Medical device manufacturers operate in a regulated, safety critical environment. All aspects of their product development lifecycle—including contributing mechanics, electronics, software, and hardware—must be carefully controlled in accordance with regulatory standards around the globe.
Manufacturers of medical devices must meet all the 21CFR820 FDA requirements before they can sell a product in the United States. To sell in Japan, they must meet the international ISO13485 standard. And in the European Union (EU), they must meet a set of regulations and a brand-new process that goes into effect in May. The result, designing products with a complete design history file and verifications, can take two or three years.
Archaic regulations or not, we need to speed up the time it takes to get medical devices to market while ensuring better patient outcomes and faster responses to adverse events. In normal times, the way that best-in-class medical device companies are achieving first-to-market positions is through digitalization and how well data is managed. If everything is digitized, with traceability and governance, it can be provided to regulators with ease.
But these are anything but normal times.
There is no time to implement a full quality management system when it comes to producing ventilators. The enemy is coming over the hill, and we are battling a global public health crisis. The FDA, fortunately, has invoked something called the Emergency Use Authorization (EUA) to accelerate production. Companies can now contact a ventilator manufacturer willing to share their design (i.e. the digitalization of their product). The automotive industry is particularly well suited for this as they already work towards strict quality standards. They have good change and configuration management. They know how to manufacture and to do proper verification and testing.
Here is how it works: To get an automotive manufacturer, or any contract manufacturer, up and running, they need to set up a collaboration portal. Together with the IP owner, they must centralize all the product related data or the DMR (Device Master Record). The DMR includes relevant engineering drawings, product structures, process and procedures, as well as Quality Assurance (QA) and Regulatory Affairs (RA) review docs used to approve the product. The portal is also used to track and log issues. For example, if one of the new ventilators breaks or there is a problem on the production line, the manufacturer needs to quickly get that information back into the design owner’s quality system for root cause analysis and corrective and preventative actions (CAPAs).
With production started and collaboration methods established, procedures can be optimized to improve line efficiencies and ramp up production. Staying in compliance with the IP Owner’s process plans, the manufacturing company can leverage connected machines to analyze worker throughput and convert work instructions into augmented reality experiences to accelerate training.
None of this is new to the Electronics and High-Tech industry (EHT) or PTC. As our EHT customers have entered the healthcare business in recent years, they have faced essentially the same challenges. In this fast-paced market, time to industrialization has been paramount. Take, for example BOSE, who orchestrates both a global supply chain and contract manufacturers. Led by Eric Pettes, Quality Executive, and leveraging a strong digital foundation already in place, a small team was challenged to go from design to contract manufacture to FDA approval and sales in just nine months. In a matter of twelve weeks, they were able to validate Windchill’s QMS SaaS (Quality Management System Software as a Service) as a backend for their processes.
Certainly, we are in challenging times. The key to ensuring success during the COVID-19 pandemic will be cross-functional collaboration and digitalization.