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Project Medtech

330 episodes - English - Latest episode: 6 days ago -

The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.

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Episodes

Episode 132 | Ty Hagler, Principal at Trig | A Biomedical Designer's Perspective on Innovation in Healthcare

March 20, 2023 05:00 - 57 minutes - 78.4 MB

In this episode, Ty Hagler and Duane Mancini discuss industrial design, Trig, their current program called med+design by Trig, how to approach innovation for healthcare, and so much more. Ty Hagler LinkedIn Trig Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 131 | Martin Müller, Senior Associate Venture Investments at Philips | Physician to Private Equity to Venture Capital: What is Next in Medtech?

March 13, 2023 05:00 - 48 minutes - 67.1 MB

In this episode, Martin Muller and Duane Mancini discuss what makes Philips Ventures unique, his background and the differences between private equity and venture capital, evaluating a company, what spaces he is most excited about, and so much more. Martin Muller LinkedIn Philips Ventures Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 130 | Leah Brownlee, President and General Counsel at Lazurite | Lessons Learned So Far and Creating an Employee Stock Option Pool

March 06, 2023 06:00 - 40 minutes - 55.7 MB

In this episode, Leah Brownlee and Duane Mancini discuss their strategy to getting through the FDA in 90 days from submission, who they have raised money so far and how they are different, her background in legal and how it prepared her for a leadership role, the biggest mistakes a startup can make, why they are a LLC over a Delaware C-Corp, how to set-up an equity pool for employees, and so much more. Leah Brownlee LinkedIn Lazurite Website Project Medtech Website Project Medtech Linke...

Episode 129 | Rob Kibler, Asim Roy, and Brandon Canfield at Dianyx | A Startup's Mission to Improve Sleep Monitoring: Lessons Learned...So Far

February 27, 2023 06:00 - 50 minutes - 69 MB

In this episode, Rob Kibler, Asim Roy, Brandon Canfield and Duane Mancini discuss their work in the sleep monitoring space, how they chose their beachhead market in dental, what they have learned so far, and so much more. Rob Kibler LinkedIn Asim Roy LinkedIn Brandon Canfield LinkedIn Dianyx LinkedIn Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 128 | Daniel Sheppard, Managing Director at MedWorld Advisors | Preparing Your Company for a Merger or Acquisition

February 20, 2023 12:30 - 39 minutes - 53.7 MB

In this episode, Daniel Sheppard and Duane Mancini discuss how we met, the importance of getting a team when working with a service provider, when do you have a call with a merger and acquisition advisor, strategics spend more money on acquisitions than their own research and development, what kind of M&A activity to expect in 2023,  and so much more. Daniel Sheppard LinkedIn MedWorld Advisors Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 127 | Rachel Robinson, COO at MassMedic | CL Tian, CEO at Phiex Technologies | Oriana Papin-Zoghbi, CEO & Co-Founder at AOA Dx | How to Take Advantage of Programs for Startups

February 13, 2023 06:00 - 58 minutes - 80.5 MB

In this episode, Rachel Robinson, CL Tian, Phiex Technologies, Oriana Papin-Zoghbi and Duane Mancini discuss the companies they are running, the MassMEDIC IGNITE program, how to take advantage of programs like these as an early stage Medtech company, surrounding yourself with good people, the timing of when you do an accelerator program, lessons learned along their entrepreneurial journal, common pitfalls, best piece of advice, and so much more. Rachel Robinson LinkedIn CL Tian LinkedIn ...

Episode 126 | Bryan Dunn and Larry Snyder at General Digital | A Companu's Focus on Aviation and Medical Devices: What the FAA and FDA have in Common

February 06, 2023 06:00 - 44 minutes - 61.3 MB

In this episode, Bryan Dunn, Larry Snyder and Duane Mancini discuss the similarities between the aviation and medical device industry, FAA vs. FDA, the 1, 10, 100 rule, verification and validation of software and so much more. Bryan Dunn LinkedIn Larry Snyder LinkedIn General Digital Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 125 | Livia Ng, CEO & Founder at Neuroute | Avoiding Clinical Trial Recruitment Purgatory

January 30, 2023 06:00 - 31 minutes - 43.9 MB

In this episode, Livia Ng and Duane Mancini discuss clinical trial recruitment, how to improve it, empowering first time founders to have the network they need to succeed, and so much more. Livia Ng LinkedIn Neuroute Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 124 | Arpit Rao, Founder at Ankr Health | Selling into Healthcare: Going from a Few Customer to a Market Leader in 1 Year

January 23, 2023 06:00 - 55 minutes - 76 MB

In this episode, Arpit Rao and Duane Mancini discuss what he is currently working on at Ankr Health, his background in the healthcare system, how he went from a handful of clinics to a market leader in one year, the importance of the sales team, sales culture, shortening the sales process, and so much more. Arpit Rao LinkedIn Ankr Health Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 123 | David Canes, Founder at WellPrept | A Reluctant Entrepreneur: Determining If You Are Solving a Systemic Problem

January 16, 2023 06:00 - 48 minutes - 66.4 MB

In this episode, David Canes and Duane Mancini discuss why he considers himself a reluctant entrepreneur, how he founded WellPrept, determining if your problem is just an isolated issue or a systemic problem, the problem with clinician retention at a hospital, being a physician entrepreneur,  and so much more. David Canes LinkedIn WellPrept Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 122 | Peeyush Shrivastava, Founder and CEO at Genetesis | $35.7M Raised So Far: Middle School Friends Drop Out of College and Start a Medtech Startup Company

January 09, 2023 06:00 - 39 minutes - 36.6 MB

In this episode, Peeyush Shrivastava and Duane Mancini discuss the company he founded with his two other middle school friends, dropping out of college together, the rise of magnetocardiography, how they raised money from Mark Cuban, the support from CincyTech, a problem centric approach, and so much more. Peeyush Shrivastava LinkedIn Genetesis Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 121 | Shannon Clark, Founder at UserWise | Human Factors Testing: What, When and Why

January 02, 2023 06:00 - 41 minutes - 56.4 MB

In this episode, Shannon Clark and Duane Mancini discuss human factors testing, IEC 62366-1 standard, why she founded UserWise, why one should consider human factors testing even if the FDA doesn’t require it, what are the cost drivers for the Human Factors testing, and so much more. Shannon Clark LinkedIn UserWise Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Episode 120 | Marissa Fayer, CEO and Founder at HERhealthEQ | Women's Health: A Seriel Entrepreneur's Path to Overhauling the Industry

December 05, 2022 17:23 - 59 minutes - 81.6 MB

In this episode, Marissa Fayer and Duane Mancini discuss what she is working on at HerHealthEQ, her role as CEO at DeepLook Medical, UltraSound AI and what she is working on there, her venture fund and there focus on women’s health, the importance of understanding the vision when you are a CEO taking over for the founding CEO, the importance of diversity on boards, her lessons learned so far, and so much more. Marissa Fayer LinkedIn Duane Mancini LinkedIn Project Medtech Website

Episode 120 | Marissa Fayer, CEO and Founder at HERhealthEQ | Women's Health: A Serial Entrepreneur's Path to Overhauling the Industry

December 05, 2022 17:23 - 59 minutes - 81.6 MB

In this episode, Marissa Fayer and Duane Mancini discuss what she is working on at HerHealthEQ, her role as CEO at DeepLook Medical, UltraSound AI and what she is working on there, her venture fund and there focus on women’s health, the importance of understanding the vision when you are a CEO taking over for the founding CEO, the importance of diversity on boards, her lessons learned so far, and so much more. Marissa Fayer LinkedIn Duane Mancini LinkedIn Project Medtech Website

Episode 119 | Milton Yarberry, Director, Project Management at Integrated Computer Solutions | Bridging the Gap Between Development and Regulatory Teams

November 28, 2022 15:29 - 38 minutes - 52.3 MB

In this episode, Milton Yarberry and Duane Mancini discuss bridging the gap between development and regulatory teams, the most common differences between the two groups, how to overcome these different thought processes, strategic shifts in thought process and so much more. Milton Yarberry LinkedIn ICS Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 118 | Kelly Stanton, Director of Quaity at Qualio | The Importance of Instilling Quality in a Medtech Company's Culture: What Does that Actually Mean?

November 21, 2022 06:00 - 38 minutes - 52.7 MB

Kelly Stanton LinkedIn Qualio Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 117 | Alison Burklund, Co-Founder & CTO at Nanopath and Kate Rumrill, President and CEO at Ablative Solutions | Two Medtech Entrepreneurs: Early Stage vs. Growth Stage

November 14, 2022 06:00 - 45 minutes - 41.7 MB

In this episode, Alison Burklund, Kate Rumrill and Duane Mancini discuss their Medtech companies, comparing and contrasting raising money at a series D vs. series A, culture at a series A vs series D, coming into the CEO role vs. being a co-founder, and so much more. Alison Burklund LinkedIn Nanopath Website Kate Rumrill LinkedIn Ablative Solutions Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 116 | Erika Cheung, Co-Founder at Ethics in Entrepreneurship | A Theranos Whistleblower: The Importance of Ethics in a Startup Company

November 07, 2022 06:00 - 47 minutes - 64.8 MB

In this episode, Erika Cheung and Duane Mancini discuss her journey of being a Theranos whistle blower, the importance of culture at a startup company, ethics within a startup company, why you should care about who you raise money from, and so much more. Erika Cheung LinkedIn Ethics in Entrepreneurship Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 115 | Brock Leonti, CEO at Prescribe FIT | The Importance of Culture in a Startup Company

October 31, 2022 05:00 - 58 minutes - 79.9 MB

In this episode, Brock Leonti and Duane Mancini discuss his journey to leading Prescribe fit, his serial entrepreneur mentality, what they are currently working on at Prescribe fit, what they learned during their early commercialization phase, remote patient monitoring codes, the importance of culture within a startup company, and so much more. Brock Leonti LinkedIn Prescribe Fit Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 114 | Vidya Murthy, COO at MedCrypt | Cybersecurity in Medtech

October 24, 2022 05:00 - 33 minutes - 46.3 MB

In this episode, Vidya Murthy and Duane Mancini discuss cybersecurity in Medtech, the evolution of how the FDA deals with cybersecurity, hack-a-thons and what those actually are, how companies should look at cybersecurity, why hospital systems are sensitive to devices that are connected to the cloud, famous cases in cyber breaches in healthcare, the hacker community, how is the rest of the world handling cybersecurity, and so much more. Vidya Murthy LinkedIn MedCrypt Website Project Medt...

Episode 113 | Nikki Hastings, Executive Director at CVilleBioHub | The Medtech Ecosystem in Charlottesville, Virginia

October 17, 2022 05:00 - 36 minutes - 50.1 MB

In this episode, Nikki Hastings and Duane Mancini discuss her background in the medical device space, her experience around Medtech startup companies, CVilleBioHub, the ecosystem in Charlottesville, Virginia, the importance of attracting outside talent so the perspectives doesn't become insular, product market fit, Research Triangle Park, North Carolina, and so much more. Nikki Hastings LinkedIn CVilleBioHub Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 112 | Andrea Davis, Founder and Patent Research Expert at Bodkin IP, LLC | What is a Patent Research Expert and Why You Would Use One

October 10, 2022 05:00 - 43 minutes - 59.6 MB

In this episode, Andrea Davis and Duane Mancini discuss patent searches, patent and IP attorneys, global IP strategy, patent infringement, when a startup would use a patent researcher and so much more. Andrea Davis LinkedIn Bodkin IP Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 111 | Sanjeev Saxena, CEO at Harae DX | Women's Cancer Diagnostics: A Serial Entrepreneur's Next Endeavor

October 03, 2022 05:00 - 40 minutes - 55.8 MB

In this episode, Sanjeev Saxena and Duane Mancini discuss Harae DX, Lawerence Livermore National Labs, women cancer diagnostics, what he has learned as a 6x entrepreneur, his best advice to the first time entrepreneur and so much more. Sanjeev Saxena LinkedIn Harae DX Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 110 | Tianna Benson, Manager at leanRAQA | How to Approach Global Regulatory Strategy as a Startup

September 26, 2022 05:00 - 45 minutes - 62.9 MB

In this episode, Ti Benson and Duane Mancini discuss global regulatory strategy, the current landscape in the EU, MDSAP, hidden expenses, terminology, and so much more. Ti Benson LinkedIn LeanRAQA Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 109 | Patrick Pfeffer, Founder & CEO at Aescuvest | The Medtech Landscape In Germany

September 19, 2022 05:00 - 39 minutes - 54.1 MB

In this episode, Patrick Pfeffer and Duane Mancini discuss the investment group he founded in Frankfurt, Germany, how they named their company, the podcast that he hosts, from sick care to healthcare, the German Medtech scene,  and so much more. Patrick Pfeffer LinkedIn Aescuvest Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 108 | Robert Packard, President at Medical Device Academy | A History Lesson on the MDR and Global Regulatory Strategy

September 12, 2022 05:00 - 58 minutes - 80.4 MB

In this episode, Rob Packard and Duane Mancini discuss the current landscape of regulatory requirements in the EU, evolution of regulatory in the EU, the MDR, what is a notified body, post market surveillance in the US, global regulatory strategy, and so much more. Rob Packard LinkedIn Medical Device Academy Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 107 | Jimmy Jin, Senior Director, Business Development and Innovation at Becton Dickinson and Ronnie Wang, Partner of Mednovation | Why You Should Want to Take Your Product to Market in China

August 29, 2022 05:00 - 33 minutes - 45.4 MB

In this episode, Jimmy Jin, Ronnie Wang and Duane Mancini discuss CIIE, Mednovation, why one would want to take their product to market in China, the process for entering the Chinese market, common mistakes companies make, the importance of commercial and IP, and so much more. Jimmy Jin LinkedIn Ronnie Wang LinkedIn Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 106 | Greg Tuers, President at RAM Technologies | Does Your Device Need to Comply with IEC 60601?

August 22, 2022 05:00 - 29 minutes - 40.9 MB

In this episode, Greg Tuers and Duane Mancini discuss IEC 60601, power supply for medical devices, normal use vs. intended use, shelf life of various components, manufacturing tips, other standards and so much more. Greg Tuers LinkedIn Ram Technologies Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 105 | Chris Lah, Senior Director at Mayfield Brain & Spine | The Effect of Middlemen and Revenue Cycle in the US Healthcare System on Your Commercialization Strategy

August 15, 2022 05:00 - 43 minutes - 60.2 MB

In this episode, Chris Lah and Duane Mancini discuss middlemen in the US healthcare system, a look into the revenue cycle at a hospital, how various players in the healthcare system evaluate technology, payment reimbursement strategies, his participation in TedX, and so much more. Chris Lah LinkedIn Mayfield Brain & Spine Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 104 | Dave Albert, Founder & Chief Medical Officer at AliveCor | A Medtech Legend: Being an Orthogonal Thinker

August 08, 2022 05:00 - 41 minutes - 56.9 MB

In this episode, Dave Albert and Duane Mancini discuss his history in the Medtech space, his various patents, his current company AliveCOR, his video that went viral, what it was like selling a company on 9/11, what it is like fighting the behemoth companies, the power of data, prediction becomes prevention, finding that complimentary team, there is no such thing as a solo entrepreneur, and so much more. Dave Albert LinkedIn AliveCor Website Project Medtech Website Duane Mancini LinkedI...

Episode 103 | Joseph Mocanu, Managing Partner at Verge HealthTech Fund | A Global Investors View on What Sucks In Healthcare Right Now and How Technology Could Fix It

August 01, 2022 10:53 - 42 minutes - 59 MB

In this episode, Joseph Mocanu and Duane Mancini discuss his current fund called Verge HealthTech Fund, what sucks in healthcare right now that could be fixed with technology, sick care vs. healthcare, global healthcare access, what it truly means to be an impact investor, how an impact fund looks at opportunities vs. a typical venture group, entrepreneurship and how it is viewed around the world, picking the right partners for a startup, and so much more. Joseph Mocanu LinkedIn Verge Hea...

Episode 102 | Keith Matheny, Founder and Chairman of the Board at Septum Solutions | Part-Time Entrepreneur, Part-Time Physician: Why It Is Important to Continue to be a Practicing Physician

July 25, 2022 05:00 - 51 minutes - 71.3 MB

In this episode, Keith Matheny and Duane Mancini discuss the complexities of spending time as an entrepreneur but also still a practicing a clinician, the benefit to continuing to practice, the multiple companies he is running, building your clinical advisor board and key opinion leaders, the US healthcare system, the need for healthcare reform and who should own that, and so much more. Keith Matheny LinkedIn Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 101 | Richard Hanbury, CEO at Sana Health | "I'm going to Die Unless I Solve My Pain Problem": An Entrepreneur's Mission to Solve Pain

July 18, 2022 05:00 - 36 minutes - 50.1 MB

In this episode, Richard Hanbury and Duane Mancini discuss what he is working on at Sana Health, how he started this journey of solving pain, how he looked at the De Novo process as a startup company, why breakthrough status was powerful for them, how he built his team, what to fractionalize and what to bring in-house, building a team to balance your gaps, his best advice for fundraising, paying attention to what motivates the type of investor you are pitching, what it is like taking on the...

Episode 100 | David Sylvan, President at UH Ventures and Brian Rothstein, CMO at UH Ventures | The Complexities of Getting Your Medtech Product into a Hospital System

July 11, 2022 05:00 - 56 minutes - 77.8 MB

In this episode, David Sylvan, Brian Rothstein and Duane Mancini discuss why Brian wanted to get into innovation, how UH Ventures got it start, the SPICE filter they apply, who uses, who benefits, who buys, who measures, and why selling into healthcare is so hard, what are the non-starters before they will work with a company, why journey mapping for a device is so important, and so much more. David Sylvan LinkedIn Brian Rothstein LinkedIn University Hospitals Ventures Website Project M...

Episode 99 | Etienne Nichols, Medical Device Guru at Greenlight Guru | Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals

June 27, 2022 05:00 - 45 minutes - 62.3 MB

In this episode, Etienne Nichols and Duane Mancini discuss how he supports Medtech companies in implementing electronic quality management systems, the 2022 benchmark study they did this year on 519 Medtech professionals, what headwinds Medtech companies are facing, what the survey said about time to market, common errors on supplier management, opportunities that a lot of the professionals saw, the risk of cybersecurity, the importance of companies spending time and resources on employee g...

Episode 98 | Jeremy Stackawitz, CEO at Senzo | Startup Mentality: Stop Being Afraid of What Can Go Wrong and Start Being Excited About What Can Go Right

June 20, 2022 05:00 - 46 minutes - 64.3 MB

In this episode, Jeremy Stackawitz and Duane Mancini discuss his current pre-commercial diagnostic company he is leading, how to choose your first indication for use when you are a platform technology, what about the second and third indication, what led him to Senzo, his experience with raising capital, the importance of naming of the rounds, what it is like being brought in to lead a company when you are not a co-founder, and so much more. Jeremy Stackawitz LinkedIn Senzo Website Proje...

Episode 97 | Jasmin Hounsell, CEO & Founder at Evolene Ltd | Commercialization Strategy: Powering Medtech Companies Towards Their Purpose

June 13, 2022 05:00 - 44 minutes - 60.6 MB

In this episode, Jasmin Hounsell and Duane Mancini discuss her company Evolene, how they support Medtech startups, how commercialization strategy differs between UK vs. US and why the differences are underestimated, commercialization strategy, reimbursement, having a commercialization plan and which countries you go to go first, dos and don’ts in Medtech companies trying to commercialize, and so much more. Jasmin Hounsell LinkedIn Evolene Website Project Medtech Website Duane Mancini Li...

Episode 96 | Shai Policker, CEO at MEDX Xelerator | How this Israel Accelerator Helps Medtech Startups Get to a Fundable Milestone

June 06, 2022 05:00 - 40 minutes - 55.3 MB

In this episode, Shai Policker and Duane Mancini discuss the incubator he is running in Israel, his past experience as an entrepreneur, the partners they work with, helping companies get to a fundable milestone, what kind of companies this is open to from a geographical perspective, what type of Medtech companies they look for, your window of opportunity, the importance of communication, what makes the Israel ecosystem so great, and so much more. Shai Policker LinkedIn MEDX Xelerator Webs...

Episode 95 | Yin He, Principal Business Development, Healthcare and Life Sciences Startups at Amazon Web Services | How One of the Largest Tech Companies in the World Engages Healthtech Startups

May 30, 2022 05:11 - 46 minutes - 64.4 MB

In this episode, Yin He and Duane Mancini discuss her background as scientist and what lead her to Amazon Web Services, how her team at AWS works with early-stage innovation, the 16 leadership principles at Amazon and how startups can use these elements at their own company, the healthy tension between scientists, engineers, and the commercial team, diversity, equity, and inclusion, women in Medtech, how do you get an investors attention, and so much more. Yin He LinkedIn AWS Website Pro...

Episode 94 | Mary Yost, Co-Founder at the Sage Group | Peripheral Arterial Disease (PAD): Undiagnosed and Under-treated --- A Dive into the Financial Burden on the Healthcare System

May 23, 2022 05:06 - 52 minutes - 71.4 MB

In this episode, Mary Yost and Duane Mancini discuss why she founded the Sage Group, her background and why she got into this role, Peripheral arterial disease (PAD), the financial cost to the healthcare system, why it is undiagnosed and under-treated, who is most affected by this disease, current treatments and diagnostic tools, new devices and diagnostics on the horizon, what is next to spread awareness about this issue, and so much more. Mary Yost LinkedIn The Sage Group Website Proje...

Episode 93 | Danielle Bodicoat | The Scientific Art of Biostats: Clinical Strategy, Sample Size Calculation, Clinical Trial Design, and CEP/CERs

May 16, 2022 05:00 - 35 minutes - 49.4 MB

In this episode, Danielle Bodicoat and Duane Mancini discuss being a biostatistician (medical statistics), why she started her own consulting practice, the importance of clinical evidence beyond regulatory requirements, the cost drivers of a clinical trial, factors that go into clinical trial design, the basics of sample size calculation, clinical evaluation plans and clinical evaluation reports, the MDR and how it is affecting clinical in the EU and UK, and so much more. Danielle Bodicoat...

Episode 92 | Nick Accordino and Will Braeutigam: Deloitte | Taking your Medtech Company Public: SPACs vs. IPOs

May 09, 2022 05:00 - 1 hour - 63.8 MB

In this episode, Nick Accordino and Will Braeutigam from Deloitte and Duane Mancini discuss discuss SPACs, what are SPACs, why would a company want to go public, the differences in going public through an IPO vs. SPAC, strategic acquisition vs. going public, the myths of going public via a SPAC, preparing your company to go public, and so much more. Nick Accordino LinkedIn Will Braeutigam LinkedIn Deloitte Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

Episode 91 | Ashley Mooneyham: President and Director of Grants at Superior Medical Experts | The Wonderful Thing about Grants Is Grants are Wonderful Things

May 02, 2022 05:00 - 47 minutes - 65.8 MB

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 mu...

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?

April 25, 2022 05:00 - 41 minutes - 57.6 MB

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 woul...

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

April 18, 2022 05:00 - 42 minutes - 58 MB

In this episode, Moshe Safran and Duane Mancini discuss his journey from physicist to c-suite, the importance of communication, the history of algorithms and software in Medtech imaging, tips on getting your technology adopted by the industry, common errors he sees with startups in this space, what makes Israel’s Startup landscape for innovation so great, and so much more. Moshe Safran LinkedIn RSIP Vision USA Website Project Medtech Website Duane Mancini LinkedIn Project Medtech Linke...

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/Incubator

April 11, 2022 05:00 - 57 minutes - 78.7 MB

In this episode, Josh Rabinowitz and Duane Mancini discuss how they founded the company, what problem they are trying to solve, remote patient monitoring reimbursement codes, how to get the most out of an accelerator, learning to think as a startup company and not as an individual, thinking of the CEO at the bottom of the organization chart rather than the top, product development tips,  and so much more. Josh Rabinowitz LinkedIn Articulate Labs Website Duane Mancini LinkedIn Project Me...

Episode 87 | Sean Bittner: Director of Programs at M1 Medtech Accelerator | Houston, Texas: The Next Medtech Hub for Startups?

April 04, 2022 05:00 - 38 minutes - 52.3 MB

In this episode, Sean Bittner and Duane Mancini discuss the new M1 accelerator in Houston, Texas, their focus in Medtech, importance of partnerships, how fatal choosing the wrong team can be for an early-stage startup, importance of warm introductions, the Houston ecosystem in Medtech, the importance of great leadership, raising too much money, and so much more. Sean Bittner LinkedIn M1 Medtech Accelerator Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

Episode 86 | Niall Casey, Neil Thompson, and Kevin Buckley | Protecting your Medtech Ideas: A Case Study with a Startup and Attorneys

March 28, 2022 05:00 - 56 minutes - 76.9 MB

Niall Casey LinkedIn Carlsmed Website Neil Thompson LinkedIn Kevin Buckley LinkedIn Torrey Pines Law Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

Episode 85 | Keith and Kevin Kallmes: Co-Founders at Nested Knowledge | Bringing Systematic Review to Clinical Data

March 21, 2022 05:00 - 51 minutes - 70.8 MB

In this episode, Kevin Kallmes, Keith Kallmes and Duane Mancini discuss how they took the problems they encountered from their first company and spun it into another company, how they are tackling systematic literature review and meta analysis as a process, the issue with clinical data storage, lessons they learned along the way in their first startup company, how to realize when you are not the best person for the job anymore, various failure modes that they have seen through interacting w...

Episode 84 | Tamir Meiri: Director, Venture Investments at Johnson & Johnson Innovation | How One of the Largest Medical Device Companies in the World Works with Startups

March 14, 2022 05:00 - 52 minutes - 71.5 MB

In this episode, Tamir Meiri and Duane Mancini discuss his background and how he became a “geek” of healthcare, the sense of pride in Israel about their healthcare innovation, we do a deep dive into Johnson & Johnson and the different branches, how they evaluate investments, the importance of partnerships to bring innovation to patients, do venture arms of strategics work together, what trends he sees in the industry, the importance of diversity on your board, and so much more. Tamir Meiri...

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@mcoopermd 2 Episodes