Kevin Parmenter, Contributor Editor
The medical electronics market is in flux due to a multitude of pressures and forces from a range of sources. Ultimately this is impacting those designing and certifying of medical electronics equipment in the market. It also impacts who they partner with for the power supply and how well they are positioned to deal with the rapid pace of change.
Historically, the requirements for medical electronics were in UL/AAMI 60601, and revisions for this standard has been around for quite some time. What has not changed is the need in the medical electronics market for reliability and adherence to standards and regulatory requirements above all else.
So when standards change, the design of power supplies and equipment may need to change as well. We are now operating on the 60601-1-3 3Rd edition presently, and now they are talking about the 4th edition/revision coming out behind it. Lets review what is accelerating the pace of these changes:
1. As global population ages and life expectancies become longer, 32% of the population is expected to be 60 or over by 2050. This demographic is taking advantage of technology and will continue to need access to advanced medical equipment as the demand for devices and technology grows.
2. The emerging BRIC countries (Brazil, Russia, India and China) combined with the growth in traditional markets means that more will want to have access to medical device technology. If you want to do business there you have to meet the local standards. This increases the number of regulations needing to be met. Systems powered from the mains supplies in these countries carry requirements for even greater surge, sag and transient immunity requirements than before.
3. China’s healthcare market is growing at a fast pace, with indigenous companies creating equipment for the local marketplace. This means that competitive companies need to again meet the local regulatory needs such as CCC.
4. The FDA510 controversy essentially the approval process itself and has resulted in approximately 60 changes to the 510k policy since 2010 getting medical equipment approved is ultimately more complex than it was a few years ago. And ISO13485, specifying manufacturing quality, which is being requested, and will likely soon be required.
5. Mergers and acquisitions – in 2014 the merger and acquisitions in the medical industry was 40 % higher than in 2013 and higher than ever. It is forecasted that 2015 will grow even more.
6. "Consumerization" and telehealth – or we could call it medicalization of consumer devices. Apps for PC’s and Cell phones, which allow consumers to take data with their consumer electronics and send it to their physician from home. Or telemetry systems, which can send data to remote physicians from the patients home. These systems sill need to meet safety standards however this is a shift and we will see the combination of consumer products and medical devices as a growth area needing certain regulatory issues to be met in the home healthcare environment.