The first thing you must determine prior to starting your project is whether or not it will be considered a medical device. According to the FDA, “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” A bed pan is considered a medical device, however the Fitbit is not – so it’s important to find out how your product will be classified. Is there any potential for harm? Are there any safety risks are involved?
John Havard, CTO of Stratos, participated on the panel for “Growth Opportunities in Patient Compliance” at MEDevice San Diego on September 2nd. John and other panelists identified the need to improve medication adherence, both from patient-centric issues, but also from therapy and infrastructure perspectives.
Here at Stratos we’ve thought a lot about how to make digital health products and wearable devices more meaningful. While it's good to know how many steps I took and how many calories I ate today, it would be even better to get some direction on what to do with the data.
Three concerns that might jump out when companies start talking about developing medical apps: who the target user might be (physicians, patients, or consumers), the regulatory strategy (which might be no regulation at all, the strictest Class I, or somewhere in between), and how useful or useless they are (which is really the only thing that matters to anyone).
The American Association for Clinical Chemistry's Annual Meeting was recently held in Atlanta and was attended by 18,000 laboratory scientists from 110 countries across the gamut of clinical laboratory medicine. This meeting included more than 400 educational sessions covering subjects from personalized medicine and infectious diseases to point of care and laboratory-developed tests.
In a recent symposium at AACC in Atlanta entitled “The Convergence of Global Point-of-Care Diagnostic Needs,” some interesting ideas and experiences were presented by a diverse panel of experts. As diagnostic testing is moving closer to the patient in developing countries in order to facilitate treatment decisions during the clinical visit and new settings for POCT at decentralized locations such as retail pharmacies within the developed world are emerging, new opportunities and business models can be identified.
It’s no surprise I’ve chosen Project Management as my profession. Planning has always been part of my daily life, and it is a vital part of any successful product development effort. The importance of effective planning has always been clear to me.