Category: Devices

LASIK results: Great impact, but room for improvement

published date
November 5th, 2014 by

This is a guest post by life sciences entrepreneur Mikael Totterman


Lifting the flap
Lifting the flap

In my last post (When it comes to investing, the eye has it) I wrote that venture investors are flocking to ophthalmic investments due to extensive unmet needs. One such need is refractive correction. The vast majority of the 150 million Americans who require refractive correction still rely on old-fashioned glasses and contact lenses. Laser-Assisted in situ Keratomileusis surgery (LASIK) is a solution for some, but there are only 700,000 procedures in the US per year, just a tiny fraction of the potential.

It led me to ask, what’s going on with LASIK, and can LASIK be improved?

Is There an Opportunity to Improve LASIK?

One of the more interesting studies presented at the 2014 American Academy of Ophthalmology meeting #aao14 were the results from the LASIK Quality of Life Collaboration Project (LQOLCP).  The study has been an extensive collaborative effort between the Food and Drug Administration, the National Institutes of Health, and the Department of Defense.

The key findings are:

  • LASIK can very reliably correct vision
  • Many patients who undergo LASIK experience unwanted side-effects and complications

My takeaway: Perhaps there is an opportunity to develop a next generation LASIK that is less invasive and has fewer side effects.

LASIK is Able to Very Reliably Correct Visual Acuity

In terms of 3-Month Visual Acuity Outcomes, over 95% of the subjects achieved 20/20 or better binocular uncorrected vision. For monocular uncorrected visual acuity, 90% of the patients achieved 20/20 or better. Not surprisingly, 96% of the subjects were satisfied with their visual acuity following the LASIK procedure.

LASIK Procedures are not Without Risk of Side Effects for Large a Number of Patients

In addition to assessing visual acuity, the objective of the study was to better understand what types of side effects LASIK patients experience.  LASIK is a surgical procedure that typically involves cutting of a flap in the eye, so it is reasonable to expect that some types of side effects will arise.

Over 45% of subjects who were symptom-free prior to the procedure developed at least one new symptom at 3 months following the procedure. These new symptoms included ghosting (3%-6%), glare (15%-18%), halos (26%-35%), and starburst (26%-27%).

Additionally, 30% of subjects developed new dry eye symptoms as a result of the LASIK procedure.

FDA’s summary comment in terms of the Public Health Impact was:

“Given the large number of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may occur in a significant number of patients”

“FDA will explore avenues to better inform patients and physicians about LASIK risks.”

In other words, LASIK works great at improving vision but there are real downsides for many patients.

Could a Better LASIK be Developed?

If the industry could develop a less invasive LASIK procedure (i.e., no flap or ablation), maybe these side effects could be reduced or eliminated.


photo credit: Jacob Davies via photopin cc

When it comes to investing, the eye has it

published date
October 30th, 2014 by

This is a guest post by life sciences entrepreneur Mikael Totterman

Eye on investing
Eye on investing

I was surprised by a recent Wall Street Journal article, which reported that venture capitalists are now investing more in the eyes than in any other organ. In 2013, VCs injected $850 million into eye-related startups, more than they invested in traditional areas such as the heart and orthopedics.

Intrigued, I attended the American Academy of Ophthalmology Annual Meeting in Chicago earlier this month. to learn more. In discussions with venture capitalists, industry thought leaders, and physicians, I heard four main explanations for the rush to invest in the eye:

  • Large and growing market with significant unmet needs
  • Lower reimbursement risk
  • Entrepreneurial and technology-friendly physicians
  • A favorable regulatory framework

Large and growing market with significant unmet needs

The eye disease segment of the ophthalmic market is driven directly by an aging population. This includes common conditions such as wet macular degeneration. It’s the leading cause of vision loss for Americans over 60, but treatment options are still quite limited. Eleven million Americans suffer from some form of macular degeneration today. That figure is expected to rise steadily to 22 million by 2050.

In addition to the disease-based market, refractive vision correction represents a significant market opportunity. The refractive correction market is very substantial with over 150 million individuals in the United States alone needing vision correction across a broad range of age groups. Historically, LASIK-related companies (both excimer and femtosecond lasers) have generated substantial returns for venture investors.

Lower reimbursement risk

Compared to other medical technology markets such as orthopedics and cardiology, the vision correction market is much less affected by reductions in insurance reimbursements. Procedures are generally paid for directly by patients, and top physicians can charge premium fees. Market dynamics are similar to the cosmetic surgery market, which has been an attractive opportunity for investors.

Entrepreneurial and technology-friendly physicians

Definitive data are scarce, but the impression I have is that the refractive surgeon market is an early adopter of technologies. Most refractive surgeons I met appear to be very open to trying new approaches and tools. This contrasts with other segments of the medical market, such as general practitioners, where adoption is slow.

Favorable regulatory framework

Most conference participants felt that the regulatory climate is improving. The FDA is providing clearer guidance into what is required to achieve regulatory approval. This is very favorable for investors who are considering putting their capital at risk.

While it’s impossible to predict the future, things seem to be looking up for ophthalmic investing and entrepreneurship. I intend to continue to track this market closely.

photo credit: Lucas Vieira Moreira via photopin cc

Apple Health App: A first taste

published date
September 19th, 2014 by
Blood alcohol might be of interest to hackers
Blood alcohol might be of interest to hackers
Nothing for now, but it's coming
Nothing for now, but it’s coming

I was brave (or stupid enough) to download iOS8 on my iPhone 5 early yesterday morning at Boston’s Logan Airport. Luckily the update completed before I had to get on the plane. It was neat to see a Health icon pop up on the home screen, and I had a chance to give it a quick look. There wasn’t all that much I could do with it for now, beyond entering some basic data like height and weight, but it’s an intuitive app that fits in with the rest of Apple’s iOS offerings. We’ll have to wait for 3rd party apps to hook into Health through HealthKit, which will take awhile. And the Apple Watch isn’t out yet either.

I think Health is going to lead the market, but not dominate. Here’s my logic:

  • Like other Apple innovations –think iPod and iPad– decent products already existed in those categories and were starting to get some traction. I had mp3 players and a tablet computer years before, but Apple did a better job of packaging everything up and taking usability to the next level. For me, the iTunes store differentiated the iPod and the long battery life made iPad worth ponying up for. In this case Apple is entering a market that others have already been prospecting in. Some of those others –like Fitbit– have taken a lesson from Apple and tried to make elegant products that won’t be so easily pushed out of the way by Apple mania
  • The soon-to-be-introduced Apple Watch should work very smoothly with the iPhone or iPad. I’m planning to get one when it arrives, and I’m holding out hope for a high quality heart rate monitor as part of the package. This is the type of product that should evolve quickly, with new sensors and improved performance, but it will take some getting used to before I start trading in my watch every year or two and charging it up every night
  • Despite the recent dustup over iCloud accounts being hacked, I do trust Apple with my personal data more than I trust competitors like Google.  Apple’s business model allows it to make money by selling products and services to consumers without resorting to data mining. Apple seems to be going out of its way on the Health side to emphasize its trustworthiness. That’s a selling point competitors will have trouble matching –because data mining is the business model. More consumers are going to care about this as things move along
  • One reason use of personal health data technology has been so low is that while younger people are open to it they are generally healthy and don’t need to deal with their records nearly as much. But it’s been seven years since Microsoft’s HealthVault was introduced –and those same tech-embracing folks are getting older. Also, there’s been a remarkable change in the level of use of smartphones in the past few years. They’ve gone from non-existent to ubiquitous, so Apple doesn’t need to convince people to bring another device along. The passive collection of data through sensors also makes a huge difference in ease of use and accuracy of the information. (See Health tracking apps: Not yet ready to make a big impact)
  • Apple’s move is going to bring a lot of app developers into the market and we’ll see some pretty clever uses for Health before long. That will include general purpose apps and those for folks with specialized needs, like those who need to track specific parameters for a chronic illness

Makers of health apps and tools will all need to look to Apple Health to figure out how they fit in. The opportunities for data suppliers and vendors serving doctors and hospitals are there, too, but it will take at least a couple years to sort out the most promising approaches.

I look forward to going along for the ride.

By healthcare business consultant David E. Williams of the Health Business Group

eResponder Personal Emergency Response System (PERS): it doesn’t get much simpler than this

published date
March 14th, 2014 by
eResponder, cellular based Personal Emergency Response System (PERS)
eResponder, cellular based Personal Emergency Response System (PERS)

Typical Personal Emergency Response System (PERS) work well around the house. They communicate reliably with a base station that’s connected to a landline and the units have long battery life. The technology is old but reliable, and the systems provide peace of mind for those who are living alone and for their kids. A greater challenge arises when trying to develop a system that works well for people who want to leave their homes and get out of range of their base stations.

The obvious solution is to use cellular technology. But cellphones are complicated for many elderly folks to use, and they have to be charged up at least every few days. Cellular service also isn’t as reliable as a landline.

For the last couple months I’ve been trying out the eResponder by Securus. It’s a small, 1.2 ounce cellphone based pendant device that you can hang around your neck or from a belt. I’ve been pretty impressed with it. In case of emergency you simply press the single button on the unit for two seconds. Within about 10 seconds you are connected to an “emergency care specialist” who asks if you need help. I’ve gotten through right away every time I’ve pressed the button. (I tell them I’m just testing the unit –and they seem cool with that.)

There is a speaker and a microphone on the device –it’s essentially a mini speaker phone. The voice on the other ends comes through loud and clear and they have had no problem hearing me. The eResponder is designed to be worn in the shower, which is a good feature since that’s where someone is likely to fall. Some, but not all other PERS systems are water resistant.

The battery life really is excellent. The company advertises that the battery will last up to 2 months between charges. I’ve been using mine a little longer than that and I didn’t even charge it up when it arrived. That’s a really great feature.

Of course there are some potential drawbacks. The system uses the T-Mobile network. I haven’t had any trouble  but if you’re not near good T-Mobile service that could be an issue for getting through to the center. Also cellphone signals don’t always reach inside of buildings in case you’re using it inside. In addition, the eResponder center uses the same location-finding system as 911 operators. That’s good but at least in my case the eResponder does not deliver pinpoint accuracy to the emergency care specialist.

When I activated the eResponder from an urban area yesterday I asked the operator to tell me if he knew where I was calling from. He answered, “Within four tenths of a mile of 284 Harvard Street.” In fact I was about 4/10 of a mile away –which would not have been good enough for an ambulance to find me. I asked if that was typical and he said that it was in fact pretty typical. He offered that he had seen situations where it located the person to within 1.2 miles of their location. I tried again this morning from the same location and was told I was within 0.6 miles of 881 Commonwealth Avenue. (Securus informs me that this information is used to determine which local emergency dispatch service to contact and isn’t meant to establish the user’s exact location. If the user is transferred to the 911 operator, that operator will have more detailed location information to find the user. Once the 911 operator hangs up, the eResponder emergency care specialist waits on the line until emergency help arrives.)

Presumably a unit with GPS would be bigger, more expensive and use more battery power but would also provide much better accuracy without needing to transfer to 911. (In fact, Securus does make an eCare+Voice device with a GPS, but its battery lasts only a few days.)

I haven’t done a rigorous head to head test of PERS systems, but based on my experience I can recommend the eResponder for people who want a PERS system that can be carried outside of the house, is easy to use and does not need to be charged frequently. Those concerned with immediate, precise location finding or who don’t reside near decent T-Mobile service should select a different solution.

By healthcare consultant David E. Williams of the Health Business Group

EarlySense makes touch-less vital sign monitoring a reality: Transcript

published date
October 24th, 2013 by

This is the transcript of my recent podcast with EarlySense’s president, Tim O’Malley.

David E. Williams: This is David Williams, president of Health Business Group. I’m speaking with Tim O’Malley, president of EarlySense.

Tim, thanks for joining me today.

Tim O’Malley: Thanks, David, for having me on.

Williams: Tim, can you explain, what is EarlySense? What does the company do in general?

O’Malley: For many years, healthcare providers have tried to find a way to monitor patients in almost all locations of the hospital and even in some subacute care and skilled nursing facilities, to make sure that patients were being served appropriately. So that if there was any sign of deterioration, if there was any sign of physical instability of the patient, they would have a way of capturing these things and giving them early warning that something potentially could be occurring, that could be an adverse event.

And so what we’ve done is developed a sensor that’s placed under the mattress of the patient to monitor the patient’s heart rate, respiratory rate and body motion so that we can help the caregivers avert adverse events, whether it be deterioration or falls and/or pressure ulcers that occur in healthcare settings.

Williams: So, as you mentioned, a lot of people have tried to do this in the past. I know there are various challenges in making it happen. It sounds like what you do is put the sensor under the mattress or the pad instead of on the patient. All else being equal, I would imagine that would maybe be less reliable to use. So, why did you take that approach and does it actually work?

O’Malley: I wouldn’t say it’s less reliable. I think it’s actually more reliable because signals from a traditional product that might be used in deterioration-monitoring would be an EKG lead. Anybody that has been in a hospital or healthcare setting that has seen an EKG lead set. It could be three-lead, it could be five-lead and in some cardiologist settings, it could be 12 leads where they paste electrodes onto the skin. And those are the source of the signals –electrical signals that are then interpreted by the traditional patient-monitoring product.

And there’s clearly still a very big need for that in the high-acuity areas. But when you take that technology and you push it out to the lower-acuity areas, you have the potential for a lot of problems. And problems like alarm fatigue have become a very real concern for the caregivers because you have so many alarms that are generated from this traditional monitoring system because of design for an ICU or acuity care environment. When you put them into an area that has a staff to patient ratio of 1:4 or 1:6 instead of an ICU with a staff ratio of 1:1 or 1:2, you now have the staff spending an awful lot of time trying to manage alarms and manage the technology and not as much time of potentially managing the patients.

So, when you eliminate those leads and sensors out of the patient, you also eliminate a lot of those problems. We have validation studies that compare our technology to the more traditional methods where you actually had sensors on the patient. The accuracy has been within a few percentage points.

And so it is very accurate, it is very proven. We were in about a dozen and a half hospitals in the United States and every day, there’s probably close to a thousand beds that are being used with our technology.

Williams: Say more about alarm fatigue. What is it and how does EarlySense contribute to reducing alarm fatigue? It sounds like this is a key benefit.

O’Malley:  It is indeed one of our benefits. Here again, it’s a tough situation in healthcare. You have a sicker and sicker patient population because the patient population is aging. You have patients that are having procedures much later in life that are somewhat complex. You have patients that are in their golden years having repeated procedures that are pretty significant procedures; those patients will end up post-operatively, maybe 24 hours post-operatively in the med/surg or general care environment.

And they may have comorbidities where they’re having respiratory issues or challenges. They may have some underlying cardiac problems. They may have diabetic issues.  So those patients now have many more comorbidities than just a few years ago.

So, having a piece of technology that you could put at every bed in a convenient way and be able to monitor in a way that is designed for that environment, seems to be a much better way to go. And traditional technology is designed, as I’ve said, for a higher acuity environment, which has a 1:1 ratio of staff to patient.

Alarms are really a kind of traditional threshold alarm. You hit the threshold, you go over that threshold or under that threshold, you’ll get an alarm. With our system, it uses an algorithm to look at the past record of cardiac or respiratory activity and then will actually add those things over that time so that the alarm rate is dramatically reduced. In the med/surg environment, patients are moving, they’re talking, they’re eating or interacting with family. And so, all those things have an impact on a traditional product’s capability to monitor and alarm effectively. And as a result, there’s an awful lot of nuisance alarms and false alarms.

Just recently ECRI and The Joint Commission came out with indicators encouraging caregivers to really watch this phenomena of alarm fatigue, because what happens is that the staff is just bombarded with alarms. Over time, they become desensitized  to those alarms. And that’s, unfortunately, an adverse event that’s starting to occur. That’s when a negative situation can develop.

Williams: Talk about how the changes in healthcare affect what EarlySense is doing. I’m assuming that your discussions about return-on-investment and use cases are influenced by what’s going on in the market. Can you talk a little bit about that please?

O’Malley: It’s an interesting time in healthcare for a lot of reasons. I’ve been in the industry for over 25 years now and I have seen a lot of change, a lot of very positive technological change that has improved patient care. Now healthcare is going to be forced to manage itself much more as a business and that means controlling costs

and managing the revenue streams so that they can maintain their margins. But the reality is that, in the last few years, there has been a dramatic squeeze on healthcare systems’ margins. In the new environment healthcare systems are looking for true tools to help.

Today, because of the downward pressure on margins and the move to capitation, administrators are being much more diligent in how they evaluate potential purchases. They’re not just looking at the clinical benefit, they’re also looking for economic benefit. Economic benefit could be things like how do you eliminate alarm fatigue in an environment to improve patient care? Or in the case of medical sciences, how do you take a piece of technology and put it into a general environment, like a med/surg environment, to potentially detect deterioration of a patient who otherwise wouldn’t be monitored.

Williams: With the Affordable Care Act, are there specific changes, for example, in hospital penalties for readmissions that affect the way customers think about EarlySense and affect the way that you go to market or develop products?

O’Malley: Yes. We have a customer that’s been using our technology for about two years. And just a few weeks ago, I met with their C-level people and we reviewed the effects of EarlySense in their care area: 36 beds that had been monitored on an ongoing basis.

We looked at the data. We looked at the number of falls and the number of pressure ulcers during all of 2012. And then we compared that to the areas of the hospital that are not using EarlySense and what their pressure ulcer and fall rates were.

It became very obvious that the amount of improvement on the EarlySense side of the hospital was dramatic. In fact, no falls and just a few pressure ulcers – and it was questionable whether or not they actually started before the patients were admitted — compared to the other side of the hospital that had double-digit rates of falls, double-digit pressure ulcer rates.

So then the discussion became, how do we help you get this technology to the rest of the hospital so that you can benefit from it across all the beds? Hospitals are looking at the cost of care for those particular events — pressure ulcers and falls. The beds that were monitored by EarlySense were within the $700 per patient range; the cost of care for the non-EarlySense beds was in the $15,000 range.

Hospitals are looking at these things much, much deeper in that regard. They’re looking at technology like ours that can help drive improvement, to potentially drive different numbers for them.

Williams: How does your business model work? Do you charge on a per bed basis or per day or per patient or based on outcomes.

O’Malley: It’s really quite flexible. We did an economic return on investment with a customer and sat down to review it. The resulting proposal was more of a pay-per-day-per-patient kind of proposal, which is more of the service model.

It can be a variety of different ways that people purchase it. In some cases, we really think we’re going to a revenue sharing model with institutions where we will put some guarantee in place to impact things like fall rates by X percent. And if we don’t meet those guarantees, then there are financial consequences.

Williams: Tim, Governor Deval Patrick traveled from Massachusetts to Israel back in 2011 on a trade mission and one of the tangible outcomes of that was that EarlySense decided to move its headquarters and locate in the US, in Massachusetts. It’s a couple of years or so since that occurred. And I’m wondering, what is the perspective from EarlySense on how that has worked out?

O’Malley: Massachusetts is a very rich environment with med-tech talent. There’s a lot of med-tech companies in Massachusetts. When you are a growing company like EarlySense, you have to look for people to come in to help you build out different parts of the organization. We’re clearly doing that. And so, we’ve been able to attract very talented people in Massachusetts because it’s such a rich environment for med-tech professionals.

In addition, we have also developed some pretty significant customer relationships in Massachusetts with a number of the Partners HealthCare facilities. And that exposure that we gained by Governor Patrick going to Israel and subsequently performing a ribbon-cutting ceremony with us in MetroWest Medical Center, I think certainly helps us gain exposure and credibility.

Williams: This is David Williams with the Health Business Group. I’ve been speaking with Tim O’Malley. He’s the president of EarlySense. Tim, thanks so much for your time today.

O’Malley: Thanks for having us on, David. I appreciate the opportunity to talk about our technology and how we’re able to help healthcare providers avoid adverse events.