Medical Devices in the Digital Health Era

A webinar on the topic was held during the 3rd international Biotech Atelier 2020 conference

 

Living in an era of digitalization, innovations are definitely part of every industry, and the healthcare and pharmaceutical sector is no exception. This is the reason  why the final webinar of the PharmaLex Bulgaria panel, during Biotech Atelier 2020, focused on the topic “Medical Devices in the Digital Health Era”.

 

The panel was made up out of experts from the sector to elaborate on the benefits and the need of digitalization in the field of healthcare. They discussed different innovations focusing on streamlining physicians’ work and optimizing systems in order to improve patient outcomes.

 

“The evolvement of digital healthcare and new technologies will give the opportunity to simplify peoples lives as app developers continue to invent software that falls into medical device applications in the healthcare categories.”, said Milena Shuytsova, Senior Manager Regulatory Affairs at PharmaLex Bulgaria.

 

Attendees of the event learned more about the future of the various medical devices in the digital health industry and their regulatory processes.

 

The first speaker of the session was Ernesto Nogueira, Founder & CEO of Valueconnected, who focused on the importance of artificial intelligence in the healthcare sector.

He explained that AI would help overcome the challenges that healthcare is facing such as a huge waste of excessive medications and costs in hospitals, inefficiencies and capturing big data. Some current AI applications like robotic surgery, virtual care and precision medicine will act as an assistant to clinicians, providing feedback, which would improve the patient empowerment and adherence.

 

The second guest of the session was Ben Modely, Owner of Leads.Healthcare.

He gave an overview of the market taxes for digital technologies in Germany and introduced the medical application – DIGA Pathway, explaining about the opportunities it provides. The application is the first structured pathway specifically designed for digital technology with mandatory funding and evidence development coverage.

 

Clare Huntington, Associate Director Regulatory Affairs for Medical Devices at PharmaLex UK was the last speaker of the online session. In her presentation she discussed the regulatory process of smartphone applications as medical devices. She concluded:

 

“Once you go through the classification process to understand if the app is a medical device or not you have to consider special requirements of having this type or product. When putting together a type of documentation, ensure you are using the appropriate standards and common specifications and verify that GDPR rules are being followed appropriately.”

 

If you would like to learn more details about the topic, you can watch the full session here: https://bit.ly/3mnNzgt