Commercializing Medical Devices – From Technology to Product

Transforming a breakthrough medical technology into a commercially viable, FDA-compliant product requires navigating a complex matrix of engineering, regulatory, usability, and manufacturing hurdles. Tensentric provides turnkey design, development, and contract manufacturing for healthcare, diagnostics, and life sciences technologies. This session will provide MedTech innovators, researchers, and early-stage companies with a practical roadmap for bridging the gap between benchtop proof-of-concept and scalable commercial manufacturing.

What Participants Will Walk Away With:

Navigating Technical vs. Commercial Risks: Learn how to balance early-stage feasibility with long-term design transfer, usability requirements, and cost-of-goods (COGS) targets.

The "Phase Zero" Advantage: Discover how pre-design-control prototyping, rapid feasibility testing, and early risk reduction prevent costly redesigns downstream.

System-Level Integration Insights: Gain practical tactics for integrating complex multidisciplinary components across microfluidics, electronics, embedded software, optics, and human factors.

Smooth Transition to Manufacturing: Understand the critical steps to move seamlessly from design verification into ISO 13485 and FDA-registered contract manufacturing without losing momentum or design control integrity.

Company Intro

Tensentric’s team spans biomedical, mechanical, electrical, and software engineering, as well as industrial design, human factors/usability, and ISO 13485-compliant manufacturing. From early "Phase Zero" technical risk reduction through to FDA-registered low- to mid-volume manufacturing, Tensentric helps innovators turn complex technologies into safe, reliable, and market-ready medical solutions.

Speakers:

Luke Palombo

Director of R&D

Jusin Inslee

Director of Engineering