The prevalence of consumables in medical device systems has risen dramatically in recent years due to advancements in medical technologies and how they diagnose, treat, or manage disease. As the costs of electronics manufacturing at volume have fallen, it has become feasible to incorporate electronics into complex consumables that maintain the healthcare industry’s traceability and safety requirements. From in-vitro diagnostic (IVD) platforms and blood glucose monitoring tools to ambulatory systems and clinical wearables, more and more of these medical devices require high-volume, complex consumables to make patient care more effective. Whether or not this design approach is an example of a “razor and blades” business model is a topic of much debate, but regardless it’s safe to say that these consumables are here to stay.
The challenge of meeting the demand for this shift is that the development of manufacturing processes for medical device consumables is unique, highly regulated, and exceedingly complex compared to any other market disposable. There are few OEMs or manufacturing services providers with the expertise and experience to develop the manufacturing processes to make these components at volume while maintaining the quality and reliability necessary. One prominent example here is product-specific process automation design, which involves the design engineering of dedicated and complex electromechanical or robotic systems that need to address a slew of technical and product requirements.
Manufacturing high-reliability disposables at scale
One of the most significant challenges for medical device manufacturers is ensuring a quality control process that enables consistency and traceability for these products. An example of this challenge involves IVD devices. Many IVD systems utilize so-called “lab-on-chip” (LOC) consumables, which bring together several complex components including biological materials, physical delivery methods, sensing, and often digital elements.
Each of these elements presents a technical challenge and adds complexity to the entire manufacturing process. For instance, when dealing with complex chemistry involved in many point-of-care (POC) testing consumables, the manufacturing process must be designed to consider a wide variety of environmental factors, including ambient temperature or ultraviolet (UV) light exposure. UV light is a common curing agent for dispensed adhesives in automated processes but can damage active chemistry components and render a single-use test cartridge unusable. Benchmark has seasoned design engineers familiar with all the options on the table who know what to look for when designing the assembly processes to maintain the yield and the integrity of the product.
Keeping track of it all
It’s essential to understand the distinct process and routing controls required in a manufacturing process to meet stringent industry standards. To manage this, Benchmark leverages its best-in-class process feedback system (PFS), which allows even automated processes to track every step in a complex process on each uniquely serialized assembly. From design to manufacturing and into test, each assembly often needs to be uniquely serialized to track its journey on the production line to prevent the oversight of any assembly processes or record any parameters that may fall out of tolerance. With complex consumables, these requirements are no different from any other medical device, and identifying and recognizing the proper manufacturing checkpoints requires both expertise and first-hand experience.
While an assembly process must be effective, it also has to be made repeatable. As devices become more complex, the likelihood of human errors grows significantly. OEMs can benefit considerably from automated manufacturing and test platforms to solve this challenge. Automation in medical device consumables helps meet high-volume production needs while managing costs effectively and can also help in the quality control process. For instance, many production lines use an automated vision system that scans component barcodes and sends the data back to PFS to track and analyze the individual assembly.
Choosing the right partner
Benchmark is uniquely positioned to meet the medical device industry’s demands for complex systems and their consumables. We have extensive experience working with emerging techniques like lab-on-chip cartridges, clinical wearables, and other medical device consumables and the manufacturing and test automation capabilities in-house designed to meet industry regulations. Additionally, our combined expertise in quality control, process and automation design, manufacturing, and test for complex electronics make us the perfect one-solution partner for medical technologies.
For more information on Benchmark’s medical manufacturing capabilities and test services, visit website at www.bench.com/medical-technologies.