Contract manufacturing
“Micro moulding knowledge must be transferred to younger engineers and technicians to ensure broader diffusion of the technology.”
machine vision and complementary assembly systems. Additionally, with the need to focus on process sustainability and life cycle assessments, they have developed a “broad device portfolio” that includes implants, dental devices, surgical tools, drug delivery systems and devices with functional surfaces. Here, Whiteside feels there will be further challenges owing to “significant pressure” on medical device designers and manufacturers to “pivot towards multi-use devices with sustainability credentials without posing extra risks to patients”.
Sharing knowledge
Distributing insight and collaboration is crucial in not only driving production forward but preparing for challenges on the horizon, says Masato. This may include adapting to still-emerging concepts, such as automation and AI. And this will be “critical to ensure global competitiveness”, he adds. Here, clear and active communication is key. Whiteside agrees: “Ultimately, excellent teams of designers, researchers, equipment/ tooling providers and a CMO with streamlined communication lines and complementary skills provide a solid foundation for navigating challenges of bringing a disruptive device to market.
“Partnerships are important and we have collaborators worldwide to support our work,” he continues. For instance, his department doesn’t focus on tooling – rather, Whiteside says their expertise is “understanding links between material formulations, process environments and functional properties of resulting components”.
For instance, many of the polymers they use are highly sensitive to heating rates, flow rates and stresses typical of microinjection moulding processes. This may sound challenging, but it provides an opportunity to create manufacturing processes for optimised products, he adds. “This can be particularly important for drug/polymer systems where poor choice of process parameters can result in reduced efficacy of active
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ingredients, due to degradation… a good knowledge of materials and process can actually allow us to control the pharmacokinetic behaviour of the systems.” Yet the team has dedicated years to building relationships with field leaders who provide micromachining, laser machining and lithography-based approaches, to access tools with the necessary precision and durability. Whiteside also encourages knowledge- sharing conversations to begin early. Crucially, this can help manufacturers also avoid potential hurdles down the line: from ensuring that new processes align with downstream implementation expectations and realising potential cost efficiencies during the scaling-up periods. That includes swapping notes with the next generation of specialists, adds Masato. “Looking ahead, a key aspect will continue being workforce development… micro moulding knowledge must be transferred to younger engineers and technicians to ensure broader diffusion of the technology plus more efficient design and manufacturing processes.”
Regulatory hurdles And then there’s the need to ensure new processes are aligned with regulations. One way that manufacturers can avoid slipping up is to regularly update their knowledge base in this area.
“A significant shift from standard manufacturing processes can introduce hurdles as you advance through the technology readiness levels and engage CMOs to address scale-up and regulatory requirements,” warns Whiteside. Technology readiness levels (TRL) are a scale from one to nine that measure the maturity of a particular technology. Here, TRL 9 means that the technology has been qualified. “CMOs can provide innovative manufacturing approaches, but methods that stray significantly from standard manufacturing processes can result in increased risk. So, it’s important to have effective communication between the research and CMO teams to work together to view challenges from both perspectives and develop effective solutions,” he suggests. Whiteside’s department has expertise in ancillary systems, like in-line machine vision for process quality assurance, robotic assembly systems and packaging solutions for fragile components. As a result, he says they can collaborate effectively with CMOs to define optimal strategies, while they, in turn, advise on meeting regulatory requirements, such as ISO 13485 compliance, and identifying the most suitable sterilisation methods. Ultimately, through forward- planning, communication and strong regulatory knowledge, CMOs should be able to overcome the inevitable hurdles they will come across during their micro moulding projects. These aren’t necessarily the easiest of tasks, but with research, persistence and flexibility, they can be overcome – and prove fruitful. ●
Medical Device Developments /
www.medicaldevice-developments.com
Andika Nur/
Shutterstock.com
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