This article is the second in a five-part series examining vital relationships in each stage of medical device development. Read part one here.
During the conceptual phase of medical device product development, we ensure that our intellectual property is protected, determine a regulatory pathway, qualify market demand for our solution, and secure the necessary budget or funding, among other things. Then what? It’s time to go 3D as we enter the design phase! This second phase of the development process can benefit greatly by forming relationships with three key design-related partners.
Deliberate Design Is Not Benign
The first vital design phase relationship is with an industrial designer. In Industrial Design: Reflection of a Century, Jocelyn De Noblet writes, “The role of an industrial designer is to create and execute design solutions for problems of form, function, usability, physical ergonomics, marketing, brand development, sustainability, and sales.” What a huge responsibility! Your industrial designer must be practical, creative, and knowledgeable in materials and manufacturing techniques. Additionally, he or she must understand how the product will be used and by whom, know how the product will be promoted, contemplate its fit with other products from the company, and know the entire product lifecycle from cradle to grave.
Another critical responsibility for the industrial designer is the application of human factors/usability knowledge. Steve Jobs is credited with saying, “Design is a funny word. Some people think design means how it looks. But of course, if you dig deeper, it’s really how it works.” The past decade has seen an increasing focus on human factors and usability in medical device design, and you need to be sure that your industrial designer is up to speed on the requirements. For a device to be safe and effective, the industrial designer must ensure the user understands how it works and how it is to be used.
Standard methods for human factors engineering were even included in the third edition of IEC-60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The FDA has come to expect usability analysis when reviewing premarket submissions. Device companies receive requests for additional information during the 510(k) process when human factors are not addressed in the submission and, sometimes, their 510(k) submissions are rejected via the Refuse to Accept Policy for this omission.
The FDA issued last February draft guidance on the highest priority devices for human factors review, clarifying for medical device manufacturers which types of device should have human factors data included in premarket submissions. The agency believes these device types have clear potential for serious harm resulting from use error. Your industrial designer must be aware of this. According to Elon Musk, “Any product that needs a manual to work is broken,” but the business magnate — whose successes include SpaceX and Tesla — has not yet wrangled with the FDA. Good industrial design and clear instructions for use minimize use errors and increase patient safety.
Medical Device Software Is Hard
The second vital design-related relationship, if your device includes programmable electronics, is the software engineer. Software has long been a concern to regulators since it does not behave in a deterministic manner, like mechanical components or even discrete electronics. Hardware can be validated once it is designed and assembled to ensure it will perform its intended function and meet user needs. However, it is impossible to exhaustively test a software application once it is compiled. Given that system inputs can occur in many combinations and at different points in time, paths through the code are virtually infinite. A software engineer must acknowledge this and follow a structured development process, providing adequate documentation to minimize risk of an undesirable outcome.
The software engineer must be fluent in addressing the FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The FDA also has recognized IEC-62304 as a consensus standard for the medical device lifecycle process. Both of these documents outline the processes and documentation necessary for a premarket submission, depending on FDA’s level of concern with that type of software, be it minor, moderate, or major.
Finally, explore your software engineer’s perspective on agile software development (ASD). ASD comprises a set of principles under which requirements and solutions evolve during the product development process. ASD progresses in smaller, incremental efforts (known as sprints), unlike a traditional waterfall development process, which begins with documentation of all requirements and progresses, sequentially, through coding, verification, and validation.
ASD has been increasing in popularity, and it has shown promise for reducing total development time while increasing engagement. However, you must make sure your software engineer does not lose sight of the necessity to produce the required documentation for FDA submission. AAMI TIR 45:2012, Guidance on the use of AGILE practices in the development of medical device software, has been recognized as an FDA consensus standard, so the door is open as long as your software engineer is on board.
No Risk (Management), No Reward
Last but not least among key design-phase relationships is a good risk management professional. The most important characteristic for this member of your team is their ability to collaborate. When it comes to identifying and analyzing risks, and making decisions about necessary mitigations, it takes a village. Your risk management professional will lead the process, but he or she requires input from marketing, clinical or medical professionals, engineering, manufacturing, and service, along with reviews of field and industry history.
A good risk manager is open-minded, initially inviting all risks to be placed on the table for consideration. The key is having an efficient process to guide the risk management process. In that respect, we are fortunate to have an excellent standard to reference. ISO-14971, Medical Devices – Application of risk management to medical devices, has been in existence for nearly 20 years. If your risk manager has experience with ISO-14971 and is a skilled facilitator, you will achieve regulatory clearance and consumers will benefit from a safe medical device that improves quality of life.
Just remember that risk management during the development phase is essentially a snapshot in time; risk management never ends. Be sure that your risk manager stays on top of complaints and field experience to facilitate post-market risk assessment, and uses that information to update the analysis as time progresses.