Hardware Podcasts

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

Let's Combinate · 24 Jun 2026 · 14m

What this episode covers

Subhi Saadeh, Founder of Let’s Combinate, explains why selecting commercially available finished medical devices for combination product kits creates significant regulatory and quality challenges. He argues that an 'already approved' device is not automatically qualified for a new combination product context, as the buyer inherits the supplier's design, QMS, and validation decisions. Saadeh outlines three critical lifecycle moments—before, during, and after supplier selection—to mitigate risks, emphasizing the need for structured qualification using PPAP concepts like PFMEA and control plans. He warns that assuming commercial availability equals suitability often leads to late-stage failures, such as coring issues or market approval gaps.

Most relevant to

early-stage companies

Topics

Mentioned

Tools
PPAP, PFMEA
Also
FDA

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