Increasing automation in health care is transforming standalone medical devices into information appliances connected to the enterprise network. Virtually all electronic medical devices face this connectivity market requirement, including devices like weight scales, urine meters, laryngoscopes, and virtually any monitoring, therapeutic or diagnostic medical device.
You're here for a reason. Perhaps driven to seek out connectivity by market demand or competitive pressure. Perhaps you're curious and more inclined to take the jump instead of waiting to be pushed. Adding connectivity means going beyond the normal limits of the embedded system device. New territory. You might be asking yourself:
"What exactly do we have to do to have connectivity?"
"What's the minimal viable product solution for connectivity?"
"Are there opportunities for competitive advantage and new revenue?"
"Can't we just outsource all the connectivity?"
"What's the best way to navigate this territory?"
Henry Ford, in response to what horse owners said they wanted in an automobile, "If I asked them, they'd say they wanted a faster horse."
In our experience eliciting connectivity requirements for different medical devices, we have seen many different use cases. These use cases often come in three variations, based on differnt use models for monitoring, therapeutic and diagnostic medical devices.
The following are a selection of common medical device connectivity use cases.
These 5 pillars, taken together, represent the "whole product solution" for medical device connectivity. Skipping all or part of one of these pillars will result in unsatisfied customers and higher costs -- for remediation and unanticipated services.
Each domain contains related tasks and their own set of challenges. How each of these domains is implemented differs by manufacturer based on the capabilities of the medical device, the skillsets, experience and organization of your company, and your strategic objectives for connectivity.
The following articles provide some background, analysis and a bit of prognostication on medical device connectivity.
PrincipalMy work in medical device connectivity started in the 1980s with the integration of cath lab recorders and software applications to automated cath study data analysis and diagnostic report generation. I didn't realize it at the time, but this integrating medical devices with information systems thing became the focus of my career. Since the cath lab, I've worked on projects across cardiology, diagnostic imaging and other diagnostic modalities, multi parameter and highly specialized single parameter monitoring devices, and numerous therapeutic devices, from heart lung machines to cardiac rhythm management.
Over the years I've learned that simply adding a network port to a medical device transforms it from a standalone embedded system device into an information appliance. This transformation entails many new requirements and responsibilities for device manufacturers and is embodied in the 5 pillars of medical device connectivity described below.
Unlike other consultants who focus on one connectivity pillar, we address the full scope required to develop and launch a successful connectivity solution. As a consultant for 10+ years, I've helped dozens of manufacturers make the transition from standalone device to information appliance.