Its never too early to start capturing design history files for medical devices.
Let’s first start with some clarifications on what is a Design History File (DHF) for a medical device, versus Design Controls, versus Design History File Ready Ideation (DHFRI).
Design Controls are part of a formal regulation (such as the FDA’s Quality System Regulation) and/or standard (such as ISO 13485). Established medical device companies will have a quality system in place and typically have a specific standard operating procedure (SOP) for Design Controls.
DHF is a documentation process that captures key relationships, often called a Trace Matrix, of User Needs, Design Inputs, Design Outputs, Verification, and Validation. The DHF will also capture history of risk reduction and Human Factors Engineering formative and summative studies.
There is most definitely a “too early” zone for Design Controls. One clear demarcation line is if you haven’t yet started a company. In this case, there’s no quality system and no SOP to be compliant to. It wouldn’t make sense to draft an SOP and/or implement such a strict quality system prior to starting a company.
However, it’s never too early to start capturing design history, aka, the building blocks for that Trace Matrix. Even at the earliest stages of a clinician and engineer talking together about potential problems; user needs are being captured for inspiration. But are they being used to build a foundation for future Design Controls?
The pain of turning on Design Controls pales in comparison to the pain of building a trace matrix. Capturing unmet needs and then articulating them into well defined user needs can be a fun process when embraced throughout the design process. However, when trying to articulate needs that are going back in time, potentially years of design history past; that’s painful. And that’s just one column of the matrix.
Design History File Ready Ideation (DHFRI) is a framework that encourages fun, iterative, and innovative design practices while assembling the foundation of future design controls.
It’s never too early to start DHFRI.
Dr. Andrew DiMeo is a 20 year seasoned expert in the Biomedical Engineering industry. He is founder and former executive director of the NC Medical Device Organization, which became an NC Biotech Center of Innovation. He also co-founded and became VP of Business Development for the design and manufacturing company EG-Gilero.
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