Infusion pump companies are perpetuating misconceptions.
Reparative medicine technology is an option to delay or avoid orthopedic surgery.
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
The explosion of this technology is changing patient interaction with physicians, hospitals, and the entire healthcare landscape in general.
Most devices are still developed in a moment of need and not in advance like adult devices.
The success of these technologies also relies on simplification to target certain patient populations, ensuring secure data transmission, and that operational models are built to make effective use of the data.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
The challenges will continue to keep medtech manufacturers and other stakeholders in the healthcare industry on their toes.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
It’s time to address this healthcare problem.