Industrial Talk is onsite at MD&M West and talking to Alexander "Alex" Shaw, CEO at Archimedic about "Medtech design, regulatory and go-to-market strategies".

Overview Archimedic’s discussion focused on helping medical-device founders move ideas from concept through design, FDA regulatory approval, and commercialization. Core Approach
  • Alexexplained thatArchimedicsupports three connected areas: design, regulatory strategy, and go-to-market planning.
  • Most product failures occur because commercialization is not defined early enough; Alex estimated 70% fail for go-to-market reasons, compared with 20% for regulatory issues and 10% for design.

Examples And Outlook
  • Active Protectivesuccessfully developed a wearable fall-detection airbag belt, but had to shift from a consumer product strategy to a regulated medical-device pathway to generate clinical evidence.
  • A smart pill case worked technically but failed commercially because insurers could not support the infrastructure needed to assemble individualized blister packs.
  • Open question: Can medical-device startups regain sufficient venture-capital and grant funding to sustain early-stage innovation?

Outline Event And Company Context
  • AlexdiscussedArchimedicat MDNM West and described the event’s growth following the pandemic.

Alex’s Background
  • Background in biochemistry and drug development consulting.
  • Later moved into medical devices because of similarities in FDA regulation and development processes.
  • Became CEO ofArchimedicapproximately one and a half years ago.

Medical Device Development
  • Archimedichelps clients advance ideas through design, regulatory approval, and commercialization.
  • Early attention to market demand is emphasized before committing heavily to design and development.

Case Studies
  • Active Protective: wearable airbag belt for nursing-home residents; ultimately required clinical evidence and FDA approval.
  • Smart pill case: technically feasible, but the insurance-based commercial model was not viable.

Market Outlook
  • Early-stage medical-device companies have faced weak venture-capital and grant funding.
  • Alexexpects renewed funding could support additional innovation and patient benefits.

If interested in being on the Industrial Talk show, simply contact us and let's have a quick conversation.

Finally, get your exclusive free access to the Industrial Academy and a series on “Why You Need To Podcast” for Greater Success in 2026. All links designed for keeping you current in this rapidly changing Industrial Market. Learn! Grow! Enjoy! ALEX SHAW'S CONTACT INFORMATION: Personal LinkedIn: https://www.linkedin.com/in/m-alexander-shaw-3a7076a/

Company LinkedIn:  https://www.linkedin.com/company/archimedicdevice/

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