Rank #1: Branding in MedTech with Bill Gullan
In 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
Jan 15 2019
Rank #2: Navigating Regulatory with Monica Ferrante
In 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 regulatory support
Feb 18 2019
Rank #3: Overcoming Pediatric Device Innovation Challenges with Matthew Maltese
In 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
Mar 25 2019
Rank #4: Clinical Evidence Insights with Joe Popowicz
In 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.
Nov 01 2018
Rank #5: Saving Infants in Respiratory Distress with Stephen, Anna, & Sunil John
On 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. Their father, Sunil, is a pediatric cardiologist and continues to split his time between practicing in Kalamazoo, Michigan and Nepal. Sunil is serving as a clinical advisor in the development of NeoVent.
They're working to bring NeoVent to market through their company, AIM Tech. You can contact them through their website or by sending an email to firstname.lastname@example.org.
"Every year, over one million infants die of severe respiratory illnesses, making it one of the leading causes of under five mortality in the world. 99% of those are in low to middle income countries, which shows you that there are good treatments for these conditions, but they're not reaching most of the world." -Stephen John, CEO, AIM Tech
Dec 04 2018