As I was preparing to write this article regarding new product development and product innovation in digital health or mobile health (mHealth), I had a chance to review an article focused on consumer product development outside of the healthcare arena by Robert G. Cooper adn Angelika Dreher, ‘VOICE-OF-CUSTOMER METHODS: WHAT IS THE BEST SOURCE OF NEW-PRODUCT IDEAS?’
In their article the importance of ‘Open Innovation’ taking advantage of VoC ideation filtered through a robust and effective idea management practices, “..results in an extra 7.2 percent of sales from new products” having a heavy impact upon the organizations bottom line. Taking a moment for those how didn’t read Cooper and Dreher’s article they expanded upon ‘idea management’ process as the critical steps guiding the internal processes within an organization whereby they identify, evaluate (screening system) and determine resource allocation moving a project through the Stage Gate process.
Now lets take some of the same principles from consumer goods and make sure we are applying VoC ideation in an appropriate way to the emerging opportunity in digital health or mHealth in humans and pets. We want to take start this discussion understanding and agreeing to fully complying with and adhering to guidance laid out by the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT report.
On the FDA U.S. Food and Drug Administration website their foundational article Digital Health defined the different categories for mobile health (mHealth), medical device and software as a medical device, and software embedded in medical devices, Wireless Medical Devices, Mobile medical apps, Health IT, Telemedicine, Medical Device Data Systems, Medical device Interoperability, Software as a Medical Device (SaMD), General Wellness, and Cybersecurity:
How can we incorporate ethnography, focus groups, lead-user analysis introduced by Eric von Hippel in the 1908’s, ‘Customer-visit Teams’ see the work in New Product Blueprinting The Handbook for B2B Organic Growth by Dan Adams where he utilizes SPIN selling techniques to enhance customer-visit teams outcomes. These are just some the VoC tools available for use to provide data and information for your idea management process in the development of new offerings.
Q: Are you using VoC in your organization, and is so what are you using in your organization today?
Q: Do you have an established idea management system in place?
Needs meets Opportunity meets the market in human and animal/pet healthcare in digital health and mHealth today with innovators like Otsuka and Proteus® who announce The First U.S. FDA Approval of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor) in November 2017, and visit the Livongo website and learn more about their Applied Health Signals AI + AI + program a closed loop low noise patient focused program, to animal health with microchips, drones for instance “heard animals using RFID tags, drones and AI technologies, ranchers can monitor herd movements, body temperature and pain levels to improve livestock health,” Bryan Hills article in Cognizant.
What are you doing? and where do you need to start?
The FDA provided the following statement regarding their work on a global level to ensure safety and regulations in their Digital Health Innovation Action Plan easily accessible on their website:
“FDA leads an international effort to converge on regulatory principles for Software as a Medical Device (SaMD) through the International Medical Device Regulators Forum (IMDRF)5. FDA, as a member of the IMDRF, has adopted converged principles on SaMD terminology, a risk classification schema, application of quality management system principles tailored to software, and more recently working towards a guidance on application of clinical evaluation for SaMD.”
I hope you enjoyed this quick over view, and I look forward to discussing and learning from everyone regarding this emerging market.
What is a ‘Spinach helpful tip’? Have you ever walked around with something in your teeth, and no one tells you. A real friend takes you to the side and tells you. It may be embarrassing at first but not as bad as finding out at the end of the day when it is too late to do anything about it. Especially if you are trying to create a positive brand image and lead your organization to success!
Chris A. Marshall