Flicker Effect is a weekly podcast that takes a look at all that is movies. David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard discuss, analyze, and maybe sometimes obsess over the latest in movies, TV, and pop culture.
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Podcast by Michelle Lott
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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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Episode 188 | Tim Lucas, CEO at NeuroTech Institute | A NeuroTech Focused Venture Studio
43:07
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In this episode, Tim Lucas at The NeuroTech Institute and Duane Mancini discuss why Universities have historically struggled to commercialize innovation, the Broad Institute, how he modeled the NeuroTech Institute after it, achieving clinical adoption, and so much more. Tim Lucas LinkedIn The NeuroTech Institute Website Duane Mancini LinkedIn Proje…
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Longlegs and The Acolyte Episode 8 Review
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In this episode, Dave and Bobby discuss Longlegs and the series finale of The Acolyte. 00:00 Intro 00:50 Russo Brothers News 06:31 Longlegs 18:21 The Acolyte Episode 8 Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 187 | Kathryn Dougherty, Founder & Owner at KCD & Co | The Intersection of Finance and Marketing
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In this episode, Kathryn Dougherty at KCD and Duane Mancini discuss her background in the medtech space, the intersection of finance and marketing, upstream and downstream marketing, the difficulties of being an entrepreneur, her best advice for medtech startup companies and so much more. Kathryn Dougherty LinkedIn Project Medtech Podcast Duane Man…
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Episode 186 | Matthew Schonauer, Intellectual Property Lawyer and Anthony Tomusko, Intellectual Property Lawyer at UB Greensfelder | The Art of Protecting Your Product
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In this episode, Matthew Schonauer and Anthony Tomusko at UB Greensfelder and Duane Mancini discuss what led them into being life science-focused IP attornies, the process of engaging an IP attorney, the intangibles an IP attorney can bring to the team, freedom to operate and so much more.
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Episode 185 | Simon Mason, President at National Evaluation System for Health Technology Coordinating Center (NEST) | Systematically Leveraging Real-World Evidence
34:58
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In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.
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Episode 184 | Matt Iorio, Senior Manager Clinical Affairs and Data Analytics at Neuros Medical | The Importance of Clinical Data and How to Collect It
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In this episode, Matt Iorio at Neuros Medical and Duane Mancini discuss his background in the Medtech space, the collection of clinical data, the importance of clinical data for regulatory and commercial purposes, and so much more.
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This week, The Acolyte is back with another episode and this was fans in a frenzy! Now it's our turn to discuss. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 183 | Rick Geoffrion, President & CEO at Cyrano Therapeutics and Chip Hance, CEO at Regatta Medical | The History and Importance of the Early Feasibility Studies (EFS) Program at the FDA
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In this episode, Rick Geoffrion at Cyrano Therapeutics and Chip Hance at Regatta Medical and Duane Mancini discuss history of the Early Feasibility Studies (EFS) Program at the @FDA, the importance of it, how @MDIC supported mission and so much more.
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This week we finally have new Star Wars content to dig into! The first two episodes of The Acolyte are here and we share our thoughts both spoiler free and spoiler filled (with plenty of warning). Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 182 | Andy Fish, CEO & President and Joe Sapiente, Senior Vice President at Medical Device Innovation Consortium (MDIC) | Facilitating Discussions between Government and Industry
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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.
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Episode 181 | Brittani Ritchie, Consultant, Operations at Project Medtech | Making Quality a Part of Company Culture
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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.
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A Conversation with Vistatec's Life Science In-Focus Podcast
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The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences.We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United…
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Episode 180 | Charles Allan, Chief Executive Officer at MY01 | Lessons Learned So Far from a Medtech Startup CEO
36:45
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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.…
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Episode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR Updates
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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.
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This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.We'll review the eSTAR 5.0 platform and what you need to know to use it eff…
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This week we review Civil War, the latest film from writer/director Alex Garland. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 178 | Kevin Saem, Commercial Director at Zapyrus | 2023 Medtech Report
42:59
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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.
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David and Bobby discuss some of the big news from this year's CinemaCon. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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David, Bobby, and Michelle review Ghostbusters: Frozen Empire. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 177 | Katrina Holland, Executive Director at MedTech Color | Increasing Diversity in Medtech
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In this episode, Katrina Holland at MedTech Color and Duane Mancini discuss her new role at MedTech Color, closing the diversity gap in Medtech, her short, medium and long term vision of Medtech Color, and so much more.
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Episode 176 | Ken Callahan, Principal at The Hargan Group; Former HHS Chief of Staff to the Deputy Secretary | United States Department of Health and Human Services (HHS)
50:56
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In this episode, Ken Callahan at The Hargan Group and Duane Mancini discuss his background with HHS, what startups need to know about the department, what are the biggest policy decisions being discussed right now, how the upcoming election could affect those policies, big issues coming up in 2025 and beyond, and so much more.…
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Episode 175 | Timothy Boire and Geoff Lucks at VenoStent | Achieving Milestone and Raising Capital as a Class III Medical Device Startup Company
55:00
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In this episode, Tim Boire and Geoff Lucks at VenoStent and Duane Mancini discuss their background in the Medtech space, how they founded VenoStent, their clinical trial, fundraising strategy, and its correlation to achieving milestones and so much more.
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The trailer for the next Star Wars show is finally here! In this episode we share our thoughts on our first look at The Acolyte as well the latest trailer for Furiosa: A Mad Max Saga. And there is a rumor going around that the next James Bond has been picked. 🤔 Learn more about your ad choices. Visit megaphone.fm/adchoices…
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David, Bobby, and Michelle discuss this years Oscars. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA?I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing questions about using 3rd party reviewers.By Michelle Lott
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Dave, Bobby, and Michelle discuss Dune Part 2. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 174 | Ronan O'Hagan, President and CEO at Bectas Therapeutics | The Importance of Clinical Validation and Data
45:13
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In this episode, Ronan O'Hagan at Bectas Therapeutics and Duane Mancini discuss the overlap between pharma and medtech, what can a medtech company learn from a pharma startup, the importance of communicating science in a digestable manner, building your team, fundraising strategy and so much more.
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Episode 173 | Matt Eisendrath, President and Chief Commercial Officer at Full Spectrum Software | The Excitement Around the Future of Medtech
54:56
54:56
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In this episode, Matt Eisendrath at Full Spectrum Software and Duane Mancini discusses his background in the medtech space, software as a medical device vs. digital therapeutics, what excites him about the future of Medtech and so much more.
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eSTAR 5.0 Q+A with Patrick Axtell from the FDA
33:52
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Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received.From file size to eSTAR type to biocompatibility - we cover it all.By Michelle Lott
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Episode 172 | Angelica Maestas, Founder & CEO at HealthTech Rx | Building a Health Innovation Hub on a Mission to Eliminate Health Inequities
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38:11
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In this episode, Angelica Maestas at Healthtech Rx and Duane Mancini discuss her time in the Medtech space, health economics and reimbursement, her obsession with data analytics, taking a company through an exit, her passion for ending health inequities and so much more.
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Episode 171 | Eric Horesnyi, CEO at Matrix Requirements | Instilling Quality Early at your Medtech Startup
36:55
36:55
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In this episode, Eric Horesnyi at Matrix Requirements and Duane Mancini discuss his background as an entrepreneur, quality management systems and the importance of quality as a key pillar for culture, and so much more.
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Fractional or Full Time Quality Support: Which is Right for You?
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When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time? This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision. In this joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring…
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Episode 170 | Ryan Confer, CFO at Genprex | Understanding Finances in an Early Stage Medtech Company
46:57
46:57
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In this episode, Ryan Confer at Genprex and Duane Mancini discuss his background in startup companies, the importance of understanding finances in an early-stage company, why they took Genprex public, and so much more.
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Episode 169 | Mark Dybul, CEO at Renovaro Biosciences | Physician to Diplomat to Entrepreneur
54:21
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In this episode, Mark Dybul at Renovaro Biosciences and Duane Mancini discusses his background in the US government, what they are working on at Renovaro Biosciences, the importance of being able to communicate complex problems in an easy-to-understand way, and so much more.
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Episode 168 | Anish Kaushal, Associate at Amplitude Ventures | From Here To There: A Niche Guide to Navigating Career Transitions
48:32
48:32
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In this episode, Anish Kaushal at Amplitude Ventures and Duane Mancini discuss his background in the medtech space, his transition from being a medical doctor to venture capitalist, his new book and so much more.
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It's been while! We are back after a break to catch up and get the ball rolling again. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 167 | Jeffrey Sirek, Chief Executive Officer, Board Member at PRIA Healthcare | The Importance of Health Economics and Reimbursement in Medtech
38:05
38:05
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In this episode, Jeffrey Sirek at PRIA Healthcare and Duane Mancini discuss the importance of health economics and reimbursement, scaling a medtech service company, the culture of a growing company, and so much more.
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Episode 166 | Scott Filer, CEO at ProMedix | Green Beret to Medtech Entrepreneur: Improving Sepsis Diagnosis
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49:41
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In this episode, Scott Filer at ProMedix and Duane Mancini discuss his background as a green beret, the problem with diagnosing sepsis, what he has learned in his entrepreneurial journey, and so much more. Scott Filer LinkedIn ProMedix Website Project Medtech Website Duane Mancini LinkedIn
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Episode 165 | Tosan Ugbeye, Founder & CEO at Scope Med | The Journey: Clinician turned Entrepreneur
28:37
28:37
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In this episode, Tosan Ugbeye at ScopeMed and Duane Mancini discuss his background as a clinician, the evolution of Scope Med, what he has learned so far, and so much more. Tosan Ugbeye LinkedIn Scope Med Website Project Medtech Website Duane Mancini LinkedIn
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Episode 164 | Karen Zaderej, President, CEO and Chairman of the Board at AxoGen | Revolutionizing Nerve Repair
52:12
52:12
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In this episode, Karen Zaderej at Axogen and Duane Mancini discuss her background in the medtech space, the story of Axogen, how they are revolutionizing nerve repair and so much more. Karen Zaderej LinkedIn AxoGen Website Project Medtech Website Duane Mancini LinkedIn
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Medical Devices, Cloud Computing and Cybersecurity with Randy Horton
27:56
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As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA plans to do to ensure the safety of connected and AI-driven devices.…
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Episode 163 | Shawnnah Monterrey, Founder & CEO at BeanStock Ventures | FDA Accredited Third Party Review Organizations and Digital Health Regulations
36:40
36:40
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In this episode, Shawnnah Monterrey at BeanStock Ventures and Duane Mancini discuss Grassroots Dx, 3rd party review accreditation for FDA, software in Medtech, digital health and so much more. Shawnnah Monterrey LinkedIn BeanStock Ventures Website Project Medtech Website Duane Mancini LinkedIn
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Episode 162 | Howie Chan, Principal & Founder at Healthy Brand Consulting | The Importance of Brand Strategy to Ensure Commercial Success
38:24
38:24
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In this episode, Howie Chan at Healthy Brand Consulting and Duane Mancini discuss brand development throughout the various stages of a Medtech startup company and so much more. Howie Chan LinkedIn Health Brand Consulting Website Project Medtech Website Duane Mancini LinkedIn
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Episode 161 | Randy Armstrong, CTO at Velentium | Innovations, Breakthroughs, and Challenges in IPG Development
34:45
34:45
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In this episode, Randy Armstrong at Velentium and Duane Mancini discuss innovations, breakthroughs, and challenges in IPG development and so much more. Randy Armstrong LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn
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Episode 160 | Dan Purvis, CEO & Founder at Velentium | The Importance of Mission, Vision, and Values
53:37
53:37
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In this episode, Dan Purvis at Velentium and Duane Mancini discuss his background in the Medtech industry, how and why he founded Velentium, the importance of why and who, culture and so much more. Dan Purvis LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn
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David, Bobby, and Michelle discuss The Fall of the House of Usher. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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Episode 159 | Susan Xu, Principal at WyDus | Author of the Book: Healthcare's Reimbursement Maze
40:28
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In this episode, Susan Xu at WyDus and Duane Mancini discuss healthcare in the United States and its reimbursement maze, reimbursement of digital health products, what payers look for, and so much more. Susan Xu LinkedIn Link to Book by Susan Xu Project Medtech Website Duane Mancini LinkedIn
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Episode 158 | Christopher Gates, Director of Product Security at Velentium | Embedded Cybersecurity for Medical Devices
41:58
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In this episode, Christopher Gates at Velentium and Duane Mancini discuss embedded cybersecurity for medical devices, the importance of addressing cybersecurity early, hackers, and so much more. Christopher Gates LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn
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Episode 157 | Chris Hanna, CEO at Pacific Therapy Access, Kathleen O'Neill, Director, Health Policy and Reimbursement at Pacific Therapy Access | Reimbursement 101
53:27
53:27
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In this episode, Chris Hanna at Pacific Therapy Access, Kathleen O'Neill at Pacific Therapy Access and Duane Mancini discuss the reimbursement process of medical technologies in the United States, the coding system, why reimbursement pathway is so important and so much more. Chris Hanna LinkedIn Kathleen O'Neill LinkedIn Pacific Therapy Access Webs…
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Dave, Bobby, and Michelle discuss the finale to season 1 of Ahsoka. Learn more about your ad choices. Visit megaphone.fm/adchoicesBy David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard
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