MTI: A New Approach to the FDA’s Special 510(k) Program
December 23, 2019
“A New Approach to the FDA’s Special 510(k) Program” by Tara Lysechko, StarFish Medical Senior QA/RA Specialist, is featured in the December 23, 2019,...
March 29, 2022
The March 29, 2022 online edition of Medical Device and Diagnostic Industry (MDDI) features Collaboration Is Key for Engineering Miniature Medical Devices by Aaron Philippsen, Mechanical Engineer at StarFish Medical. Philippsen explains why miniaturization is a chance to think a little differently to successfully integrate subsystems into compact medical devices.
Engineering decisions have additional constraints in the miniaturized realm. “In a miniaturized electromechanical device, the mechanical and electrical systems become more tightly integrated, and subsystem integration takes on more risk […] space is pushed to the limit. You can’t leave any buffer, and you can’t realize maximum spatial efficiently until all subsystems are fairly mature.”
Referring to the specific challenges encountered when working on the electromechanical systems for an ingestible capsule, Philippsen notes, “The design for the capsule interior took a lot of innovative development from the electrical team and the mechanical team with regular exchange to find an architecture that met space constraints.”
Philippsen turns to integration as another challenge in mechanical engineering miniature medical devices which can eventually turn out to be a “valuable learning experience” as “everything is designed to maximize the use of space, and you need a fairly mature design for each subsystem before you can design a spatially optimized version of each subsystem.”