Episode Details

Alex Shaw with Archimedic

Published 16 hours ago

Description

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 heavi