Friday, March 22, 2019

Digital Therapeutics and Software as Medical Devices

Technology / Innovation / Mobile

There’s a new set of medicines being developed and it’s unlike the pills you may have seen before. These new products are called digital therapeutics and their impact can be just as potent as traditional medicines.

For years drug companies have spent billions of dollars researching new molecules and medicines that you can find at your local pharmacy, but a new breed of therapeutics is being developed to run right on your phone. You’ve heard that brain-games could be good for your memory or that meditation can lower your blood pressure but now a new class of applications is being developed that has gone through a validation and verification process with the FDA to give credibility to some of these claims.

Digital Therapeutics use software to create habits, trigger behaviors and train your brain. It offers millions of people and their doctors an alternative to inform, diagnose and treat medical conditions with the power of technology. It’s being used on diabetes, Alzheimer's, dementia, COPD, asthma, obesity, substance abuse, insomnia, hypertension, anxiety, depression, and much more.

Digital Therapy doesn’t have to be complex. The simplest form of digital therapy is a reminder. By reminding people of the things they should be doing, they can take an active role in improving their condition. We’ve seen digital reminders across a spectrum of health and wellness products but now we’re seeing these solutions being used and prescribed as treatments. Beyond reminding people, digital therapeutics can help to build healthy habits and break bad habits.

More sophisticated Therapeutics blend the digital with physical by reading information from connected devices, scales, monitors and drug regiments. Software applications can produce results that are better than just medicines on their own. As these solutions are adopted, you’ll begin to see a trend where digital plus physical solutions will become more and more common in healthcare.

What’s required to build digital therapeutic software?

Unlike regular software applications, a company producing products that go through the FDA has to follow a stricter process to control the quality of their software products. This software process is defined by a Quality Management System (QMS) and the specifics of the QMS are in-turn defined and certified by an international standard called ISO 13485. This standard defines how medical devices are built. Traditionally medical devices have been physical devices but now we’re seeing that software is being defined as a medical device. The term for this is Software as Medical Device (SaMD).

We believe that the exciting future of Healthcare is in the combination of digital and physical and digital therapy is at the center of this trend. In the future your doctor is more than likely to prescribe two apps and they will call you in the morning.


Gregory Raiz is the Chief Innovation Officer at Rightpoint, the independent customer experience agency that is certified for ISO 13485 SaMD development and has been working in the field for a number of years helping develop medical and healthcare products. Rightpoint Health is aimed at improving lives through technology and design.