Wanted: Advanced training for caregivers + intuitive devices

May 6th, 2013 by David E. Williams of the Health business blog

Increasingly, family caregivers with no formal training are doing the kind of work more commonly associated with hospital-based nurses: operating dialysis machines and ventilators, administering IVs and injections, and using monitors for blood glucose, oxygen saturation and more. AARPs’ Public Policy Institute and the United Hospital Fund have released a new survey on the topic. The Boston Globe has a good article on the subject.

Many of the caregivers are performing advanced tasks such as those described above, but few report getting appropriate (or any) training to do these jobs. In my experience the equipment can be complex and it’s extremely easy to make a mistake. (See my recent, related post about managing a complex pediatric regimen at home.)

It’s unlikely that a great influx of trained, affordable nurses will be arriving anytime soon, but there are a couple paths that hold promise:

  • Hands-on training for caregivers, integrated into doctor visits, with follow-up available by phone and videoconference using Skype and similar readily available technologies
  • Intuitive, consumer oriented equipment and supplies, akin to what Apple has done in the consumer electronics sector. You see it to some extent already in self blood glucose monitoring for diabetes, but there’s a lot further to go. FDA should encourage better consumer usability in its approval process
There should be plenty of profits for those who figure out how to tackle this problem.


Posted in Devices, Entrepreneurs | No Comments »

Medical device connectivity: Interview with Capsule’s Stuart Long

April 19th, 2013 by David E. Williams of the Health business blog

Hospitals have many devices collecting data on patients, but until recently information from those devices has not been routinely integrated nor stored in electronic medical records. In this interview, Stuart Long, Chief Marketing and Sales Officer of Capsule explains the benefits of medical device integration and how it works in a hospital.

Why is medical device connectivity important, and what benefits does it bring to the patient?

Rapidly becoming a priority for many hospitals, biomedical device connectivity to the hospital network—or medical device integration (MDI)– enables medical devices to transfer patient data from the point-of-care over the network into an electronic medical record (EMR) system or other charting systems. Device integration delivers patient data to clinicians in near real time so that information supporting patient care decisions is delivered timely and accurately.  Without MDI, patient data, particularly vital signs, is transcribed on paper charts and the recording is duplicated by manually having to key the data into the patient’s electronic record. MDI helps assure data accuracy by eliminating manual transcription errors while relieving caregivers from burdensome manual tasks, enabling more quality time with patients.  The bottom line is increased patient safety and care.

 

Why is it important to automate the collection of patient data (i.e. vital signs) and how does this improve the quality of data entering the EMR?

End-to-end automation of patient data collection ensures accuracy and precision.  Full automation removes potential error points along the way as device information is sent to the EMR or other systems.  For example, as I mentioned before that many caregivers read data from a device, manually record it and then input it into the electronic system.  From an administrative standpoint, the need for absolute accuracy of data is greater than ever before.  In addition, having data in electronic format is essential to ensure the full realization of a complete electronic record, which enables data exchange with other hospital IT systems and access to this information hospital-wide. Again, from a regulatory and reimbursement standpoint, the importance of this electronic format is increasing as Meaningful Use (MU) guidelines become more defined.

 

What happens to patient data as it moves throughout the hospital? How is that data being used?

As patient data is collected through electronic means, it is aggregated from software or hardware, analyzed by the connectivity software, and translated into a format appropriate for the hospital IT system receiving the information.  Various hospital departments—whether the ED, OR, ICU or med-surg–may output device data in disparate formats, often completely proprietary formats.  That data then must be translated into a standard format for the EMR and perhaps reinterpreted once again for compatibility with specialized departmental IT systems.  As each new department inputs information, the data is normalized as required and translated for the needs of specific hospital IT systems.  In that way, device information can follow the patient through the hospital, wherever it is needed.

 

What are some of the differences across care units in the hospital? How does that impact the technology being used?

Workflow varies greatly among various care units—the ED, OR, med-surg and step-down, for example, and also varies by hospital.  Med-surg units often have many beds with a limited number of devices shared among them on mobile carts.  Intensive Care, by contrast, may rely on a greater number of devices, which are fixed in location and associated with a particular bed. A quality MDI system seeks to reduce the complexity of its technology by supporting the existing workflow already in place in a particular setting.  Capsule has different hardware and software solutions to support various settings and workflow requirements. Some are wall-mounted units that accept fixed-position devices and are already associated with a specific bed for continuous data collection. Another solution would be a mobile device interface for equipment with no fixed location, which must be associated with the individual patient for periodic data collection.  Data must be validated, and in some settings, a nurse requires flexibility about the timeframe care patients may require immediate attention before caregivers have time to accept data.

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Interview conducted by David E. Williams of the Health Business Group.


Posted in Devices, e-health, Hospitals | No Comments »

Bionic eye: seeing the future

February 15th, 2013 by David E. Williams of the Health business blog

FDA just approved an implant for certain people with severely limited vision. This “bionic eye” does not restore sight but it does help “detect light and dark and help [people] identify the location and movement of objects.” So it could be a big help from a functional standpoint for certain individuals, even though it’s far from perfect and may not be completely safe.

Fast forward a decade or two or three and imagine a time when implants (or some other approach) can restore vision to normal. That will be pretty cool for the many people whose vision is relatively poor and there will likely be a lot of demand for such treatments/devices, even from people that we would not consider visually impaired today.

But then imagine that the technology keeps advancing and gets to the point where technology can improve on natural vision, so that someone with a bionic eye becomes more like the Six Million Dollar Man, especially if they get enhancements not just to the eye but to other body parts as well. I’m in my mid-40s and have a reasonable expectation of living to the time when this moves from science fiction to reality.

If you think about it, we are already starting to get there in limited cases.  Oscar Pistorius, now infamous for other reasons, shows that a double amputee can be as fast or faster as Olympic runners. How soon until other Olympians –who already commit their lives and bodies to the pursuit of excellence– will want body modifications to improve competitiveness?

Obviously the path of medical technology will raise all kinds of ethical issues. It’s time to start the discussion.


Posted in Culture, Devices, Research | No Comments »

Rerun: Well done Wall Street Journal for your stent study coverage!

August 23rd, 2012 by David E. Williams of the Health business blog

The Health Business Blog is taking a break this week, and re-running some posts from August 2008. If you’d like to comment, please do so on the original post.

I’m a big fan of the Wall Street Journal, which I’ve always found heads and shoulders above any other business news source, so naturally I have been concerned about what will happen to it under new owner Rupert Murdoch. I’ve tried to keep an open mind and so far I’d say Murdoch has improved the paper overall. There’s more non-business news and more independent analysis than before, which is great.

But I was really excited and heartened by the story I saw today, tucked away at the bottom of page B1: Boston Scientific Study Flawed. As I started reading the article I noticed that something was different. What was it? When I got to the ninth paragraph and encountered the first quote (from Boston Scientific’s chief scientific and medical officer) I realized what the Journal was up to: Not the usual reporting on what the New England Journal of Medicine had printed the previous today or what some scientist had said at a conference or what some think tank had come up with, but theJournal’s own, independent analysis.

The issues raised are hard-hitting and direct:

  • That the Wald equation used by Boston Scientific in the Taxus Liberte Atlas study –and also used by Boston Scientific’s rivals– is a flawed measure
  • That using any other measure would have rendered the study a failure “by the common standards of statistical significance in research”
  • That non-inferiority studies like this one aren’t a particularly high standard to meet
  • That omission of a control group biases the study in Boston Scientific’s favor

Here’s a taste of the Journal’s critique:

In a vital part of its calculation, called the “standard error,” Boston Scientific assumed that the difference between the true rates of reclogging between Liberte and Express was one percentage point-what the trial showed. In a sense, the company’s equation assumed that Liberte definitely isn’t inferior. That’s a problem, since the equation was supposed to be deciding whether Liberte might be inferior after all. As a result, Boston Scientific’s equation gives wrong answers that consistently favor the Liberte.

To remove that flaw, the standard-error calculation should be modified so that it assumes the true difference between rates is three percentage points. When done that way, the chance falls above 5% — meaning the results failed to reach statistical significance.

In typical Journal style, the article is fact-based and neutral in its tone. It doesn’t include loaded terms or use “experts” to act as proxies for the reporter’s personal opinions. I’m sure the Journal will publish letters that it receives in response and that they won’t all be patting the paper on the back the way I am.

I think this type of reporting is great, and much needed. It’s hard to find trustworthy, unbiased sources of medical information these days. Device and pharmaceutical companies have an obvious bias in favor of their products, researchers are influenced by fees they receive from the companies, medical journals are heavily supported by industry revenue, payers are focused on cost control, and the FDA is understaffed and limited in its freedom. We need another voice and I’m glad the Journal is providing it.

I had a look at the comments on the topic at the Wall Street Journal’sHealth Blog. A few praise the coverage, but others are skeptical. Issues include: who supplied the data, why didn’t the Journal raise the issue when the study came out, what about the Journal’s own bias toward its advertisers, and a couple of people who say this is a whole lot of fuss about nothing. I’m all for the debate –and say thanks to the Journal for enabling it to occur.

 


Posted in Devices, Policy and politics, Research | No Comments »

Medtronic’s doctor centered approach helps patients, too

August 16th, 2012 by David E. Williams of the Health business blog

As I described on Tuesday, orthopedic device makers are putting more control in the hands of patients to make adjustments that used to be handled by physicians. It’s more convenient for patients, but the key to the business model is that such moves reduce the demands on physicians, who otherwise would have to participate in these low-margin, unexciting activities. I mentioned cardiology as another field where device makers think similarly. And I was rewarded today when a colleague showed me an article that illustrates my point perfectly.

When patients with implanted cardiac devices go to the emergency room –even for something unrelated to their heart– they end up having to wait around a long time to have their device checked by someone with special expertise. That has to be done in person and is a real pain in the neck  for the patient, especially when it happens on a night, weekend or rural area. The new service included a wand that can pick up data from the device, transmit it to an expert wherever that person is, and integrate the information into the electronic medical record of the hospital and/or physician office.

Don’t get me wrong. Medtronic definitely cares about the patient. But the primary economic motivation for this technology is to take cost and hassle off of physicians and clinics that have to deal with this after-sales service. You can bet that a doctor who gains the benefit of CareLink Express will look favorably on the opportunity to implant more Medtronic devices in the future, compared to a manufacturer who doesn’t have this offering.


Posted in Devices, Economics | No Comments »

Making patients with devices less dependent on doctors

August 14th, 2012 by David E. Williams of the Health business blog

New Medical Devices Get Smart in today’s Wall Street Journal tells an encouraging story about how patients with prosthetics are gaining more autonomy from physicians. It features a man who lost his leg in a motorcycle crash and has a prosthetic. Used to be whenever he bought a new pair of shoes he’s have to go to the orthopedist to make adjustments to his prosthesis –otherwise he’d have discomfort and an awkward gait. Now he can make adjustments himself using a smartphone as a controller, or even let the prosthesis adjust itself.

Advancements like this have real potential to improve the quality of life for patients and reduce the demand for high-priced physicians and other clinicians. We should keep these innovations in mind as a partial solution to what otherwise could be a shortage of physicians and nurses. The orthopedics industry is actually a good one to look to for such solutions. That’s because orthopedic companies are quite focused on tamping down the demand for follow-up maintenance for their devices. They know orthopedists would much rather do the initial, lucrative procedure to install or implant the device rather than the low margin, mundane work of follow-up. Not only that, if an orthopedist has more capacity, s/he (usually he) can be a bigger customer of the device maker since more time is devoted to new procedures rather than follow-up.

Orthopedic companies are careful not to burden physicians, but there are definitely concerns that providing more technology to patients could lead to more demands on the providers rather than less. For example, with remote patient monitoring patients and physicians can become aware of random deviations and false positives that could compel a patient to seek care that they would have never thought to pursue before. So keep your eye on the device companies –not just orthopedics but cardiac, too– to see how their innovations help patients while decreasing the load on doctors.


Posted in Devices, Technology | 2 Comments »

Image gently or be punished harshly

May 9th, 2012 by David E. Williams of the Health business blog

It’s not exactly new information that ionizing radiation is dangerous, so I was a bit shocked four years ago when I learned just how cavalier large segments of the medical community have been in exposing children to larger-than-needed doses of radiation. I wasn’t surprised at all that the number of CT scans done on kids was high –after all the scans provide a lot of information, are easy for explaining things to patients, and the financial incentives are there. But I was angry when I found out that kids are often scanned using adult settings. (There is a huge range in how this issue is addressed.  I’ve been very impressed with how physicians at Children’s Hospital in Boston carefully weigh the pluses and minuses before ordering a CT.)

I first described the Image Gently campaign in early 2008, and am happy to see that it has continued to make progress. Now the FDA is moving forward with a plan to require manufacturers to take pediatric safety into account with new devices. As AuntMinnie reports, FDA proposes to require the following:

  • Specific preset pediatric control settings that are appropriate for the intended patient
  • Pediatric procedures, labeling, and protocols that are designed to minimize radiation exposure while providing image quality of acceptable clinical value
  • Display and recording of patient dose or dose index and ability to record other patient information, e.g., age, height, and weight (either manual entry or automatic calculation)
  • Software interface features that alert the end user to important pediatric use issues (e.g., interactive software pop-ups that remind users of special pediatric issues when setting up the image acquisition)

Makers that don’t meet the requirements will have a warning label attached indicating that the equipment shouldn’t be used with children.

Interestingly, the device industry and radiologists seem to be pleased with FDA stepping up its oversight of how approved equipment is used. They’re worried –and rightly so– that patients and families will push back against the use of scans as awareness of radiation dangers rises.

In an era of hostility toward government intervention (and I’m willing to bet Republicans are well-represented in the ranks of radiology) it’s interesting to see the embrace.


Posted in Devices, Policy and politics | 1 Comment »

Hospital robots are on their way

March 15th, 2012 by David E. Williams of the Health business blog

Hospitals are labor intensive, 24 x 7 institutions, making it tempting for hospital administrators to replace people with machines over the long term. High tech machines that extend doctors’ skills or presence –such as the da Vinci robot for prostate surgery and videoconference robots on wheels—get a lot of the attention. But the big impact in terms of number of workers displaced will be in other areas: lower skilled jobs such as aides and orderlies, and eventually nursing.

According to today’s Wall Street Journal (The Robots Are Coming to Hospitals) it’s already starting to happen. So far at least, the staff are welcoming the robots and don’t feel threatened. But there are only about 1000 such robots deployed nationwide. Attitudes may change when it becomes clear that these are not novelty items, but serious competitors to humans in performing important but routine tasks. There’s no reason robots can’t continue to expand their roles into more and more of what humans do. (Maybe there will be a new version of the John Henry story to read to the kids.)

There’s good news in this if hospitals use robots to decrease costs and increase the reliability of processes, which is what I expect. There’s certainly the potential that something will be lost in the way of human contact. But at least for some patients relying more on robots and less on people will be a comforting thing. Think of the patient or family who’s scared to push the call button again for fear of getting on the nurse’s bad side. If things are done right, nurses will actually have more time to perform the most high value, personalized functions, and job satisfaction will increase.

All this supports my view that the pending nursing shortage is nothing to worry about. To the extent that nurse workforce predictions fail to account for the tasks that can or will be done by robots, they will exaggerate the number of nurses actually needed. Nursing will be an entirely different profession a generation from now, and many of the low skill jobs in hospitals will disappear completely.


Posted in Devices, Hospitals, Technology | 3 Comments »

Capsule rides medical device connectivity wave (transcript)

November 29th, 2011 by David E. Williams of the Health business blog

This is the transcript of my recent podcast interview with Stuart Long, president of North America for Capsule.

David Williams:            This David Williams, co-founder of MedPharma Partners and author of the Health Business Blog.  I’m speaking today with Stuart Long, Capsule’s North American President.  Stuart, thanks for being with me today.

Staurt Long:            Thanks David.  Glad to be here.

Williams:            Stuart, tell me a little bit about what Capsule is and specifically what you mean by the term “medical device connectivity.”

Long:            Capsule is a 15 year old international company. We provide solutions for medical device integration into hospitals and clinics.  We were founded on the understanding that the electronic medical record would ultimately need automation with respect to medical device data.

What we mean by medical device integration –and why it’s important– is the fact that medical devices such as cardiac monitors, IV balloon pumps, and ventilators all produce data that comes directly from a patient, generally at the point of care.  Given the Meaningful Use criteria and a lot of inertia in the environment with respect to the adoption of clinical systems and automation that surrounds all the elements, that information is important.

The data then has to land in a solution; it’s part of the EMR. The typical destination for us today is the charting and documentation system, which can be in the intensive care unit or the medical and surgical environments.

Capsule takes the data that comes from those medical devices and translates that in a particular way using HL7. Then we send that information to the target system.

We can send the information to additional target systems such as third party research engines, alarms and alerts and other IT systems.

Williams:            Who is usually the customer that is initially interested in Capsule? Who is typically the decision-maker?

Long:            Today typically it’s a hospital. We do have customers in the clinics as well, but the groundswell with respect to automation and having unique, enterprise-wide identifiers comes mainly from hospitals.

I’ll give you a little context.  Historically we sold departmental solutions, namely ICUs. The audience that was buying those was typically the biomedical engineering departments; they were putting a black box under the bed,  connecting monitors and putting that information into an ICU charting and documentation system.

That has evolved now. We can address not just the ICU, but also multiple high acuity environments such as PACUs and EDs as well as lower acuity areas such as medical and surgical environments.  By doing that, the buying audience is now completely different.

The audience that’s making decisions with us today is typically the CIO, the CNO and the CMIO.  They are choosing this because it’s an enterprise-wide decision.  They’re look for a single platform for connectivity of medical devices and then the ability for that system to translate and push that to any target system.

Williams:            I imagine 15 years ago when this started, there was a different philosophy towards getting data out of these devices. Probably the nature and quantity of the data have changed, too

Long:            Capsule was founded by a French engineer and a U.S. engineer. Initially they developed a solution for Philips Healthcare to integrate their vital signs monitors into their ICU application.  Of course all that information was definitely very important and there was, at the time, a lot of data.

Ultimately there was the need for more than just ICU monitors connected at the bedside. That progressed next to ventilators and then to IV pumps and balloon pumps –anywhere from three to five to 10 devices at the bedside.

Over time Capsule developed solutions to allow all those devices to be connected.  At the very core of the thinking was that we knew that there would be mountains of data that would be coming from these devices.

Interestingly enough, in the early days when connectivity needs were evolving, any device that would send information to any target system, all of that information could not be assimilated or taken in.  There was a challenge around the rate at which data could be taken in.

Fast forward to today’s world where we have multiple devices. We have to deal with the sheer complexity of devices, networking, subnets and wireless. The complexity and connectivity is significant, but also the sheer amount of data.

Capsule takes all of that information –100% of that information at whatever speed or time interval that the devices are able to send out– collects it, aggregates it, filters it, translates it, and then sends it to a target system, which could be an EMR charting application or alarms and alerts.

We’re seeing a big growth in research systems for data analytics for the measurement of information for doing research on health care data outcomes.

Because of our ability to have the intelligence in the system, we can really tune the system to meet any needs in today’s health care environment, whether it’s a single ICU application, an enterprise-wide deployment of an EMR or any third party system that can receive the data at whatever rate they want us to send it to them.

Williams:            When you have more information available, does it raise medical/legal issues? Before this data might have been used to trigger an alarm, which may or may not have been documented. But in a system like what you’re describing it might be easier for someone to go back and second guess what happened in the hospital because there’s a lot more data on what occurred or at least what the devices were saying was occurring.  Is that an issue that you’ve come up against?

Long:            It’s not an issue from our perspective.  Typically when we’re sending information to an EMR charting system or some third party component, the data that’s being requested has been tuned specifically for their application. Therefore those vendors have worked out the kinds of data that are most appropriate, so that they’re not overburdened.

Williams:            What about security?  Certainly with a lot of other devices that are out there transmitting data, there are concerns about hackers, viruses and the like.  Is that an issue that you face either directly or indirectly?

Long:            Well it’s certainly a topic we face on a day-to-day basis.  I wouldn’t consider it an issue at this point only because of the way that we’ve architected the system.  It’s highly flexible with respect to the security that’s built into the systems.  We can accommodate a small single hospital with a smaller staffed IT department that is really focused on getting systems deployed.  Although security is important, it certainly may differ from a 160 hospital enterprise deployment with very sophisticated networks.

We’ve been able to fit our solution into virtually any environment with respect to security needs and built a tremendous amount of security into the system.

We’re regulated as a FDA Class II medical device, so there is rigor that goes into our testing, validation, and quality. That ultimately points to safety at the point of care.

The combined efforts of our focus around security being scalable and flexible and our FDA compliance tends to alleviate most of the concerns that we come across.

Williams:            Tell about your activities in countries outside of the U.S. and whether there are any key differences or whether the customers and markets are pretty similar.

Long:            We’re in over 30 countries. The bulk of our business is in the U.S., however we’re growing rapidly in international markets.  We do see a fundamental difference with respect to health care in the U.S. versus other global regions. They all require different go-to-market strategies and types of products. The speed at which they might deploy and the environments of how health care is actually provided and managed are quite a bit different as well.

I think it’s a strong proof statement that Capsule is the global leader in medical device connectivity.  We’ve deployed in excess of 200 implementations outside of the U.S. That’s growing rapidly because device connectivity and electronic systems are maturing quite a bit in overseas markets.  I think they are equally sophisticated as the U.S., but I would say that the drivers to require the adoption of electronic systems that would then remove the rate limiting factor for device integration are greater in the U.S. So we’re seeing a faster deployment here in the U.S.

Williams:            Take out your crystal ball for a minute and have a look into the future five years or so.  Are we likely to see continued incremental changes that we’ve witnessed over the last several years or are things like iPads, smartphones, Meaningful Use and changes to the payment system in the U.S. and elsewhere going to cause more fundamental change?

Long:            If we look at a three to five year timeline, connectivity is very quickly moving beyond the basics of device connections to electronic systems.  We still believe that there is a very large percentage of hospitals that need to implement the basic device connectivity.

A lot of our customers are going department by department.  We see that moving into what we call the “enterprise,” meaning they’ll be addressing both the higher and the lower acuities or every bed in their institution.

We still see a fairly large demand for the foreseeable future; within the next three to five years.

Once those are implemented the things that are on the horizon are the sophistication around the devices themselves and how to solve connectivity.  We know that the integration of pumps is going to have to be solved in a very meaningful way because of their ability to integrate into bar code medication administration.

Beyond that there is a lot of desire and discussion about device interoperability and two-way communication between devices and there’s a tremendous amount that needs to be solved with respect to clinic workflows and having devices interoperate.  Those are portions of the criteria that we see in the Meaningful Use rules out in 2015.

We know that once all of these things come together and the basic needs are met, we have the ability to look at larger things within clinical workflows and the management of all the data that is being collected for analytics and outcomes. We have the ability to progress from alarms and alerts to build intelligence and context into that information and to disseminate that information to mobile health care providers. This can be done not just at the point of care but also through iPads, smartphones and potentially other third party vendors that are enabling those markets.

We see “small leap frogs” coming every 24 months or so, which are significant changes with the use of the data that’s being collected and moving well beyond the basics of connectivity.

Williams:            I’ve been speaking today with Stuart Long, Capsule North American President.  We’ve been talking about medical device connectivity.  Stuart, thanks so much for your time.

Long:            Happy to do it.


Posted in Devices, Podcast, Technology | 1 Comment »

Capsule rides medical device connectivity wave (podcast)

November 21st, 2011 by David E. Williams of the Health business blog

Capsule is a leader in medical device connectivity (MDC) –the integration of medical devices with information systems. Hospitalized patients are often hooked to several devices, each of which is generating a large volume of data. At the same time hospitals are increasing adoption of electronic medical record systems and striving to better incorporate –and eventually analyze and act on– clinical data of all kinds.

In this podcast interview, Capsule’s president of North America Stuart Long and I discuss the market for medical device connectivity, how it’s changing with the advent of meaningful use, data security challenges and differences among US and international markets.


Posted in Devices, Podcast, Technology | 3 Comments »

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