Use strategic collaboration to overcome these five common challenges in medical technology product development.
Overcoming obstacles to product development – the subject of a recent Device for talks on Tuesdays Celestica sponsored webinar – requires elimination of design silos and adoption of partnership opportunities. So how does this happen? Kevin Walsh, vice president of Celestica’s HealthTech division, and Kevin McFarlin, director of engineering, had some responses.
“It’s about protecting and nurturing a company’s intellectual property so that it gets to market as quickly as possible,” said Walsh.
As a service provider for OEMs and startups, “we seek to avoid errors in manufacturing and assembly processes,” added McFarlin, who described five common product design challenges and strategies for them. overcome.
1. Usability engineering: prioritizing
Emphasizing the criticality of the ease of use of a medical device, Walsh stressed that it is fundamental for widespread adoption and requires product developers to make a concerted effort to “design outside the vacuum” in order to understand. application and use of the product.
“The best way to do this is to perform usability testing in a simulated environment where users are observed interacting with the device, often revealing user interface errors,” McFarlin said. . Common user interface errors include unique multi-function buttons, such as an on / off button that also dims or brightens the screen, resulting in uncertainty in the operating room. Other UI errors can include misusing the high alert colors (red and yellow) for situations that do not require intervention by a surgeon or doctor. In addition, improper handling of printing errors can lead to the appearance of pop-up windows that may cover the patient’s physiological information displayed on the screen.
To perform usability testing, Walsh advised auditors to consider partnering with a design and manufacturing service provider with easy access to medical professionals and observation rooms equipped with one-way mirrors.
2. Early collaboration between design and manufacture: start early
Another proactive measure in the product development process comes from the Design for Manufacturability Assessment (DFM). Even when a company only has a computer-aided design model, McFarlin said it wasn’t too early to hire a design and manufacturing services partner with in-depth knowledge of the manufacturing process. medical devices for evaluating such things as the effective orientation of components for assembly. “We can do design workshops and we have specialized software to identify design considerations,” he said.
3. Independent design reviews: consider using a manufacturing partner as a reviewer
When left to design products in a vacuum, design teams often focus exclusively on demonstrating the feasibility of core functions. Tunnel vision, McFarlin said, can cause them to overlook serious design issues, which is why the FDA requires design reviews using independent reviewers with relevant technical experience or training. While McFarlin noted that a member of the design team can serve as a reviewer, he questioned whether such a person could be a truly independent reviewer. Instead, a service provider acting as a manufacturing partner “might be a good option to counter the stigma of your group,” he said.
4. Pre-compliance testing: Test early and often
Once there is a first working prototype, it is time to proceed with pre-compliance testing such as electromagnetic compatibility (EMC). In the case of EMC, the project team must measure emissions and assess frequencies because it “focuses on the offending frequencies,” McFarlin said.
Pre-compliance testing is a great tool, according to McFarlin, who has advised its use early and often to ensure that the product architecture meets safety standards and that there are no issues with electromagnetic compatibility. “Fifty percent of devices, noted McFarlin,” will fail EMC tests the first time, “which makes the mantra early and often even more critical.
5. Eliminate manufacturing challenges by design: incorporate design techniques to make products easier to test
To eliminate manufacturing challenges, product developers and their service providers should strive for a complete design for testability to reduce test times while improving manufacturing time so costs are lower, better yields and faster time to market, McFarlin concluded.
Finally, from a quality standpoint, Walsh said, understanding the regulations is essential to ensure that a product remains viable once it hits the market. “Document, document, document,” he proclaimed. “Over 50% of FDA recalls are related to documentation. Do your companies have the necessary processes in place to ensure solid documentation? “
Since 1980, Cleveland-based writer-editor Joe Jancsurak has covered a myriad of medical, industrial and business topics for national publications and organizations.