Roger Mazzella, The Qt Co.
[Photo by rawpixel.com on Unsplash]
Patient and medical device safety and medical device efficacy are the utmost priority. During the past year, we have seen the top two medical device markets’ health agencies either planning to adopt or adopting new regulations in an attempt to keep pace with innovation.
The E.U. MDR has finally been adopted after five years of planning and more than 20 years of recognizing an outdated system. New innovation in medical device design was certainly not the only factor for this change; however, with the system being in place for decades, it was time to stop amending and do a complete overhaul. Improved ways to regulate new technology was definitely a factor.
New breakthroughs in digital health are the driving force for the FDA planning to adopt new regulations and guidance. The Pre-Cert program, the “Deciding When to Submit a 510(k) for a Software Change to an Existing Device” draft guidance, and new cybersecurity guidance and standards (for both premarket and post market) demonstrate the FDA’s efforts to keep up with device innovation.
The regulatory landscape: We are all in this together
Requirements to certify with the FDA or E.U. lie directly with the medical device manufacturer. Over the past decade or so, an increasing number of medical device manufacturers have required the companies with whom they work to either comply or certify to certain quality, safety and risk standards as part of their qualification process.
Medical device vendors will limit their ability to work with customers if they take the position of “not applicable” when faced with complying with standards, simply because different ministries of health do not require it.
However, complying with or certifying to standards simply to satisfy a customer’s requirements is a very short-sided way to view things. As vendors continue to approach new and different manufacturers, the manufacturers might do one of two things. First, they might ask vendors why they chose certain standards. To provide an answer that it was a requirement of another customer shows a lack of a strategic approach. Second, different manufacturers might require compliance with different standards. Having a strategy when it comes to standards compliance, and communicating which standards apply to a vendor’s business, and which do not, gives a vendor a better negotiating stance with the customer.
For instance, let’s say a software company is looking to work with a medical device manufacturer. Compliance to IEC 62304- Software Lifecycle Processes might make more sense than certification to ISO 13485 Medical Devices- Quality Management Systems. However, the vendor qualification form provided by a customer lists ISO 13485 as a required standard with which to certify. Understanding the nuances of each standard and being able to discuss where complying with IEC 62304 can satisfy the need of the customer to certify to ISO 13485 (perhaps it’s all about having a Quality Management System) could be the difference of working with this customer or being opted out.
Manufacturers of medical devices and companies that supply them must provide products and services that are both safe and effective. Vendors to medical device manufacturers need to share the regulatory burden with the manufacturers they work with. When vendors harmonize their processes with the processes of customers, it creates confidence that what is supplied is both safe and effective, that risk is satisfactorily mitigated. A compliance and certification strategy proves that a vendor truly places a top priority on safety, quality and risk aversion.
Roger Mazzella is a Boston-based senior product manager for The Qt Co. (Espoo, Finland), in charge of Qt’s cross platform UI/UX software for the medical industry. Mazzella has extensive experience in product and services management, regulatory law, compliance, and marketing for the medical device and diagnostics industry. He has a master’s degree in biomedical engineering from Worcester Polytechnic Institute, where his focus of study was on medical device design and FDA regulatory law.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
