While the overall R&D process for a medical device takes years, most of this timeline is absorbed by tooling and component lead times, market feedback, life testing, and regulatory approval. Design engineers often have only very tight windows to complete their next deliverable before the deadline.
To meet early stage deadlines, it is a common and accepted practice to design the proof-of-concept (POC) sample around readily available standard components with the intention of fine-tuning the design using customised parts during the next round of prototyping. However, ongoing time pressures during subsequent iterations can again make custom component lead times prohibitive. As a result, concessions made even in the most rudimentary prototypes frequently survive to production, lowering product performance and increasing total costs.
But it doesn’t have to be this way. Consider an alternative scenario, working with a strategic supply partner. Let’s assume that the design engineer needs a motor for their latest surgical power tool. A POC design is needed in three weeks with complete testing for regulatory submission in 6 months and volume production planned to commence in two years.
The deadline for the POC clearly dictates an off-the-shelf motor, but the design engineer chooses a concept stage supplier it knows can also deliver the necessary custom version and meet the right price and quality level for production. Within days or even hours of initial contact, the design engineer and the motor supplier could be in a conference call to discuss the long-term goals of the design.
The supplier recommends a motor that can be delivered within a week. It’s a standard motor, but, based on the supplier’s industry experience, it can be delivered ready tailored to the majority of the application requirements. The ability to incorporate common customisation requests into the motor results in a POC build that is closer to the final design criteria. This can avoid an extra iteration before design freeze, potentially saving many weeks or months, unnecessary engineering effort, and significant cost.
Any remaining customisation needed (output shaft configurations, dialled in windings and gear ratios, feedback systems, etc.) is planned during the initial discussion so the design engineer can account for the differences during POC testing.
Once the POC testing is complete, the strategic motor supplier can then provide custom prototypes in as little as four weeks when there is a cohesive development strategy that allows design work and long lead time component or tooling to be initiated pre-emptively. This leaves the device design engineer with ample time to complete product design work, iterate on the motor design, or resolve other issues before the six-month regulatory filing deadline.
After testing is completed on each iteration of prototypes, the motor supplier sends its engineers to the customer’s site for detailed design reviews of the motor and system. When it comes time to move to production, the design engineer has the assurance that the supplier is capable of executing the design.
The result of this collaboration is the successful incorporation of a custom motor which maximises power and efficiency while eliminating extra components and therefore reducing cost, size, and complexity. The total development time is also shortened thanks to the seamless transition between motor iterations and the elimination of surprises that could have rippled through the device design.
This scenario is based on Portescap’s real world experience of working collaboratively with medical device manufacturers at the earliest stages of a design. Over the years, Portescap has worked with the leading names in medical device technology, supplying precision motors, gearheads, encoders and assemblies for applications such as surgical power tools, infusion pumps and ventilators.
The relationship between the design engineer and the supplier is critical. More than just a reliance on the supplier’s ability to ship products optimised to the POC build within a matter of days, it is a relationship that is cemented in the supplier’s experience. The supplier must be trusted to anticipate and resolve common pitfalls, and to contribute design suggestions for product improvement. Ideally, the supplier should have a design and manufacturing team readily available for customer collaboration at all stages of the project.
Given some of the design challenges unique to the medical device market, design engineers should also look for suppliers whose prototype and new product development capabilities are structured to meet the requirements of that market. They should look for suppliers who have facilities with robust validation and change control processes that regularly pass quality audits relevant to the medical device industry.
Portescap can offer all of these assurances, while also offering a clear plan to achieve the target production price, built on a sound technology foundation with a wide array of options that won’t restrict the product design.
To take full advantage of such a supplier’s capabilities, the relationship must begin to be built at the concept stage or earlier, perhaps even as the first ideas are being bounced around. The right supply partner will be able to provide valuable insight to choose the best path from the outset. Just a few hours spent up-front with the supplier’s experts can reduce future design hours many-fold, cut overall development time by months, and ultimately deliver a better optimised and more valuable product to the market.