Design Controls

Medical Device design is simpler than I expected...

Sure, there is more documentation, more scrutiny, higher risks, higher costs and longer lead times, especially when clinical trials are involved. But I was actually surprised at how intuitive a lot of the processes are.

When consumer product portfolios start drifting towards medical regulation, you will hear phrases like "ISO 13485" and "FDA" whispered in the hallways like a teacher is about to catch us without having done our homework.

Understanding Design Controls really highlight how uncontrolled design can be in less regulated industries:

- Product visions sit in the mind of a Product Manager who is not in the office

- Out-of-date requirements hide in unwieldy documents or clunky software

- Engineers design, build and test with no real direction

- Design Reviews are for spinning CAD, playing with prototypes and giving personal opinions

- Decisions are made verbally by whoever is most senior or loud in a meeting

Design Controls force development teams to review and document decisions at regular intervals:

- Projects start with User Needs (stakeholder requirements)

- Design Inputs (product requirements) are clearly traceable to those User Needs

- Design Outputs (BoM, drawings, specs) represent an efficient manifestation of those requirements

- Verification confirms all Design Inputs have been met

- Validation confirms all User Needs have been met

Smart teams go further to tie User Needs with clear target markets and purchase drivers from the outset.

Even Clinical Trials sound terrifying but they just boil down to proving that the device is SAFE and EFFECTIVE.

If you're dipping your toe into medical regulations for the first time or if you'd like to see how a controlled design process can be applied to your product, book a call with me today.