Best-In-Class Integration of Design and Manufacturing

The development of a new medical device has two essential phases: design and manufacturing.  Both must be done with exacting precision, and the skill sets for each are different, especially when developing a new in-vitro diagnostic (IVD) or drug delivery device.  The former includes an in-depth understanding of the physical sciences related to micro-fluidics, magnetics, heat transfer, and strengths of materials, as well as developing intuitive user interface designs and related software and firmware development.  The latter requires an expertise in manufacturing processes, sourcing, process workflow, and reliability testing.  Some have tried to develop both of these functions under one roof, which is difficult, with inconsistent results.  But regardless, the design phase and the manufacturing phase are different, with discrete interface points where they need to talk with one another. The following is a summary of the best approach we have found for integrating these two phases.

How the process is structured

At Key Tech our sweet spot is design and development. We have seen a large number of our products through the manufacturing stage, and we understand and appreciate the intricacies of this work.  We also appreciate that we need to do what we do best, and work with best-in-class contract manufacturers (CMs), to do what they do best.

In most, if not all, IVD projects, there is a durable component (the reusable device) and the disposable component (the single-use disposable cartridge).  In most cases, the CMs will specialize in one or the other, rarely both.  Some CMs are best in class at making complex, electro-mechanical devices, while others make low-cost, plastic disposables with highly tooled fluidic chambers and channels.  Expect to need both, and that each will need a different CM.

The process of integrating design and manufacturing does not just happen one day, all at once. It has a gradual process, where the CM slowly builds their knowledge of what they will be soon manufacturing, and simultaneously shares their knowledge with the designers. This back and forth optimizes the overall process and development steps, and ensures the CM is comfortable and ready to ‘own’ manufacturing, when the times comes.   A high-level overview of the integration steps and sharing between the designers and the CMs is shown below.

In looking at this overview, there are three product development phases: Alpha, Beta and Pilot. The ‘Alpha’ product is the first physical rendering of the design once the architecture has been developed. The Alpha usually has the majority of the functionality of the final product, but it is not in a final form or with all the final materials or features. The ‘Beta’ product is typically the second prototype of the design, and is very close to the final sellable design, including the correct size and weight. The Beta is typically used for near-final performance and safety testing, and to identify any final bugs that remain. The ‘Pilot’ product is made exclusively by the CMs, with final tooling and production set up, and is considered the sellable product. This Pilot is used for formal safety and performance testing.

In the Alpha stage, Key Tech designs and builds both the durable instrument and the cartridge to centralize the integration of the two, which is vital.  Best in class CMs are identified pre-Alpha (by Key Tech or our client) and are introduced to the project as the Alpha design is being developed. The CMs provide input on design for manufacturing (DFM) and design for assembly (DFA) in the Alpha phase, as well as subsequent phases.  It’s worth emphasizing that the foundation for successful manufacturing transfer happens before the Alpha design is even locked down.  It’s smart to create sufficient Alphas of both the instrument and the disposables to share these with your CMs, which will allow for continued design input as the product develops.

There are times when our client needs Alpha cartridges in high volumes (hundreds or thousands), often to support assay development that is ongoing in parallel.  In these cases, we may transfer the cartridge to the disposable CM at the Alpha stage.  There are risks with this approach in that Alpha design changes are frequent.  Make sure your disposable CM is nimble and willing to adjust their manufacturing tooling and processes quickly based on real-time design changes.  Nimbleness is a strength at Key Tech, and one reason we like to do the early cartridge fabrication work.

In the Beta stage, Key Tech typically controls the designs and the builds of both the durable instrument and the cartridge to best control the seamless operation of the two, although some subassemblies may be transferred to one or both CMs.  Transition to cartridge manufacturing by the disposable CM generally works well at the end of the Beta.  Beta versions are very close to the final design and are in high demand.  Make enough Betas to share between all the team members, to support continued testing and design improvements.  Natural variations in a large volume of Beta builds will help reveal sensitive features that will need to be handled in final production.  We work with our clients to determine if Betas are appropriate for verification testing or if tests should wait for formal production pilot runs.  Usually, it is a mix.  Some testing can be performed with the Beta, while others need to wait. Safety screening tests are ideal with Alpha’s and Beta’s.

We have seen cases where the manufacture of Beta instruments is be split between Key Tech and the instrument CM. This can produce the best of both worlds: Key Tech efficiency can put early Betas in the hands of assay development teams and customers, while the CMs’ larger capacity can bring more Betas online to supplement these objectives. Additionally, this enables further design review input from the CM.  Throughout this process, Key Tech maintains ownership of design files through our PDM system, enabling us to properly track design evolution for eventual incorporation into the client’s design history file.

The Pilot stage, as expected, is when the CMs are responsible for all manufacturing, assembly, and testing.  This is the best time to transfer design history files to the CMs (or client) when the instruments and cartridges are in full production. This allows the client to more easily make future changes as needed.

Benefits of the process

Our approach is based on best-in-class designers and engineers, working hand-in-hand with best-in-class contract manufacturers.  It ensures a method that identifies and incorporates both design and manufacturing inputs at multiple stages, quickly and effectively, optimizing the design and minimizing unexpected delays. If you are interested in learning more about our transfer to manufacturing process reach out at TalktoUs@keytechinc.com.

Brian Murphy


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