The Seven Deadly Software-as-Medical-Device Challenges

Jeff McBride joins Diarmuid for questions and answers after a short presentation. They explain,

“For a medical device to be successful it needs to fulfil three essential criteria. It must fill an unmet medical need, it must demonstrate clinical utility, and it must have the support and endorsement of key opinion leaders. Software, is no different.

Doctors and clinicians are essentially in the business of data acquisition. “”How long have you felt this way?”” “”Where does it hurt?”” “”Have you changed your lifestyle recently?”” Is there a family history of this condition?”” Not all medical devices contain software, and not all health-related software is a medical device.

Understanding the classification of your software product or idea is critical towards determining the success or failure of your start-up company. Development of Software as a Medical Device (SaMD) presents a number of challenges to budding medical technology entrepreneurs. These include a wide range of hurdles to overcome including, finance, investment, technology, hardware, procurement, regulatory, legal etc. etc. The SaMD entrepreneur needs to be a master of all of these, or so it would appear.

SaMD entrepreneurs will get insights into best practices for developing products and meeting the challenges they face. Potential investors can gain insight into the mindset of the SaMD world. Potential suppliers and vendors can discover the most suitable ways of interacting with SaMD companies. Most importantly, by applying a patient-outcome approach towards the successful deployment of novel medical technologies, everyone will empathise and understand the needs and benefits of a successful product journey from concept to market.”