POC Development: When to Engage a Contract Manufacturing Partner

If your company is developing a complex point-of-care (POC) instrument, and is planning to hire a contract engineering, manufacturing partner to design and manufacture the instrument itself, at what point should you engage the partner?


Point-of-care instruments can require intricate disposable cartridges, which contain growing technical complexities and 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 cartridges. Such changes to the medical device design can result in costly re-designs and lost time if not approached with forethought and planning from the beginning. That's why it's important to integrate a contract manufacturing and engineering partner from the start. 

To clear this hurdle, first evaluate and demonstrate 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 a contract manufacturer early in the process.

Partnering early in the project 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 for medical instrument engineering, design and manufacturing ensures that the cartridge and instrument work perfectly together, which helps avoid costly changes and a delay to market.

What does your manufacturing readiness checklist look like? Download KMC Systems' Manufacturing Readiness Review Checklist to learn more about our process.  

Download KMC's Manufacturing Readiness Review Checklist

Topics: contract medical manufacturing