Disruptive Technology and Health Care
In today’s Health Affairs, there is an interview of Clayton Christensen, the Harvard Business School professor and Mark Smith, California Health Care Foundation President and CEO – I’m not really sure who’s interviewing who, but it is very interesting none the less. To set the stage, Christensen defines a disruptive innovation as, “…a technology that brings a much more affordable product or service that is much simpler to use into a market. And so it allows a whole new population of consumers to afford to own and have the skill to use a product or service, whereas historically, the ability to access was limited to people who have a lot of money or a lot of skill.”
The rub is applying this disruptive concept to the delivery of health care. As Smith observes, “health care isn’t really one industry–it’s more like ten or twelve different industries.” Christensen comes up with a great observation:
If you have the same surgeons performing the surgery in the same way, but just in a different environment, then you wouldn’t expect to see a big impact on cost. But if the technology to perform the surgery became more routinized, so that the ability to perform the surgery correctly every time was more embedded in the equipment and the procedure than the intuition and skill of the doctor, that’s the mechanism by which the cost would come down. And so, for example, the cost of LASIK [laser-assisted in situ keratomileusis] surgeries has come way down, as a result of its becoming essentially an automated, standardized procedure that almost doesn’t even require the skill of an ophthalmologist. I bet you that if you decouple or disaggregate the data, you would find that those procedures that have become routinized and standardized, with the “skill” to some extent embedded in devices or equipment, you would find that costs have gone down. Where people are just doing the same thing in the same way but in a different venue, you wouldn’t expect to see much decrease.
Much of Christensen’s thoughts about disruptive health care revolve around low cost alternatives that empower patients – the choice of visiting a retail MinuteClinic over a traditional office visit, or diagnostic tests for chronic diseases that are done by or for the patient (and reported directly to the patient, rather than through a doctor).
Those of us in health care known that it changes very slowly. There are many structural barriers that mitigate against change, barriers to entry like regulations, Group Purchasing Organizations, and a consolidation of many market segments within health care. Ironically, the decentralized and fragmented aspects of health care (especially physician practices) serve to limit change. Smith and Christensen use consumer directed health care – health savings accounts – to discuss a way to lower market barriers to innovation. After trotting out another great technology example of the same principal, Christensen offers this:
If along with HSAs there were companies like MinuteClinic, then you could see how, oh my gosh, I’ve got my own money and I can choose whether I go to a doctor’s office and get soaked $150 to get diagnosed for my strep throat, or I could go to a MinuteClinic and for $39 in fifteen minutes, they’re going to not only give me a diagnosis, but a prescription for the medication. You can see how people would actually be delighted to have the HSA solution and a MinuteClinic, because they can get the job done cheaper, faster, and more conveniently. So if there were a totally different system out here that could disrupt the existing system and enable these types of choices, then HSAs might be seen as good news. But when we just present it as HSAs in the old system, it really is a pretty ambiguous thing.
Chronic disease is mentioned as a fertile ground for disintermediation. With the high frequency of health care required to manage chronic disease, and the physicians, labs and diagnostic tests required, there are numerous opportunities to provide solutions directly to patients that are empowering, more immediate, and lower cost. As a diabetic, Christensen’s examples revolve around his personal experience with managing his own condition. Next the discussion moved to technology, which frequently gets the blame as a major contributor to the high costs of health care.
There are two ways that technology can get deployed in health care. One is to help the experts in the health care system do even more sophisticated things that historically were not possible to do, so ultrasound or MRI [magnetic resonance imaging] screens allow people to see things in greater detail and at an earlier stage that historically just weren’t possible. When you bring technology to the experts to do more sophisticated things, in fact, it does bring a lot of cost into the system. But when you deploy the technology to commoditize the caregiver, to enable a lower-cost provider to do something that historically had required higher cost, then it actually takes cost out of the system. So you can’t just make a blanket statement about the technology. You have to be subtle about what kind of technology we are talking about and how it will be deployed in the business.
The biggest barrier to harnessing technology to the service of lowering health care costs are the barriers I mentioned above combined with the relatively small number of established technology vendors who wish to avoid disruptive technologies at all costs. Compared to the medical device markets, health care IT is a much more dynamic and innovative market – low barriers to entry bring new competitors with innovative solutions. Diagnostic imaging has seen new players address market niches that market leaders couldn’t be bothered to address – companies like Hologic and NeuroLogica. When was the last time an innovator brought a disruptive technology to the patient monitoring or infusion pump markets? Certainly there are many long standing unmet market requirements in those device markets, but without competitors who are willing to, you know, rock the boat, progress moves forward at a glacial pace. Christensen offers further observations:
I think there are three classes of medical problems. The first class are problems I’d call acute and amenable to precise diagnosis, which then enables rules-based therapy. And I actually would put even cancer in that category, in that I bet you fifteen years from now, most cancers–which at this point seem to be just very nonstandard and expertise-intensive to diagnose and treat–have the potential to become rules based. So it’s that class of rules-based acute diseases, I think, that are most amenable to a disruptive approach.
The second class is chronic diseases that people just are learning to live with–lupus and diabetes and so on. I think that they’re amenable but in a lower-impact way, in that I don’t think the cost of dealing with these chronic diseases will drop as much through disruption. But the sort of business model that American Healthways in Nashville is bringing to the management of chronic disease, I think, is really quite disruptive–actually lower cost and more efficacious than the conventional doctor-centric mode of caring for these chronic diseases.
The third class–the high end, nonstandard, medically complex cases–I don’t think you can address through disruption. But I do think that we need to begin addressing it. We need to try to improve quality and bring costs down for this group by applying the rules of the Toyota production system to the hospitals that care for them. The evidence is beginning to roll in; not a lot of hospitals have begun to do this, but some have. In a service or a manufacturing setting, when somebody redesigns processes to conform to these rules, they find that the overhead cost in the operation–this is overhead per unit of direct labor–drops by about 65 percent. And that’s because the expediting, the scheduling, the unscheduled down time, and the materials handling–scrap and rework–those costs just disappear. The direct cost, the cost of direct labor, falls by about 7 percent. And that is mainly because people stop working around problems–they just solve the problems.
Capacity utilization also increases significantly because you understand the bottleneck. So those kinds of innovations would be implemented in the tertiary care hospitals that care for medically complex individuals. I think that there are better ways to run those hospitals, and we know how to do it. We just haven’t implemented these solutions.
Smith closes the discussion with a greate question:
Where we see high-end marginal improvements in technology, we see costs going up rather than down–which is part of why so many health policy people cite technology as the problem rather than the answer to health care costs. What is it about health care that allows the kinds of technical advances that in other industries would lead to dramatic reductions in cost to actually lead to higher costs?
You’ll have to read the article for Christensen’s reply. As the question hints, the problem with costs is not the technology, it is the way the market is distorted by regulation and misalligned financial incentives between providers, payors and consumers (and employers too).
Christensen comes across as a libertarian with his preference to assume control and responsibility for his own chronic desease and choosing the most convenient, lowest cost options that give him the greatest control. This contrasts nicely with most of what I read in Health Affairs, with their tendencies towards paternalistic social welfare soltuions to health care’s challenges – which Smith trotts out and Christensen
rejects. A great interview, read the whole thing.
If this topic interests you, be sure to read “Why Most Health Care Innovations Fail.”
NHS to Target Patient Safety
It seems the UK's National Health Service will be receiving more attention regarding adverse events and patient safety in the near future. (Bold in the original story.)
300 chance of a hospital patient dying as a result of medical error.
One in 10 is estimated to suffer harm, of whom a third suffer serious
harm, while studies suggest that 600 errors are made a day in primary
care with more thanone in 10 prescriptions containing errors.
“It is clear that when you put those figures together, along with some
of the individual issues we have investigated [such as avoidable deaths
in maternity units and from hospital-acquired infections], then there
is a lot still to be done on safety,” said Anna Walker, chief executive of the Healthcare Commission, which acts as the healthcare inspectorate.
[...]
In the coming year, the commission would check more rigorously on
the hygiene code aimed at reducing hospital-acquired infections,
intervene where data showed high rates of MRSA and C. difficile
infections, and look more closely at the use of controlled drugs and of
radiation for both diagnosis and treatment.
But it would also be
putting pressure on the boards of health organisations, which were
responsible for standards, to ensure that they “monitor, analyse, and
learn lessons from safety episodes” in their hospitals, “and then act
on them”, she said.
Indeed, it's all about the data, or to put it another way, “you manage what you can measure.”
Monitoring Currently Unmonitored Patients
I came across some interesting posts in the Biomed Listserv. A biomed from a 250 bed hospital is looking for feedback on GE and Philips telemetry systems. This 260 bed community hospital is going to buy a 12 channel system, and ramp up to about 150 of the devices over the next few years. All sorts of questions came to my mind, and came to this fellow as well:
Instead of what to purchase, please assure that you ask the question – from a clinical patient perspective – what are you attempting to accomplish? Telemetry is intended to allow patients to ambulate and improve their outcome and therefore leave the hospital sooner. It was developed specifically to assist post open heart patients get out of bed and let clinical staff still watch the heart. If you are installing hundreds of channels of telemetry to just add monitoring – what is the patient benefit?
Also the clinical operating concerns can not be underestimated. What nurse is responsible for patient care? How many nurses per floor? Is there a central station, monitor techs? Most telemetry systems in hospital are (my opinion) not properly set up technically or operationally.
Most patients on telemetry do not ambulate, so why not have bedside monitoring? Most nurses taking care of patients on telemetry can not even see the ECG being technically transmitted as only the monitor tech can. Most monitor techs are not licensed to manage patient care – RN’s are. Most telemetry units also lack physician criteria for admission and discharge causing the need to always have more telemetry. I think most adult hospitals could benefit from the lessons learned at pediatric hospitals. If the patient needs to be monitored and is not ambulatory, put a networked bedside monitor at the patient bedside. Some vendors – Spacelabs – even have modules that allow for telemetry to be at bedside for those patients that require same.
Great questions. Fitting the monitoring device to match the patient profile is important. And effective alarm notification is essential.
Every hospital has some unmonitored patients that could benefit from being monitored. Patients on pain medications, especially PCA pumps, should be monitored. According to the literature, almost half of all cardiopulmonary arrests in hospitals are unwitnessed. While the survival rate of witnessed codes is 22%, the survival rate for unwitnessed codes is just 1%. Increased monitoring can reduce adverse events, improve outcomes, reduce length of stay, and minimize legal liability.
For these reasons and more, the current standard of practice for patient monitoring is changing. A greater number of hospitals are using telemetry monitors to monitor previously unmonitored patients. Patients that would normally not qualify for the telemetry unit or some other high dependency unit are being monitored – and usually this means telemetry packs.
Telemetry is a good choice because these patients are usually ambulatory, and telemetry transmitters are light weight and small. At the same time, telemetry monitors are a bad choice for several reasons. Telemetry transmitters have no local alarms; you can be right next to a patient in arrest, and unless you see their lips turn blue (or some other physical sign) you won’t know there’s an alarm condition. Telemetry alarms traditionally annunciate at the central station, and some installations include additional audible alarms, message panels or flashing lights. A related weakness of telemetry transmitters is the lack of a display. To view the patient’s physiological parameters you must leave the patient and go to the central station.
Another telemetry system limitation mentioned above is the requirement to have someone actually watch the central station displays. Some hospitals have monitor techs man central stations in a central location – frequently called the “war room.” While this is a safe approach, it is also very expensive – an 800 bed hospital can spend $1 million per year on their war room. Other hospitals distribute their monitoring techs on individual nursing units. Depending on patient volumes on nursing units, this could be more expensive than the centralized approach. Finally, many hospitals put central stations in nursing stations and make the nurses on the unit responsible for surveillance. This is certainly the most cost effective approach, but also the most vulnerable to alarm fatigue, especially when you have one or two patients who constantly throw off false positive alarms.
The final challenge is cost. Telemetry monitors, as inadequate as they are, cost about $8,000 per channel – still too high for the many hospitals that have yet to adopt broader patient monitoring. A contributing factor to cost is the use of WMTS by GE and Philips. While both vendors justify their use of WMTS on the fact that it is a “protected” frequency, that provides protection only against intentional interference (people purposely using the same frequency). The major source of interference in hospitals is from unintentional interference – noisy hair dryers, florescent light ballasts, elevator motors, microwave ovens, the list is endless. While WMTS is a frequency band authorized by the FCC, there is no mandate to use it. In fact, there are no operating standards for WMTS to ensure coexistence between vendors. When they first switched their access points over to WMTS, GE and Philips interfered with each other’s systems. It was only a gentlemens agreement (and time) that facilitated technical adjustments to allow both vendor’s systems to operate in the same hospital. Systems using WMTS simply cost more money than systems that use your hospital’s infrastructure – and the wider you deploy their proprietary WMTS infrastructure the more it will cost you when you want to change vendors (and you always do, sooner or later).
While we can’t solve the cost issue today, there are alternatives to the traditional telemetry monitor. Our perfect solution would include a real patient worn monitor, meaning a device with a display and local alarms, and you really should have both ECG and SpO2. Such devices include the new Draeger Infinity telemetry system, and a couple of Welch Allyn monitors – the Micropaq and the Propaq LT. The Draeger monitors run on 802.11 b/g, and Welch Alllyn just announced support for 802.11a/b/g on their monitors at HIMSS. None of these products is perfect, but you get important clinical features and you’re not investing unecessarily in a proprietary infrastructure that only works with one vendor’s products – and in the case of GE, only supports telemetry – all their patient monitors run on WiFi.
Pictured above is the Draeger Infinity telememetry monitor, shown in bedside dock with trickle charge.
UPDATE: Reader Dan Davis MD suggests that most hospitals looking to broaden their patient monitoring are trying to reduce failure to rescue incidents (that’s patients who have an adverse event, go into cardiopulmonary arrest and usually die). Certainly saving lives is a primary motivator for increased patient monitoring. But I would argue that there is a greater need (and hopefully market demand) for electronic surveillance that alerts caregivers long before patients become obvious failure to rescue statistics. This requires the ability to identify patients who are pre-arrest, at a stage when clinical intervention is less expensive and much more successful. Patients who arrest in hospitals have low survival rates – 22% for witnessed arrests and a grim 1% for unwitnessed codes.
Dan also mentions Hoana Medical, and their passive non-invasive sensors that can be incorprated into patient beds as a possible solution. I’ve written about them a number of times (here, here and here), and they have a very interesting system – check them out. The only thing that I can see that keeps it from becoming a natural choice for hospitals is that the kind of patients who would benefit most (currently unmonitored patients) are also active – they are encouraged to get up and walk around. Hospitals need solutions that cover patients in bed and when ambulatory.
Cell Phones in Hospitals – Really, Really It's Okay
Yet another in a string of studies showing the relative safety of cell phones in hospitals has been published. I would stop posting on this if more hospitals would update their cell phone policies; but alas, this is health care.
Once again, Mayo Clinic Proceedings publishes a paper (abstract here) on more tests (as if more were needed) designed to assess the dangers posed by cell phones for medical devices. From the story on Yahoo News:
Tests at the Mayo Clinic in Rochester, Minnesota showed
normal use of cell phones, also called mobile phones, caused no
noticeable interference with patient care equipment, they said.
But a portable CD player caused an abnormal
electrocardiographic (ECG) reading when a patient used it near
one of the leads of the device, according to one of several
reports in the March issue of Mayo Clinic Proceedings.
And at least two reports suggest that anti-theft devices
set up near the doors of retail stores can cause implantable
rhythm devices such as pacemakers and defibrillators to
malfunction.
Most hospitals forbid the use of cell phones.
Dr. David Hayes and colleagues said their tests suggest the
ban is unmerited. They tested cell phones using two different
technologies from different carriers, switching them on near
192 different medical devices.
During 300 tests run over five months, they reported no
trouble with the equipment.
Bottom line: interference happens, from all kinds of sources. Devices shown to be relatively safe should be allowed. And regardless of whether you ban cell phones or not, you should train staff to be able to recognize electrical interference and know how to respond when interference strikes. The anecdotal case of a cell phone resetting a ventilator really doesn't justify banning phones when there are a myriad of devices that could interfere with a medical device if put in close proximity – like a portable CD player.
If you'd like more info on cell phones in hospitals, use the Google search box in the left hand column – enter “cell phone” and be sure to click the “this site” button.
FDA Clears Baxter's Collegue Pump
The FDA has cleared for marketing Baxter's Colleague infusion pump that was the subject of recalls and product seizures in 2005. From the FDA press release:
Confusing display screens, software defects, swollen batteries and other defects
could have resulted in the pumps either shutting down or under- or over-delivering
critical medication and fluids to patients and were associated with serious
injuries and deaths.
In June 2006, the manufacturer, Baxter Healthcare Corporation signed a consent
decree with FDA detailing the steps that must be taken before the Colleague
pump would meet appropriate regulatory requirements and could be sold again.
The agreement resolved a court action by FDA that began with the October 2005
product seizure.
[...]
The
Colleague device was one of the most commonly used volumetric pumps in the
U.S. when FDA asked U.S. marshals to seize all pumps stored in Baxter Healthcare's
northern Illinois warehouses in October 2005. However, hospitals and clinics
were allowed to continue to use pumps already in their possession, guided
by instructions provided by Baxter Healthcare.
Baxter Healthcare's pre-market submission for the modified pump included:
- detailed testing to demonstrate that the pump meets the latest
electromagnetic testing compatibility standard; - complete redesign of the battery protection circuit;
- improved interface to warn user of battery depletion problems;
- complete documentation to support unit and system-level software verification
and validation of the final finished device to alleviate software problems
that could lead to over and under infusion; - a human factors evaluation to alleviate concerns about silent failures
and unclear operating instructions; - information to support hardware redesigns; and
- a rewritten user manual.
FDA will continue working with Baxter Healthcare to ensure that infusion
pumps are safe and effective for their intended use. FDA is committed to
assuring that the company fully addresses the issues identified in the consent
decree. Pumps seized by the government are not in distribution at this time.
Baxter Healthcare is located in Deerfield, Ill.
I'd hate to guess what Baxter's market share is at the present time. Nor would I care to contemplate the what this little detour did to their product roadmap and future product introductions. Welcome back Colleague.
You can read some past posts on Baxter's infusion pumps here and here, and one on the FDA and recalls here. Pictured right is a Colleague shown in the Philips booth at a trade show in 2005.
