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Episode 3

Increasing Speed to Market For MedTech Startups with Bold Type

Aired On: November 7, 2023

Hosted By

Michael Roberts

Michael Roberts

Justin Bantuelle

Justin Bantuelle

Medtech startups tend to underestimate the balance that’s needed across three key factors of development: cybersecurity, usability, and software architecture. Host Michael Roberts welcomes Health Connective’s Justin Bantuelle and Bold Type‘s Jose Bohorquez, Mohamad Foustok, and Andres Echeverry to dive deep on increasing speed to market.

Resources

  • Bold Type
  • Bold Type’s Blog
  • March 2023 FDA Cybersecurity Guidance

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Download Transcript

In this Episode

  • 00:01:41 – Security Considerations
  • 00:12:46 – Usability: A Definition and a Comparison to Marketing
  • 00:22:41 – Software Architecture

Quotes From This Episode

Cybersecurity is an ongoing threat. So you may analyze your system, put in place all the controls needed to submit a secure system today, but that’s not enough. The FDA will then turn around and say, okay, how do you maintain that posture? How do you ensure that your device remains secure six months after release, eight, 12 months, etcetera? So you need to propose to them a plan on how you will achieve that. Now, I haven’t seen this yet, but it’ll be interesting to see if FDA does follow through with all this. 

Mohamad Foustok

Surrendering possibilities is one of the hardest things in product development because everybody wants the best product possible, the widest scope possible that reaches as many different markets as possible. 

Andres Echeverry

If your focus is time to market, don’t cut corners early, especially like the really good high-level stuff like your user analysis, your task analysis, your cybersecurity analysis, your usability stuff. It’s important to do that stuff early, and it’s a process that will really help you understand what the requirements need to be, which is also one of those things that is just necessary to do as part of design controls. So don’t think that you’re saving time. You’re actually probably going to cost yourself a lot of time if you don’t do those things early. 

Jose Bohorquez
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