The idea is clear. Market analysis identifies the potential. Early prototypes confirm product viability. Now it’s time to get real and go to market.
On the journey to full-scale production for medical devices incorporating optics, a series of steps early in the process can make all the difference for successfully launching new products and introducing next-generation upgrades. During these critical early stages, working closely with the right partner can help minimize risks and maximize long-term return on investment.
Four considerations illustrate the need to build for the future from a strong foundation today.
One: Precision Tolerances—No Margin for Error
All medical devices built with advanced technology require a high degree of precision to meet real-world clinical requirements, but optical devices add a layer of complexity. Translating high precision optical designs at micron-level tolerances into viable, manufacturable commercial products requires seamless integration between their fundamental materials of glass or plastic (the optical design) and metal (the optomechanical design).
How these materials interface calls for considerable expertise and not only on the bench creating the initial prototype. Translating early designs to full-scale commercial production with precision and reliability reduces the margin for error even further.
Two: Device Systems Integration—All Together Now
An optical subassembly also needs to function with precision and reliability as part of a complete medical device. In fact, even well functioning optical subassemblies can fail to produce the desired result during integration into the rest of the device design.
With a wide range of mechanical, electrical and software systems coming together—and because of the unique challenges in optical design—the integration of the optical system with these other engineering disciplines must be carefully coordinated and evaluated for trade-offs to meet performance targets and prepare the groundwork for regulatory approvals and ongoing compliance mandates.
For example, during the integration process, it is a best practice to optimize the electrical, signal processing and image processing portions of the system design to achieve desired outcomes. Image processing increasingly involves artificial intelligence (AI), which can add even more complexity during integration.
Three: Production Lead Times—Supply Chain Management
There’s no way around it. The components of an optical system are expensive and can be hard to source as innovation continues to enhance product capabilities and improve performance. Instead of a smooth, streamlined supply chain, the optical component supply chain is very fragmented. This reality introduces risk factors to producing and launching a device.
“Removing the burden of process development, engineering, manufacturing and supply chain management helps our customers focus on the big picture of commercializing a true medical innovation so they can grow their business. Complex technology integration calls for a comprehensive, streamlined approach to implementation. Using our expertise in advanced optical systems, we help ensure customers accelerate their path to market under tight deadlines.” – Matt Adams, Minnetronix
Considerations include integration across vendors, tolerance mismatches, lead-time misalignment and the inability to dual-source or secure replacement vendors if parts go end-of-life. Having the right supply chain with the right vendors and relationships to produce the right components at desired tolerances is the only way to keep project development plans on schedule and on budget.
Four: Repeatability—Achieving Consistencies and Cost-Efficiencies
In an R&D lab, building the first working prototype demonstrates early potential. Building 10 helps validate and refine the concept. The jump to 1,000 or more market-ready products can be a quantum leap, especially as the time allowed for assembly, testing and distribution decreases into ever-tightening windows. Many optical devices are designed with too many alignment degrees of freedom, which can ultimately mean that units take so long to assemble and require so much specialized expertise that the unit cost is not commercially viable at scale.
Also essential is the ability to objectively characterize the performance of each device with in-line production testing. For optical devices, that could mean image quality testing or other optical characterization measurements. Likewise, dedicated support across the complete manufacturing lifecycle mitigates risk and allows for improvements over time. And of course, clean material handling and assembly environments are critical. Optimizing the manufacturability of the device during the design phase (design for manufacturability or DFM) and planning ahead for a variety of contingencies contribute toward the production of repeatable, high-performance optical systems.
Scaling Production for a Complex Concussion Diagnostic Device
A new medical device for concussion diagnostics serves as an example of how systems expertise and manufacturing capabilities can accelerate a successful product launch.
EyeBOX from Oculogica uses ocular motility and other domains of brain function to detect concussion. It is the only FDA-cleared objective diagnostic based on cranial nerve function and its relation to eye movement.
Go-to-market challenges centered on streamlining the production transfer process to optimize unit costs, reduce risks and support regulatory approvals, all on a fast-tracked timeline. Oculogica chose a medical device technology partner for its knowledge of complex optical systems, integrated optical manufacturing line test capabilities and strategic supply chain management experience.
Streamlining Processes, Saving Costs, Driving Innovation
Optical systems are complex and present challenges unique to the medical device field. From product development to manufacturing, a single partner offering end-to-end, multi-disciplinary expertise can help optics innovators navigate the transfer to manufacturing process smoothly and cost-effectively.
Instead of trying to manage and integrate a variety of design inputs from multiple vendors, a proactive partnership with a high-performance team of experts in the optics, optomechanical, electrical, image processing, and manufacturing processes can collaborate to solve complex challenges and produce fully optimized outcomes, saving a significant amount of time in bringing a new device to market.
Navigating regulatory approvals for FDA clearance is critical too, as are proven quality management systems. Only a partner with end-to-end optical expertise can offer medical device companies the efficiencies of a one-stop shop for taking a product from research to design and development and full-scale commercial manufacturing.