Navigating Today’s Medical Device Landscape

The medical device landscape today is more complicated than it used to be:

  • Regulatory burdens face off against rapidly changing technology and an increasing number of stakeholders
    in device design,
  • An aging, independent population demands affordable healthcare that can be used in the home environment,
  • Payers such as Medicare and private insurers are increasingly wanting to “see the numbers” that prove that new treatments are not only safe and effective but also worth the increased price tag,
  • For healthcare professionals, having a device that treats an ailment is no longer enough; providers now want to be able to monitor their patients’ outcomes following procedures to see how well they respond to treatment, and
  • Cybercriminals are now targeting medical devices, which demands ever-increasing manufacturer vigilance against cybercrimes.


Yet it’s not all bad news:

As we mentioned in our Fighting Medical Device Cybercrime article, regulators are actively seeking ways to streamline the submission process, and with “The Internet of Things” becoming a household phrase, more opportunities are available than before for companies to develop novel, useful, and lucrative products. Industry leaders will be those who adapt quickly to opportunities and threats alike and who are efficient in all of their processes: design, test, submission, marketing, and responding to feedback from post-market surveillance.


Our compliance experts keep on top of regulatory changes (such as the recent addition of UL 2900 to the FDA’s Recognized Consensus Standards list and the fourth edition of IEC 60601-1-2 compliance), recognize the unique challenges associated with developing products intended for home use, and know how to take advantage of the streamlined submission process. We can help you simplify and cost-reduce your designs and identify services you can offer your providers to make your products stand out above your competitors. You don’t have to navigate today’s landscape alone; call The Realtime Group today at 972 985-9100 and let our experts help keep you afloat.