Dan Purvis, CEO and co-founder of Velentium, highlights seven areas for medical device manufacturers to consider when designing their product.
Designing a medical device is not a simple undertaking. With advances in automation and AI happening alongside the buzz over “disrupting” industries, it’s not uncommon to see start-ups with big dreams of creating new tech that delivers superior therapies, improves patient outcomes, and changes the course of medical innovation. These are great dreams – they deserve to be pursued. But as all companies who enter this arena discover, there’s a lot more going on in medical than in typical consumer projects.
One major concern in medical device design is minimising time-to-market. This is a critical metric not just from an ROI and cost-recoup standpoint – sometimes, “one more month” can mean the difference between sink and swim – but because delay means a lengthier wait before your device is available to patients.
Time-to-market represents efficiency of cost and schedule. Failure to hold it down usually stems from not paying enough attention to seven key design considerations. Keeping these at the forefront of your design efforts may feel like an overabundance of caution but pays dividends later in the lifecycle and reduces overall time-to-market.
- Keep it simple. If you want an MVP, as in Most Valuable Player, design an MVP – as in Minimum Viable Product. Maintain an uncompromising, laser-like focus on your device’s target indication. Deny “feature creep.” Ruthlessly cut “nice-to-haves.” Remember, you can add new features to the next generation.
- Design with approval in mind. When it comes time to approach regulatory bodies like the FDA, you’ll need a DHF – Design History File. As its name suggests, this is a complete record of the entire design and development history of your device. Retrofitting this document package after the fact won’t pass an audit. Don’t neglect regulatory research during R&D. From the outset, you need to know who the approving authorities are for each of your target market regions and what they expect.
- Design with the user in mind. Whether your intended users are trained professionals or patients, human factors are a big deal. You’ll have to design and get approval for formative and summative studies that demonstrate the usability of your device. Interface design and user experience should be accounted for early. If you tolerate clunky and arcane at the proof-of-concept stage, you’re setting yourself up for a hard pivot to simple and intuitive. It could mean scrapping your concept work and starting back at square one.
- Design with security in mind. Regulators expect manufacturers to prove that their devices are secured. This means conducting vulnerability evaluations and deploying mitigations during design, employing best practices during development and production, and being capable of monitoring emerging cybersecurity threats and securely delivering remote updates to devices “in the field.”
- Design with Manufacturing in Mind. How “fiddly” are your manufacturing procedures? Unnecessary manual processes and custom inventory drives up lead times, takt times, and production costs. And what about testing? Testability is an important part of design and development. With the right planning, the same test system designed to characterise your device can be efficiently scaled for validation testing, verification testing, and ultimately, manufacturing testing on the production floor.
- Sprint to gate. The regulatory environment appears to demand a “classic waterfall” or “engineering vee.” Rigid adherence to this paradigm is slow, but it’s more than possible to adopt agile principles within the formal approach. During project planning, map design and development milestones as “gates” and schedule sprints for each one. This sets the pace, keeps energy high, and allows you to see resource loading challenges before they turn into problems.
- Design with speed in mind. Once you’ve mapped your project plan and resource plan as a series of sprints, you can minimise your team and maximise your effort for each “gate.” Parkinson’s Law suggests that work expands to fill the time – and team – allotted. Divvying up the project enables efficient working groups, involving no more people than is needed to reach each milestone in the allotted time.
