In August, 2014, consulting firm, PriceWaterouse Coopers released a report “Digital accelerators for a new innovation era”. In it, the authors note, “Drug and device companies need the right mix of digital tools and processes to accelerate innovation, or they risk displacement and missed growth opportunities in a New Health Economy that is demanding technologies to support measurable, value-driven care.”
Thanks to all who attended Stratos' Open House Oktoberfest. The weather could not have been more beautiful and the company was pretty great too. Thanks to everyone on the Stratos team who worked hard to put this event together. Kaspar's Catering and the Bonnie Birch Trio also contributed to a memorable evening of great food and live music. Please be sure to join us next year. Prost!
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).