Medical device testing is serious business. Big business. The medical device market in the USA alone produces over $148 Billion in revenue annually (pre-2017), according to SelectUSA. The market for these devices comes from everything from contact lenses to insulin pumps to Ventricular Assist Devices, to syringes and many, many more products.
These are tightly regulated products, with many government agencies, industry associations, and independent organizations involved in the accurate and proficient production of safe and effective products. These devices make their way into our homes and into our bodies. It is of the upmost importance that they be safe, that their operation be reliable and predictable, and they pose no real threat to the patient/consumer. Not to mention they need to be affordable to produce, operate, and maintain.
As diverse as this market is, the means and technologies for properly testing and evaluating them is just as broad. These systems help to verify and assure the devices' performance to specifications, as well as validate their compliance with international, federal, and other regulations. Specifically, Quality Management Systems such as ISO 13485 specify requirements to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, including design and development, production, testing, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). Also, specifically, “Title 21” is the portion of the Code of Federal Regulations (CFR) that governs food and drugs within the United States for the Food and Drug Administration (FDA), among other agencies. The FDA has many regulatory touchpoints within the realm of devices.
Generally, as a medical device is being fabricated and assembled, in-process testing stations are employed to provide the manufacturer with assurance that each step in the process is not only being performed to specification, but also that any underperforming components are caught early in the value chain. End of line testers, systems that test the final devices against a battery of requirements, simulate real world performance, having a no-failure tolerance. This ensures that products that go to patients and consumers have been not only rigorously tested, but also meet all the criteria laid down in the governance for the product.
As with most regulated industries, medical devices are subject to evolving and changing scrutiny. Ongoing change and validation services are vital, whereby hardware and software changes can be implemented in the field and/or remotely. This provides longer life to the testers, and a beneficial return on the investment to our clients. Building on stable and proven platforms by continuously upgrading existing systems reduces the risk of development and of course shortens the timetable for deploying modernized testing systems, specifically section 800 (21CFR800). Current Good Manufacturing Practices (cGMP) and the use of well-accepted and state-of-the-art technologies such as precision data collection and analysis tools form National Instruments (NI) and others assure the highest quality and greatest reliability in these important design decisions.
Working with a partner experienced in the intricacies of these regulatory landscapes saves companies money, process integrity, and risk—both schedule and approval. Getting premarket approvals, other favorable findings that device manufacturers may want to pursue can be made more likely if the relevant process are understood and followed. As we have seen, from the engineering and design activities through to the build and the testing to the documentation, the details matter and they are very specific.
In the past Optimation has maintained our own ISO 13485 accreditation and we now generally work under the auspices of our clients’ own certification. As the manufacturers generally want their Quality Management System to have primacy, we then work within various clients’ own QMS and conform to their methods and practices, demonstrating equal compliance and leveraging our experience.
Now more than ever we rely on the affordable availability of safe and reliable medical devices to improve and even save our lives. Ensuring that the processes in place to safeguard these are followed, and that the equipment used to test and validate their efficiency, efficacy, and performance is one of the most important task we can perform.