My company is developing a complex disposable cartridge for a point-of-care technology, but will hire a contract partner to design and manufacture the instrument itself. At what point should we engage the partner and begin the design phase?

Walter Gilde, Business Development Manager, KMC Systems, Inc.

Point-of-care (POC) instruments can require intricate disposable cartridges, which contain multiple reagents to process only one patient sample at a time. Given this complexity, changes in the disposable design can be a precursor to major architecture overhauls in the instrument that processes the cartridge. Such changes to the medical device design result in costly re-designs and lost time.

To avoid this pitfall, we first recommend demonstrating feasibility before beginning the hardware and software development of the instrument. Because cartridge and instrument design are so interrelated, it is also critical to involve the contract design and manufacturing partner early.

This allows both parties to prioritize features and functions at the concept stage in order to meet end-user price and performance requirements. Using a well-defined proven process ensures that the cartridge and instrument work together, which helps avoid costly changes and a delays to market.

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Have a question that’s not answered? Send your question to Bob Evans at kmc@elbitsystems-us.com and check back for the answer.