18 Sep Amplify MedTech – De-risking MedTech Product Development – From Idea to FDA
Amplify MedTech Recap – De-risking MedTech Product Development – From Idea to FDA
On September 18, 2025, Amplify MedTech’s Dr. Fehmida Kapadia hosted an hour-long online panel on de-risking medtech product development, featuring insights from Lauren Eskew (Key Tech) and serial entrepreneur Steve Schaefer (CoolTech/MiHelper). The discussion explored early-stage challenges like product-market fit, regulatory strategy, and subsystem risk reduction, as well as best practices for usability, manufacturability, and scaling. The speakers emphasized designing with the end in mind, setting clear pass/fail criteria, and strategically sequencing features to balance innovation, regulatory approval, and commercial success.
Watch the full episode here:
Alexis coordinates Key Tech’s marketing and business development efforts alongside Andy. She is also active corralling the undergraduate recruiting process at Key Tech. Alexis previously worked for an AM 100 law firm in marketing communications where she specialized in event planning. She received a BA and MA from Shippensburg University in Applied History.
A history nerd at heart, Alexis fits right into the quirky culture at Key Tech (though she still can’t speak binary). Weekends are spent chasing her two boys and spending time on her boat.
A history nerd at heart, Alexis fits right into the quirky culture at Key Tech (though she still can’t speak binary). Weekends are spent chasing her two boys and spending time on her boat.
Latest posts by Alexis McKenzie (see all)
- Amplify MedTech – De-risking MedTech Product Development – From Idea to FDA - September 18, 2025
- Key Tech Joins GE HealthCare-led Team Advancing Bacterial Detection - August 7, 2025
- SPARK Webinar – The Importance of Early DFX - July 17, 2025