Product Startup
Product Startup
Dec 1, 2021
104: Medical Device Certification vs Wellness Device
Play • 24 min

Bryon Bhagwandin is a 20-year medical device entrepreneur with over a half dozen products in the market. He has won a number of awards, including the Top100 in R&D Magazine. He also has a PhD from the University of Washington in Medical Devices and Hardware. Today Bryon is going to share some valuable knowledge for hardware startups, inventors, and small manufacturers on the difference between a medical device and a wellness device, and if going the medical device route, what are the steps and best practices to get certified.

Today you will hear us talk about:

  • The difference between medical devices and a wellness device
  • What are the benefits of a medical device (you can’t market into the clinical space without FDA approval)
  • Benefits of a wellness device over a medical device
  • What are the steps to get cleared as a medical device
  • Safety
  • Efficacy processes / user data of the prototypes
  • Manufacturing process
  • If you are already in the market with a wellness device, create a new improved medical version of the device.


Bryon Bhagwandin Link:

The Product Startup Podcast Links:

Mako Design Links:

Kevin Mako Links:

About: MAKO Design + Invent is the original firm providing world-class consumer product development services tailored to startups, small manufacturers, and inventors. Simply put, we are the leading one-stop-shop for developing your physical product from idea to store shelves, all in a high-quality, cost-effective, and timely manner. We operate as one powerhouse 30-person product design team spread across 4 offices to serve you (Austin, Miami, San Francisco, & Toronto). We have full-stack in-house industrial design, mechanical engineering, electrical engineering, patent referral, prototyping, and manufacturing services. To assist our startup and inventor clients, in addition to above, we help with business strategy, product strategy, marketing, and sales/distribution for all consumer product categories. Also, our founder Kevin Mako hosts The Product Startup Podcast, the industry’s leading hardware podcast. Check it out for tips, interviews, and best practices for hardware startups, inventors, and product developers. Click HERE to learn more about Mako Design + Invent!

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