Since last year’s conference so much has come to pass:

• The FDA published their final rule for Medical Device Data Systems, and signaled their intent to regulate health care providers who develop their own MDDS solutions.
• The FDA also published the long anticipated draft guidance on mobile apps, clarifying the boundaries around what is and is not regulated medical device software, and laying out a bit of the FDA’s enforcement strategy.
• The transition of health care technology from the hospital to home health has also received some attention from the National Research Council in their report, Health Care Comes Home: The Human Factors.
• An FDA Workshop on Medical Device Interoperability was held a few months after last year’s Medical Device Connectivity conference. This event was just part of an effort to develop a regulatory framework tailored to plug and play medical device interoperability. The group behind this event has published a number of important papers this year on interoperability, risk management and other topics.
• Founded in July of 2010, the mHealth Regulatory Coalition has  contributed greatly to advancing a different set of regulatory policies for mobile apps and also published important papers this year on the optimal regulatory framework for mHealth medical devices.

On the standards front, IEC 80001 will mark its first year as a formal standard this September. And the Integrated Clinical Environment (ICE) standard (ASTM F2761-2009) has been advanced by a number of grants that will result in the creation of solutions that implement portions of the ICE standard. Both ICE and ongoing efforts by the IHE PCD have seen continued adoption of ISO/IEEE 11072.

This year’s conference will explore all of these topics, along with a number of case studies.

The Medical Device Connectivity conference remains the sole industry event dedicated to workflow automation through the integration of medical devices and information systems. And there is no other venue where clinicians, clinical engineers, medical device manufacturers and connectivity suppliers can all meet, learn and exchange ideas.

Thanks in advance to all of this year’s  speakers for their participation and support of the advancement of connectivity, and this conference. Both their expertise and efforts to share their connectivity experience will create an exceptional conference experience for all attendees.

Here are some of the conference agenda highlights:

• As principal investigator for the $10 million Quantum Grant for the “Development of a Prototype Healthcare Intranet for Improved Health Outcomes,” Julian Goldman MD will report on progress in patient centric care.
• With connectivity, medical devices are becoming information appliances. As medical devices become more connected and smarter, where will it all end? Glen Allmendinger, President of Harbor Research will answer those questions in his presentation on medical devices and the Internet of things.
• After Glen’s exploration of the broader industry trends impacting medical devices, yours truly will describe how medical devices themselves are evolving, and look at some likely outcomes.
• Few people have impacted medical device connectivity as much as the inventor of the “smart” infusion pump, Nat Sims MD. Since the birth of the smart pump, Nat has been quite busy and you will learn a bit of what he’s been up to when he presents a survey of 5 different connectivity applications implemented at Partners Healthcare.
• Medical device networking – both wired and wireless – continues to be a challenge for health care providers. As an independent nonprofit dedicated to the mission of lowering health care costs by accelerating the availability of wireless health, the West Wireless Health Institute has initiated a program to improve wireless networking for medical devices in hospitals. Ed Cantwell, will present his institute’s proposed solution to the vexing problem of harmonizing enterprise networks to wireless medical devices.
• The ECRI Institute has taken a leadership position on health care technology challenges for over 40 years. Jim Keller, leader of ECRI’s medical device evaluation program will present the Institute’s perspective on the challenges and potential solutions medical device connectivity presents to health care providers.
• The FDA Workshop on Medical Device Interoperability mentioned above, is one of the activities of the AAMI HIT and Interoperability Ad-Hoc Committee. Steering committee member, Michael Robking (and Principal of Anakena Solutions) will provide an update on the committees activities and how they may impact the future regulation of interoperable medical devices.
• The mHealth Regulatory Coalition, also mentioned above, is tackling a different set of interoperability regulatory challenges. Dane Stout, Director Connected Health and Biomedical Communication Practice, The Anson Group, is also a leader in the coalition. Dane will provide an update on the coalition’s efforts to assist the FDA in the development of draft guidance for mHealth products.

In addition to the above, there will be three tracks of presentations focused on topics for health care providers, medical device manufacturers and regulatory issues. These represent more than 16 additional presentations.

After the conference, attendees have the option to sign up for one of 3 post-conference workshops. These in depth 4 hour workshops provide meaty “deep dives” into each of their subjects. All workshop instructors are industry leaders.

• Vendor agnostic alarm design and performance metrics is the title of workshop from Kourtney Govro, CEO of Sphere3 Consulting. Kourtney will show how alerts and alarms from nurse call systems can be transformed into leading indicators of care, reflecting a hospital’s patient satisfaction levels and financial success. This workshop will describe how patient’s needs can be met more effectively by looking at numbers that are produced by technology used every day at the hospital.
• Distributed antenna systems in hospitals: best practices, is a topic that continues to vex health care providers. Between legal mandates to support public safety frequencies with the hospital, and dealing with integrating networked medical device systems on enterprise networks, few hospitals have resolved their networking issues. Distributed antenna systems are often mentioned as a potential solution to all or some of these problems. In this workshop, David Hoglund, Principal of Integra Systems will instruct attendees on what technologies are available, what works and what doesn’t, and how best to plan for, deploy and support distributed antenna systems in your enterprise.
• A practical design workshop for creating connected medical devices and gateways based on open source, and open architecture components is the follow up to last year’s workshop on a similar topic. Presented by Shahid Shah, CEO of Netspective will delve into medical device product architectures optimized for connectivity applications. He will show how these architectures, based on open source and open architecture components can result in reliable and feature rich devices with a significantly lower time-to-market and cost of goods sold.

Be sure to check TCBI’s web site for this conference for updates and the latest agenda.

One change this year, is that my blog posts from the conference will be appearing on the Medical Electronic Design magazine blog, found here. As usual, I’ll also be taking lots of photos, some of which may also be posted on the MED blog. Eventually most all the photos (the good ones that aren’t confidential) will be posted on my Flickr account, here.

The rationale behind the workshop is the need to clear up confusion on the part of many product developers regarding regulatory issues like,

• Is my product a regulated medical device?
• What does it mean to be regulated?
• If I don’t want to be regulated, can I avoid regulation – and if so, how?

Ideally, we can structure the workshop around attendees actual products and situations. This, of course, will depend on folks registering in advance with sufficient lead time to actually prepare some content around their unique situations. Using participant’s products as case studies should be more engaging and relevant for everyone. If you’re registered for the workshop and want to provide a case study, let me know by completing this contact form.

If we can’t get participant provided cases, I plan to use some example products from companies like AirStrip Technologies, MIM Software’s Mobile MIM, and MobiSante’s MobiUS ultrasound product.  I’m also open to suggestions about other companies or products for case studies (again, leave your thoughts on the contact form.

Like any other business activity, if you want any hope of meeting your objectives, you need a plan. The same holds true regarding regulatory issues, whether you want to avoid or embrace being regulated by FDA. The objective of the workshop is to lead you through the process of putting together a plan.

Here are the topics I’m pulling together for the workshop. The first issue is whether your product as it exists or is conceived meets the legal definition of a medical device. For those outside the regulatory field, the answer to this question is both simpler and more complex than many think. We’ll look at the typical artifacts and indications for making this determination.

Next we’ll work to bring into focus the boundaries between what makes a product a regulated medical device or not. You will find that the degree of focus will vary depending on the nature and characteristics of the product. We will then consider what would be necessary for the product to move from being regulated to unregulated and vice a versa.

The most basic decision in your regulatory strategy is whether or not your product will be regulated. Once we’ve worked that out, we will develop a plan to realize your strategy. This plan will focus mostly on your product roadmap, sales and marketing. We’ll define the strategy as it will be applied company operations, to include clearly defined product feature boundaries, a defined claims and intended use framework, and a few other components. In cases where the strategy entails being regulated, we’ll include those requirements in the plan as well.

I’m already working to line up speakers – if you’ve got a topic to suggest, or want to present yourself, let me know.

The focus of this year’s conference may extend a bit beyond the acute care (hospital) market into ambulatory settings (patient’s homes and use in daily life). Now there are already several conferences on connectivity in ambulatory markets (Healthcare Unbound, mHealth Summit, Connected Health Symposium), but they focus little on specific connectivity issues.

Conference topics typically come from recent and current issues that crop up  in my consulting practice, and buzz in the industry (which is where you come in). Here are some of the topics that are being considered for this year’s conference:

• Provider case studies on connectivity experience – EMR clinical documentation, surveillance, data aggregation, alarm notification, etc.
• Physician office medical device connectivity – current state, trends, best practices, provider experience
• A survey of the current state of medical device connectivity – solutions from medical device manufacturers and third party solutions
• Standards – a survey of relevant standards, updates on IHE and HL7, which are getting adoption, recommendations for moving ahead
• Hospital and IT governance issues that arise from the adoption of medical device connectivity
• How connectivity is impacting Biomed and IT outsourcing business
• A deeper dive into issues around IT and Biomed integration
• Meaningful Use 2015:  “medical device interoperability” – what does it mean, and how can we achieve it in 4 short years?
• Hospital experiences with Wi-Fi deployments
• Wireless sensors, personal and body area networks – products, trends, success factors
• Best practices for testing medical device connectivity, including IT infrastructure, for both manufacturers and providers
• Remote service and connectivity, can they piggyback or leverage one another?
• Topics around EMR integration – EMR vendor’s rules of engagement, provider requirements, industry best practice

Current thoughts on post conference workshops:

• Remote device management
• Merging biomed and IT departments
• Implementing IEC 80001
• Testing wireless medical devices for providers and manufacturers
• A how-to on use cases for connectivity workflow requirements
• Implementation strategies for EMR/medical device connectivity

If you have any suggestions for this year’s conference, you can leave comments here, or contact me directly. I’ll also be at HIMSS and would be glad to meet up there.

Pictured are Eric McDonald with Hill-Rom and Trey Lauderdale of Voalte, at the 2009 Medical Device Connectivity Conference in Boston.

Here are some posts on previous years conferences:

Medical Device Connectivity Conference Wrap-up

First Ever Medical Device Connectivity Conference

The event is just kicking off as I’m writing this (loud techno music before the speakers come up to the podium). Focus is squarely on wireless broadband (cell phones) offering ubiquitous connectivity.  Applications discussed provide education, diagnostics, therapy delivery and monitoring.

The Twitter hash for this conference is #mhs10. The opening keynote is being held in a full ballroom at the Washington DC Convention Center. There are an estimated couple thousand attendees– I’ll provide an official number later.

Dr Francis Collings, the 16th director of the NIH presented the first keynote. He provided a survey of sample mhealth applications, all in the research phase: lens free microscope — attached to cell phone, of course — for detecting contaminates in drinking water, a patient worn environmental monitor for hydrocarbons, an activity and diet monitor that provides objective evidence (as opposed to the fantasy patient’s typically include in conventional diaries), and the real-time adherence monitoring for HIV antiretroviral therapy in Uganda (generates signal when pill box is opened). Dr Collins also mentioned a new NIH summer institute on mobile technology research to enhance health. This will be a 5 day training session for 25 junior investigators, in La Jolla.  More info here.

Todd Park, CTO of HHS was up next. Todd was a founder of Athena Health and recently found his way to HHS. He provided a survey of the mhealth efforts of HHS. One service he described is Text for baby, a free SMS service for prenatal care that provides educational information on prenatal care over the term of a pregnancy. Over 100k moms have registered with service. A new Secretary’s “text for health program” will extend this texting service beyond prenatal care to other health issues.

Probably the biggest news this morning is that HHS is currently studying reimbursement policy to revise incentives for mhealth. In many cases, providers are either not incented, or disincented to utilize or support mhealth applications. This revision of reimbursement policy will ensure that financial incentives are aligned with the utilization of mhealth technology that will reduce costs and improve care.

Todd closed his presentation with the promise that in future, health data will be available much like weather data is available from NOAA. The URL will be healthdata.gov.

Another meaty point was the need to improve validation of mheath applications. Taking 18 or 24 months (or many times, longer) to validate the value and efficacy — the classic huge multi site randomized clinical trials — of mhealth applications is inefficient and poorly suited for a technology that changes as rapidly as it does. Deciding on a more suitable approach was described as a consensus building effort. Perhaps we need a multi-site randomized clinical trail on the most likely validation methods… just kidding.

Pictured is the Wocket open source wireless sensor and an Android smart phone acting as a gateway device.

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.) Last year the FDA was one of several organizers in a series of workshops on wireless medical devices. Oh, and I almost forgot the FDA’s proposed rule on Medical Device Data Systems (MDDS) it was published so long ago (2 years ago next month). You can read more about the draft MDDS rule here, here, here, and here. Finally, the FDA has participated in a number of standards and test and certification efforts, such as the IHE’s Patient Care Device workgroup.

In many ways, the FDA’s regulatory framework is based on the concept of medical devices as stand alone black boxes controlled by manufacturers and used by health care providers. With stand alone medical devices, a regulatory framework that only applies to manufacturers is fine. But when medical devices become components in wider systems that are designed and implemented by sometimes unregulated third parties and maintained by customers, things can break down. As a result, the efficacy of this long standing regulatory framework is called into question. The blog post Medical Device Networks Trouble Industry, offers another example of the potential gaps resulting from limiting regulatory requirements to manufacturers. Medical device networking was also the subject of my presentation proposal for the workshop.

So what’s the purpose or desired outcome of this workshop? From the workshop web page:

The purpose of the workshop is to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to safe and effective interoperable medical devices.

This is an uninspiring, or more accurately, overly broad objective. In fact, anyone who attends is likely to have more substantive objectives they’d like to see realized. For example:

• A desire to be educated, either industry’s interests in the regulatory requirements for medical device interoperability, or regulators interests in the kinds of interoperable solutions offered or under consideration by manufacturers
• A goal of convincing the FDA to adopt a new and less onerous regulatory framework within which to realize interoperability
• The objective to gain specific regulatory guidance from the FDA on how to apply current regulations to specific products incorporating interoperability
• As always, there will be some health care providers in attendance who simply want to know how they can go about buying or creating the interoperable solutions they’ve been waiting for so long

After chairing last September’s inaugural Medical Device Connectivity Conference in Boston, I’m just glad to be an attendee.

UPDATE: A revised agenda (dated January 20, 2010), including descriptions of all the presentations, has been released. You can download it here.

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.

This conference includes an innovation that’s just starting to appear in conferences like this. On the second day, there is an additional track where attendees can meet with conference sponsors. This is your opportunity to get an indepth demonstration or have a meaty discussion with one or more of the sponsors.

Sponsors for the event are many of the leading manufacturers in connectivity or patient care device integration (PCDI) market:

• Capsule
• Cardiopulmonary
• Cerner
• Hill-Rom
• Cisco
• Nuvon
• Philips

Just today, I heard that Fluke Networks has joined as a sponsor.

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.

Another Qualcomm solution, eZone universal wireless charging tech, an induction-like recharging solution was touted. Something like this is the future of charging for reusable wireless sensors or patient worn gateways.

Paul wrapped things up by announcing Qualcomm’s contribution to a wireless innovation challenge for universities in southern California.  He equated this effort to past market development efforts of Qualcomm’s. Their approach to collaborate with wireless network operators (carriers), cell phone manufacturers, media/services and application providers, and web companies like eBay, Amazon and others.

Next up was Katherine Kalin, vice president of strategy, J&J Corporate Development. She bragged on her company (120k employees, $60 billion revenue, 250 operating companies, etc.) emphasizing their decentralized management structure. This allows each operating unit to get closer to their customers and better bend their operations to their specific market segment.

Katherine talked about how J&J is targeting what they call “white spaces” for new business opportunities. Wellness and prevention was designated a business platform, including two new acquisitions: HealthMedia and Human Performance Institute.

Part of the disruptive solution evolution she mentioned includes unusual partnerships: Intel/GE Healthcare, Walmart/Dell, and other cross-market alliances.

The first panel was up next: Dr. Eric Topol, Philip Low, MD, Jeff Augenstein, MD, and Stan Kachnowski, MD, moderated by David Gruber, MD.

Jeff started things off. He contrasted the promise of health care IT (HIT) and the reality. He noted a litany of very expensive, high profile HIT failures. He presented a scenario — a strawman of a sort — centered on trauma. Trauma is the most expensive disease, and it is almost always preventable.  This trauma example, self inflicted by the victim, offers examples of how current and soon to be available tech is applied to the situation.

In response to Jeff’s scenario, Stan Kachnowski noted that the type of innovation that is required must be low cost, small and easy to use. Stan went on to describe research he’s done looking at clinician workflows and how various communications methods impact workflow. His research has shown that workflow problems like process interruptions, can result in patient injury or death.

Philip Low described technology to provide feedback to the patient about their neurological state, whether they are intoxicated or falling asleep behind the wheel. He also suggested that we not confuse wellness with health care. Health care is delivered to patients by providers; wellness is a physiological condition attained by individuals.

Topol stated the health care delivery system in the US has already crashed. Anything you do can only improve the situation. He was not optimistic about EMR interoperability. Jeff’s genomic component of his trauma scenario was of interest. One fifth of the population has a gene that makes them more susceptible to brain swelling from head trauma. If you’ve not had your genome sequenced, you don’t know if you have that risk.

Dave asked the group about the current paradigm of research, randomized double-blind trials, and how that applies to evaluating software and other tech that impacts care delivery. Great question; manufacturers and physicians perennially tussle over this issue. The conventional scientific method is great for drugs and some devices like stents, pacemakers and heart valves, but worthless in evaluating workflow automation.

Jeff noted that the focus in this event is about how care is delivered rather than the basic science of diagnosis and therapy. The implication being that conventional randomized trials are not appropriate to evaluate improved workflows resulting from improved communications or software applications. Stan argued for a lower hurdle for the regulatory approval for new and innovative technologies to get them to market more often and in a shorter period of time. He suggested that post market surveillance might be a way to do that without compromising safety.

Jeff noted that we need to overcome the poor adoption of many purported trends in health care: he noted EMRs and patient self management as two examples. Stan observed that physician technology adoption can be very rapid — pagers, fax machines, new diagnostic technologies, etc. — if it works and delivers value, they will adopt. Philip noted that some physician resistance is the concern that new technologies will replace them rather than just make them more efficient. Eric noted that the administration of TPA (tissue plasminogen activator) for heart attacks and stroke took almost 10 years to become a standard of care, and a trial with 40,000 patients, suggesting that this is too long.

Wrap up comments captured an interesting dog/cat perspective: health care delivery (and providers) is transaction oriented, while patients look to form relationships with providers.

After the break, Andy Thompson, founder and CEO of Proteus Biomedical, talked about How can Wireless-Life Sciences Transform the (Broken) Economics of Global Healthcare? He suggested the acute care hospital is the “epicenter of economic distortion.” In the UK, they’ve built up a primary care network and moved the “becoming acutely sick” and the “chronically sick” patients out of the hospital. The promise of wireless convergence is to move the chronically sick out to “community and family care networks.” He defined the family care whole product solution to include therapy, monitoring, applications and community, and incentives. His company, Proteus, can deliver a highly profitable solution for $2 per day. Andy’s message was that the technology exists, what’s missing is the whole product solution combined with an alignment of incentives.

The next panel included Agnes Brzsenyi, general manager of GE’s home health business, Terry Hinsey, vice chair at Deloitte, and Jeff Goldsmith, blogger and president of Health Futures. Jeff Belk, principal of ITC 168 Capital moderated. Terry sees many companies focused on finishing a product, and missing things in regulatory and the “whole product solution” that will drive adoption. Agnes talked about recent CMS studies that showed cost increases or no meaningful cost savings using remote monitoring or Healthcare Unbound technologies. GE is heavily focused on value, which is what people require before they buy. Another issue was product design: usability and good workflow automation. She contrasted the group here lobbying for e-health with a conference she attended in Prague last week was attended by the ministers of health from many of the members of the European Union — who described how they’re adopting e-health. This contrasted with this conference where a bunch of providers and entrepreneurs are trying to drive adoption.

Jeff asked the question, how many of these products are we welling to adopt ourselves? He noted that he’s 60 and has no interest in going to a  retirement home and living with a bunch of other old people. Nor is he looking forward to getting calls from his daughter to put his smart shirt back on. He referenced Clint Eastwood’s character in Gran Torino as a model for the soon to be elderly. He suggested that the paternalistic bent of many of these solutions was a huge barrier to adoption.

Regarding reimbursement, Jeff noted that that really went out the window with capitated care. The trend is to disperse risk across the care delivery system. For example, CHF readmissions: a hospital that knows they won’t be reimbursed for the next frequent flyer admission will be motivated to manage that patient to avoid that readmission. Terry noted the list of CPT codes that vendors used to promote how providers could generate revenue with their products. Now cost avoidance and improved outcomes are an increasing factor due to shifts in incentives and reimbursement. Terry sees market incentives aligned to foster cross party interoperability — across providers, payors, technology solutions.

Jeff sees the hospital as a huge market for the technologies represented at this meeting. He noted the need to greatly increase productivity to enable the growing shortage of health care workers to serve the soon to explode number of elderly. Jeff Belk suggested that disruptive technologies will just as likely to come from developing country markets, and not necessarily the developed world as most people seem to expect. One of the factors here is that many emerging markets can’t afford the same technology adoption path followed by developed markets. Consequently, these emerging markets try completely different things by necessity, some of which will have applicability world wide. Agnes: technology itself is just technology, it is the people, workflow and importance of the information that comes out of it that is key. The secret sauce is figuring out how to leverage this to change behavior — especially important with chronic disease management.

There is a strong idealistic theme in wireless health care that we can save people from themselves. This seems true especially of the obese, smokers, substance abusers, and extends even to chronic diseases like diabetes, CHF, and COPD. A question from the audience asked about personal responsibility on the part of the patient. She suggested financial responsibility (i.e., consequences) are necessary.Terry agreed that, “stick beats carrot every time.”

Next up: part one of award finalist presentations. Presenters include GreatCall/Jitterbug, MedApps, CellTrak Technologies, BeWell Mobile, Diversinet/AllOne Mobile, and Epocrates. Each company CEO had 2 minutes each to tell their story. They failed miserably.

Lunch saw a presentation from Jay Parkinson, MD, founder of HelloHealth. HelloHealth supports a direct pay (cash) business model for patients and physicians. Like Amazon for resellers, HelloHeath handles payment transactions. Like Facebook, there is a rich environment for scheduling appointments (in office, text or video), rating providers, tracking health care information and supports messaging and activity feeds for patients and physicians. The software is effectively an electronic medical record and billing/payment system for both providers and patients. There’s also a social networking angle amongst physicians and patients. Potentially a game changing platform for health care. According to Jay, HelloHealth is ideal many relatively healthy people when combined with a high deductable health plan and health savings account. Jay pointed out that many people in the US are actually over insured.

After lunch Clint McClellan, Qualcomm, moderated a panel looking at international wireless health initiatives. Panel members included Karl Brown, Rockefeller Foundation, David Edelstein, Grameen Foundation, and Mitul Shah, United Nations Foundation. These groups are looking to leverage the low cost disruptive capabilities of wireless health to improve health care in developing countries.

Grameen is using a simple Java app deployed on a low cost cell phone to replace most of the current log books and statistics worksheets in clinics.  Mitul noted that many undeveloped markets have an advantage in that they don’t have the health care system baggage that countries like the US have. This could allow these countries to leapfrog developed countries in their utilization of wireless health and other technologies. The lack of legacy systems is a real advantage.

The agenda broke into two tracks, continuing the international focus and another applying Gameboy/Xbox like consumer electronics to wireless health. I picked the international track. The previous panel was expanded to include Shawn Covell, Qualcomm, Yuri Ostrovsky, Click Diagnostics, and Dr. Krishnan Ganapathy, Apollo Telemedicine Networking Foundation. Ashok Kual of ARCS Global moderated.

In environments where the population is uneducated, i.e., illiterate, an effective solution is to use a local proxy (who can at least read at a grade school level) to operate the technology and mediate the communications between the physician and patient. The general population in developing markets, while not formally educated, are intelligent. Properly designed products have been very successfully adopted in these markets. Shawn noted that, regardless of education, users need to be trained.

Cultural issues equates to local needs and how to address those needs in the local community. There’s a tension between the need for scalability and high-touch capabilities. The basic economics of wireless health technologies are of much greater importance — to the foundations and those in underdeveloped markets — are much more important than cultural issues.  A common mistake is to “dumb down” a product for developed markets, when you need to know what the market requirements are for those international markets. In every market the users are different, and this must be taken into account.

Karl noted that historically on a world wide basis the cost of health care always grows substantially faster than growth in GDP. For example, over the past 20 years, health care costs in China have grown 50 times — several times faster than their GDP. To a great extent, this makes sense to me — as a society gets more affluent, what better to spend your money on than health care? From a market opportunity perspective, diabetes represents a huge target market for developing countries.

In summary, developing countries represent a great opportunity to test products. Their receptivity to technological innovation, low regulatory hurdles, and the potential for demonstrating benefits makes them a great target for initial product releases.

Aaron Goldmuntz provided an update on CardioNet, the first wireless health application using a carrier network for communications. A big part of CardioNet’s success is based on research done to validate the clincal benefits of CardioNet over loop event cardiac monitoring. CardioNet is looking to extend their franchise to grow the business. They plan to leverage their service model, build share within their current market, and expand current technology to adjacent cardiac segments. Their new atrial fibrillation monitoring is both a diagnostic and management tool. They’re also getting in to the clinical trails business. CardioNet is also looking to expand outside the US to international markets. Finally, they’re looking beyond ECG and cardiac monitoring to look at new therapeutic and diagnostic modalities. Neurology (strokes, sleep disorders) are recent targets for CardioNet.

Part two of award finalist presentations include: IntelliDot, Triage Wireless, Tagnos, MicroCHIPS, PhiloMetron, and Proteus (which Andy talked about earlier today). Jim Sweeney with IntelliDot, noted that CMS’ list of never events, the adverse events that should never happen — which they won’t reimburse hospitals for — is now up to 27 items. This group of CEOs did worse than the previous one at limiting their comments to 2 minutes each.

Now for the Triple Tree aware in three categories: clinical applications using wireless tech, consumer oriented solution, operational effectiveness solution. (Oops, the actual award trophies are a few days late and will be sent to the winners.)

Proteus Biomedical wins the clincial applications using wireless technology solution.  Best consumer experience goes to Great Call/Jitterbug. Best operational effectiveness is IntelliDot. And thus ends the first day’s sessions.

Photo at top: Computational modules for wearable health monitors from Nyx. Very cool stuff.

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.)

Delta Controls monitors building boilers, air conditioning, lighting and other basic building systems. Like with WatchMate, a user at a computer display has been replaced by automated notification through ConnexALL. Also like with WatchMate, alarms are received by appropriate staff more quickly and reliably. Unlike with WatchMate, interactions and dependencies among building systems can result in multiple subsystems generating alarms on the same change in conditions — essentially duplicate alarms. The ConnexALL system analyzes these multiple alarms and filters out duplicate nuisance alarms.

The Siemens fire control panel monitors both elevators and fire alarms. The application and benefits are similar to the building systems automation system. Because ConnexALL is integrated with both the building automation system and fire control panel, alarm analysis and management takes co dependencies and interactions between the two system, consolidating alarms and reducing nuisance alarms.

Their legacy alarm monitoring solution for these three systems was custom engineered and was no longer supported by the original vendor. The system only consolidated  alarms in a central location (the switchboard) but alarm notification remained a manual process. Alarm escalation was dependent on a switchboard operator monitoring alarm notification success and responses to alarms, and escalating alarms manually. And of course, if the switchboard operator was busy or not present, alarms could be missed. Because alarm management was completely manual, auditing alarm responses was difficult, at best.

A variety of notification devices were contemplated. Many wanted to use pagers, but their pagers were not two way pagers and thus could not ensure alarms were received by the device or send back acknowledgments from those responding to alarms. Many users Blackberrys, wireless phones and desk top phones. Everyone’s desk top computer also has a client application that pops into focus when an alarm condition occurs.

Grand River Hospital’s lessons learned were the importance of weekly team meetings and the proper involvement with the vendor. Due to the impact of automating (and thus changing) workflows, getting all the operational issues and changes worked out and agreed to prior to implementation is essential. In their case, the Facilities department didn’t want to be responsible for alarms, they liked having the switchboard having this responsibility. Once they understood that ConnexALL would automate the alarm process they were agreeable. Issues like this are important to work out as early in the process as possible.

They ended up having to reconfigure their building automation and fire control systems during the implementation. They didn’t realize that a comprehensive assessment of alarm notification would result in decisions to optimize the other systems to improve overall processes.

Susan Bisaillon, with Trillium Health Centre leveraged ConnexALL for a house-wide process reengineering effort in a hospital new-construction project, the West wing project. The new wing is designed for decentralized care, rather than the conventional large central stations on large nursing units (30-40 beds). The new wing has 12 bed pods, 3 pods per floor. Each pod has what is effectively a mini central station, with more technology at the bed side. Computers on wheels located outside patient rooms are used by staff rather than workstations at the pod, or mini central stations. This minimizes time at the central station and provides caregivers more time at the bedside.

The underlying concept driving the design and implementation of the new West Wing was patient centered care. A big part of this was leveraging technology to realize a more patient centric view. The existing hospital has stand alone (that is, not integrated) wireless LAN, phone system and nurse call. The new building has combined wireless VoIP phones and wireless LAN from Cisco, and the nurse call is Rauland-Borg — both are integrated using ConnexALL.

In a decentralized nursing environment, relying on the central station as a hub for workflow automation does not work — there is no central station, and nurses spend little time at the decentralized pods that replaced central stations. As a result, workflow changes included the move of nurse call  from central stations to calls dispatched by ConnexALL directly to the caregiver’s phone that is responsible for that patient.

They evaluated Ascom, Blackberry, Vocera and Cisco 7921 phones. They had a cross functional team evaluate the phones. The evaluation was accomplished in a two day beauty contest. There were 60 participants, 6 two-hour sessions where vendors presented their solutions and how they would perform in specific scenarios. The hospital chose the Cisco 7921 IP phone.

Interestingly, while the Blackberry was a popular device among caregivers, the hospital could not justify the monthly cellular bill that came with them. Until Research In Motion, the maker of the Blackberry, figures out a distribution channel for enterprise Wi-Fi deployments, they will see limited adoption in hospitals.

The hospital ultimately chose to support 2 devices: Blackberry and the 7921 Cisco handset. The carrier cost of the Blackberry was the barrier to adopting this device for the nurses.  They use a plastic sleeve on the Cisco phones to improve ruggedness, make them easier to clean and protect the plastic from the detrimental effects of disinfectants. (After the presentation, there was some discussion about the potential for an increased risk of infection from the phone sleeves, an issue that will require more study.)

Besides the integration of their nurse call with the new phones, ConnexALL also drove large automated displays that replaced manual white boards to reflect patient status, staff assignments, attending physician, etc.

Trillium did a pilot to ensure integrations worked and were configured properly for optimal workflow. The pilot served as a major shake out for the wireless LAN. There were a lot of wireless LAN issues. The wireless LAN was engineered for wireless data. The addition of wireless VoIP represented a major change in performance requirements for which the initial network was not designed.

Not surprisingly, they found they had to reengineer their wireless LAN to realize sufficient performance for their new application. After initial problems during the pilot, their Cisco VAR (value added reseller), FlexITy, did a comprehensive site survey and revised the wireless LAN (upgrading existing access points,  adding and moving access points) to achieve the required performance. There are presently no medical devices on the wireless LAN. The issue for them is, “what devices need to be wireless to facilitate patient centered care?” And when the time comes, the hospital will be well served to review the specifications for any wireless medical devices, do another site survey, and reengineer their network as needed — before the pilot.

Nurse managers on each unit are responsible for developing a process for managing, deploying and retaining wireless devices. So far only one Blackberry has disappeared. Another customer in the audience noted that they’d lost 30 phones out of their ED. While many of these phones don’t work outside the facility, they can be sold on eBay and other places.

A lot of effort went into preparing the staff in the new units for the differences in the care environment (especially no central stations), the new workflows, and new devices — automated display panels, phones, COWs, etc. Human factors engineers were also brought in to ensure proper body mechanics.

With the implementation of more direct and efficient communications, Susan noted increased communications between patients and the interdisciplinary team. ConnexALL is used to integrate messaging to caregivers assigned to individual patients, backup caregivers, and MET team for responding to patients with a deteriorating clinical condition.

The new technology has created a more quite care environment. Communications, nurse calls and alarms are communicated directly to the responsible caregiver without disturbing patients and coworkers. Patients have noted the more quite environment, and are complimenting nurses at a higher rate than in the existing hospital units.

Susan notes that they’re still on the learning curve with ConnexALL and working with mobile technology. Staff is still making some adjustments to the decentralized care delivery model. Staff sometimes feel isolated, especially at night.

Throughout the project hospital leadership was very supportive, a critical success factor according to Susan. All the vendors involved collaborated effectively. The planning and implementation teams met weekly to discuss strategy, planning and evaluation.

Loookin to the future, they want to integrate telemetry and their PBX. The next big project is to retrofit the units in their existing hospital. Those units will retain their central stations, but they will use the same technology as was deployed in the West wing. Longer down the road, they’re working on EMR adoption and broader more comprehensive workflow automation.

Farrah Hirji with Markham Stouffville Hospital spoke on The LEAN Evolution at Markham Stouffville Hospital: Transforming Care. After an introduction to LEAN fundamentals, Farrah launched into the application of LEAN at her hospital and the results they have realized. Their hospital was built to serve about a population of 100,000 but they serve almost double that.

Their incentives for embarking on LEAN were a rapidly growing population (24% in past 3 years) and the resulting need to improve throughput, and also the need to improve patient safety and outcomes.

Culture change is required for success with any focused process reengineering methodology. LEAN is a continuous quality improvement methodology that identifies and eliminates muda (Japanese for waste) in processes. Muda is any activity that uses resources without creating value. Most importantly, it is the patient that defines value.

The major tools are the process, implemented with people, post-it notes and butcher paper to do affinity grouping and process documentation to document the initial state. From this a value stream analysis is done that results in a strategic improvement plan. These tools are used within a specific framework called a Kaizen. A Kaizen event is a 7 week cycle centered on a major 5 day Kaizen event. The first day of the Kaizen documents the current state. Day two does rapid experiments considering process and workflow changes. Day three is focused on defining implementation changes. Day four is centered on trails and testing and creating standard work. The last day is a review and briefing the rest of the hospital staff.

Markham Stouffville targeted the ED for their first LEAN project. Their initial changes included the creation of a Rapid Assessment Zone, EMS protocol, and volunteer greeter. The result of these changes reduced triage to physician assessment interval, reduced ED LOS, and fewer patients left without being seen. In Canada, ED wait times are publicly reported, and these changes have helped the hospital meet their provincial performance targets.

Success factors: a balance of top down and bottom up innovation, collaborative leadership, and treating front line staff as the experts in the work being done. LEAN and Kaizen are cross functional teams, and this process creates the expectation of the need to change — sort of a built in change mangement process. They’ve also adopted the “Vegas” rule: whatever’s said in the Kaizen meeting, stays in the Kaizen meeting. A further technique, the “Gemba” walk takes the team to where the actual work is done and places them in the patient’s perspective. They can also see what their colleagues in different roles have to deal with and how they get their work done.

Typical change in health care takes 6 to 18 months. LEAN results in a much quicker time line, with immediate measurements of results to optimize and reinforce the positive change. The challenge is of course, resistance to change. People also ask why front line staff are making the changes. Hospital’s traditional silo organizational structures are also a barrier. Front line managers need to understand how to manage in a LEAN environment; they no longer call all the shots, but faciliate a broader group process for planning and realizing positive change.

The requirement to collect real time data to measure initial states and documents the impact of changes is a big issue. Without operational data, the LEAN process can’t analyze the current state, nor test and verify that new processes are an improvement. Finally, some operational data is needed going forward to ensure that reengineered processes don’t slip back into the comfortable old way of doing things.

LEAN thinking needs to be integrated into everyday patient care.

Farrah next laid out how to get started in LEAN process. The first things needed are a change agent and lever. This is typically a new requirement imposed on the department or oganization. An executive sponsor is also critical. This is someone who will provide appropriate commitment and “head banging” when required. Physician involvement is important, if difficult to achieve. Use an external consultant to facilitate the initiation of the project. Sustaining positive change is key; follow up meetings and audits are essential to sustaining change. Steal shamelessly from other organizations who have dealt with similar problems or implemented interesting innovations. Develop a long term strategy for transforming your organization.

Brent Maranzan from Thunder Bay asked about gaining physician involvement. Brent presented on Monday, describing how they improved OR workflow. Farrah described a couple of techniques. First she nicely but persistently asked for physician involvement. The catalyst for physician involvement in her project was letting physicians know that improved ED throughput would allow them to see more patients, and thus increase their income.

Getting started in LEAN: a very few hospitals have the luxury of their own process improvement department. At Farrah’s hospital, senior management wanted to try the LEAN methodology. Farrah also had a personal interest in LEAN techniques and was quickly drafted to lead this effort. LEAN process improvement is only part of Farrah’s full time job. Their hospital heavily relies on line staff to implement the LEAN process.

Markham Stouffville is not a GlobeStar customer; Farrah was invited to present based on GlobeStar’s recognition of the necessity of changing workflow to realize operational improvements — whether facilitated by technology or not.

Closing Thoughts

As the conference came to an end, several thoughts came to mind. Messaging middleware deployments are usually point to point types of purchases. They’re focused on a small portion of the organization. Such systems are of modest scope, complexity and cost. The rub is that automating workflow through improved messaging is a need that spans the enterprise. Consequently, manufacturers in this market segment have enhanced their products and repositioned them as enterprise wide solutions. While they may still be implemented in a department by department or application by application fashion, an enterprise architecture is more cost effective and is easier to manage than a series of disparate messaging products.

It also struck this observer that there are several market segments targeting the point of care that may eventually merge into one market. These markets include nurse call, wireless phones, real time location systems, patient flow optimization applications, messaging middleware, and medical device connectivity. Much of the meta information used by these systems is common, and there is a frequent tussle between niche vendors as to who will control things like nurse to patient associations and patient to device associations. Workflow automation that impacts direct care, care coordination, therapy delivery and point of care diagnostic testing frequently bleeds across these niche markets, creating additional systems integration work for vendors, and additional complexities for buyers.

The challenge for vendors is to figure out the best ways to position and sell their solutions. While these solutions are highly flexible, hospitals want to buy solutions rather than tools. But when your product can be configured or implemented in many different ways, to create a variety of solutions, do you try to market each solution separately? Or is it best to offer a tool that can be used to realize several solutions?

Hospitals are even more challenged than vendors. There is almost nothing at the point of care that can be changed without impacting something else. The increasing overlap and integration between these six market segments has transformed a simple phone or nurse call decision into a broader workflow automation decision that impacts existing and future systems used at the point of care. Hospitals that don’t consider this new complexity, and think longer term will end up foregoing important workflow automation or face unanticipated costs in replacing or upgrading something they recently bought.

Of course supporting all these market segments, and more, is the enterprise network — specifically the wireless network. There is a general lack of appreciation among both buyers and sellers that wireless LANs must be designed to meet the specific requirements for the application at hand, whether it be wireless handsets, indoor positioning systems, or wireless medical devices. Some of these repeated site survey and reengineering costs can be mitigated with longer range planning. But in any event, a realization is needed that with each change in networking requirements, there must be a change in the network.

What impressed me most about the case studies presented by customers at this event, was their ability to apply the capabilities of the ConnexALL system to their operational requirements in thoughtful and creative ways. Sometimes this was done with the full support and involvement of GlobeStar Systems. More impressively, this was sometimes done by the hospital on their own.