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Explorez tous les épisodes du podcast Project Medtech

Plongez dans la liste complète des épisodes de Project Medtech . Chaque épisode est catalogué accompagné de descriptions détaillées, ce qui facilite la recherche et l'exploration de sujets spécifiques. Suivez tous les épisodes de votre podcast préféré et ne manquez aucun contenu pertinent.

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TitreDateDurée
Episode 192 | Monica Vajani, Executive Director, Medtech Accelerator at mHUB | 80,000+ sq ft Innovation Center in Chicago, Illinois26 Aug 202400:46:11

In this episode, Monica Vajani at mHUB and Duane Mancini discuss her background at Abbott and Medtronic, carrying the bag, early adopters vs. laggers, mHUB, the next cohort of companies for their medtech accelerator, and so much more.

Monica Vajani LinkedIn

mHub Medtech Accelerator Application

mHub LinkedIn

mHub Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website








Episode 191 | Craig Misrach, President & Chief Executive Officer at UpLyft | Choosing the Right Contract Manufacturer based on Your Stage of Commercialization19 Aug 202400:50:00

In this episode, Craig Misrach at UpLyft and Duane Mancini discuss what has changed since his last appearance on the podcast, choosing and changing your contract manufacturer based on the commercialization stage, the importance of quality, creative ways to finance your startup, and so much more.


Craig Misrach LinkedIn

UpLyft LinkedIn

UpLyft Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website


Episode 182 | Andy Fish, CEO & President and Joe Sapiente, Senior Vice President at Medical Device Innovation Consortium (MDIC) | Facilitating Discussions between Government and Industry03 Jun 202400:42:32

In this episode, Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) and Duane Mancini discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more.

Episode 92 | Nick Accordino and Will Braeutigam: Deloitte | Taking your Medtech Company Public: SPACs vs. IPOs09 May 202201:08:58
Episode 91 | Ashley Mooneyham: President and Director of Grants at Superior Medical Experts | The Wonderful Thing about Grants Is Grants are Wonderful Things02 May 202200:47:54
  • In this episode, Ashley Mooneyham from Superior Medical Experts and Duane Mancini discuss the world of grants in the United States, the SBIR and STTR grant mechanisms, America’s seed fund, the mechanics of where the money can go if you get grant funding, the NIH vs. NSF grant opportunities, phase I vs. Phase II, the application process for both, what you can do with the money in each stage, tips and pitfalls when putting together your application, success rates, budget exceptions, and so much more.
  • Ashley Mooneyham LinkedIn
  • Superior Medical Experts Website
  • Project Medtech Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
Episode 90 | Kyle Rose: President at Rook Quality Systems | FDA's ISO 13485 Transition Plan...What Does it Mean for Your Medtech's Quality Plan?25 Apr 202200:41:54
  • In this episode, Kyle Rose from Rook Quality Systems and Duane Mancini discussthe FDA’s ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR Part 820 vs. ISO 13485, the importance of a risk based approach in quality, updates on the MDR and current trends, could the FDA move towards requiring more clinical data from medical device manufacturers, if regulatory and quality were the only factors in determining your global get-to-market strategy…where would you go, and so much more.
  • Kyle Rose LinkedIn
  • Rook Quality System Website
  • Project Medtech Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
Episode 89 | Moshe Safran: CEO at RSIP Vision USA | Medical Imaging and the use of Algorithms and Software: Tips to Achieve Successful Development and Commercialization 18 Apr 202200:42:12
Episode 88 | Josh Rabinowitz: Co-Founder & CEO at Articulate Labs | An Entrepreneur's Perspective: Remote Patient Monitoring Reimbursement Codes and How to get the Most out of an Accelerator/Incubator11 Apr 202200:57:17
Episode 87 | Sean Bittner: Director of Programs at M1 Medtech Accelerator | Houston, Texas: The Next Medtech Hub for Startups?04 Apr 202200:38:02
Episode 86 | Niall Casey, Neil Thompson, and Kevin Buckley | Protecting your Medtech Ideas: A Case Study with a Startup and Attorneys28 Mar 202200:56:00
Episode 85 | Keith and Kevin Kallmes: Co-Founders at Nested Knowledge | Bringing Systematic Review to Clinical Data21 Mar 202200:51:31
Episode 84 | Tamir Meiri: Director, Venture Investments at Johnson & Johnson Innovation | How One of the Largest Medical Device Companies in the World Works with Startups14 Mar 202200:52:02
Episode 83 | Matt McBride: Partner at Wave Strategies | How Innovation Teams at Healthcare Systems Evaluate New Technology and their Commercial Viability 07 Mar 202200:53:13
  • In this episode, Matt McBride and Duane Mancini discuss his background at Cleveland Clinic Innovation and Bioenterprise, the main buckets of clients that Wave Strategy supports, the importance of determining not just your clinical unmet need but determining if you are truly different enough than the current solution, what is their process to identifying their clinical problem, pinning down what success looks like at an innovation group, what it is like to help set-up a family office thesis, does the regulatory pathway deter investors and innovation groups, and so much more.
  • Matt McBride LinkedIn
  • Wave Strategy Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 181 | Brittani Ritchie, Consultant, Operations at Project Medtech | Making Quality a Part of Company Culture27 May 202400:34:00

In this episode, Brittani Ritchie at Project Medtech and Duane Mancini discuss her background in the Medtech industry, making quality a part of your culture, what to expect in an FDA audit and so much more.

Episode 82 | Joe Runge: Associate Director at UNeTech | Nebraska: The Up and Coming Medtech Ecosystem 28 Feb 202200:48:35
  • In this episode, Joe Runge and Duane Mancini discuss what it going on at UNeTech, his background on what lead him to UNeTech, the importance of intellectual property and the reason companies struggle with this topic, the difficulty of when a company might have to expand out of a local ecosystem in order to continue the success of their company, the challenge with capital for midwestern companies, technology that is coming out of UNeTech, non-dilutive funding in the Medtech space and its importance, where UNeTech is going next, and so much more.
  • Joe Runge LinkedIn
  • UNeTech Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 81 | Adam Steadman: CCO at Smart-Trial | CRO's & Clinical Trials & Data...Oh My! 21 Feb 202200:54:35
Episode 80 | Karandeep Singh Badwal: Director at QRA Medical | The Global Regulatory Environment around Artificial Intelligence and SaMD in Medtech14 Feb 202200:35:28
  • In this episode, Karandeep Singh Badwal and Duane Mancini discuss comparing regulatory at a startup vs. large organization, the growth of strategics regulatory department, software and AI as a medical device, how companies straddle the line of being a medical device vs. not, how various regulatory bodies are dealing with the rise in software as a medical device, why the FDA is doing such a great job in this space, a common error he sees with companies with software as a medical device, his background on how he launched his own regulatory practice, his favorite thing about being a consultant and so much more.
  • Karandeep Singh Badwal LinkedIn
  • QRA Medical LinkedIn
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 79 | Ladan Jiracek: Host of the Neural Implant Podcast | The Future of Neurotechnology in Medtech07 Feb 202200:27:05
Episode 78 | Andrew Elder and Christoph Ruedig: Partners at AlbionVC | Digital Health: Past, Present and Future31 Jan 202200:41:32
  • In this episode, Andrew Elder, Christoph Ruedig and Duane Mancini discuss the background of Albion VC, their focus on late-seed and series A stage investments, their focus on health tech, geographical focus, why they made the switch from practicing physicians to investors, what sparked their interest in digital health, what areas of digital health they focus on, where they see the digital health industry going, the importance of messaging to achieve technology adoption, some of the various companies they have invested in, how do we continue the digital health revolution and so much more.
  • Andrew Elder LinkedIn
  • Christoph Ruedig LinkedIn
  • Albion VC Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 77 | Isabella Schmitt: Director of Regulatory Affairs at Proxima CRO | The Overlap of Regulatory Strategy and Business Strategy 24 Jan 202200:42:33
  • In this episode, our guest Isabella Schmitt and Duane Mancini discuss the rapid growth Proxima has seen in the last 5 years, the new accelerator she founded called M1 Accelerator, the importance of regulatory strategy, why one might choose a de novo vs. 510k, why startups shouldn’t be afraid of a PMA, implementing regulatory strategy into your business strategy, the common mistakes Isabella sees with startups, her best advice for startups and so much more.
  • Isabella Schmitt LinkedIn
  • Proxima CRO Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 76 | Mitch Robbins: Founder and Managing Director at The Anthony Michael Group | How does a Medtech Startup Company Attract the Best Talent17 Jan 202200:39:46
Episode 75 | Bradley Beach: CEO at Covellus | Augmenting Your Weaknesses as a Medtech CEO by Building a Strong Core Team10 Jan 202200:29:29
  • In this episode, Bradley and Duane Mancini discuss his background in the Medtech space, the timeline of exiting to a Medtech strategic, his new Project at Covellus and the unique path to market he has taken, his thoughts on who is his core team members, the importance of augmenting your weaknesses when building your core team, intellectual property strategy, the importance of storytelling as a Medtech entrepreneur, and so much more.
  • Bradley Beach LinkedIn
  • Covellus Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 74 | Craig Misrach: CEO at UpLyft | Medtech Startup Invests in Digital Marketing and the Return on Investment20 Dec 202100:40:13
Episode 73 | Alejandro Badia, MD: Orthopedic Hand Surgeon and CEO of Orthonow | Too Many Hands in the Cookie Jar and the Prevention of Product Adoption14 Dec 202100:40:16
  • In this episode, Alejandro and Duane Mancini discuss why it is so difficult to get to a specialist in the US healthcare system, his new book “healthcare from the trenches” and why he wrote it, the barriers to use for your product and why a startup needs to be concerned with this issue, the adoption of technology and why “too many hands in the cookie jar” will stunt good products from getting to market, the importance of procedures being done outside the hospital, why he thinks the insurance companies should be not-for-profits, and more.
  • Alejandro Badia LinkedIn
  • Orthonow Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 180 | Charles Allan, Chief Executive Officer at MY01 | Lessons Learned So Far from a Medtech Startup CEO29 Apr 202400:36:45

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.

Episode 72 | Jon Bergsteinsson: Founder and Vice President of Global Business Development at Smart-Trial | The Importance of Clinical Strategy in the Early Phases of a Medtech Startup Company06 Dec 202100:42:22
Episode 71 | Michelle Lott: Principal and Founder at LeanRAQA | Regulatory Strategy and its Place in a Medtech Startup Business Plan29 Nov 202100:48:32
Episode 70 | Neil Ray: CEO and Founder at Raydiant Oximetry | Why this Medtech Startup Isn't Afraid of Taking on a PMA Process with the FDA23 Nov 202100:33:45
Episode 69 | Andy Doraiswamy: CEO at Koya Medical | The Importance of Trust of Team when Building a Successful Medtech Startup21 Nov 202100:42:49
Episode 68 | David Ferrera: Medtech Entrepreneur, Investor, Innovator and Advisor | Author of "Innovation in Translation: How Big Ideas Really Happen"15 Nov 202100:55:05
Episode 67 | Krista Moon: President at Ascend Business Growth | Focusing on your Digital Footprint: The ROI08 Nov 202100:21:31
Episode 66 | Patty Post, Founder and CEO at Checkable Medical | The Importance of Non-Dilutive Funding: North Dakota's Business Friendly Ecosystem 01 Nov 202100:37:46
Episode 65 | Krista Moon: President at Ascend Business Growth | Your Medtech Company's Digital Footprint: The Basics25 Oct 202100:32:41
Episode 64 | Krista Moon: President at Ascend Business Growth | Medtech Marketing Challenges that Hinder Growth18 Oct 202100:31:48
Episode 63 | Jeff Levine: CEO at Advanced Scanners | Serial Entrepreneur takes on his first Medtech Company: Lessons Learned along the Way --- So Far11 Oct 202100:39:34
  • In this episode, Jeff and I discuss what Advanced Scanners is working on, comparing his experience as an entrepreneur in other industries vs. Medtech, who else to talk to besides just the end-users, how to deal with investors when you have a platform technology, how to choose which indication of use to go after based on market feedback, investors, etc., lessons learned in raising capital as a first time Medtech entrepreneur, other advice and speed bumps to be aware of and more.
  • Jeff Levine LinkedIn
  • Advanced Scanners Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn
  • Project Medtech Website
Episode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR Updates22 Apr 202400:35:16

In this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.

Episode 62 | Abbas Dhilawala: CTO of Galen Data | Cybersecurity in Medtech: Do the Positives Outweigh the Risk04 Oct 202100:41:36
Episode 61 | Talya Miron-Shatz, PhD | What Medtech Innovators Need to Know about the Psychology of Patients and Physicians 27 Sep 202100:42:04
Episode 60 | Abbas Dhilawala: CTO of Galen Data | Connecting your Medical Device to the Cloud: Build Your Own vs. Using an Already Established One20 Sep 202100:37:16
Episode 59 | Kyle Rose: President and Founder of Rook Quality System | The Importance of Implementing a Scalable Quality System Early 13 Sep 202100:35:59
Episode 58 | Karen Krygier: Senior Director of Clinical Affairs at Global Kinetics | Utilizing RPM Codes and Remote Patient Monitoring in Clinical Trials30 Aug 202100:37:35
Episode 57 | Andrew Wu: General Manager (Taiwan Branch) at Rook Quality System | The Current Regulatory and Quality Landscape for Software as a Medical Device and Where it is Going23 Aug 202100:53:44
Episode 56 | Lucien Blondel: CTO at Quantum Surgical | Stories of Going Through an Acquisition by an Industry Leader for the First Time16 Aug 202100:39:49
Episode 55 | Brian Doughty: Principal, Delta Force Group | Stop! Validating your Idea before Moving Forward26 Jul 202100:43:29
Episode 54 | Jennifer Fried: CEO and Co-Founder at ExplORer Surgical | Advice and Tips from an Investor Turned Entrepreneur19 Jul 202100:44:55
Episode 53 | Dr. Uri Geiger: Founder & General Partner at Accelmed | Where are Investor Dollars Flowing within the Medtech Space12 Jul 202100:41:44
Episode 178 | Kevin Saem, Commercial Director at Zapyrus | 2023 Medtech Report15 Apr 202400:42:59

In this episode, Kevin Saem at Zapyrus and Duane Mancini discuss what Zapyrus does, their 2023 Medtech report on the industry and so much more.

Episode 52 | Mina Fahim, President and CTO at MediView | Strategic to Startup 05 Jul 202101:09:12
Episode 51 | Ames Gross, President of Pacific Bridge Medical | Taking your Medical Device to the Asia Pacific Market28 Jun 202100:49:06
Episode 50 | Giovanni Lauricella | Medtech Money Podcast and Project Medtech Partnership 14 Jun 202100:23:05
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