIn

ISO 11607-1

ISO 11607-2

ISO 13485

ASTM International

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.

• When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.
• If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.
• It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.
• Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.
• Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.
• When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.
• It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.
• Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations. 

“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”

“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”

“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”

“Let’s try to keep out anything of potential concern that we can at any concentration.”

Chris Parker on LinkedIn

Labcorp

Etienne Nichols on LinkedIn

FDA - Overview of Device Regulation

FDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

ISO 10993-1:2018 - Biological evaluation of medical devices

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company’s CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?

• Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. 
• The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.
• If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).
• Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?
• CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.
• CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA’s as an opportunity to improve a product and prevent problems in the future. 
• People do not follow procedures because sometimes they don’t even know that procedures exist, or those procedures are not updated/revised after events.

“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer

 “People don’t focus on the common sensical understanding.” Mike Drues

 “Unless regulation makes sense, I don’t care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues

 “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues

 “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike Drues

FDA - Corrective and Preventive Actions (CAPA)

FDA - Form 483 Observations and Warning Letters

FDA - Medical Device Overview

International Medical Device Regulators Forum (IMDRF)

ISO 13485 CAPA

21 CFR Part 820

Mike Drues on LinkedIn

Greenlight Guru Academy

What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the four quadrants of UDI that companies need to be aware of? Don’t underestimate your time to comply because it always takes longer than expected.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Gary Saner, Senior Manager of Information Solutions for Life Sciences at Reed Tech, about UDI and the current state of global implementation.

Gary has been helping companies achieve UDI compliance on a global scale for years.  He is considered to be a thought leader and recognized authority on medical device UDI compliance.

• As the U.S. FDA Class I UDI deadline approaches, companies should refer to the FDA’s final guidance, which describes the compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.
• Delays seem to be a part of the history of UDI. Manufacturers face challenges and pitfalls from UDI being rolled out easily. There are a number of issues with the brand new requirement in the United States.
• The four quadrants of UDI are identifying a product, reprocessed/reused products, reporting attributes, and documenting standard operating procedures (SOPs) in a quality management system (QMS).
• The EU has a complicated UDI implementation schedule, as well. Delays have been announced, but the impact was due to the European Commission completely revamping the regulatory platform. 
• In Europe, UDI becomes one of the many things that a manufacturer has to learn, be educated on, and respond to. There’s no grandfathering of products, notified bodies, and patients. Portfolios are re-evaluated to meet new regulations.
• With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some health authorities around the world base their policies on one or the other. However, good global harmonization is not in place.

“This is a challenge in that this particular dataset has never really been assembled before. So, there’s no precedent for this.”

“The other issue is sometimes you find the data and it’s not accurate or it hasn’t been touched for a while. It’s not current. It’s obsolete. There’s issues with formatting. Sometimes, the formatting of that data that’s held for internal processes is not the format that actually gets submitted to the FDA.”

“There’s a little bit of a nuance about making sure the acknowledgements that come back from CDRH, there’s three acknowledgements, and making sure that they’re all complete for every single record.”

“UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to and there was no grandfathering of products.”

“With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some of the other health authorities around the world will kind of base their policies on one or the other - US or EU.” 

Information Solutions - Life Sciences at Reed Tech

Gary Saner on LinkedIn

The Ultimate Guide to UDI

How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access?   

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Joe Mullings, chairman and CEO of the Mullings Group companies, about finding true quality talent and celebrating excellence and hyper-competency to make lives better. 

Joe’s search firm is responsible for more than 8,000 successful searches in the medtech/healthtech/life sciences industry. DragonFly Stories produces attention and awareness campaigns for companies globally through TrueFuture. TMG360 Media utilizes the power of media and outreach in medtech/healthtech to move businesses and health forward.

• Quality of Outcome vs. Opportunity: Organizations are realizing that it’s much more expensive to lose and replace a good player rather than retain a good player. The quality and output of an employee’s work matters.
• Networking should occur when you don’t need it. Be clever, bring value, give and not take, and create a brand around yourself.
• The workforce and global economy has changed because of the worldwide pandemic. Things are starting to settle down, and it’s time to reset, re-define, and re-evaluate employees’ responses to work and fulfillment.
• WFX: Where are employees willing and wanting to work—from home, anywhere, or in the office—and how does that affect organizations’ willingness when it comes to compensation, flexibility, and the networking process to retain talent?
• Two-way communication between workers and employers needs to be created to find balance and reduce friction for healthy relationships. The catalyst for people switching or leaving their jobs is to make more money. However, top performers want to move forward in their career from their own developmental perspective and grow their skills.
• The non-negotiables of working in the office or not depends on your degree and years of experience. If you’re new, it’s best to work in the office to learn and mimic others. Then, it depends on your job function.
• The best way to represent yourself in the marketplace is based on your behaviors and how you package yourself when appearing in front of others.

“We are the #1 search firm in the world, first of all, in the medical device/healthtech industry with more than 8,000 successful placements over three decades.”

“Compensation, right now, is also being driven by supply and demand.”

“You’ve got better career choices now, and you’ve also got the ability to live, potentially, a better life.”

“Let’s keep a better balance of power in the workforce instead of it being futile in nature where the companies call all the shots.”

“The digital scales your idiocy as well as your competency equally.”

Joe Mullings on LinkedIn

The Mullings Group - TMG Search

TMG360 Media

DragonFly Stories

TrueFuture

Out of the Crisis

Etienne Nichols on LinkedIn

What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, about digitizing your SaMD testing.

Rahul builds teams that help companies proactively manage compliance risks toward a true digital enterprise. He is an innovative thinker with more than 18 years of experience in risk management, compliance, and internal controls focused on information technology and data. 

• Rahul defines SaMD as software used to perform a medical purpose without being part of a hardware medical device. SaMD is capable of running on any general purpose platform, such as your Android or iOS mobile phone.
• SaMD is different from software in a medical device (SiMD). SaMD is independent from hardware; SiMD is embedded in a physical medical device.
• Also, there’s differences between SaMD and medical device data systems (MDDS). MDDS only transfers, stores, or displays medical device data, but it does not have an algorithm or business rule to help make medical decisions.
• IEC 62304 impacts SaMD organizations and how they approach the risk of their solution. All SaMDs are not equal, and it’s important to understand the level of risk in every SaMD.
• Companies should prepare for SaMD testing with a clinical evaluation to demonstrate a valid clinical association between SaMD’s output and targeted clinical condition.
• Before thinking about designing and developing a product, a quality management system (QMS) should be established. Software companies need to adopt and modify their QMS to serve their product and its users, while fulfilling FDA requirements.
• Rahul discusses the pros and cons of manual versus automated/electronic  documentation and testing, including risk management for patient safety.
• Best practices for SaMD testing are using agile and devops methodologies. Potential pitfalls are not testing continuously, even after the product is on the market. 

“Software as a medical device - it is software that is intended to be used for a medical purpose, and it performs that purpose without being part of a hardware medical device.”

“There is no physical device, in this case, that you can touch and feel. It’s purely software.”

“The nature of software - it’s something that you cannot touch or see. It’s all code. From a testing perspective, especially, there’s a lot of things that you need to pay attention to.”

 “The quality management system or quality management process, that has to be established even before you think about the product, even before you design the product.”

Rahul Kallampunathil on LinkedIn

Etienne Nichols on LinkedIn

Arbour Group LLC

FDA - SaMD

FDA - Medical Device Data Systems (MDDS)

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA’s Refusal to Accept (RTA) policy and guidance. 

• After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.
• If a submission is rejected on the administrative review, it is completely the company’s fault, not the FDA’s. If the substantive review is rejected, however, there’s room for negotiation with the FDA.
• Most of the FDA’s acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.
• Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.
• Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.
• Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It’s a company’s responsibility to make sure the FDA understands their device.
• The draft guidance documents have been published for a reason - don’t ignore them and risk a rejection for what could easily have been avoided. 

“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues

“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues

“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer

“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues

“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike Drues

How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)

Guidance: Refuse to Accept (RTA) Policy for 510(k)s

Guidance: Acceptance Review for De Novo Classification Requests

Guidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Acceptance Checklists for 510(k)s

What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required - especially when there is the potential for personnel to resist change? 

In this episode of the Global Medical Device Podcast, Etienne Nichols discusses lean QMS implementation with Steve Gompertz, a leader in quality systems management with more than 30 years of experience in the medical device/technology industry. 

• Guerilla tactics for quality leadership that involve thinking outside of the box and trying to get things done without asking for permission from authorities. Sometimes the FDA unintentionally creates fear and creates imaginary boundaries in people’s minds that stifle their creativity.
• People will struggle and become frustrated when working with a burdened QMS and restrictive standard operating procedures (SOPs).
• The regulations and standards are intentionally vague and open to interpretation because it’s not possible to have a one-size-fits-all. Meet the intent of the requirements and be ready to defend them.
• Lean documentation is the best approach. Weed out the things you don’t need. In a regulated or unregulated space, it’s better to have clear, precise, and intentional documentation rather than a pile of papers.
• Sometimes regulations and standards create negative opinions because it’s human nature to not want to be told what to do. However, what is their purpose? To produce safe and effective medical devices while also turning a profit.
• Approaches to implementing guerilla tactics include burying or sneaking something in without calling it what it is and getting people to do the right thing without them always knowing they are doing it.
• Make sure your metrics don’t incentivize the wrong thing. Some companies measure document control in QMS based on time—how fast it takes to make changes? But does that actually make the process more effective and cost less? More likely, it incentivizes cutting corners.
• Steve recommends shifting your mindset about document control or value-added changes by first defining the problem correctly. Don’t make assumptions.

“The regs and the standards aren’t actually that specific too often. They are intentionally vague. Sometimes, that is a point of frustration with people. But when you think about it, they have to be.”

“Step back, stop just reading what the words say, and start thinking about why are they there?”

“When you create a quality system, you have to think about the architecture.”

“If it isn’t documented, right, it didn’t happen. If it’s not documented right, things are going to go bad.”

Quality & Regulatory Consulting - QRx Partners

Ask Me Anything Session with Steve Gompertz

ISO 13485

FDA - Guidance Documents (Medical Devices)

21 CFR Part 820 - Quality System Regulation

The 7 Habits of Highly Effective...

The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and increased costs are leading to diminished returns. What are specific tactics that MedTech companies can take to develop their sales process?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Omar Khateeb about preventing the death of medical sales with new data that shows where you can find prospective buyers for your medical device products.

Omar is the founder of Khateeb and Co., which helps MedTech companies grow sales and drive product adoption through social media and content.

• Omar describes the death of medical sales as the death of an old way. The world has changed and buyers in every industry have become more sophisticated. Social media content now influences buying decisions.
• Rather than unscheduled clinic and hospital visits with physicians, Omar describes the new way of medical sales as liking, commenting, and resharing their content.
• LinkedIn and other social media channels are powerful for communication and influence. The real value is building thought leadership and creating attention-getting content to persuade someone to meet with salespeople.
• Companies need new categories or different ways of doing something. A marketing campaign should include: What problem do you solve? Who do you solve that for? How are you solving it in a unique way?
• Be as specific as possible because your message needs to resonate with specific people. If you can’t satisfy one specific person, how can you satisfy an entire market? The riches are in the niches.
• There are pitfalls that some people and companies get into when utilizing a social media approach on their own. Spend more money to buy time. You can always make your money back, but you cannot get your time back. 

“How the buyer’s journey for everybody, not just doctors, has become more sophisticated.”

“We should be selling and marketing to physicians and hospitals using social media.”

“You shouldn’t be posting stuff about your product as a salesperson.”

“The riches are in the niches.”

“I help medtech startups drive technology adoption and gross sales using social media.”

Omar Khateeb on LinkedIn

The Death of Medical Sales: Igniting a New Future

Upending the Medtech Sales Model

Alex Hormozi on LinkedIn

Geoffrey Moore

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

Greenlight Guru Community

Greenlight Guru

In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journey, the importance of effective elevator pitches, the nuances of regulatory pathways, and practical tips for aspiring inventors. With insights on avoiding common pitfalls and strategies for securing funding, this episode is a treasure trove for anyone interested in MedTech innovations.

• [00:00] - Introduction and Ron Richard’s background
• [04:50] - Early successes in inventing and bringing products to market
• [10:30] - Validating ideas and market need
• [17:15] - Regulatory pathways: 510(k) vs. PMA
• [24:00] - Class I products and direct-to-consumer strategies
• [30:45] - Funding strategies: Family and friends, VC, and IPO
• [42:20] - Overcoming pitfalls and avoiding shiny object syndrome
• [49:10] - The importance of having a clear cap table
• [55:30] - The chasm: Making the leap from idea to market
• [01:01:45] - Final takeaways and advice for MedTech innovators

1. Ron Richard: “One of the biggest things I tell inventors is that in order for you to raise money, people have to trust you and like you. You have to share within 30 seconds what your product does and what problem it solves.”
2. Etienne Nichols: “Pioneers get shot, settlers get rich. You can be innovative with a 510(k) product by making evolutionary improvements.”
3. Ron Richard: “The road to success is always under construction. Be prepared for obstacles and have a plan to navigate through them.”

1. Elevator Pitch: Develop a concise and compelling elevator pitch that clearly communicates your product’s value.
2. Validate Early: Use focus groups and stakeholder interviews to validate your idea before heavily investing.
3. Funding Strategy: Start with family and friends for initial funding, then approach VCs once you have patents and prototypes.

1. Increased Scrutiny: Regulatory bodies like the FDA may become more stringent, requiring more comprehensive testing and validation.
2. Telemedicine Integration: Future medical devices will likely need to integrate telemedicine capabilities to stay competitive.
3. AI and Diagnostics: Artificial Intelligence will play a significant role in diagnostics and personalized medicine, offering new avenues for innovation.

1. Ron Richard's Book: "Someday is Today: Get Your Ideas Out of Your Coffee Cup and on the Market" - [Amazon Link]
2. Etienne Nichols' LinkedIn: Etienne Nichols on LinkedIn
3. Ron Richard’s Website: Inventing Starts Today

• Class I: Low risk, often exempt from premarket notification (510(k)).
• Class II: Moderate risk, typically requires 510(k) premarket notification.
• Class III: High risk, requires PMA (Premarket Approval) with extensive data.

• Poll: What MedTech innovation do you think will have the most significant impact in the next five years? (Options: AI-driven diagnostics, wearable health monitors, surgical robots)
• Share your thoughts with us at podcast@greenlight.guru

We’d...

FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare. 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD. 

• Chris views the FDA’s recent activity around cybersecurity requirements, regulations, and laws for SaMD as a necessity because manufacturers cannot seem to self-regulate. 
• The Protecting and Transforming Cyber Health Care Act (PATCH) will give the FDA a direct mandate to manage the cybersecurity of medical devices.
• However, a clause in the PATCH Act allows for cybersecurity to extend to all existing legacy medical devices—not just new devices entering the market.
• As medical device manufacturers (MDMs) become aware of the clause, it’ll have a huge impact. MDMs will likely end support for device lines due to high costs. 
• The biggest issue with the new guidance consensus vs. regulatory standards is alignment with software bill of materials (SBOM) tools.
• The most effort-intensive part of the new draft guidance is ongoing testing of anomalies to determine if they can be turned into vulnerabilities. The industry will be unable to keep up with additional testing because of resources and demand.
• All this added burden will be placed on MDMs at the cost of marginal improvements in cybersecurity. So, there’s no real benefit to the manufacturer.
• Structure a standard by not creating something brand new that is ill/undefined but align best practices to create secure medical devices.

“Legally-backed cybersecurity requirements by a regulatory agency are necessary to ensure secure devices are entering the marketplace and hopefully replacing the insecure legacy devices.”

“This clause is going to have a huge impact on medical device manufacturers (MDMs) and I find it amazing how many MDMs are completely unaware of this.”

“An SBOM is a software bill of materials. It’s an ingredients list for your application.”

“This isn’t just one-and-done testing in your life cycle.”

“You’re going to have a lot of extra work coming your way.”

Medical Device Cybersecurity for Engineers and Manufacturers

Regulations (Submit comments to the FDA)

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

PATCH Act

International Electrotechnical Commission (IEC)

ISO (International Organization for Standardization)

International Medical Device Regulators Forum (IMDRF)

Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical devices in today's market...and there's a new revenue intelligence tool to help you bridge the gap.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Skylar Talley and Mark Mescher from MedScout, a territory prioritization and sales enablement platform.

Skylar and Mark discuss early stage territory planning to get more medical device sales, different aspects of go-to-market strategies, and building and demonstrating meaningful value by understanding pain points. 

• Tools have evolved and MedScout’s platform is a huge step forward. Basically, it brings an Excel spreadsheet to life, maximizes territory data, and is very intuitive and useful for sales reps to understand.
• Skylar has observed an evolution from frameworks/methodologies on the market based on geographic coverage to put numbers, early sales, and clinical proof-points out as fast as possible and leverage an early budgeted staff.
• Companies should start thinking about territory planning early on during the fundraising phase to benefit the commercialization and purchase processes.
• Skylar describes the 3-stage early commercialization roadmap strategy as getting the product into market, developing case studies and understanding where to take them, and knowing the distribution or rep model to execute.
• Relationships are vital early on with the development and commercialization of a medical device company. Physicians educate and innovate, just like engineers.
• Skylar and Mark agree that it’s worth being thoughtful when evaluating available solutions to make sure they are not adding time to your managers and reps.
• Marketers find and generate leads through interesting means, so there’s much better coexistence and co-creation between sales and marketing teams today.

“Sales reps aren’t always the best at Excel spreadsheets. Most of them don’t have any idea what a pivot table is.” Mark Mescher

“I don’t hear from a lot of reps out there in the field that they’re just over the moon with how they have to use Salesforce on a day-to-day basis and if they use it on a day-to-day basis.” Mark Mescher

“No two health systems are created equal when it comes to product approval.” Mark Mescher

“Marketing teams are really at the forefront of being very creative in finding and generating leads through really interesting means that weren’t necessarily accessible previously.” Mark Mescher

“Anytime you’re in an early stage environment, or doing something entrepreneurial, go talk to 20 to 30 people that you’re going to be trying to create an impact for.” Skylar Talley

MedScout

MedScout on LinkedIn

The Rise of the Next Generation of Medtech “Milkmen”

Omnichannel engagement in medtech: The time is now

The rise of digital marketing

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach to whether or not this technology should be regulated?

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. 

• Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.
• FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”
• Classic or traditional manufacturing is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.
• FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.
• For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.
• FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.

“There’s been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues

“The phrase, ‘additive manufacturing,’ comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues

“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer

“There’s two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues

“The blending of tech and med device, it’s scary on one hand, but it can be exciting, as well. I’m looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon Speer

FDA - 3D Printing of Medical Devices

FDA - Technical Considerations for Additive Manufactured Medical Devices Guidance

FDA’s Role in 3D Printing

FDA - Process of 3D Printing Medical Devices

FDA - 3D Printing Medical Devices at...

How does a quality management system (QMS) and regulatory factors impact fundraising, pre-money valuation, market access, and commercialization for medical device companies?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Cristiano Fontana, founder and CEO of ThreeBridges.

ThreeBridges is a consulting firm that provides business development advisory services for startups, distribution companies, and subject matter experts (SMEs) in the global medtech market. Also, Cristiano is a co-founder of CrossBay Medical, Inc., and partner of IStarter and ClubDealOnline. 

• When someone evaluates and/or values a company, QMS and regulatory impacts fundraising rounds and pre-money valuation by asking for backup evidence as well as understanding business models and financial motives.
• Cristiano describes the common paths that startups and entrepreneurs take when considering valuation. Start with a clear idea of the entire journey to create a reliable and consistent business plan.
• Cristiano’s fundraising strategy is knowing how much money is needed for different stages and consistently targeting the ideal investor (tier 1 or 2).
• When approaching investors, expect a lot of ‘no’s’ from investors, but you only need one, ‘yes.’ It’s a learning process to identify QMS/regulatory inconsistencies related to fundraising and pre-money valuation.
• Medical device companies may face specific challenges, such as demand, expertise, and selecting investors. Also, know about regulatory approval, debt, and reimbursement and mitigate risk, generate cash flow, and grow with a QMS.
• There are several differences when it comes to fundraising in the United States compared to the European Union (EU), including the amount of equity/money in the market and investors’ expectations of how a company is managed.
• Cristiano offers advice on the dilution of funds and company ownership. Consider how the money will be used and the actual versus relative numbers of valuation.

“Come up with a business plan that is reliable as far as a business plan can be reliable.”

“You need a deep understanding of your business model, your market potential, your value position, so that you understand what really is the potential of the product.”

“Many times, people are not succeeding in fundraising or are delaying the time for getting their money because they’re not targeting the right people.”

“You need, also, to show that you know what a QMS is, you have that in place already, and it is really efficient and well managed. Having something that is well structured that is tailor made but is well recognized on the market that is working.”

ThreeBridges

Cristiano Fontana on LinkedIn

EU Medical Device Regulation (MDR)

FDA - Pathway to Approval

ISO 13485

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical devices.  

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Julio Martinez-Clark, CEO and co-founder of Bioaccess, about early feasibility studies in Latin America.

Since 2010, Julio has supported more than 100 Medtech opportunities to design and operationalize successful clinical trial, regulatory, and market access strategies in Colombia and other countries in Latin America. 

• Julio is a big believer in the potential for medical device companies in Latin America. He explains how U.S. Medtech companies can succeed in Latin America with early feasibility clinical trials and market access entry initiatives.
• Latin America is a good location to conduct easy feasibility clinical trials because U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.
• More companies are coming to Columbia because it is difficult, expensive, and time consuming to recruit patients in the United States and achieve regulatory approval at the FDA.
• Although the FDA implemented its Early Feasibility Studies (EFS) Program several years ago, it does not work well. Trials are still expensive, and it’s still difficult to recruit patients in the United States.
• Patients and physicians in the United States and those in Latin America tend to share a similar culture when it comes to their health and lifestyle.
• However, there are challenges for companies in Columbia, such as language barriers. Documents for regulatory approval need to be translated into Spanish.
• Columbia’s reputation has evolved into a knowledgeable country for companies to visit, feel safe/comfortable, and find patients to conduct trials for quality data.

“U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.”

“The struggle that these companies go through is immense. They find it very difficult, very expensive, and time consuming to recruit patients in the United States, not to mention the regulatory approval at the FDA.”

“The Early Feasibility Studies Program that they implemented about seven, 10 years ago, it hasn’t really worked because of the dynamics of the U.S. system. Trials are still expensive and it’s still difficult to recruit patients in the United States.”

“It’s really a bargain to buy services from a hospital in a country like Columbia.”

“These companies are, in essence, looking for fast regulatory approval, ease of patient recruitment, and cost savings.”

Bioaccess

Julio Martinez-Clark on LinkedIn

OECD

Pacific Alliance

FDA - Early Feasibility Studies (EFS) Program

ISO 13485

True Quality 2022

The Greenlight Guru True Quality Virtual Summit

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Ken Zalevsky, Certified CyberSecurity Leader and CEO of Vigilant Ops, about software bill of materials (SBOMs) and cybersecurity in the medical device industry.

Ken has collaborated with the FDA, U.S. Department of Homeland Security (DHS), and National Telecommunications and Information Administration (NTIA) on cybersecurity initiatives, including cyber simulation exercises, industry guidance documents, and SBOMs. Ken’s written work advises medical device manufacturers on cybersecurity best practices and coaches hospitals on handling record numbers of breaches.

• Ken defines an SBOM as a list of software components that compose any system, application, or device. In health care, medical devices are computer-based systems with software components.
• Engineers may know all about software and security, but not with medical devices and SBOMs. Medical device manufacturers are familiar with safety and efficacy in a regulated industry and may need to overcome software challenges.
• Most medical device software teams don’t build everything that is in a medical device. Scope appropriately because third-party components may involve risk.
• Safety is not the same as security, but both should be included early in the product life cycle. Cybersecurity standards include authorization, authentication, and encryption versus safety recalls, use cases, and vulnerabilities.
• SBOMs are not evergreen documents. They need to be maintained and updated regularly to act, react, and take action.
• Health care is the primary target for hackers over other verticals and the response time in health care has always been the slowest. Today, it takes about 160 days for a healthcare organization to discover a security breach. 

“A detailed list of those software components is really the essence of an SBOM.”

“At the heart of it, the idea and the purpose of the SBOM is to give that transparency into software components that are utilized in medical devices.”

“Most software companies, especially medical device software teams, don’t build everything that’s in the device. They take components from other third parties and there’s risk associated with those components.”

“You can’t blame it all on the hospital because the hospital has no idea what’s running in those devices.”

“Providing that transparency, understanding what you’re deploying on your network, just is common sense.”

Medical Device Security Made Easy - InSight Platform by Vigilant Ops

SBOM - National Telecommunications and Information Administration (NTIA)

NTIA - Minimum Elements For a Software Bill of Materials

FDA - Guidance Documents (Medical Devices and Radiation-Emitting Products)

FDA - Medical Device Overview

AAMI TIR57: Principles for medical device security - Risk management

How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give users what they want and need to safely use it as intended.

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Abbas Dhilawala, a cybersecurity and SaMD expert with Galen Data, about a new approach to cybersecurity and usability for SaMD companies to ensure products are both secure and user-friendly.

Abbas has 18 years of experience developing enterprise-grade software for the medical device industry and is well-versed with technology, industry standards, and the privacy of data.

• Usability and human factors testing standards exist. However, there’s no standard approach to follow for cybersecurity. Abbas’s approach is to obtain user feedback as soon as possible for SaMD to still be secure and user-friendly.
• Different kinds of users in the healthcare spectrum can be trained to use SaMD, including hospital staff and patients - depending on their level of trust and understanding of technology.
• Potential Pitfalls: Classification and credential layers, such as permissions and passwords, can put the security burden on the users but leads to the need for risk assessment/management for possible harm. 
• Biometrics: Cutting-edge technology, such as fingerprint, eye, and face scanning is not as secure, reliable, or consistent, but it’s getting better. Always have a backup plan.
• Key Takeaway: There’s a lot of push on cybersecurity, but don’t take away the convenience or the usability aspect. Find a way to balance both usability and cybersecurity.

“Ultimately, if you make the product in a way that’s hard to use, you can be secure. If nobody uses it, it doesn’t really matter.”

“There’s lots of standards, just no harmonization.”

“What can you do to minimize stress? Health care is already a stressful environment.”

“The fundamental layer of security is to know who the user is.”

“Having standards is a nice thing because then you can develop tooling around that.”

Galen Data (Schedule a Demo)

FDA - Guidances

FDA - Cybersecurity

HIPAA

True Quality 2022

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

Greenlight Guru

Global Medical Device Podcast Email

How many COVID tests have you taken at home, in hospitals, or at drive-thru clinics? Are you sick and tired of the long wait times to access the tests you need? Do you worry about whether you followed the instructions correctly or not? Does it take too long to process results - only to get false positives or negatives?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Jeremy Stackawitz, CEO of Senzo Health about his company's focus on improving current testing product offerings through better performance. Jeremy has more than 20 years of experience in the healthcare industry and Senzo Health is an in vitro diagnostics and point-of-care company working on COVID-19 technology. 

• Positive vs. Negative Test Results: Jeremy discusses the pros and cons of COVID testing by using lateral flow products to increase the time to results and improve performance. 
• Supply and Demand Constraints: Senzo Health’s reason for being is to offer a better test that resonates with end-users, government contractors, healthcare providers, and others.
• Main Barrier: Lateral flow tests are simple, but the technology and performance is limited. However, these tests could be good tools to use to monitor your own health, are relatively inexpensive, user-friendly, and fast.
• Data: With new technologies, Jeremy gains confidence and believes in Senzo Health’s products because of data generated and shared with investors, regulatory bodies, and other people in the industry.
• Healthcare reform: People are genuinely interested in having an active role in managing their health care and know the system is broken. It makes more sense to bundle tests, take in one place, get results fast, and develop a treatment plan. 
• Mitigate Risk: Make decisions based on priorities, different technologies, and limitations. It takes the right technology, team, and vision - know when to pivot.

“Our test is 10,000 times more sensitive than the dozen or so current offerings that you can buy.”

“People have realized, ‘Wow, these could be really good tools for me to use to monitor my own health, they’re relatively inexpensive, they’re fast.’”

“With new technologies, what gives you confidence is seeing data and then seeing data in other people’s hands.”

“I think our problem will be not so much finding a home for the technology, it’s going to be prioritizing what the best match for what our technology can deliver and the unmet needs in various markets.”

Jeremy Stackawitz on LinkedIn

Senzo Health

FDA - Emergency Use Authorization (EUA) Pathway

FDA - 510(k) Pathway

Teladoc

Theranos

Greenlight Guru Academy

True Quality 2022

Greenlight Guru YouTube Channel

How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission. 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space.

Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. Its staff does meaningful work on clients’ behalf to bring products to market.

• Dan describes quality through culture as a way to move beyond compliance to get true buy-in and engagement throughout your organization.
• Quality through culture is like a three-legged stool consisting of people, business, and quality. The three legs must work together and learn from mistakes.
• Dan’s definition of quality depends on industry. In the medical device space, quality aligns with risk and safety. A risk-based approach is needed to understand the harm that will ultimately happen to someone using your device.
• Compliance obviously matters, as much as safety. A medical device could be fully compliant and still unsafe, or it could be fully safe and not compliant.
• Team Effort: A high-performing organization needs a dedicated leader and excellent talent. If you’re teachable, there’s always hope. Also, even if you can’t hire perfectly, you can fire perfectly.
• The culture of quality management can be considered a partnership or the police. Create a process, not a problem for people to conduct reviews.
• Instill quality and get people to say ‘yes’ by creating and crafting a culture-forward company for people to be ready for anything at any time.
• Dan wrote the book, 28 Days to Save the World, which details how Velentium partnered with a small medical device company and large vehicle manufacturer to increase emergency ventilator production.

“In our space, quality really, really aligns itself well with risk and safety.” 

“Quality - it really is driving your organization towards perfection. That doesn’t mean perfect people. That doesn’t exist. We’re all fallible. But how have I created the processes, the thinking, and ultimately, the culture that gives us the best shot at removing risk and creating devices that are not only ethical and helpful to people but safe for the long haul.”

“You could be fully compliant, and still unsafe. You could be fully safe, and not compliant, and so compliance obviously matters. You can’t go to market with non-compliant devices because you’ll get shut down, and you should be shut down.”

“The only rules in this company should be rules that are inspiring.”

Velentium

Dan Purvis on LinkedIn

28 Days to Save the World by Dan Purvis

Quality Is Free by Philip B. Crosby

ISO 13485 - Medical Devices

FDA

Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product that they can use and want to use, without sacrificing any elements that would otherwise exist in a clinical setting.

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Dylan Horvath, Founder, President, and Chief Product Officer at Cortex Design.

Dylan has a degree in Systems Design Engineering and founded Cortex Design to be a firm that fosters human connection, improves health outcomes, and allows people to do things that they couldn’t do before.

• Dylan describes design as a tool for understanding how people react and relate to technology. The design of those experiences should create empathy and fit in with a person’s lifestyle and their experience.
• When people bring home and use a new medical device or product, it should not be a completely foreign object. There should be familiarity with it already because it has features that exist in the person’s cultural landscape.
• When developing new medical products, engineers and scientists use different human-led design activities to get something to fit in someone’s home design.
• When designing a product, it’s important for engineers and scientists to understand that they may not be the audience. Ultimately, they’re designing the product for those that are going to use the product.
• Objects tell people how to interact with them. Unexpected behaviors and accordances signify improvements to bad design. Even small changes early on in the design process can have a big impact on user experience.
• Adding risk management methodologies to a product design/development approach and decision-making process is to use economic, regulatory, and market constraints to accurately assume, define, and validate user needs.
• The role beauty plays in medical products and devices is subjective, but there is beauty in well-functioning devices. The thing that is beautiful is when something considers how it appears and how it lives with the people that have it.
• Design only works within the constraints in which both manufacturability and aesthetic perception are successful. You can’t get away with one or the other.

“Design is a tool for understanding how people react to a technology and how people relate with technology, and specifically the design of those experiences so that we can empathize and create products that fit in with a person’s lifestyle and fit in with their experience.”

“The challenge when developing medical products is the people and the skill sets and the activities that engineers and scientists typically go through to develop a new product can be very different from the types of activities that you go through to try and get something to fit in someone’s home.”

“People design their environments, unknowingly, to sort of fit with the image that they want to project about themselves.”

“When you’re designing a product, if you’re designing it for yourself, you can guarantee one sale.”

“I really got interested in medical systems because of the opportunity for improving lives. That’s our philosophy to this day.”

Dylan Horvath on LinkedIn

Cortex Design

FDA - Medical Device Overview

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.

• 00:01:20 – Introduction to Dr. Mike Drues and his accolades.
• 00:05:30 – Explanation of IRBs and their role in clinical trials.
• 00:15:10 – Differences between traditional and commercial IRBs.
• 00:22:40 – Discussion on significant vs. non-significant risk devices.
• 00:32:00 – Importance of pre-submission meetings with the FDA.
• 00:44:15 – Steps to take when an IRB disapproves your clinical trial.
• 01:00:30 – Practical tips for choosing the right IRB for your study.

• "Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues
• "You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues
• "The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike Drues

1. Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.
2. Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.
3. Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.

1. IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.
2. Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.
3. Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.

1. How will the evolving landscape of MedTech regulations impact the approval process for new devices?
2. What role will real-world evidence play in future clinical trials for medical devices?
3. How can smaller companies navigate the complexities of FDA and IRB requirements effectively?

• Etienne Nichols on LinkedIn
• Mike Drues on LinkedIn
• Greenlight Guru can help with Clinical Investigations
• Good Clinical Practices (GCP) regulations for IRBs

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.

An Investigational Device...

How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations?

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner. 

• In the medical device industry, De Novo refers to something new and innovative.  When you have an idea that has not been done before and is not substantially equivalent, then the De Novo pathway may be the right choice.
• The De Novo process is not as commonly used as the 510(k) pathway. The rate of innovation compared to incrementals tends to not be as often.
• Rob describes the pros and cons of the De Novo pathway. Some people think it requires extra work and higher submission fees, but it’s an opportunity to work with the FDA to create and regulate a new product category that may be copied.
• The De Novo pathway takes longer to review than 510(k) submissions due to risk management activities. It’s worth it to be the first innovative leader in the field.
• Think, prepare, and plan for different scenarios and conflicting messages when choosing a pathway to avoid pitfalls, such as analysis paralysis.
• Don’t compromise core technology and features when making a product/device. Focus on quality without sacrificing compliance to improve quality of life.
• Work together and collaborate to understand the client’s needs and amount of key information to give to the FDA to provide meaningful and quality feedback. 

“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.”

“The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.”

“The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.”

“Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.”

“Don’t be afraid of the De Novo process. It’s actually a really great tool.”

FDA - De Novo Classification Request

FDA - Medical Device Overview

FDA - Q-Submission Program Guidance

FDA - 510(k) Submission

FDA - Premarket Approval (PMA)

FDA - Case for Quality

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. 

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGMPAC).

Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, audit preparation and remediation, due diligence, quality systems, and compliance.

• Why new clients work with Michelle: It’s easy to find a competent regulatory person, but how many are you going to enjoy working with and able to make you laugh when you really feel like crying?
• Even with the adoption of EU MDR, people are still in denial when it comes to those with certificates that expire in May 2024 and think they still have time to get certificates reissued.
• Several small companies, as well as large corporations, are choosing to not go to market or withdraw products in the EU because of the lack of value and revenue.
• The cost, clinical data, and limited number of notified bodies are some of the biggest challenges for those in the EU versus U.S. market.
• Companies should perform a market analysis to determine if their revenue model will support year-over-year costs and third-party fees to stay in the EU market.
• The impact to quality in the European healthcare system could turn the U.S. into a destination for medical tourism. It could happen if an analysis is not done by the government or competent authority.
• A quality management system (QMS) has to have an ISO 13485 certification in the EU. The U.S. doesn’t require a QMS until a product is put into commercialization and meets performances, standards, and expectations.
• According to Michelle, the five stages of regulatory grief are denial, anger, bargaining, depression, and acceptance.

“If you don’t have a relationship with a notified body yet, you’re already almost too late. You just can’t make any commitments to or marketing plans for the EU right now, in terms of timing.”

“The first thing is to do that market analysis, and then, if they decide that Europe is still  something that they want to do, second, you need to get in line with a notified body.”

“There’s no such thing as grandfathering underneath the EU.”

“There were 18,000 certificates issued under MDD, and only one percent of those have made it all the way through MDR.”

“To properly prepare technical documentation, it is truly a cross-functional effort and it’s going to require a lot of very in-depth expertise.”

Michelle Lott on LinkedIn

Regulatory + Quality Assurance (leanRAQA)

leanRAQA - Free Guides

RAQA Today Podcast

FDA - Device Good Manufacturing Practice Advisory Committee (DGMPAC)

European Union - Medical Device Regulation (EU MDR)

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Shawn Regan, CEO and Co-founder of Rhythmlink International, at the South Carolina Biosciences (SCBIO) Conference.

From startup to industry leader, Rhythmlink is a company that designs, manufactures, and distributes medical devices that physically connect patients to machines to elicit or record neurophysiologic information.  

Rhythmlink’s products are used during risky surgeries to help prevent or reduce paralysis, identify tumors, map the nervous system, and monitor brain waves. Its devices were the first of their kind to be cleared by the FDA to work specifically in MRIs.

• Shawn describes neurophysiology as electrodes put on or under a patient’s skin to monitor their nervous system in real-time to identify dangerous situations.
• As a startup, Rhythmlink recognized the need to change from reusable to disposable products. Although the company did not know when that was going to happen in the medical industry, they knew it would and why.
• Early on, Rhythmlink experienced several challenges as a medical device company. It didn’t have any money, patentable technology, or intellectual property (IP). Co-founders had an idea, figured out how to create it, and bootstrapped it. 
• Collaborating with the FDA 20 years ago was easy and straightforward. Rhythmlink wanted to know how to submit a 510(k) to get FDA clearance.
• Rhythmlink’s electrodes can be put on and left on during an imaging study to allow the brain to be monitored more often, which results in much better clinical information quicker and consistently to find and treat dangerous situations.
• Rhythmlink decided to automate some of its products because shipping rates changed, led to higher quality products, and customers liked the products better.
• Rhythmlink makes its products in China and sells its products in the United States, European Union (EU), and nine other countries.
• Cost-Benefit Analysis: Rhythmlink’s regulatory strategy is to identify all the different regulatory requirements for all the different countries the company wants to be in and make sure there is enough of a market to be worthwhile.

“If you remember the game operation when you touch the side and the nose buzzes and goes off, it really is a lot like that.” 

“With our electrodes, the ability to put the electrodes on once and keep them on and leave them on during an imaging study allows the brain to be monitored more often.” 

“You get much better clinical information quicker and consistently all the time. So, you’re able to find those dangerous situations and then treat them.” 

“For our products, not every country has made the switch from reusables to disposables. All of the products that we make are disposable products, none of them are reusable at this point.” 

RhythmLink

Shawn Regan Email

South Carolina Biosciences Organization (SCBio)

South Carolina Research Authority (SCRA)

FDA - Medical Device Overview

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become more frequent, severe, and impactful. 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, Director of Product Security at Velentium and author of Medical Device Cybersecurity for Engineers and Manufacturers.

Chris has more than 30 years of experience developing and securing medical devices for device manufacturers and collaborates with regulatory and standardization agencies to present, clarify, and systemize tools, techniques, and processes that enable the creation of secure medical devices.

• Although the FDA understands the importance of updating cybersecurity guidance, it should tie the documents to real standards from ISO and EU MDR, rather than only referencing consensus standards for global harmonization.
• To make secure medical devices, a standard cybersecurity requirement needs to be created for manufacturers to do it the same way based on research and tools.
• During the development portion of the product life cycle, manufacturers need to identify threats. However, if there is not a workable requirement and the developer does not know what to do or not do, then nothing is done but ignored.
• Manufacturers have to look for the vulnerabilities or end-root cause of all exploits and threats during development. Vulnerabilities occur during the design, implementation, and use of third-party software components.
• Software Bill of Materials (SBOMs) need to be readable and consumable. An asset management system needs to be built in to address risk mitigation.
• When buying medical devices, health delivery organizations (HDOs) want SBOMs, support, and other cybersecurity expectations included in contracts.
• Find out what you need to do to create secure medical devices. At the very least, look at it as a competitive advantage in the industry.

“I want something that’s workable, something that’s harmonized.” 

“What you have to look for are the vulnerabilities or the end-root cause of all exploits and threats.” 

“We want SBOMs. We want people to talk to. In case of a breach, we want some help.” 

“Take a look at what you need to do to be a good corporate citizen and create secure medical devices. At the very least, look at it as a competitive advantage in the industry.” 

Velentium

Medical Device Cybersecurity for Engineers and Manufacturers

FDA - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

FDA - Quality Management System Regulation (QMSR)

International Organization for Standardization (ISO)

European Union - Medical Device Regulation (EU MDR)

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting.

CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-efficient manner.

• CAI utilizes integrative services to identify clients’ needs to achieve operational readiness. Then, operational excellence is the end goal. 
• Most CAI agents are Project Management Professional (PMP) qualified through Project Management Institute (PMI). Patrick encourages and recommends people to attain PMP certification to enhance their degree of success.
• Patrick describes the steps of a solid project management process. It includes planning, integration, and execution.
• The earned value calculation is where every action item is shown a direct correlation to the amount of money spent. Basically, you are getting more or equal to what you paid.
• If a small company with 2-5 employees is not ready to use or formalize a project management process, Patrick advises people to invest in education and training. 
• The project manager is a hub of communication. Always keep everything accurate to create a sense of security for having everything that will be needed. 

“Everybody strives for operational excellence, but yes, a strong package with operational readiness is the key.”

“In a project, especially with startups, I’d say there’s no such thing as over communicating.”

“Anything in the medical device industry directly affects, correlates, and supports the public. It’s a huge market and it’s a very important market.”

“Never make any shortcuts to your quality.”

Patrick Hayes on LinkedIn

CAI

South Carolina Bio Conference (SCBio)

FDA - Medical Device Overview

Project Management Institute (PMI)

PMP Certification

PMI - Roles, Responsibilities, and Resources (Responsible, Accountable, Consulted, and Informed - RACI Chart)

Earned Value Calculation

LinkedIn Learning

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices⁠—not shortcuts⁠—to bridge the gap between medical devices and clinical data.

SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software generates, collects, and manages data used in clinical studies.

• EDC is a newer concept or discipline for the medical device industry. Compared to the pharmaceutical space, automation from the clinical trial perspective has been a bit slower because of smaller sample sizes.
• Post-market surveillance activities are driven by EU MDR. In Europe, medical device companies are now being forced to prove to the world that their device continues to be effective against its peers and new products getting to market.
• Pre- and post-market data is to get medical devices to market and continue to be adopted, reliable, effective, and not discontinued due to new products.
• Another type of data that SMART-TRIAL can capture is related to payors. Does your product show an economic benefit to get reimbursed? 
• It’s difficult to get feedback from those in the field, during tests, and clinical trials. If something’s not working, expect more feedback. If it’s working, you get less.
• EU MDR has had two significant impacts: the number of notified bodies is still not where it needs to be and it has created rationalization of product SKUs.
• Decentralization or remote patient care can change data results in clinical trials by using medical devices and technology to work more efficiently. For example, what’s the difference between medical device vs. health/lifestyle product data?
• Rules are slightly different when developing algorithms and software for medical devices. They’re not written that differently and updated standards are not typically complete overhauls.

“The device industry in terms of automating from a clinical trial perspective has been a little bit slower than the pharma side of things. One of the reasons is we have much smaller sample sizes.”

“Technology has gotten to the point now where we can do it efficiently and inexpensively at the same time.”

“What’s really happening in Europe now is that you’re being forced to prove to the world that your device continues to be effective against its peers and against other products that are coming out on the market as new products.” 

“There’s a good reason for regulation. There’s a good reason why we changed the regulations in Europe. We’ve got to have these standards for everyone’s benefit.”

“When you’re developing algorithms, when you’re developing software for medical devices, the rules are slightly different and they’re not written that differently.”

SMART-TRIAL

Adam Steadman on LinkedIn

ISO 14155:2020

ISO 20916:2019

European Union Medical Device Regulation (EU MDR)

FDA - Medical Device Overview

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved by FDA. Any medical device company considering MDSAP should be familiar with what the program is and is not.

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides quality management system (QMS) and regulatory affairs services.

Listen to Jon, Etienne, and Danny as they help to align expectations about the MDSAP journey so manufacturers can understand both how program works and how it should be leveraged from a regulatory strategy standpoint.

• The reaction to requiring MDSAP certification to access and sell medical devices in Canada created price increases and smaller companies were unable to justify changing the notified body or auditing organization.
• MDSAP provided opportunities and benefitted some distributors by getting and using technical files and documents provided by the original manufacturers.
• MDSAP satisfies the need for some countries, including the United States and Canada, but some companies in other countries think the approach takes too much time, money, and resources for a single audit.
• MDSAP involves assigned tasks, questions, and interpretations for seven processes during the single audit. For ISO 13485 certification, there is variability and jurisdictions are not always asked the same questions by all auditors.
• There should not be any surprises during an audit if companies conform to requirements outlined in regulatory resources, such as guidance documents, FAQs, procedures and forms.
• The FDA’s MDSAP model and approach should be an easy process, but it depends on your company and the level of maturity of your quality system.
• Easily find and retrieve tribal knowledge by capturing and organizing it in your company’s quality system in the event of an audit. 

“If you do want to sell into a country, especially Canada, you need to have an MDSAP certificate.” 

“It made things more expensive and it made the barriers for entry much higher.”

“What is the purpose of an audit? It’s to see if you conform to the requirements.” 

“It should be an easy process. It isn’t so easy because some companies’ systems are mature and they go through it quite easily and others are not. It depends on your company, it depends on the level of maturity of your quality system.” 

“A certain level of tribal knowledge is still there because you have the system.” 

FDA - Medical Device Single Audit Program (MDSAP)

FDA - MDSAP Audit Approach

FDA - MDSAP Audit Procedures and Forms

ISO 9001

ISO 13485:2016

European Union Medical Device Regulation (EU MDR)

Health Canada

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old.

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, ​CEO and President of MediView, about bringing augmented reality (AR) medical technology to market.

MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Previously, Mina worked at Medtronic, Abbott, Beckman Coulter, and Excelen.

Mina is a serial entrepreneur in the medtech and fintech spaces. He approaches his life with a foundation of trust, team, transparency, and track record to encourage collaboration and innovation focused on advancing people’s everyday lives. 

• MediView solved the problem of how to place a 3-D representation of a patient’s specific anatomy underneath the skin to millimeter accuracy.
• MediView’s solution enables opportunities for digital health care for minimally invasive procedural guidance and data analytics.
• MediView’s imaging technology and data feed its platform through a pre-operative or intraoperative scan, such as a CT or MRI, taken of the patient.
• The scan is communicated to a headset and an algorithm combines/lines up digital AR and physical coordinates to create a 3-D reconstruction that’s put directly into and onto the patient.
• In the U.S., between physical therapy, loss of productivity, and time off, there’s $120-billion of economic impact due to ergonomic injury of medical imaging.
• The first therapeutic area and clinical unmet need MediView is targeting is liver and kidney cancer. Only 1 or 2 patients receive a minimally invasive procedure, while the others have to go through chemotherapy or resection.
• Mina describes the differences of virtual reality (VR) versus AR. VR puts you in a fully digital world, while AR superimposes digital content onto the physical world.
• MediView’s work culture materializes into the company’s business strategy and model across four functions—trust, transparency, team, and track record. 

“We are hardware agnostic. So, we don’t depend, actually, on any one specific headset because of the unique algorithms that we built in.”

“We have an algorithm that combines the digital world in AR with the physical world.”

“The interventionists are not comfortable taking a needle, sticking it into the abdomen, trying to hit a grape inside of a watermelon blindly to get that tumor ablated.”

“We give clinicians imaging modalities they trust and are comfortable with today to validate the new way we’re providing them to practice and exercise medicine.”

“If a company’s exit strategy is acquisition, having a robust QMS that someone can look at effectively, efficiently, and simply…that has a mental impact, an emotional impact, a burden impact."

Mina Fahim on LinkedIn

MediView

Medtronic

Mark Griswold

FDA - Medical Device Overview

Code of Federal Regulations (CFR)

What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? 

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.

Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you don’t have the information needed to support questions. 

• Informational meetings are valuable and important for helping medical device professionals and manufacturers build a relationship with the FDA.
• Informational meetings tend to focus on the early stages of a specific product, technology, or suite of products.
• Being prepared for informational meetings is beneficial. Rehearse ahead of time and identify pain points according to the FDA.
• During the informational meeting, pay close attention to what questions the FDA asks as well as address its feedback and suggestions.
• Some companies do not have or make time and resources available for anything not required, such as informational meetings. However, time and money can be saved in the future by addressing FDA concerns/issues.
• The FDA is more inclined to attend informational meetings than other meetings because they like learning about new products and technologies.

“With FDA, the relationship building from informational meetings is a huge component, and anything relational done with FDA is valuable and important.” 

“It’s never too early for a pre-sub, but sometimes it is if you don’t actually have the information that you need to support the questions that you’re asking.”

“To find them valuable, you need to conduct them in a way that creates the value.”

“They like to attend informational meetings because we’re not really asking anything of them and they just get to be nerds again and geek out over the technology.”

“If you have a complex product, I would plan to do an informational meeting before pre-subs, just to talk about the product and get FDA to understand it foundationally.”

FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Isabella Schmitt

Isabella Schmitt on LinkedIn

Proxima CRO

M1 MedTech

Inventing Tomorrow Podcast

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing?

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box.

Mark has more than 30 years of experience in the medical device industry and takes organizations to the next level of quality system, product development, and operational excellence. His vision, experience, and hands-on leadership drive best practices in quality system processes and project management.

• The FDA and ISO quality system requirements include design controls, which have a direct correlation to BOMs.
• The Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are parts associated with design controls. Mark explains the difference between the three to build a product.
• For BOMs, there needs to be one source of the truth and everything else needs to match it. A master document needs to be defined, then other files and records copy and configure the same data.
• Based on configuration management, BOMs should include several components, such as a unique identifier/part number, description of part, quantity, unit of measure, operations step, assemblies, and reference designators.
• When building a BOM, define attributes or metadata that accommodate manufacturing and design points of view to avoid confusion.
• Design a flexible system. If you design for flexibility, then you’ll never have to worry about changing your quality system because it can’t handle a new product.
• Determine the rules of interchangeability. As products change, remember to change the part number and update the version on the BOM.
• Who owns the BOM? The medical device manufacturer owns the BOM because they are the approver and own the DMR and DHF.

“The Bill of Materials, you can also grow it to be a Bill of Documents and a Bill of Operations. All that is sort of what’s required to build a product.”

“That’s why there’s multiple documents today. The manufacturing people want to see it this way. The design people want to see it this way. They’re not talking to each other.” 

“If you design for flexibility, then you’re never going to have to worry about, ‘Oh, I ve got to change my quality system because I got this new product because my quality system can’t handle it.’” 

“Every digit in the part number means something.” 

FDA - Quality System (QS) Regulation

ISO - Quality Management Systems Requirement

Mark Rutkiewicz on LinkedIn

Mark Rutkiewicz on Twitter

Innovize

Consiliso LLC

Medical Device Company In A Box: The Case For...

In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals.

Key Timestamps:

• [02:15] - Introduction and Etienne’s journey to becoming a podcast host
• [12:30] - The importance of vulnerability and honesty in product development
• [22:45] - Balancing quality for audits versus operational benefits
• [30:10] - Human factors and usability in MedTech product development
• [37:55] - Simplifying quality management systems
• [45:00] - The mantra of learn, lead, and love in networking
• [54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulations

Quotes:

1. "The heart of the problem is the seed of the solution."
2. "Quality management documents should benefit your company first and be audit-ready second."
3. "Be genuinely curious. Assume the person in front of you knows something worth listening to."

Takeaways:

Key Insights on the Latest MedTech Trends:

1. Human factors and usability are often misunderstood but crucial in MedTech product development.
2. Quality management systems should be practical and beneficial for the company, not just for audits.
3. Networking is more than collecting business cards; it's about building meaningful connections.

Practical Tips for MedTech Professionals:

1. Be vulnerable and honest about the state of your projects.
2. Focus on solving the right problems and avoid over-engineering.
3. Create quality management documents that are easy to understand and useful for your team.

Questions Predicting Future Developments:

1. How will AI and machine learning shape the future of MedTech product development?
2. What emerging trends in usability and human factors will impact regulatory changes?
3. How can MedTech companies better prepare for cybersecurity challenges?

References:

• Greenlight Guru - Quality management software for medical devices.
• Etienne Nichols - LinkedIn
• Devon Campbell - LinkedIn
• Prodct LLC - Devon's advisory firm
• Fred Crosby’s Quality is Free - A book on quality management principles.

Beginner's Section: MedTech 101

• Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality.
• Human Factors and Usability: The study of how people interact with products to improve design and user experience.
• Regulatory Strategy: The plan for complying with regulations to bring a medical device to market.

Questions for the Audience:

• Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.

• The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.
• How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made or are they a waste of time and money? Good regulation is agnostic of time and technology.
• Government bodies in different parts of the world want to protect their citizens. Will there ever be global harmonization for quality? Are the most important principles of quality a function of geography? No, quality is quality.
• The timeline to transition is one year, but companies and inspectors may need or want more time due to a limited number of resources and notified bodies.
• If a company does what it should do for the safety and efficacy of medical devices, it should really be a tiny or no leap at all to make changes. The only changes are in the paperwork and forms.
• Medical device professionals should know about ISO 13485. If they do not know about this standard, whether it is required or not, that could be a problem.
• For those adhering to ISO 13485, if there are new requirements that make sense from a biology and engineering perspective, that’s the way to do something.

“They are not going to adopt ISO or any other standards across the board. They’ll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues

“When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues

“Good regulation is timeless.” George Zack

“While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George Zack

ANSI/AAMI/ISO 13485:2016 Handbook

NIST's "ABC's of Conformity Assessment"

International Medical Device Regulators Forum (IMDRF)

ISO 13485:2016

21 CFR Part 820 - Quality System Regulation

FDA - Design Control Guidance for Medical Device Manufacturers

FDA - Case for Quality Program

When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership.

• At a university, Stephanie describes the process that professors and students follow when they have an idea. Before they publish it, if they think they have something novel and meets the definition for a patent, they file a disclosure.
• In the private sector, Kevin describes the publishing, patent, and funding process as being very different. To patent a trade secret, it must be incredibly robust and support a very valuable program. Funding for commercial entities or for-profit companies does not include grant monies.
• On the university side, there is no equivalent to a trade secret but the know-how  in the quest to do research and common sense in licensing agreements. There’s no protection for know-how and only royalties are paid related to patents and in countries where patents are enforced.
• Roles associated with an IP differ depending on the school and its policies and licensing terms. Restrictive conditions are put on IP and licenses because they know they will be negotiated, applied, and sold. 

“Do we keep this trade secret or do we patent it? If we’re going to patent it, this better be incredibly robust and it better support some commercial embodiment, some very valuable program. Otherwise, there is no publication.” Kevin Buckley

“Some companies do not want their secret sauce—how they’re making a drug, what the drug is—eventually, drugs will be disclosed and basically hidden in a patent application until they go into clinical trials. When the drug is published.” Kevin Buckley

“If all you have is trade secrets and you don’t have any patents, you’re not going to be seen as valuable.” Neil Thompson

“There’s a big difference between inventorship and ownership.” Kevin Buckley

“It’s a lot different if you make something in your garage or if you spend five years making it in your research lab.” Stephanie Willerth

Patent Cooperation Treaty (PCT)

Creative Destruction Lab (CDL)

Stephanie Willerth on LinkedIn

Neil Thompson

Kevin Buckley

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool to guide development, allowing you to improve your products by turning risk into a value-add type of activity.

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Shannon Hoste, President of Agilis Consulting Group and former lead for the FDA’s Human Factors Team.

Shannon explains her philosophy and approach on how the pieces of human factors, risk management, and product development come together. It’s all about user-related risks and making the right design decisions early on during product development.

• Human factors is a risk management activity that the FDA and International Organization for Standardization (ISO) requests. It’s all about use-related risk.
• Risk management helps make design decisions around safety and efficacy, and human factors provide a focused view on user- and use-related risks.
• The main contributor that companies come across are deficiencies and questions regarding the human factors process, including the use-related risk assessment.
• Probability and occurrence is challenging for most people. To understand product risk, understand risk is probability and disparity. To know what’s driving human factors, understand what could lead to high-disparity harm or kill someone.
• Based on user needs and human behavior, risk management helps companies understand users, how they interact with your product, and what can go wrong.
• Step-by-step process of risk assessment is to identify all tasks, identify what can go wrong, stay focused to build information, and then identify solutions.
• Product development engineers want their product to be safe and work. Embrace human factors to improve that as a likelihood. Do not resist it.

“Human factors at its core, at least the regulatory aspect of human factors, is a risk management activity. It’s all about use-related risk.”

“All of it is a tool to guide development.”

“I need to look at anything that could lead to high-disparity harm, regardless of if it doesn’t happen that often, if it’s going to kill someone, then I want to understand it.”

“Engineers really like to solve problems. We’re going to jump in and look for solutions, and I think that the human factors, the user needs work, as well, is all about understanding the problem and not solving it.”

Shannon Hoste on LinkedIn

Agilis Consulting Group

Pathway for Patient Health

FDA - Medical Devices

FDA - Human Factors Considerations

FDA - Human Factors and Medical Devices

ISO 62366 - Medical Devices — Part 1: Application of usability engineering to medical devices

The Greenlight Guru True Quality Virtual Summit

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement.

In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach!

Jon and Mike share tips on what you can do to improve upon your medical device company’s quality philosophy to ensure that true quality becomes a part of your company’s culture.

• Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.
• If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.
• In the regulatory and FDA space, quality is not about good or bad, but about consistency. A company can make a consistently good or bad product.
• The difference between product and process quality depends on understanding acceptance criteria, levels, and specifications involved that need to be followed.
• Not whom but what is ultimately responsible for quality? Consistency. Appreciate what the word ‘quality’ means and whether what you’re doing is good or bad.
• Quality management systems (QMS) shouldn’t emphasize checking all boxes to be in compliance, but describe how business is done and how KPIs, objectives, and criteria are measured to demonstrate quality at process/product levels.

“The problem I have with that simple explanation is there’s subjectivity involved to that, right? What you think is good or bad, might be completely different to what I think is good or bad.” Jon Speer

“For quality to be meaningful, it’s something we have to define in as least subjective terms as we possibly can. We need to make it as objective as we can, but I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.” Jon Speer

“Quality is not about good or bad. Quality in the regulatory sense is about consistency.” Mike Drues

“From the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional.” Jon Speer

“You have culpability and responsibility for quality at some level. It sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality and influence the decisions that are made.” Jon Speer 

A Regulatory Gap Analysis of FDA's Systems & Policies

Ultimate Guide to 21 CFR Part 820

ISO 13485

FDA - Classify Your Medical Device

FDA - Premarket Notification 510(k)

FDA - De Novo...

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal eye movement? 

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Scott Anderson, Chief Clinical Officer (CCO) at SyncThink about the groundbreaking work the company is doing in advancing neurological assessments by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.

You’ll hear how Scott went from his position as Head of Sports Medicine program at Stanford University, where he was part of a multidisciplinary research collaborative studying the natural history of head injuries. Though the technology was initially developed to aid in concussion protocol and the clinical care of athletes with head injuries, the potential of EYE-SYNC technology is now used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.

• SyncThink specializes in neurological assessment by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.
• Besides concussions, EYE-SYNC technology is used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.
• Verbal or motor actions are the result of real-time brain function using the eyes to orient yourself to what’s happening and respond in real-time. Neurological deficits in performance occur across one’s lifespan due to disease or impairment.
• SyncThink’s EYE-SYNC technology has the potential to proactively prevent health problems in the future. It could facilitate the migration of hospital-based care to consumer-based driven care to preserve brain health. 
• If used as a surveillance or monitoring tool, EYE-SYNC can identify improvement in brain function based on medication deployment. It helps clinicians learn to better titrate medication to specific individuals, such as children with ADHD.
• Scott admits that he faced logistical challenges and obstacles when doing clinical trials to get the first FDA clearance for following concussion patients. 

“There’s a whole host of neurological disorders that have a high prevalence of abnormal eye movements associated with it.” 

“Your eyes actually serve as the window to the brain. It allows you to orient yourself to the things that are happening around you.” 

“Your brain uses your eyes to select content it wants to interact with.” 

“Our bread and butter is the software and analytics and the eye tracking measurement, and there’s a whole host of these cases for this.” 

“As technology evolves, too, as well, there will be, I think, several opportunities in order to accelerate the clinical utility of something like eye tracking for a whole host of neurological conditions.” 

Scott Anderson on LinkedIn

SyncThink

FDA - Medical Device Overview

FDA - 510(k) Clearances

Q-Collar

What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he wants to share with listeners of the show. 

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, founder of Consiliso LLC, and author of Medical Device Company In A Box.

As a contract manufacturer himself, Mark brings a wealth of knowledge and insight to his discussion with Jon and Etienne, helping listeners understand how to navigate the selection process for medical device contract manufacturers.

• Characteristics to consider when evaluating a contract manufacturer include cost, plant location, services provided, complexity of product, process validation, and available technology.
• Who’s doing what? Create a quality agreement because the overlap and what’s covered under the contract manufacturer’s and medical device company’s quality management system (QMS) should interact and intermix.
• There are four levels of risk and criticality when selecting suppliers for contract manufacturing: Zero (office supplies) to Level 3 - what you do is going to directly affect the patient experience.
• Some contract manufacturers have dedicated auditors to control information. MedAccred is an outsourced organization that conducts audits of medical devices and products.
• When outsourcing to contractor manufacturers, manual work may be cheaper, but automation provides consistent and better quality products.
• A master validation plan should set expectations of how to validate the product. Modify plan, release reports, and conduct risk assessment to make a product that meets a spec.
• Contract manufacturers need to communicate to share knowledge and understanding of what a medical device/product is used for as well as the scope and process controls.

“You can outsource all these different aspects and that’s all part of contract manufacturing.”

“The price of the part and what your volume is going to be is directly related.”

“What you do is going to directly affect the patient experience. If you mess up, they might die.”

“Contract manufacturers - we just take a little cut. We’re not making huge profits.”

Mark Rutkiewicz on LinkedIn

Mark Rutkiewicz on Twitter

Innovize

Consiliso LLC

Medical Device Company In A Box: The Case For Consiliso

How to Select a Contract Manufacturer for your Medical Device - White Paper

FDA - Device Registration and Listing

ISO Standards - Sterilization and Validation Services

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?

In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.

• Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.
• Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.
• The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.
• The biggest problem with 510(k) is predicate creep. There’s room for improvement because the 510(k) is the workhorse of the medical device industry.
• Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA. 
• Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device.
• "Change Creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.
• A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons. 

“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”

“As we all know, the 510(k) is the workhorse of the medical device industry.”

“I’m a huge advocate of communication with the FDA.”

“We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”

FDA - Corrective Action/Preventative Action (CAPA)

FDA - Overview of Device Regulation

FDA - Premarket Notification 510(k)

FDA - Premarket Approval (PMA)

FDA - General Wellness

FDA - Case for Quality

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?

In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.

• EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.
• The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.
• The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.
• Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don’t work? Both the regulatory and quality burden is higher for companies in the medical device industry.
• Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. 
• Don’t waste the FDA’s time. The EUA needs to be a part of a company’s overall regulatory strategy to determine how it fits into the bigger picture.

“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there’s things that you should be doing and frankly you should have already been doing them.” Jon Speer

 “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues

 “Basically, it’s a very, very special kind of pathway. It is not an approval. It is not a clearance. It’s an authorization.” Mike Drues

 “If you’re not building a plan, a strategy, and starting to execute that strategy, you’re going to be leaving the market with your products.” Jon Speer

FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Webinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?

The End of EUA Is Coming Soon

FDA - Medical Device...

Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.

TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.

• The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.
• According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.
• UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.
• The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking). 
• For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.
• A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.
• Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.
• The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.

“Every part that you use in the hospital room has a barcode on it.”

“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” 

“Nobody's really standardized." 

“You can scan it to make sure that you are using the right product with the right other products and with the right patient.” 

Mark Rutkiewicz on LinkedIn

Mark Rutkiewicz on Twitter

Innovize

Consiliso LLC

Medical Device Company In A Box: The Case For Consiliso

FDA - Unique Device Identification System (UDI System)

European Union Medical Device Regulation (EU MDR)

Medical Device Innovation Consortium (MDIC)

ISO 13485 - Medical Devices

Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that matters.

In this episode Jon is joined by Etienne Nichols, a medical device guru at Greenlight Guru and Jon’s new co-host of the Global Medical Device Podcast. This is a must-listen-to episode, offering details into this exciting news and other key thoughts and observations Jon and Etienne share about the medical device industry.

• Etienne is passionate about the medical device industry and decided to join Greenlight Guru to help make things better, such as documentation. 
• Guru Edge: Greenlight Guru is the only medical device system platform for the medical device industry built by actual medical device professionals.
• Greenlight Guru runs the gamut and covers everything from electrical and mechanical to packaging and production. There’s more medical device experience at Greenlight Guru than at most medical device companies.  
• In the future, Etienne predicts that data-driven decision making involving patients will be one of the biggest trends or themes in the medical device industry.
• Jon is anticipating the convergence or blending of technology with everyday devices (i.e., wellness wearables). The lines between what is and is not a medical device are blurry. 
• The COVID pandemic has created opportunities for innovation in healthcare. Wellness, telehealth, and home-use products have become more common and make patients more comfortable.
• Etienne has experienced highs and lows with the FDA in the past. Now, he appreciates and is thankful for FDA regulations as guardrails, not limitations, that are flexible and open to interpretation. 
• The FDA’s job is to protect and promote the health of U.S. citizens. It not only covers medical devices, but many other areas. It’s an awesome responsibility that encourages collaboration and communication.

“When I came to Greenlight Guru, part of what kind of led me here, was the desire for things to be better.” Etienne Nichols

“No one guru has all the answers on our team, self included." Jon Speer

“I’m excited about all the different ways the medical device industry is going to be improving our lives in the future.” Etienne Nichols

“The more data that can be behind a decision, I love that.” Etienne Nichols

Meet a Guru: Etienne Nichols

Etienne Nichols on LinkedIn

21 CFR Part 820

FDA - Medical Devices

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories...

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates.

The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.

• [00:00:15] - Introduction by Etienne Nichols.
• [00:01:30] - Howard Root's background and the origins of Vascular Solutions.
• [00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.
• [00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.
• [00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.
• [00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.
• [01:10:00] - Closing remarks and takeaways.

• Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It’s why you drive 55 in a 60 zone."
• Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."

Latest MedTech Trends:

1. Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.
2. Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.
3. The role of ethical practices in sustaining innovation within the MedTech industry.

Practical Tips for MedTech Professionals:

1. Ensure thorough understanding and compliance with FDA guidelines and local regulations.
2. Implement robust training and compliance programs for all staff, particularly in sales and marketing.
3. Engage experienced legal counsel to navigate complex regulatory landscapes.

Future Predictions in MedTech:

1. Enhanced regulatory frameworks to better define and manage off-label use.
2. Greater use of AI and data analytics to monitor compliance and ethical practices.
3. Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.

• Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List"
• Mark DuVal on LinkedIn
• DuVal & Associates Client Alerts
• FDA guidelines on off-label promotions

Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary.

In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI).

• AR is a relatively new technology that some people don’t quite understand how it is or can be used in healthcare today and in the future. It’s important for people to try Magic Leap’s AR device and platform to expand their thinking of use cases.
• AR is not the same as VR and other technologies. VR is completely immersive and involves wearing a headset. You can’t see the real world. All you’re seeing is digital content. VR has advantages and limitations.
• Magic Leap’s AR headset device allows users to not only see the real world, but digital content can be overlayed on top of the real world while maintaining spatial awareness and sensibility.
• Magic Leap isn’t just about AR, but the convergence of other elements and capabilities, such as AI, 5G, and Internet of Things (IoT). AR is going to be the catalyst that generates additional new sources of data not currently captured.
• AR is not replacing healthcare providers, doctors, nurses, and others. It augments the clinical workforce to present/provide insights that advance and enhance the practice and expertise of medicine when delivering care.

“There are places where the differences between those technologies is actually really important in terms of deciding which one you would use for a certain use case.”

“What we’re doing isn’t really just about AR. It is this convergence of these other capabilities.”

“Augmented reality is also going to be the catalyst to generate additional new sources of data that we don’t currently have.”

Jennifer Esposito on LinkedIn

Magic Leap: Augmented reality platform for Enterprise

Medical Device Innovation Consortium (MDIC)

FDA - Medical Devices

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.

The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. 

• According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”
• As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.
• There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.
• For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies’ products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.
• According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.
• FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.
• Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.
• Regulated or not, usability testing is a must. What if your software tells patients they don’t have a problem, but actually do, and wait to take care of it? 

“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”

“Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.”

“FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.”

 “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”

Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021)

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

CDRH Guidance: Clinical Decision Support Software (September 2019)

FDA - Medical Devices

Software as a Medical Device (SaMD)

Combination Products Webinar

Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.

In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.

Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.

• Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.
• Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by doing their work correctly.
• Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. They should not have to overcome barriers and adapt to the device. It should be easy to use, safe, and supportive.
• Determine if you are on track when developing a product by conducting formative evaluations of tasks that need to be done and how they should be done.
• When done with development, a summative evaluation shows the use of a medical device does not come with any unacceptable risks. It offers proof of use.
• Opportunities for Improvement: Some mistakes that Michaela has observed include not meeting or listening to users, starting too late, and not conducting formative before summative evaluations for feedback. 

“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.”

“You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.”

“Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.”

“See usability as something that you have to do constantly. It’s not a one-time activity that you do.”

Michaela Kauer-Franz

Custom Medical

Greenlight Guru Academy

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru