There is little question the workflow automation and intelligence offered by interconnecting medical devices can improve patient safety. There’s also little doubt that there is significant market demand for such solutions.  For example, if hospitals could purchase PCA pumps and SpO2 monitors that were interoperable, i.e., the monitor could suspend drug delivery at the first indication of respiratory arrest, such a capability would quickly become a standard of care. Interoperability is a huge opportunity.

There is no doubt that there are unintended — and in some respects, unregulated by the FDA — systems of systems made up of medical devices  sold and in use by health care providers. At the most basic level, there are medical devices with serial ports that were never intended to provide connectivity (or Medical Device Data Systems as the FDA called them in a draft rule issued almost 2 years ago). At the other extreme, you have systems like closed loop infusion therapy delivery, made up of components that are both regulated and unregulated, and that were originally developed with little or no thought to the demands of interoperability. This is a problem.

The FDA’s been interested in this area for some time. Way back in 2005, the FDA held a workgroup to discuss the system of systems issue regarding networked medical devices (see the blog posts here, here and here).  The outgrowth of this meeting was IEC 80001, which is scheduled to be completed this year. In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on how to apply the Quality System regulation to wireless medical devices. (I can’t help but wonder why this is still a “draft” guidance.) Also back in 2007, the FDA provided a rather limp statement on interoperability at the 2007 conference on Medical Device Interoperability and High Confidence Software (see the posts in this search). (Offered as the first example of the FDA’s interest in interoperability is their dubious buy-in to the questionable patient safety benefits of new medical device unique device identification requirements was not inspiring — more here.) (more…)

The program focused on regulatory changes (the FDA’s proposed MDDS rule and the new IEC 80001) and industry standards (IHE PCD, HL7, 11073, ICE, 802.11x, etc.) and patient safety. The second day had separate tracks for:

• Trends in connectivity infrastructure, like networking, converging hospital IT and Biomed departments, and wireless sensors;
• A survey of predominate medical device connectivity applications — EMR documentation, infusion pumps, operating room integration; and
• A clinical track looking at why people make and buy connectivity, to improve patient safety and improve outcomes.

There were over 200 attendees at the conference, split about 60/40, manufacturers and health care providers. Among the providers, there was a preponderance of clinical engineers, then came IT folks, and finally clinicians. Manufacturers were mostly senior level product management and engineering people.

There were 9 sponsors for the event: Capsule, Cardiopulmonary Corp., Cerner, Cisco, Fluke Network, Hill-Rom, Medical Connectivity Consulting, Nuvon, and Philips.

I’m proud to note the following supporting organizations, with which many speakers and attendees are affiliated: AAMI, ACCE, ACCE Healthcare Technology Foundation, Mass Technology Leadership Council, the Medical Device Group, and RFID in Healthcare Foundation.

The nature of the conference business is that the first year’s always the hardest. The biggest challenge is that, because your conference did not exist last year, no one has budgeted money to sponsor or attend the first year. Under that handicap, we did quite well — which is a testament to both the organizer’s acumen (TCBI) and market interest in the topic.

Next year — yes, there will be another event next year — will be bigger and better. Thanks to everyone who participated for helping create a great event. Any comments, observations, critiques and suggestions are welcome — just leave a comment.

Here’s an overview of the agenda:

• Define and frame medical device connectivity for this event
• Industry standards
• Regulatory issues
  • FDA’s proposed MDDS rule
  • IEC 80001
• “Systems of systems” patient safety issues
• A review of the real costs of connectivity

Day two is divided into three tracks:

• Infrastructure, especially converging medical device and enterprise networks
• Connectivity solutions, a review of the most common connectivity applications (it’s not just about EMR integration)
• Clinical and workflow impacts of connectivity

Friday afternoon, there are two great post-conference workshops. One workshop delves into Distributed Antenna Systems (DAS), describing best practices for the selection and implementation of DAS. The second workshop is for providers and manufacturers getting ready for IEC 80001. You are getting ready, aren’t you? This workshop details the standard’s requirements with special focus on the risk management process that’s at the heart of IEC 80001.

The conference well be September 10 and 11 (Thursday and Friday) in Boston, at the Joseph B Martin Conference Center at Harvard Medical School. This is a pretty snazzy venue, as you can see by the photo. (more…)

During breakfast, I chatted with Michael Kurgan, CEO of start-up Service Wing Healthcare. They’re targeting the wireless gateway market to support body area networks. I mentioned a company I heard about yesterday, GainSpan and Michael had some great perspective on the challenges picking tech winners in immature markets. GainSpan has an ultra low power wireless SOC (system-on-chip) that includes an 802.11b radio and two ARM processors, one for the radio and one to drive whatever device the chip is enabling. In an immature market, just because a component comes from a big company does not mean that their component will have long term success. A much smaller competitor with a better solution may win, or the big company may acquire a better solution in order to be a big player in that market segment.

Rob McCray, chair of the Wireless-Life Sciences Alliance, kicked things off. Camille Sobrian was up next, touting San Diego as the biggest wireless hot spot in the world (perhaps for cellular wireless). She also mentioned the West Wireless Health Institute, and the upcoming TEDMED event. Dr. Paul Jacobs, CEO and chair of Qualcomm passed on introductory remarks and jumped right into things wireless.

Paul noted that what’s going on right now is convergence, and it’s those who understand both industries that can lead that convergence. He described the new mobile internet experience: networks, devices and applications in the cloud. Multiple air interfaces are a key enabling component. The newest radios are only a few percent more efficient, but they tend to support broader bandwidth to improve network performance. He mentioned a mobile WAN, and various wireless LANs and BANs. A future trend is where applications control the radio to optimize performance for that application.

In Europe, mobile broadband radio dongles for connecting laptops outsell all the 3G phones sold there. Paul defined convergence as the overlapping of computing devices, consumer electronics and wireless tech. Paul alluded to the Amazon Kindle, as a prototypical device for the future, where an embedded system includes a cell phone built in for connectivity. He also highlighted Snapdragon as a platform for mobile data processing, multimedia performance, 3G wireless connectivity and the low power consumption.

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According to Brenda the implementation of ConnexALL was initiated to better align with their hospital’s patient and staff safety goals.  After installation they were able to consolidate much of the management and interaction of these three event driven systems into an automated and consolidated system using ConnexALL. Specific benefits included, improved reliability, managed group notification, reduction in manual interventions, automatic alarm escalation, increased mobility (no sitting at a workstation or watching a panel), quicker decision making, and a consolidated auditing capability.

WatchMate is used for wandering, patient elopement and infant abduction. The hospital’s security is based on the premise that it’s easier to contain (a potential security situation) than retrieve, and that it’s easier to catch someone in the act than is to try to find them after the fact. WatchMate provides notification to a user at a workstation. The hospital used  switchboard operators to monitor WatchMate, since they’re usually at their desks. They had to recognize the alarm, look up who to notify, and ensure that notification is made. Now, ConnexALL automatically receives alarms, notifies appropriate staff, ensures alarm delivery (including necessary automatic retry), and escalates alarm notification when necessary. (After some googling, it seems that GlobeStar integrated with WatchMate even though the product is no longer sold by the manufacturer, Xmark.)

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Shawn Sicard, CEO of PiiComm in Toronto, Canada lead the customer presentations with a discussion about putting togeter complete solutions.  PiiComm is a systems integrator targeting the health care vertical market, with a long term relationship with GlobeStar. As an event sponsor, PiiComm has an exhibit demonstrating many of the products they support. Sean highlighted the Motorola CA 50 wireless VoIP phone with built-in barcode scanner. Built orignally for Home Depot, the phone has found some interest in health care. The phone has push to talk (PTT), a 1D barcode scanner in a small size (4.37″x 1.81″ x 1″ and about 4 ounces). The CA 50 is rather like a large Vocera pendant, there is no phone keypad. The phones are configured based on user profiles and voice input and text based menus on the phone to place calls. He also talked about the new Motorola EWP 1000/2000 wireless VoIP smart phones. The Moto phones were prominent in the Vocera/Motorola announcement at HIMSS, and is only one of two wireless phones that meet all the basic hospital requirements — ruggedized, water resistant and impervious to hospital disinfectants. (The other phone is the also new Ascom DECT IP phone, the d62.)

Shawn described asset management, preventive maintenance, temperature monitoring, patient and staff safety and workflow and resource management as key applications supported by AeroScout. PiiCommis also an Ascom reseller. Shawn noted that going wireless, including wireless VoIP is hard; part of his company’s mission is to help with that transition. He positioned Ascom as a DECT wireless phone solution that doesn’t require Wi-Fi.

Patient Monitor Integration

After the break Stephen Rocha with St Vincent Heart Center of Indiana presented Patient Monitoring Integration.  Stephen described the corporate culture and noted that Siemens/Draeger are the predominate medical device vendors (Hospira too). They also have Dukane for nurse call, Hill-Rom beds and Siemens (the Chantry Networks acqusition?), Meru and InnerWireless provide wireless networking. ConnexALL is used as messaging middleware.

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The messaging middleware market is transitioning from middleware to an enterprise application. GlobeStar has been in the business just over 10 years. Unlike Emergin, who started in paging messaging,  GlobeStar got their start in the 1990s integrating Austco nurse call and Nortel’s Companion (the first wireless phone system in North America). Over the years, the company (and the market) have evolved from a single nurse call/phone integration to a platform supporting many different systems and devices both on the input and output sides — and incorporating workflow automation through rules, alert initiation, and escalation.

The conference kicked off with introductory presentations from David Tavares, CEO of GlobeStar; Dr Teresa Sustelo, President of Centro Hospitalar de Lisboa Central (a large multi hospital system); and Dr Miguel Correia, Regional  Secretary of  Health, Azores. During his opening remarks, Miguel Correia noted the broad applicability of improved messaging. He spoke to the extension of messaging systems to tracking and eventually orchestrating complext processes and tasks. This is a vital requirement in health care delivery.

GlobeStar’s technology has been applied outside health care too. They monitor automobile painting production lines and “man down” systems in mining. Miguel Correia mentioned that they’re using ConnexAll in CO2 monitoring at volcanos in the Azorres. Now they’re moving further into workflow automation.

Keynote Presentation

My keynote presentation theme was, “everything is connected” and contrasted this with provider’s tendency to only focus on the immediate problem — or what they think is the problem.

Putting the health care IT market aside, the point of care market is divided into 6 separate market segments: wireless phones, patient flow applications, medical device connectivity, messaging middleware, nurse call, and real time location systems (RTLS), not to be confused with indoor positioning system infrastructure vendors like Sonitor and CenTrak. For some time, buyer’s haven’t been able to buy a product from one of these segments without impacting one or more of the others. Connections to medical devices, and the nurse-to-patient assignment process are common points of contention.

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As always, I’ll be blogging from the conference, and writing a HIMSS wrap-up story for Canon Communications. If you’re interested in a story for your publication, let me know (contact info here).

Some Interesting Exhibitors

There seem to be an increase in new and interesting vendors this year. Just a few of the exhibitors that I’ll be seeing for the first time include: point of care communications vendor Voalte, wireless sensor company KAI Sensors — wireless and no-contact sounds intriguing, CaraFlow with an interesting in-room nurse automation solution, workflow automation vendor Mobile Matrix, some new distributed antenna system (DAS) vendors (Tri-Power, Cellular Specialties, and Cell Antenna - okay they only sort of qualify as a DAS, but interesting none the less), and a bunch of new wireless networking vendors — from services (Scientel Wireless, Wantering WiFi and Presidio Networked Solutions) to infrastructure (Aerohive Networks, Fatpipe Networks and Ruckus Wireless).

If I’ve missed anyone you think I should check out, you can drop me a line (my contact info is on the About page).

Meetings & Communication During the Conference

If you want to meet up at HIMSS, you have two options. First, you can look at my calendar and request a meeting in advance. Be sure to note the timezones displayed on the left when proposing times — on my calendar page, both Pacific (where I live) and Central times (the meeting location) are shown. Confirm which timezones are displayed on your page (you may see Central and your own time zone displayed).

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The following are some notes from some of the more interesting presentations - be sure to keep scrolling, this is a long post! I’ll follow this up with a post on my presentation at this year’s conference, “How the Network Effect Impacts Adoption of Healthcare Unbound Technologies,” and a wrap-up post.

At 8 am Monday morning, Teri Louden kicked things off. She started her career at Baxter Travenol in the 1970s. Referring to The Graduate, Baxter’s innovative technology of the day was plastic IV bags. Today, things have come a long way from plastics to Healthcare Unbound.

There have been few breakthrough industry segments over time - disease management, home infusion therapy, outpatient surgery - and Healthcare Unbound (HU) is an important pioneering new industry segment.

Teri prognosticated that many of the really breakthrough solutions in health care will come from companies outside of health care - mentioning Intel, Qualcomm, and other electronics and communications companies.

Using CardioNet as an example, Teri described how a new type of solution presents substantive challenges for adoption and effective use. The CardioNet value proposition was unique and required new ways of selling, patient use, and reimbursement.

She introduced Vince Kuraitis and David Kibble, and their topic: The Personal Health Information Network (PHIN): Opportunities and Implications for Healthcare Unbound

The Personal Health Information Network (PHIN): Opportunities and Implications for Healthcare Unbound

Vince introduced the topic with a classic example of the network effect, phones. He asked, what is the value of a single phone? The health care industry is currently the equivalent of two phones representing one to one solutions. The real value comes to the fore when many phones are interconnected, allowing users to contact many other users whenever they want. (more…)

Designing for the unforeseen: preparing your facility for evolving technologies

Presenters: Barrett Franklin and Sudhakar Nagavalli of KJWW Engineering; Valmik Thakare, Christner; and Dennis Minsent, OHSU.

Major trends that they see:

• Diagnostic imaging - portability
• Monitoring/connectivity
• Integration
  • Clinical information systems
  • Video capture
  • Communications
• Transparency (RTLS)

Diagnostic imaging is moving out of conventional settings into surgery, procedure rooms and intensive care. This impacts workflow and consequently, workflow automation. Imaging is becoming an enterprise application, going beyond distributing images on an enterprise basis to include image acquisition anywhere and any time.

Patient monitoring is transitioning from disparate stand alone systems to an enterprise system. This creates specific infrastructure requirements, encompassing wired and wireless networks. Raising patient acuity and an increasing trend to spread higher acuity patients out to their medical services has increased the need for pervasive monitoring capabilities.

Integration was grouped into 3 different applications. Integration started in the operating room, and this trend evolving into a unified enterprise system. There is a growing requirement for disparate systems to work in concert, including: patient monitoring, ventilators, infusion pumps, defibrillators and information systems. This gives rise to challenges in defining a coherent network infrastructure. (more…)