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by Wade Tipton and Jon Powell
The challenges of bridging the ‘design transfer chasm’ are well known in the medical device industry. If your approach to design and innovation has not fully anticipated the intricacies of volume production in a regulated environment, then difficulties will arise when it is sent to your manufacturing partner to be made at scale.
Developing high volume medical devices is a complex challenge, there are many issues beyond the design itself to consider such as usability, component cost, part variability and suitability for high-speed assembly and inspection. Product designers creating new products from a clean sheet often rely on manufacturing engineers to rectify issues later down the line.
Unfortunately, rectification can be a tortuous process as each design change can have many unintended knock-on effects. When manufacturing delays impact the launch of a product, the direct costs and financial damage can be significant. The window of opportunity in which to sell a new product while it is still under a patent is limited, causing unforeseen harm to income potential.
Some contract manufacturers address this concern by offering a design and manufacture package, however this strategy can leave the manufacturer’s intellectual property and know-how embedded in the product. This ties in the manufacturer and restricts your ability to control supply chain profit margins in the long term by competitive second sourcing, adding risk in the future.
To address these challenges, Cambridge Design Partnership has created a product innovation model called Potential Realised. We find it offers a better solution by developing the new product within an environment where a holistic team of product development and manufacturing engineers work in parallel. The benefit of having the design and manufacturing teams working closely together is that production problems are foreseen, and issues fixed quickly, by either design or manufacturing changes.
The key step that leads to the success of this approach is a robust phase of short-run manufacturing organised by an extended design team towards the end of product development. The manufacturing team develops a comprehensive pilot manufacturing process which includes tooling and process qualification. This run provides both regulated product for clinical trials and verifies the capability of the design and manufacturing process.
The result is a detailed and tested package of manufacturing documentation alongside the completed technical file and clinical trial data. The designs are handed over with a quality control plan, standard operating procedures, jigs, and validated test methods. This means that all the intellectual property including the know-how relating to both the design and manufacturing process is transferred, enabling a competitive tender process to identify the most cost-effective volume manufacturing partner.
A key advantage of Potential Realised is revealed when conducting clinical trials. Trials normally start between design and full manufacture, so there is a danger that if design transfer requires alterations to the product, elements of the controlled clinical trial may need to be repeated. There are countless examples of pharmaceutical companies needing to repeat or extend clinical trials due to delivery device design changes during design transfer, or to take extra time to perform bridging studies to demonstrate to regulators that changes have not impacted clinical performance. Instead, with the Potential Realised approach, a short manufacturing run for clinical trials is integrated into the development process and is conducted in a manner representative of how the product will be made once it goes into volume manufacture, thus significantly reducing these risks.
In the field of medical device innovation, Potential Realised integrates short-run manufacture into product development bringing a raft of advantages, not only saving both time and money in commercialisation but bringing forward product launch and vital product revenues.
You can meet the team behind this blog at Med Tech Innovation Expo on stand F30, 15 - 16th May at NEC Birmingham.
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