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Plexus Q&A: Taking RUO Products from the Research Lab to the IVD Market

DATE: 06 Aug, 2019

Bill Fitzgerald is the Director of Engineering Solutions, Life Sciences at Plexus. A member of the Plexus Engineering Solutions team for 12 years, Bill is focused on providing product development and commercialization solutions for customers within the life sciences market.

Q: Where do you see commercialization becoming more important in the market right now?

A: Scientific innovation across the life sciences industry is driving the rapid expansion of the instrumentation market with products that provide better results, faster. In particular, Research Use Only (RUO) applications seem to be growing at an exponential rate and many companies are looking to pursue in-vitro diagnostic (IVD) applications with the same instrument.

This is a big undertaking, which is why companies find value in working with Plexus. Commercializing an RUO solution for the IVD market comes with challenges, such as greater regulatory demands, and finding the optimum balance for a high-quality, yet cost effective product requires a unique, technical skill-set and strong understanding of the regulatory environment.

Q: How do you help companies make the leap from the lab to the commercial market?

A: With expertise across the product life cycle, from initial design to manufacturing to aftermarket services, Plexus can partner with the customer’s clinical team to address any control gaps that exist before categorizing the assay, or instrument, as an IVD device capable of clinical applications.

That expertise is also combined with a deep familiarity of the complex regulatory environment that life sciences products need to navigate. FDA regulations are simpler for RUO solutions compared to those required for the IVD market. We have decades of experience developing healthcare and life sciences products ranging from Class I to Class III. We also continually invest in our regulatory and compliance expertise to ensure the safety, dependability, and quality of the products we support.

Q: Can you describe an instance where you helped a customer get to market?

We helped one major company bring an HPV diagnostic system to market that could screen women for cervical cancer. This involved redesigning a system that was originally built for lab use to obtain IVD certification. 

Time was precious. We needed to help the company get to market ahead of competing HPV diagnostic offerings. To do this, we leveraged some of the system’s existing components in the redesign to save time. We also worked closely with the customer to realize the efficiencies of having a single partner. For example, we were directly involved with prototype trials and testing. This helped us iterate the design as we discovered areas to improve, or as requirements changed.

The project was completed in less than three years, helping the company capture early share in the market. Using our deep regulatory experience, we helped the company comply with all regulatory requirements, including EMC, electrical safety, and IEC 62304.