Explore every episode of the podcast Mastering Medical Device
| Title | Pub. Date | Duration | |
|---|---|---|---|
| Defining and Managing Your Brand in a Complex Marketplace featuring Howie Chan | 20 Aug 2024 | 00:59:59 | |
In this episode, we dive into the essentials of branding with expert Howie Chan, founder of Healthy Brand Consulting. The discussion covers the critical role of understanding and managing one's brand, both for companies and individuals. Howie shares insights from his journey from biomedical engineering to branding, offers practical advice for building and differentiating a brand, and highlights the importance of company values and leadership in navigating external events. Whether you're responsible for your company's brand or interested in personal branding, this episode provides valuable lessons on aligning brand strategy with business goals and values.
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| How to Build and Manage a Powerful Advisory Board featuring Paul Hickey | 16 Jul 2024 | 00:52:14 | |
In this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and managing advisory boards, emphasizing the importance of team involvement and maintaining high-quality standards. Paul shares his extensive career journey across different companies, detailing how advisory boards have provided key insights and contributed to successful product innovations. The episode also explores the fight against obesity and how ReShape is working to deliver effective solutions. Key takeaways include the strategic formation of advisory boards, the need for cross-functional collaboration, and the pursuit of unarticulated customer needs for innovation.
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| What You Need to Know About the New Cybersecurity Regulations for Medical Device with Milton Yarberry | 14 Nov 2023 | 00:49:16 | |
Milton Yarberry is Director of Project Management at Integrated Computer Solutions. Milton has developed or managed software development for Motorola, Lucent, Cognex, Inktomi, and FEI, before moving into the medical software sector in 2006 with Foliage, Ivenix and now ICS. In this episode he shares about the Protecting and Transforming Cyber Health Care, or Patch Act, which FDA implemented in October 2023, including what software is impacted, the key take-aways from this regulation, if this effects legacy devices, and how medical device companies will be impacted.
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| Inside Advanced Heart Failure with Dr. Jessica Brown | 18 Jan 2021 | 00:53:33 | |
Dr. Jessica Brown shares insights into her practice as a Cardiologist, specializing in Advanced Heart Failure and Transplant Cardiology. The conversation includes a description of advanced heart failure, devices used, how referrals work, how reimbursement does or does not impact patient management decisions, and physician compensation. Additionally, she shares how she obtains information on medical devices, what sales reps do right and wrong, what works best on the floor of a medical device congress and more. Connect with Mastering Medical Device:
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| How to Work With a Visionary Physician with Dr. Alejandro Berenstein | 18 Jan 2021 | 00:52:08 | |
Dr. Alejandro Berenstein is a visionary physician who helped develop a whole new field of medicine - interventional neuroradiology or endo-vascular surgery. In this episode Dr. Berenstein discusses how he became interested in medicine and what prompted him to transform radiology from a diagnostic to a therapeutic specialty. After initially developing his own devices, he established great relationships with industry to jointly develop tools that would allow a growing number of clinicians to treat patients with neurological issues. He also shares valuable tips for companies and representatives on the best ways to work with visionary physicians. Connect with Mastering Medical Device:
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| Mastering Medical Device Intro Trailer | 10 Jan 2021 | 00:06:08 | |
This episode introduces you to the Mastering Medical Device Podcast and explains how it will help you become more effective in your current role, and put your career on the fast-track. The host, Pat Kothe, shares how the podcast is structured and some of the topics to be covered, along with his background. Welcome to Mastering Medical Device! Connect with Mastering Medical Device:
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| Transitions - From Sales Leader to CEO, From COVID Ventilator to Full-Featured Product with Rich Walsh | 07 Nov 2023 | 00:56:10 | |
Rich Walsh is CEO of Corvent, a company that is focused on providing solutions in the ventilator market. Rich has a long history in sales and sales management, and has transitioned from sales to become a first-time CEO. At the same time, Rich and the team are transitioning from providing a ventilator for COVID, to a full-featured product. In this episode Rich shares about the foundation of his career and the importance of discipline, openness and leader engagement, how direct feedback can make or break a career, locating a company in a non-traditional city and state, building an internship program that benefits the company and interns, and leadership lessons learned from legends in our industry.
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| Persevering and Pivoting - The Entrepreneur's Companions with Joe Landolina | 24 Oct 2023 | 00:58:44 | |
Joe Landolina is CEO of Cresilon, a company that has developed a technology and product intended to stop bleeding quickly and reliably. In this episode Joe shares how he began his journey at age 17, how a short project has turned into more than a decade of hard work, the impact pivots made on his team and investors, why open communication is best for the team and the well-being of the founder, and the importance of doing things the right way - even if it means delays and more investment.
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| Solidly Starting Your Medical Device Career with Jordan Griffin | 10 Oct 2023 | 00:48:13 | |
Jordan Griffin is a Field Clinical Specialist at Boston Scientific. Jordan’s no stranger to the medical device field, as her dad owns a distributorship focused on spinal implants. In this episode she shares what it was like to be a daughter of a busy, successful surgical distributor, product and sales education and how it differs in direct and distributor companies, managing a rural territory, how a clinical specialist differs from a sales rep, and what it’s like to interview and break into a large company.
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| How a Non-Medical Serial Entrepreneur is Shaking Up In Vitro Fertilization with Marty Gauvin | 03 Oct 2023 | 00:54:10 | |
Marty Gauvin is CEO of Fertilis, a company focused on helping prospective parents have a better experience with in-vitro fertilization. Marty is a serial entrepreneur and Fertilis is his first in medical device. In this episode Marty shares his views on entrepreneurship, where ideas come from, the differences and similarities between industries, what we can learn from outside medical device, and how the Fertilis products are aiming to increase the chance of people becoming parents.
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| Why You Should Implement a Direct to Consumer Strategy and How You Can Help Patients with Zach Champeau | 26 Sep 2023 | 00:59:38 | |
Zach Champeau is Sr. Director of Operations at Saleytics, an inside sales organization that has a program focused on DTC strategy. In this episode he shares the objectives companies have with DTC, where DTC activities have the most influence, types of programs that can help with lead generation, the main reasons why patients who need care drop out before receiving it, and how to measure the success of your program.
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| How a New Autonomous Robot May Help Solve a Patient Access Problem with Johannes Schaeferhoff | 19 Sep 2023 | 00:54:42 | |
Johannes Schaeferhoff is CEO of ROPCA, a company focused on an autonomous robotic solution to aid in the diagnosis and monitoring of Rheumatoid Arthritis. In this episode, Johannes shares some of the cultural differences in the countries he has lived in and what he learned, trends in medicine that led their team to develop their innovative solution, how efficiency in medicine can be as important as efficacy, and how the ROPCA system may help solve issues with patient access and the timely and accurate diagnosis and monitoring of patients with Rheumatoid Arthritis.
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| How to Expand and Effectively Sell in International Markets with Zach Selch | 05 Sep 2023 | 00:50:53 | |
Zach Selch is CEO of Global Sales Mentor, and has decades of experience selling medical products in over 135 countries. He has authored books on international sales and has some great free resources that you can access from his website. In this episode he shares why you should consider international sales, whether direct or a distributor model is preferred, key buying influences in different countries, setting up a distributor for success, contract considerations, and managing a distributor sales process.
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| Career Pivot - From Clinical Cardiology to CMO of a Startup Focused on Hypertension with Jay Shah, MD | 22 Aug 2023 | 00:59:07 | |
Dr. Jay Shah is Chief Medical Officer at Aktii, where they are developing technology focused on identifying and monitoring hypertension. Dr. Shah is a practicing Cardiologist who pivoted his career from strictly patent care, to becoming the CMO of a start-up. In this episode he shares his thoughts on career pivots, how he researched options that were the right fit for him, what it is like to be a CMO in a start-up, what hypertension is and the difficulty of diagnosis, and how wearables can change the way hypertension is managed.
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| Winning the Complex Medical Device Sale - How to Train Your Team to Act Strategically with Steve Gielda | 08 Aug 2023 | 01:12:55 | |
Steve Gielda is President and Co-founder of Ignite Selling, a global sales training, simulation and consulting organization. He’s co-authored two books – Ignite Your Sales Strategy: A Field Guide to Accelerating Your Pipeline, and Premeditated Selling: Tools for Developing the Right Strategy for Every Opportunity. In this episode we discuss the changing medical device environment, why strategic planning is vital in today’s environment, what a sales simulation is and how it clarifies strategy and aligns your internal resources, tips for managers to make them more effective with their reps, and considerations in hiring your sales team.
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| Commercializing a Disruptive Technology in a Hospital with Multiple Decision Makers and Influencers - Featuring Joe Steele | 07 May 2024 | 01:00:54 | |
Joe Steele is Head of Commercialization at Hemosonics, where they are providing point-of-care solutions to help clinicians make more informed decisions on blood product usage. In this episode Joe shares why moving up the ladder too fast may not be the best way to go, why experiencing failure will help in the long-run, how to use wisdom from past experiences and apply it to new situations, the challenges of hiring, training and managing a group of hard-charging people, getting into the C suite, and how Hemosonics is helping doctors make blood product usage decisions quicker and better.
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| All Plastics Are Not Equal - Choosing the Right One For Your Device with Lucas Pianegonda | 25 Jul 2023 | 00:56:07 | |
Lucas Piandegonda is Managing Director of Gradical, which provides specialized expertise to companies that need help with plastic evaluation, material compliance and testing, and training. In this episode he shares the challenge and opportunity of becoming a consultant, considerations in choosing a plastic, how additives and manufacturing processes changes plastics, the importance of supplier choice and management, and options for making our devices more sustainable.
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| How to Expand a Market Using a Direct to Consumer Strategy with Kevin Hardage | 11 Jul 2023 | 00:53:44 | |
Kevin Hardage is President and General Manager at Teleflex Interventional Urology. They’re treating a common problem males face as we age - Benign Prostatic Hyperplasia, or BPH. Their minimally invasive treatment provides relief for patients, and an effective way for physicians to better treat the disease. In this Episode Kevin shares the issues with BPH, educating physicians who use the product, direct to consumer marketing, metrics and objectives within DTC, how to involve referring physicians, and team development.
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| Changing to Customer-Centric Design While Develping a Major New Product with Rich Wintersteller | 27 Jun 2023 | 00:58:00 | |
Rich Wintersteller is VP Global Sales and Marketing Cardiopulmonary at LivaNova. In this episode Rich shares why market leaders need to change their approach to product design, how LivaNova moved to embrace customer-centric design, the benefits to this approach, why software and interoperability are keys in their new product, how to manage change, and how LivaNova’s new technology is helping perfusionists deliver better patient care.
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| How an Enabling Technology Can Unlock Product Performance with Tim Sullivan | 13 Jun 2023 | 00:55:40 | |
Tim Sullivan is CEO of Zeteo Biomedical, a company dedicated to providing drug and biologic delivery systems. In this episode Tim shares how an enabling technology effects the efficacy of treatment, understanding each stakeholders needs, a systematic approach for gathering stakeholder input, working with pharma companies on combination products, and the future of vaccine administration.
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| Moving a Technology Out of a University and Into a Company with Chris Idelson | 30 May 2023 | 00:53:31 | |
Chris Idelson is Co-Founder and Chief Technology Officer at ClearCam, a company dedicated to developing technology to improve surgeons visual field during minimally invasive procedures. In this episode we discuss what a Mechanical Engineering Ph.D. program is like, the importance of hands-on education, how the NSF I-Corps program has informed his view on product development, IP development and ownership in a University, how ClearCam is helping to solve a common problem with laparoscopes, and what universities can do to better educate aspiring medical device developers.
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| How a Clear Vision Clarifies Product Portfolio Strategy and Team Development with Brady Shirley | 16 May 2023 | 01:01:57 | |
Brady Shirley is President and Chief Operating Officer of Enovis, an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. The Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. In this episode Brady shares the history of the company, how they are leveraging market leadership in one segment into a broader vision, why they decided to rebrand, the importance of divesting and acquiring companies and technologies to align with vision, how outcomes are a key driver in their strategy, and why team development is key to their growth and future.
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| How to Promote Your Product and Company When You're Challenging the Big Dogs with John Gumas | 02 May 2023 | 01:04:06 | |
John Gumas is the Founder and CEO of Gumas Advertising, a full service advertising agency based in San Francisco. John is recognized as one of the country’s foremost authorities on Challenger Brand Marketing®. He is the author of the popular books “Marketing Smart” and “Challenger Brand Marketing”. In this episode John shares how the medical device market is the same and different than other markets, selling without selling, positioning to be a go-to, trusted resource, the importance of messaging, interviewing your external and internal customers to develop your messaging, common promotional mistakes, and the Challenger Brand Marketing approach.
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| Accelerate Your Success by Engaging with the Right Consultant with Dean Gray | 18 Apr 2023 | 01:06:54 | |
Dean Gray is a Partner at PA Consulting, a company with over 4,000 employees that operates globally, and helps companies in several industries become more effective. Dean also has has significant experience within industry at Pfizer, BD, Boston Scientific, Sanofi Genzyme, and Heidelberg Engineering. In this episode he shares how consulting is utilized, what a good or bad engagement looks like, best practices for consultants and what you should expect, how to begin a project correctly, the importance of building relationships and how you can be a good partner. Connect with Mastering Medical Device:
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| Prioritizing Complex Markets, Products, Regulations and Reimbursement with Karen Zaderej | 04 Apr 2023 | 01:06:10 | |
Karen Zaderej is CEO of Axogen, where they provide technology solutions to help restore feeling and functionality to damaged peripheral nerves. After a 17-year career at the Ethicon Division of Johnson and Johnson, Karen took on the challenge of a start-up, and has built a successful company that is delivering much-needed solutions to clinicians and patients. In this episode she shares what nerve repair is, why it is important to bodily function and the quality of life of patients, why regulatory excellence is one of their key strategies, building a successful career, and the unique way they funded their company. Connect with Mastering Medical Device:
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| Applying a Consumer Market Mindset to Medical Device with Scott Nelson | 21 Mar 2023 | 00:59:57 | |
Scott Nelson is Co-Founder and CEO of FastWave Medical. He is also the host of the Medsider Podcast, as well as the Founding Partner and Managing Director of Big Sky Biomedical, a leading medtech accelerator. Scott is a medical device veteran, and has held leadership roles at Medtronic, Covidien, Boston Scientific, C.R. Bard and ConMed. He also co-founded Joovv, a popular health and wellness brand. His unique background moving from traditional medical device to the consumer market and back again, opened his eyes to challenge some of his old mindsets. In this episode he shares what he learned at big companies, the differences in working in start-ups and how he applied his big-company experience, speed of iteration in the consumer space, the key drivers in evaluating early product ideas, and the importance of curiosity and developing your own learning plan. Connect with Mastering Medical Device:
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| Open or Closed Robotic Systems – Are We at a Crossroads? Featuring Stuart Simpson | 30 Apr 2024 | 01:04:38 | |
Stuart Simpson is CEO of Think Surgical. During his stellar 24-year career at Stryker he led an orthopedic industry transformation that established surgical robotic joint replacement as a standard of care, beginning with the acquisition of Mako Surgical in 2013. In this episode he shares his roots in medical device and how orthopedics became his passion, how competition is deeply imbedded in him, the challenges surgeons and hospitals face with the proliferation of robotics in the OR, how Think Surgical is trying to solve clinical, logistical and monetary issues, and his thoughts on how you can become a stronger leader.
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| Training with Virtual Reality – Accelerating Confidence, Competence and Experience with Richard Vincent | 07 Mar 2023 | 00:59:18 | |
Richard Vincent is CEO and Co-founder of FundamentalVR, a company that is focused on improving patient outcomes by revolutionizing medical training through virtual learning platforms. Richard is experienced in building international businesses and has a keen interest in seeking out opportunities to disrupt markets through development and adoption of new technology. In this episode Richard shares insights into past medical training methods, where they excel and the limitations of the different methods, what virtual training is and its benefits, the data supporting VR learning, what haptics are and why they matter, and how medical device companies can get involved. Connect with Mastering Medical Device:
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| Building a High Impact Customer Education Program with Lori Harada | 21 Feb 2023 | 00:53:45 | |
Lori Harada is Senior Manager of Commercial Technical Excellence at Terumo Blood and Cell Technologies. Starting out as a nurse, Lori found that education was her passion and she’s been involved in it ever since. In this episode she shares the importance of education, what types of people are drawn to it and how to prepare them for success, considerations for designing an education program, and how Terumo Blood and Cell Technologies is changing the lives of patients. Connect with Mastering Medical Device:
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| Working With Health Plans to Deliver Value with David Smith | 31 Jan 2023 | 00:55:50 | |
David Smith is President and Chief Revenue Officer of Ilumivu, a company that is taking data from common smartwatches and using AI and machine learning to gain insights into the early detection of certain medical conditions. In this episode he shares how health plans are evolving, how physician perceptions of the plans are changing, how well care and early disease detection is good for their bottom line, and how Ilumivu can help individual patients and large populations. Connect with Mastering Medical Device:
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| Confronting Physician Burnout - Help is on the Way with Dr. Laura Cazier | 13 Dec 2022 | 00:48:35 | |
Dr. Laura Cazier is a Board Certified emergency medicine physician who is also helping other doctors deal with burnout and other challenges through life skills coaching. She co-founded The Whole Physician with two other board-certified ED doctors, providing mindset and wellness coaching for physicians, by physicians. In this episode Dr. Cazier shares the reasons why physicians feel burnout, what specialties are most impacted, the issues and reasons why burnout is different between men and women, why physicians don’t seek help, the differences between mental health care and coaching, and what you should do if you or someone you know is struggling. Connect with Mastering Medical Device:
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| Applying AI in Ultrasound - Helping Clinicians Become More Effective with Ohad Arazi | 06 Dec 2022 | 00:48:23 | |
Ohad Arazi is President & CEO of Clarius, a company that provides a high-definition wireless ultrasound system that includes AI to help reduce the complexity of ultrasound. In this episode he shares about his time in the Israeli military and the surprising environment that encourages entrepreneurship, what you can learn while working in large and small companies, where AI is and where it’s going, how point-of-care ultrasound can benefit clinicians and patients, and how Clarius and their high definition, wireless ultrasound system is putting a powerful tool in the hands of all types of clinicians. Connect with Mastering Medical Device:
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| Personal ECG - Creating a New Product Category with Dr. David Albert | 29 Nov 2022 | 01:02:29 | |
David Albert is a physician, inventor, and serial entrepreneur. He is the Founder and Chief Medical Officer of Alivecor, the leading company in personal ECG technology. He has founded 5 companies, and sold two – one to Arrhythmia Research Technology and one to GE which he joined as Chief Scientist of GE Cardiology. David has 32 issued US patents and has authored or co-authored over 50 scientific abstracts and publications. In this episode David shares what makes ECG such useful tool, how the idea for personalized ECG came about, ECG regulatory strategy, technology development, the importance of robust clinical data, and the challenge of managing massive amounts of data. Connect with Mastering Medical Device:
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| Managing Your Career - Are You Doing It or Just Letting Things Happen? with Patrick Jamnik | 25 Oct 2022 | 00:59:39 | |
Patrick Jamnik is President of Episurf Medical, an orthopedic company who provides individualized technology for the treatment of painful joint injuries. In this episode Patrick shares why a company personal development plan may not be the best for your career, why you need to be a lifelong learner, how to seek out mentors and where to find them, what a mastermind group is and how it can benefit you, some of the things to do when importing a technology to the US, and what Episurf is doing to help an underserved orthopedic patient community. Connect with Mastering Medical Device:
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| Medical Affairs and How To Deliver Long Term Results with Dr. Agim Beshiri | 18 Oct 2022 | 01:05:57 | |
Dr. Agim Beshiri is the Chief Medical Officer at Nutromics, where they have developed technology for continuous diagnostic monitoring through a ‘lab-on-a-patch’ approach. Dr. Beshiri is a leading industry expert in developing medical affairs organizations and driving medical research and education. Prior to joining Nutromics, he contributed at Abbott Laboratories for over 16 years, serving as Senior Medical Director. In this episode he shares about earning a medical degree and applying it inside industry, what doctors and companies need to recognize about each other, what Medical Affairs is and how it is structured, the long-term objectives of a company and how medical affairs can drive massive growth, and how Nutromics is positioned to help change how monitoring of critical parameters is performed. Connect with Mastering Medical Device:
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| How a Regulatory Change Created a Product Opportunity with Ethan Drower | 04 Oct 2022 | 00:55:12 | |
Ethan Drower is the Founder and Operating Partner at CiteMed Solutions, who provide full Clinical Evaluation Report services for EU MDR. Ethan is a software engineer and entrepreneur, trained to identify problems and implement solutions. In this episode Ethan shares how to listen for new ideas, R&D differences and similarities in industries, building early prototypes and capturing customer feedback, scoping a project, pricing for value, and how CiteMed has positioned itself. Connect with Mastering Medical Device:
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| Tackling an R&D Project When the "R" is as Large as the "D" with Andrew Buckler | 27 Sep 2022 | 01:01:02 | |
Andrew Buckler is the Founder, President and CTO of Elucid, a company that is focused on characterizing placque, with the goal of providing clinicians better information on placque stability, vessel structure, treatment options, and risk factors for cardiac events. In this episode, Andrew shares how to found a company when you have a significant amount of research ahead of you, the importance of understanding biology when designing devices, the evolution of coronary angioplasty, translating research into a product, the importance of staging a project, and the problems Elucid is targeting. Connect with Mastering Medical Device:
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| How Challenging Assignments and Brutally Honest Feedback Makes You Better with Dave Rosa | 16 Jan 2024 | 01:00:12 | |
Dave Rosa is CEO of NeuroOne Medical Technologies, a company that has developed high-definition, minimally invasive diagnostic and treatment devices based on a unique thin film electrode technology, with an initial focus on epilepsy and the fast-growing neurostimulation market. In this episode he shares some times when tough feedback helped him grow as a leader, why taking the stretch assignment was the better choice, structuring a marketing group, key criteria when evaluating distribution options in a start-up company, and how NeuroOne is providing technology helpful to patients and clinicians.
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| Why You Need to Embrace the New Go-To-Market Strategy with Scott Alexander | 30 Aug 2022 | 01:07:12 | |
Scott Alexander is the CEO of iVelocity Marketing, and has been on the leading edge of identifying market shifts and building strategies and programs to embrace a new and improved go-to-market strategy. In this episode he shares what providers don’t understand about medical device companies, what we don’t understand about providers, the reasons why the old go-to-market strategy no longer works in medical device, the benefits of using a digital strategy, and why sales will love – and prosper – from embracing this change. Connect with Mastering Medical Device:
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| Choosing the Right Problems to Solve and Aligning Your Core Technologies with Stephen Mariano | 23 Aug 2022 | 00:55:59 | |
Stephen Mariano is Vice President of Global Endosurgical R&D at FUJIFILM Healthcare Americas Corporation. Stephen has a long history of success in research and development for the medical device industry and has helped bring numerous innovative technologies to market. In this episode Stephen shares how a company chooses the types of problems to solve, how to choose a specific problem, leveraging capabilities and core technologies, strategic direction and planning, what to do when a technology you own doesn’t fit in your portfolio, and an overview of FUJIFILM and how they’ve grown their helathcare segment. Connect with Mastering Medical Device:
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| Studying vs. Experiencing Entrepreneurship - Shortening Your Learning Curve with Amit Vohra | 09 Aug 2022 | 01:02:54 | |
Amit Vohra is the Founder and CEO of Promaxo, a medical technology company that is commercializing an office-based MRI system. In this episode he shares why entrepreneurs need a support system around them, how culture is really built in a company, identifying good start-up team members, why everyone needs to be a salesperson, working with advisors, the balance between being flexible and holding true to what you believe, and what Promaxo does and why the technology is a game changer. Connect with Mastering Medical Device:
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| Objectively Measuring Motion - A New Frontier with Frank Fornari | 19 Jul 2022 | 01:03:57 | |
Frank Fornari is the Founder and Chairman of BioMech, a leading company in motion analytics. In this episode Frank shares information on how our movement can indicate health, injury, decline, disease or neglect; why assessing motion can help to understand if we are getting better or worse over time, or after an intervention or surgery; the BioMech system; options for commercializing a platform technology; and the future of motion analytics. Connect with Mastering Medical Device:
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| Patient Preferences and Their Impact on Healthcare Facilities with Amber Schiada | 12 Jul 2022 | 01:04:08 | |
Amber Schiada is the Head of Americas Work Dynamic Research at JLL, one of the largest real estate services firms in the world. In this episode she shares the results of their 2022 Patient Consumer Survey and other topics, including the most important consideration in choosing a health care facility, generational differences in healthcare choices, attitudes toward tele-health, differences by geographical region and if you reside in an urban, suburban or rural location, life science hot spots in the US and globally, and trends in the short and mid-term. Connect with Mastering Medical Device:
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| Leveraging Data to Target Customers and Optimize Sales Territories with Skylar Talley | 05 Jul 2022 | 00:54:47 | |
Skylar Talley is CEO of MedScout, a company that provides life science companies data and insights to help sales reps and sales managers be more targeted and effective. In this episode Skyler discusses upstream and downstream marketing, bootstrapping a company, why inside sales is becoming more popular, leveraging distributor organizations, why digital marketing should be moving higher on your radar, using data to design territories and target customers, surprising things medical device companies don’t do that are common in other industries, aligning the sales team targets, and how sharing data to with providers can lead to stronger relationships. Connect with Mastering Medical Device:
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| Proven Processes to Simplify and Assure Sales Success - Part 2 with Jim Surek | 28 Jun 2022 | 00:46:36 | |
Jim Surek is a recognized sales leader whose teams have performed wherever he has been, based on proven sales principles. Jim is currently VP of Sales at Explorer Surgical and is also host of the podcast, Medical Sales Nation. In this episode Jim shares the sales process, including translating engineering language into customer language, aligning the company behind customer messaging, building a learning culture, question-based selling, setting sales targets for a new product, and identifying and segmenting buyer types. Connect with Mastering Medical Device:
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| Proven Processes to Simplify and Assure Sales Success - Part 1 with Jim Surek | 21 Jun 2022 | 00:40:35 | |
Jim Surek is a recognized sales leader whose teams have performed wherever he has been, based on proven sales principles. Jim is currently VP of Sales at Explorer Surgical and is also host of the podcast, Medical Sales Nation. In this episode Jim shares how medical sales has changed, why reps have evolved into enterprise salespeople, his mindset of helping to heal our healthcare system, developing a value proposition for a multi-headed customer, commercialization as an initiative, the importance of sales skills, sales training based on real customer knowledge, and how to begin a salesforce in a start-up. Connect with Mastering Medical Device:
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| Understanding Software as a Medical Device with Vivek Thakkar | 07 Jun 2022 | 00:50:10 | |
Vivek Thakkar has over a dozen years of experience in regulatory affairs for Class II and III medical devices, while at Roche, JUUL, Cardinal Health, and Abbott Vascular. He is also a frequent speaker on software, artificial intelligence, and machine learning. Vivek is now focused on start-ups and consults with medical device companies to identify and refine their regulatory strategies in the software as a medical device space. In this episodeVivek shares the definition of software as a medical device, the regulatory requirements during product development, how hardware and software programs are similar and different, working with teams that do not have a medical device background, how changes are made to software products, AI and machine learning and what is being done today vs. what will be coming, and the challenges specific to software products that the industry and regulatory bodies are attempting to overcome. Connect with Mastering Medical Device:
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| How New Technology Can Make Wearable Medical Devices and Smart Watches Smarter with Andrew Rickman | 31 May 2022 | 00:57:46 | |
Wearable devices have become common for a number of applications – from fitness tracking to tracking medical parameters for people with conditions like diabetes or heart arrhythmias. The overlap between consumer and regulated medical device wearables is becoming very fuzzy, but has a bright future. In this episode, Andrew Rickman, the CEO of Rockley Photonics, discusses why wearables have taken off, the differences in consumer and medical wearables, how multi-parameter data can lead to better healthcare, the benefits of longitudinal data, the products Rockley is introducing, how medical device companies may benefit from this emerging technology, and the future of wearables. Connect with Mastering Medical Device:
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| An Inside View of FDA and Three New Guidance Documents on the 510(k) Process with Ken Riordan | 19 Dec 2023 | 01:00:13 | |
Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the private sector with Bayer Pharmaceuticals, Philips Respironics and others enables him to apply creative and effective solutions to his clients. In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new Guidance’s on the 510(k) process that were recently released, and how Telos Partners helps medical device companies.
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| What a Pulmonologist Wants You to Know About Your Lungs with Dr. Meilan Han | 12 Apr 2022 | 01:00:46 | |
Meilan Han, MD is a Professor of Medicine and Chief of the Division of Pulmonary and Critical Care at the University of Michigan, and a spokesperson for the American Lung Association. She is the author of a recently released book, “Breathing Lessons, A Doctor’s Guide to Lung Health.” In this episode Dr. Han describes how the lungs function, what can go wrong with them, lung development and why we need to pay attention to how we treat our lungs during their development phases, what medical devices she uses, her advice for companies developing technology, and why we should be testing and monitoring a fifth vital sign.
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