Blog Article
As part of our strategic partnership with Aptyx, we've co-created a practical checklist for MedTech founders on one of the most consequential decisions an early-stage company makes: which capabilities to build in-house, which to leave with a manufacturing partner, and when that answer should change.
What we did together
The piece brings together two perspectives on the same problem. Aptyx sees it from the manufacturing side, supporting programs from early prototype through full-scale commercial production. Guided Solutions sees it from the search side, building the leadership teams that sit around those devices. Between the two of us, the same question comes up on almost every program, so we decided to work through it capability by capability.
The checklist is anchored in a real Aptyx program: a physician-inventor who arrived with a clinical vision and a sketch of an aortic implant, but no delivery system, no documented specifications and no quality system. Aptyx held the program's design controls in its earliest years, and the device went on to CE Mark approval, FDA Breakthrough Device Designation, full FDA premarket approval and acquisition by a global medical device company, with Aptyx still the manufacturing partner more than a decade later.
What's inside
- Three ways to close a capability gap: build it, partner for it, or bridge it with a fractional or interim resource
- The gap that shows up most often: why a regulatory, or ideally clinical-and-regulatory, resource matters long before design freeze
- A Capability Map: covering design and engineering, quality systems, manufacturing, regulatory strategy, and commercial and clinical leadership, with the signals that tell you it's time to bring each one in-house
- The Startup Hiring Self-Check: 21 items across five categories that founders can work through against where their program stands today
Read the full checklist and work through the self-check on the Aptyx website: https://aptyx.com/blog/what-a-cdmo-wishes-every-startup-knew-about-hiring/
About Aptyx
Aptyx is a leading contract manufacturer for the medical device industry, with 75+ years of experience and a global network of 10+ locations across the US, Canada, Mexico, and China. Its integrated capabilities span design and development, complex molding, precision extrusion, specialty coatings, and finished device assembly. ISO 13485:2016 certified and FDA registered, Aptyx serves MedTech companies from early prototype through full-scale commercial manufacturing. The program featured in the checklist sits within Aptyx Interventional Systems, the division delivering expertise in implants, complex catheters, and delivery systems. Learn more at aptyx.com.
