Incorporating Design Controls can be a daunting task for medical device product development teams. For a variety of reasons, including unfamiliarity of regulatory expectations, inexperience with implementation, or viewing them as a burden preventing innovation, too many teams incorporate Design Controls reactively instead of proactively.
Here are three ways to proactively and practically incorporate design controls in your medical device development process that results in better market adoption, faster time to market, and regulatory compliance.
1. Plan for it
Design controls is not a singular activity or simple set of static deliverables that can be accomplished at the last minute successfully. Planning how your organization will incorporate design controls throughout the product development life cycle is key for a successful medical device product. At the highest level of planning is an organization’s standard operating procedure for device development that incorporates the major aspects of design controls. At the next level is the project plan for the development of a particular medical device. The complexity of the plans is scaled with the risk and complexity of the medical device being developed. Higher risk and higher complexity devices require higher sophistication of planning processes and tools than lower risk and lower complexity devices.
2. Incorporate risk management as part of your requirement setting process
Risk management is expected to be incorporated throughout the product development life cycle. One best practice is to perform the application risk analysis concurrently with determining user needs and the top level design inputs; not after development as a check-the-box activity. As risks associated for foreseeable misuse are uncovered, the team can proactively decide how the risk will be addressed, whether safety by design, protective measures, and/or information for safety and create a corresponding user need and/or design input. Now the team has a comprehensive list of requirements at the beginning of detailed design and development, not at the end.
3. Organize user needs, design inputs, and risk management information
Maintaining and organizing user needs, design inputs, sub-requirements, and individual risks is key to proactively incorporating design controls. In addition to the high number of items, there is the common scenario of many-to-one or one-to-many relationships that must be kept clear as well. For example, one design input can address multiple user needs or vice versa.
Thus, without proper organization, it is possible to miss creating a corresponding design input to a user need, linking a risk item to a corresponding design input, or missing the actual development of a design input during the development phase; all leading to unwanted, reactive last-minute development efforts. In addition, once the user needs, design inputs, and risk management are well organized, tracing the corresponding design verification and design validation efforts is much easier.
Choosing the appropriate tool can simplify these requirements management efforts. For lower complexity devices, management of design inputs and risk may be sufficiently organized using a word document or spreadsheet. Note that even a ‘simple’ device can create a list of requirements and risks of notable length. I’ve worked on a plastic sub-assembly that sat over a nasal spray pump as part of a drug-device combination device. With no mechanical moving parts or software, the list of design inputs still spanned a dozen pages, and the risk analysis FMEAs numbered hundreds of line items.
As the medical device or technology being developed increases in complexity, so does management of the requirements and risks. In contrast to a drug-delivery sub-assembly, I’ve also been involved with the development of a robotic surgical system. With a handful of sub-systems, embedded software and software user interface, the resulting requirements, sub-requirements, and sub sub-requirements were a challenge to manage via simple word docs and spreadsheets, to say the least. These days, software tools such as Jama Connect® allow for visual management and traceability of user needs, design inputs, risk management, design outputs, design verification, and design validation. With all items in an integrated platform versus disparate spreadsheets and documents that are linked manually, teams can spend less time on the requirements management, thus leading to faster, better product development with high confidence in meeting regulatory compliance.
These are just three of the ways to integrate design controls proactively into your organization’s medical device product development process. Proactive integration done practically adds value and enhances, not hinders, innovation.
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