MedTech Mindset
12 episodes - English - Latest episode: almost 5 years ago - ★★★★★ - 11 ratingsMedtech Mindset has been in hibernation the last couple of years. It's coming back! If you have suggestions on topics or speakers, please send email them to [email protected].
MedTech Mindset brings together thought leaders, entrepreneurs, investors, clinicians, and other guests from the medical device and health technologies industries. We discuss:-Exciting new Medtech Projects, Companies, and Trends-Engineering, Design and Prototyping-Fundraising and Investor Pitching-Intellectual Property Issues-How to Collect, Evaluate and Present Clinical Data-Regulatory Pathway Approaches-Reimbursement and CMS CodesMedTech Mindset is a production of Archimedic, a medical device development firm with offices in Boston and Philadelphia. About Archimedic: Archimedic partners with innovators to transform novel concepts into market-ready medical devices that improve and save lives.From surgical instrumentation and point-of-care diagnostics to medical robotics, wearables,and drug delivery devices, Archimedic accelerates the development of breakthrough medicaltechnologies from napkin sketch through production.
Homepage Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
Episodes
Maintaining Agility & Quality in Device Software Development with Rightley McConnell
August 28, 2019 23:00 - 41 minutes - 28.5 MBIn this episode, Rightley McConnell, VP of Operations at Precision Systems, Inc., covers how to maintain quality and speed when developing medical device software. Rightley and Dan discuss: Challenges to device software development for complex systems Use of AGILE methodology in a regulated environment Applicable standards including 21 CFR 820, ISO 13485, ISO 14971 How quality can remain central at each development phase And more. Rightley can be reached at rmcconnell@psi-s...
Data Flow Medtech Innovation with Seth Goldenberg
July 31, 2019 02:00 - 35 minutes - 24.2 MBIn this episode, Seth Goldenberg, VP of Vault Medical Device & Diagnostics at Veeva Systems, cover data flow throughout the product lifecyle and how advanced data management can speed devices along the path to market. Seth and Dan discuss: How data management and access impact the product lifecycle What the device industry can learn from pharma's data practices How EU MDR is changing the data landscape When in a device company's growth does a cloud system start to make sense? ...
Securing Funding with Adam Dakin, Part II
June 13, 2019 10:00 - 27 minutes - 12.8 MBIn Part II of this two-part episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. Adam and Dan discuss: Medtech funding trends and how they've changed in recent years Investor perspectives on medtech vs. digital health How to build value to make your startup attractive Tips for success at the pitch table
Securing Funding with Adam Dakin, Part I
June 06, 2019 12:00 - 28 minutes - 13 MBIn this episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part I of II) Adam and Dan discuss: Medtech funding trends and how they've changed in recent years Investor perspectives on medtech vs. digital health How to build value to make your startup attractive Tips for success at the pitch table
Staking Your IP Claim with Gregory Bernabeo
May 07, 2019 15:00 - 40 minutes - 18.5 MBIn this episode, Gregory Bernabeo, Patent Attorney and Partner at FisherBroyles, covers intellectual property ground rules and special topics in the medtech space. Greg and Dan discuss: Why a patent isn't what (exactly) what you thought it was Is my medtech innovation patentable? Are patents valuable if I can't afford to litigate? Can medtech innovators protect their IP rights and publish their research? What's important when selecting a patent attorney for my medtech project...
Overcoming Pediatric Device Innovation Challenges with Matthew Maltese
March 25, 2019 04:00 - 48 minutes - 22 MBIn this episode, Matt Maltese, Executive Director of the PA Pediatric Medical Device Consortium and Dan Henrich discuss: Current barrier to pediatric device innovation How pediatric specialists operate without pediatric devices Risk/Benefit rationale for small patient populations Current industry and FDA initiatives to bring more devices to market for kids
Navigating Regulatory with Monica Ferrante
February 18, 2019 05:00 - 47 minutes - 21.6 MBIn this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market. Monica and Dan discuss: FDA risk classifications and how to steer down various regulatory pathways How FDA is changing in recent years Trends in regulation--are medical devices under-regulated by FDA? Formal vs. informal pre-submission meetings with FDA How to go about finding trustworthy regula...
Branding in MedTech with Bill Gullan
January 15, 2019 05:00 - 43 minutes - 20.1 MBIn this episode, branding expert Bill Gullan, President of Finch Brands, speaks with Smithwise Marketing Director Daniel Henrich about what branding is and why's it's critical in the world of medtech ventures. Bill and Dan discuss: What branding is, and what it's not How company identity and go-to-market strategy are reflected in a brand When is the right time to worry about branding? Developing market and buyer insights Naming your product and company
Saving Infants in Respiratory Distress with Stephen, Anna, & Sunil John
December 04, 2018 15:00 - 31 minutes - 14.6 MBOn this episode, we sit down with Stephen and Anna John, a brother-sister team of medical device developers, working to bring life-saving respiratory therapy to the developing world. Their device, NeoVent, is a low-cost, mechanical solution to deliver two levels of air pressure to infants in respiratory distress without the need for continuous electric power. Stephen and Anna grew up in rural Nepal, where their family worked to meet the medical needs of an undeserved population. Th...
Clinical Evidence Insights with Joe Popowicz
November 01, 2018 04:00 - 44 minutes - 20.4 MBIn this episode, Joe Popowicz, founder of Emergent Clinical Consulting, sits down with Smithwise President Eric Sugalski to talk about clinical evidence strategies surrounding new medtech. They cover pre/postmarket data needs, regulatory pathways, Value Analysis Committees, Significant Risk vs. Nonsignificant Risk, Institutional Review Boards, and more. See more and find contact info for Joe on the Smithwise.com blog.
Actively Protecting Seniors with Wamis Singhatat
October 31, 2018 04:00 - 31 minutes - 14.3 MBWe're joined this episode by Wamis Singhatat, VP of Product Development and CTO of Active Protective, a medtech company working to bring a really cool new piece of technology to market. Their product is a smart belt that can detect a fall in progress and deploy airbags to cushion the hips of the wearer. You can see a video of the deployment in action on the Smithwise blog. Wamis sat down with Smithwise President Eric Sugalski to discuss their strategies for bringing this product t...
A MedTech Mindset with Eric Sugalski
October 29, 2018 04:00 - 38 minutes - 17.9 MBWelcome to Medtech Mindset, a production of Smithwise. This episode is a great way to tell if this podcast is for you. Eric Sugalski and Dan Henrich sit down to discuss the big picture of bringing a new piece of medical technology to market. We touch on product development and design regulatory pathways clinical evidence go-to-market strategy intellectual property other themes. In coming episodes, we'll explore these topics in more detail with guests who are experts in t...