Boston recently played host to the first-ever conference dedicated to the integration of medical devices and information systems, the Inaugural Medical Device Connectivity Conference and Exhibition.
The conference, which attracted more than 200 attendees and dealt with the technical and clinical issues associated with acquiring, pooling, and interpreting data from various medical devices, was especially timely considering a key aspect of the latest Obama gold rush (AKA the American Recovery and Reinvestment Act of 2009 (PDF)).
The ARRA specifically requires “meaningful use” of electronic health records in order for physicians to be in line for certain reimbursement. You’ll find much opinion and information about what exactly will comprise “meaningful use” (including the website www.meaningfuluse.org, maintained by The Assn. of Medical Directors of Information Systems). While the government won’t fully define this term for months, it’s clear that data from medical devices must be ported into EHRs and clinicians must be able to act on this data.
In essence, the ARRA legislation provides a giant carrot for healthcare providers to purchase medical devices which can connect with each other and, ultimately, the central server system of the hospital. Hospitals will qualify for incentives only if they adopt, use and document connectable technology.
As the conference wore on, it became clear that hospitals are willing to turn around and use this opportunity as a stick with which to push greater connectivity on their vendors, the medical device manufacturers. Hospital administrators, IT staff and nurses see that this connectivity can allow them to be more efficient and provide superior patient care.
Interestingly, the conference audience was split about evenly between engineers and IT folk, but the number of clinicians was limited to one or two MDs and a small handful of RNs. Also, nearly half the attendees were from hospitals, while the other half were from vendor companies with a vested interest in the field. The remaining 10 percent was mainly comprised of consultants and academics.
The majority of attendees were local, with representation from area medical device companies including Picis, Stryker, Phillips Healthcare, iRobot, Covidien, Smiths Medical, GE Healthcare, Linc Health and Capsule Tech. That said, there were U.S. attendees from as far away as Oregon and California and even one from abroad (Germany).
More importantly, who didn’t come — and why should they have?
FDA: Even with the fairly recent publication of a draft document about medical device data systems, there are many more regulatory questions than answers. At this point, systems that don’t alter the function of medical devices in any way, but rather just store, retrieve, display, or convert the data, seem to be Class I devices. But what about systems that provide clinical decision advice or generate an alarm? Are they Class II? Similarly, what about systems that provide closed loop scrutiny? Are they Class III? Hearing the opinions of consultants is somewhat useful, but we really needed the FDA to weigh in on how they are treating devices and systems in this evolving field.
Clinicians: Despite a heavy representation from hospitals, the vast majority of attendees were in IT or clinical engineering. Since medical device connectivity is not purely a technical issue, but also has ramifications on clinical best practices and decision-making, it would have been nice to have better representation from both nurses and doctors. Actually, more so nurses than doctors — because the implementation of clinical data entry and first-line interpretation falls more on them (especially post-operatively but less so during the operation).
In any case, all of these engineers and software coders are creating products they think will improve patient care, and clinicians need to be right there providing input. They are the end-users and it will be their burden to meaningfully use connectivity to improve patient outcomes.
Other medical device companies (you!): Right now, medical device companies can get away with creating and testing their products in isolation. Some can even still get away with outputting patient data in stand-alone systems. However, those days are coming to an end, partially because early adopters of connected devices see the greater efficiency and lower costs and partially because of the ARRA legislation. Sure, if you have a pure implantable device that provides no feedback relating to the patient, you can safely focus on other areas.
But if your product has a display or an alarm or touches patient data in any way, you should have come to this conference. Fortunately, the success of this conference means that a follow-up for next year is likely. If you’re interested in learning more about medical device connectivity, I recommend checking out Tim Gee’s blog.