Traditionally, medical device OEMs have had all the expertise they needed to develop, validate, manufacture and support medical devices. Currently, the IoT revolution brings many challenges for them. In the past, for example, they did not have to worry about device interoperability or processing data except on proprietary devices and closed networks. Since many device and data providers are now taking advantage of the benefits of, for example, cloud computing and real-time data access, many OEMs must rethink their device designs in terms of connectivity and data handling/exchanges.
Class II and Class III medtech product lifecycles (from design and development through regulatory approval, market launch and on to sustaining) are typically very long (10‑15 years is not unusual). In fact, they are considerably longer than in the automotive and consumer electronics industries. And unlike the rapid innovation seen in those industries, innovation in medtech happens much more slowly due to a) the life-prolonging or life-saving nature of the products and b) the paramount importance of preparing for and ensuring regulatory compliance. A poorly tested or prematurely launched product could cripple a company by harming healthcare providers or patients. For these reasons, few OEMs would sacrifice the integrity of their device development and quality strategies just to meet the latest trend. Innovation does happen, just more slowly than in other industries.
An effective strategy for many life sciences companies in the face of accelerated technological evolution is to partner with companies from other sectors that have proven IP and technology that they do not have and that would require significant resources to acquire. For example, a company producing traditional vital-sign or respiratory monitors could partner with a company that excels in wireless connectivity and another company that specializes in electronic health record (EHR) processing and analytics.
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