ARTICLE SUMMARY:
Standards promote consensus and efficiency, but small companies face barriers in identifying, leveraging, and helping shape standards that can benefit their business. In this edition of Consultants Corner, Elisabeth George offers advice from her years of experience putting standards to use in medtech.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
|
Elisabeth George provides quality, regulatory, and standards services to medical device companies via her independent consulting company (Elisabeth George Consulting, LLC) and also via other consultancies. She sits on the board of multiple organizations, including the American National Standards Institute (ANSI). George is a veteran of the device industry, and she most recently served as the head of global government affairs, standards, and regulations for Philips. |
Question: What Are the Right Standards for My Company?
Technical standards provide an important foundation for the functioning of the medtech sector, as they do in every industry. Standards help ensure more consistent practices across manufacturers and countries. They are also tools to save time: if everyone understands how a standard is supposed to work and the testing involved, it’s a lot easier to assess whether a product meets the mark.
But for a small company trying to operate in medtech, leveraging standards isn’t always straightforward, consultant Elisabeth George says. In particular, it’s a challenge for companies with fewer resources and less experience to get a handle on the vast and constantly evolving universe of standards, explains George, who was a long-time leader for global standards and regulation strategy for Philips.
Keeping track of all the possible standards and identifying the ones that a company should aim to comply with can be “a very confusing, very challenging process,” George says. While there are some standards that are crucial for just about everyone in medtech (see, for example, ISO 13485 for quality management systems or ISO 14155 for device clinical investigations), there are countless items that address much more technology- or process-specific topics. There is also an array of different organizations, both global and regional in focus, that create standards.
“Even the simplest product could have hundreds to thousands of potential standards that apply,” George points out. “So that’s where it becomes somewhat challenging—‘Which ones do I pick?’”
