Contract manufacturing
with clinicians. “Our task is to look into and develop ideas, build prototypes and gain feedback, and to develop these ideas further to join the regular development later on if it comes to a product decision,” he says. Using the CIARTIC Move as an example, Gemmel
explains that clinician involvement throughout the design transfer process is crucial for success. After soliciting clinical feedback from around the world, Siemens learned that many surgeons were frustrated by conventional imaging processes, which rely on surgeons communicating with another person to receive the correct image. “The obvious idea was why shouldn’t we enable
the surgeon to do this task on his or her own?” asks Gemmel. “Then we communicated this idea with our close collaboration partners, built a prototype and involved more and more clinicians.” Gemmel says it’s best practice to involve
“outsiders” – medical experts outside a company’s connected community – to preserve an idea’s core functionality from prototype to product and to check that assumptions hold throughout the process. While working on the CIARTIC Move, Gemmel and his team held frequent meetings with surgeons, nurses and suppliers to ensure the final product would not contradict the device’s original purpose. Tim Richter, head of industrial design at Siemens
Healthineers, says finding ways to make design transfers successful within technical limitations is crucial. “It’s bridging the gap between a showcase and the real product. And with technical limitations, I also include manufacturing costs that can be expected and accepted in the market.” Richter highlights the need for extensive user testing
and says prototypes often don’t graduate into products because of a lack of user feedback. Some devices don’t offer the advanced functionality users want, while others are too complex and cumbersome to use. Software, not just hardware, is a part of more and more medical devices, Richter notes. Failing to focus on the interaction between hardware and software can cause costly delays in the transfer process. Prototypes need to account for all the manufacturing
processes required to produce products at scale, Richter explains. Siemens works with multiple manufacturers to produce products, which solves some problems but can also create complications. “Sometimes we source from different
manufacturers for one system, and then you have to consider colour deviations of parts, tolerances and timelines,” Richter says. “You need to consider all the different influences when you bring parts together from different sources.”
Making design transfer a continuous process
Liza Davis is vice-president of R&D – endoscopy new product development at Boston Scientific. For Davis,
www.medicaldevice-developments.com
the biggest challenge in managing design transfers is ensuring ideas translate into products that perform consistently at scale. A prototype demonstrates what’s possible, Davis says, but manufacturing requires repeatable processes, reliable suppliers and standardised quality systems. “In Boston Scientific’s endoscopy portfolio, we think about manufacturability early because meaningful innovation isn’t just about developing new technology – it’s about delivering reliable technologies that help physicians provide high- quality care to every patient, every time,” Davis says. “That means designing products that can be manufactured consistently without compromising quality or performance.”
Davis believes design transfer can be difficult because it’s a highly collaborative phase of the product life cycle and the point at which ideas move from prototypes into actual clinical practice. The strongest design transfers aren’t a single hand-off; they’re the result of continuous collaboration throughout the process, she explains.
“It’s important to involve manufacturing and quality engineers early.”
Liza Davis, Boston Scientific
“Throughout development, we’re listening to physicians, learning from manufacturing teams, and refining the product so innovation can successfully move from concept to clinical practice.” Davis explains that design transfer delays often occur when manufacturability, supplier readiness or process validation aren’t addressed early enough. The strongest outcomes come when engineering, manufacturing and quality teams work together from the outset to anticipate challenges before production begins, she says.
Davis advises those interested in traversing the transfer gap to build partnerships, not just conduct transactions. “Successful collaboration goes beyond exchanging drawings and specifications. Teams should understand not only ‘what’ needs to be built, but ‘why’ design requirements matter,” she says. “It’s also important to involve manufacturing and quality engineers early, encourage open communication and establish shared measures of success,” Davis notes. “When everyone is aligned around delivering safe, reliable technologies, design transfer becomes a collaborative development process rather than a transactional hand-off.” Ultimately, Davis adds, design transfer is about more than moving a product into manufacturing. It requires ensuring that innovative ideas become reliable technologies that help physicians expand treatment options and improve patient care. ●
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