Time for a New Standard In Developing Standards

Abstract

No more than a decade ago, standards development was seen as important to the quality, safety, and effectiveness of medical devices, but it proceeded without much regulatory support. Today, medical device standards are the workhorse of the regulatory clearance process in the United States and, increasingly, abroad. The review process of the Center for Devices and Radiological Health (CDRH), part of the U.S. Food and Drug Administration (FDA), incorporates their use. The European model requires the use of standards to achieve harmonization, and most Asian regulators either require them by law or highly encourage their use. More recently, Brazil and other South American countries have joined the small world of medical device standards development.So with the growth in the industry, interest in new and revised standards, and improved development infrastructure (e.g., virtual meetings, virtual document development and editing, online balloting), why is it so hard to get the right people involved in the development process, why do standards take so to develop, and what would it take to turn it around?We need more users, clinicians, and academics involved in standards development. Regulators and manufacturers can write the standards, but it is still a wobbly stool that needs the input of users. If standards developers could find a way to support and/or reward the users, they may be more willing to participate. In some cases, the standards development organizations (SDOs) can support user participation through reimbursement of expenses such as travel. But what if we could offer something akin to continuing education credits (CEUs)? The FDA has long believed that participating in the standards development process is as good as continuing education. I don't know what this would take or if it is even feasible, but I know I have been asked about this more than once.Medical device standards cannot nor should not routinely follow a fast-track development model because of obvious risk and patient safety considerations. But the development process takes far longer than it needs to. In many cases, this contributes to development fatigue and impedes getting good, cross-cultural participation. Some of this can be due to ineffective committee leadership, but a reluctance to embrace new meeting technologies is also eating up valuable time. No technology will take the place of face-to-face meetings, nor should it, but medical device technology is changing faster than the standards process— meaning that these changes are necessary if we are going to remain relevant. Finding a balance between meeting around a table to discuss the important issues, and virtually meeting to edit documents and resolve comments is critical.Turning it around will take time, but the process has begun. While availability is spotty and acceptance is mixed, virtual meetings are gradually become the norm. The document collaboration tools should eventually become routine. But for these changes to work, the SDOs need to take a leadership role. We need to ensure the committees are staffed with and led by qualified and motivated people. When that is not the case, we need to make the necessary changes to improve productivity and, ultimately, the product.Last but not least, SDOs need to be the champions for the standards and not just the administrators. They need to invest in the infrastructure necessary to facilitate change and promote a true partnership with the liaisons who staff the committees and bring their expertise to the development of the product. Neither can be successful without the other!