Dick Rubin has over 30 years of experience in the lab instrument industry, an educational background in chemistry and a certificate in FDA regulatory affairs. As a Senior Manager of Engineering Solutions at Plexus, Dick works with Plexus engineering staff to draft development solutions and supports active development projects to ensure Plexus’ commitment to flawless execution.
Q: What trends are you noticing 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. A pull for more point-of-care and home-use technology is also driving innovation. In particular, we’re seeing more companies looking to move instruments from Research Use Only (RUO) applications 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 between high quality and cost-effectiveness. Realizing such products 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 clinical market?
A: With expertise across the product lifecycle, from initial design to manufacturing to aftermarket services, Plexus can partner with the customer’s clinical team to address any documentation gaps before categorizing the assay, or instrument, as an IVD device capable of clinical applications.
Our team brings deep familiarity with the complex regulatory environment that life sciences products need to navigate for market clearance. We have decades of experience developing healthcare and life sciences products ranging from Class I to Class III, and 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 bring an RUO instrument to market?
A: We recently helped a customer transition an RUO instrument to IVD application for COVID-19 in the near term, and other diagnostic applications afterward. This involved critical analysis and partial redesigning of a system that was originally built for lab use to obtain IVD certification. It may sound simple, but one thing that’s frequently missed in RUO product development is a rigorous quality system for documentation of initial design inputs, and the subsequent crosscheck to ensure design outputs meet the input objectives.
For this application especially, time was precious. We leveraged as much of the system’s existing components as possible in the redesign to save time. Using a systems engineering approach, we brought our full depth of experience to the table to get this project to market quickly. We also worked to ensure the customer met all regulatory requirements, including EMC, electrical safety and IEC 62304.