Smaller, faster, lighter, cheaper medical devices

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image via singularityhub.com

Is it just me or does it seem that most interesting medical device innovations are coming from startups and not from established companies? Here are a few medical devices being developed that are smaller, faster, lighter, and cheaper than established technologies and products.

The point of care diagnostic system being developed by startup Theranos relies heavily on microfluidic and automation technologies. The technology, while impressive, is not revolutionary. Theranos is using readily accessible technology to develop a point-of-care diagnostic test device that can be operated by virtually anyone. The test uses a pinprick to collect a drop of blood to perform all of its tests. No need for a nurse or technician. The test is completely automated so there is no need for a diagnostic technician.

Time is saved because the sample is processed onsite instead of being transported to a central lab and there is negligible wait time compared with large diagnostic equipment. One of the biggest drawbacks to present diagnostic testing is the wait: patients are anxious and physicians often can’t administer medicine or therapy until and unless an initial diagnosis is confirmed.

Tribogenics is developing the next generation of x-ray imaging technology. From the company website:

Tribogenics technology enables portable, compact X-ray solutions for applications in industrial testing, medical diagnosis, security screening and other industries. By miniaturizing X-ray sources and eliminating the need for high voltage, we can create products and solutions unattainable using existing X-ray technology.

While I’m not sure how big the opportunity is for pocket-sized x-ray machines in medicine, there are plenty of industrial and commercial uses. Plus, the potential for portability, low cost, and simplicity may make the Tribogenics device well-suited for deployment in developing countries with little or no medical infrastructure.

The third technology I’m writing about isn’t a product but a concept. The Smartphone Physical is being termed “the physician’s bag of the 21st century.” In a recent TED Talk, Shiv Gaglani showed that a complete physical exam could be conducted with a smartphone and what are essentially smart attachments. For example, companies have developed or are developing ECG leads, a stethoscope, otoscope, ultrasound wand, and even a spiromoter. Gaglani and his colleagues are creating a database of connected devices and apps and hope to start a company to commercialize the Smartphone Physical.

One concern about the Smartphone Physical is a condition that is described by a new word, cyberchondria. Yes, it means hypochondria that is facilitated (or exacerbated) by the ready availability of digital and connected devices and apps. Don’t think it could happen? Ask any doctor about how many patients self-diagnose on the Internet before their office visit. Cyberchondria is real.

Takeaways: If you can take an existing medical device or technology and improve it by making it smaller, faster, lighter, and/or cheaper, you have the makings of a company. Your new device doesn’t have to be better than what it replaces but it would make it easier to sell if it had the same quality, accuracy, etc.

There are plenty of examples of medical devices that are big, bulky, slow and costly. Give customers two or more benefits based on eliminating or minimizing these undesirable features and you will create a market niche for your products.

Read more:

Small, Fast and Cheap, Theranos Is the Poster Child of Med Tech — and It’s in Walgreen’s | Singularity Hub.

http://www.theranos.com/

California Startup, Tribogenics, Develops Smart Phone Sized Portable X-ray Machines | Singularity Hub.

http://tribogenics.com/

Smartphone Physicals Are Taking Off With Explosion of Apps, Attachments | Singularity Hub.

http://www.smartphonephysical.com/

 

Too good to be true…or just hype?

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image via getairo.com

In a development many were expecting, Canadian mobile health startup Airo Health backed off on its launch of the world’s first wearable device that could track caloric intake. The bold initial product announcement and aggressive commercialization timing led many to think it was too good to be true. Others dismissed the story as just hype.

 

In a story on techvibes.com, the company announced today that it was cancelling pre-orders and issuing refunds to prospective customers.

“Our early testing of AIRO shows tremendous promise, but through conversations with others in the industry, we have come to realize that it requires further testing and calibration through more extensive trials before it will be ready for general market availability,” wrote founder Abhilash Jayakumar in an email to backers this week. “The additional validation required will take us some time and, unfortunately, we no longer expect to be able to ship the first AIRO wristbands by Fall 2014 as initially indicated.”

From the Airo Health website:

NUTRITION

We all know the importance of eating right, but keeping track of what we eat takes too much effort. AIRO is able to automatically track both the calories you consume and the quality of your meals. With a built in spectrometer, AIRO uses different wavelengths of light to detect nutrients released into the bloodstream as they are broken down during and after your meals.

STRESS

AIRO helps you become proactive about stress. It measures heart rate variability, the aggregate response of your autonomic nervous system, derived from heart rate, to measure the smallest fluctuations in your stress levels. AIRO can not only warn you as your stress levels rise but can also provide recommendations as to how best to deal with it. Over time, AIRO gets smarter by learning what calms you and what doesn’t.

SLEEP

We spend a third of our lives sleeping but we know very little about it. AIRO tracks your circadian rhythm and can see distinct sleep cycles. It’ll wake you up at the optimum time and will let you know how much of your night’s sleep was restorative.

EXERCISE

It’s no secret that living an active lifestyle can lead to a long and healthy life. The best way to keep track of your daily activity is to monitor your heart rate; everything else is just a proxy. By tracking your heart rate, AIRO calculates the number of calories your body burns throughout the day.

I wrote about Airo Health and my healthy skepticism of its commercialization timing here. So did MedCityNews and mobilehealthnews.

Takeaways: Developing new medical technology is difficult, much more so than envisioning it. What works in the lab seldom works as well in humans. Unfortunately, it’s easy to get free PR for new and interesting technology without much proof. You can even generate orders without having a functional prototype.

It’s too soon to know if Airo Health actually has unique and innovative mobile health technology. It’s also too soon to know if the company has forever tarnished its reputation. I’m guessing they have “one more chance to make it right”. If they go away and perfect their technology and then try to promote it, the media will grab the story because of the company’s previous sins. If they fail again, I believe it will be virtually impossible to get press or investor attention.

Good luck, Airo.

Read more:

http://www.techvibes.com/blog/airo-health-cancels-preorders-2013-11-21

Startup unveils a wearable device it says can count calories — but it doesn’t actually exist yet – MedCity News.

Question marks, incredulity meet the announcement of Airo | mobihealthnews.

The Clever Bottle vs. the Smart Pill

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image via clevercaprx.com

Patients are terrible at taking prescription medications. A couple of startups have developed devices that aim to solve the problem, but with wildly different solutions: The Clever Bottle vs. the Smart Pill.

A recent study by WHO estimated that 50% of patients with chronic illnesses don’t take their drugs as prescribed. This behavior increases deaths and complications. Further, it costs about $100 billion per year in avoidable healthcare costs.

 

 

Medication compliance is a problem that has been around for thousands of years. In fact, a paper in The Mayo Clinic Proceedings included a quote from Hippocrates who lived and practiced medicine more than two thousand years ago:

Keep a watch…on the faults of the patients, which often make them lie about the taking of things prescribed. For through not taking disagreeable drinks, purgative or other, they sometimes die.

Hippocrates, Decorum

Ensuring that patients take their medications seems to be an unglamorous approach to a big and costly healthcare problem. It’s also a potentially lucrative market. While neither of the solutions would be considered simple or low tech by most people, they are direct in how they address the issue.

The Clever Cap pill bottle is something most of us might say, “hey, I thought of that!” The people at Compliance Meds Technologies in south Florida took the next step and developed their idea. The Clever Cap fits on standard pill bottles, dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with mobile devices or with a special hub. The hub is a device made by Qualcomm in their attempt to cash in on the vast potential in mobile and digital health data.

CleverCap can also be reprogrammed and reused. The device is reported to work even without a wireless connection. It’s not clear what happens if the batteries die. What the CleverCap can’t do is know if the patient really swallowed the pills.

The Smart Pill, branded as the Ingestion Event Marker or IEM by its developer, Proteus Digital Health of Redwood City, California, aims to embed a microchip in each pill. The chip is activated and powered by stomach acid and apparently passes harmlessly through the digestive system and is eliminated. The chip communicates time and date ingested as well as physiological and behavioral patient data to a wrist patch worn by the patient.

Very high tech. Indeed, the company has partnerships with Novartis, Medtronic, St. Jude Medical, and Oracle among others. The company has raised a lot of money including $62.5 million in “the second closing of its F round.” Proteus has received FDA marketing clearance, a de novo 510(k) for its technology. It remains to be seen if drug manufacturers will need additional FDA clearance to use the technology with their pharmaceuticals.

The Smart Pill definitely knows if the patient swallowed the pills. The big question is whether patients want this much technology in their bodies vs. the less intrusive CleverCap. My guess is that there is probably room for both solutions in this potentially large emerging market.

Takeaways: There are unsolved problems and unmet needs everywhere in healthcare. We’ve all daydreamed about things like smart pills and clever caps. Keep an open mind and perhaps you will recognize a new opportunity.

Both of these technologies are potentially disruptive and they both make use of the latest information technology including cloud analytics and reporting. The CleverCap seems to have the quickest path to market but the Smart Pill has all sorts of other potential capabilities and that’s probably why the company is well-funded and flush with partners. Both strategies seem viable and there’s plenty of room in the market for their innovations and more.

Read more:

CleverCap Pill Bottle Connects to Wifi, Dispenses Only as Directed, Uploads To The Cloud | Singularity Hub.

The Pills Have Eyes: Microchipped Medicine Is Coming | Singularity Hub.

Medication Adherence: WHO Cares?.

What’s killing us and what’s holding us back

http://viz.healthmetricsandevaluation.org/gbd-compare/
Analyze the world’s health levels and trends in one interactive tool. Image via Institute for Health Metrics and Evaluation

Here are a couple of excellent online resources that delve into the details of what’s literally killing people around the world and how various countries, including the USA, are ranked for health, government, education, and business related factors in the global economy. The resources are windows into what’s killing us and what’s holding us back as people and as societies.

If you’re a startup CEO or product manager for a new medical device-based therapy or diagnostic, these resources will come in handy as you write and execute your business plan. If you are in public health or global health, the tools are great ways to visualize diseases, risk factors, causes of death and disability and much more. If you’re neither, they are still interesting and fun places to get informed and marvel at the incredible diversity in the world.

The first resource was created by Seattle’s own Institute for Health Metrics and Evaluation at the Univer­sity of Washington. The tool is called the Global Burden of Disease, or GBD Compare. It is a web-based interactive graphic based on a huge database of health statistics from all over the world.  You can use the visualization tool to see the incidence and impact of all sorts of illnesses and conditions.

For example, you can examine a vast number of causes of causes of disease or injury by country or region every five years from 1990 to 2010. You can also slice the data by sex and age bracket. As you make your selections, the graphics change in real time. It’s mesmerizing.

The second resource is a report from the World Economic Forum titled the Human Capital Report 2013. From the report’s preface:

Through the Human Capital Report, the World Economic Forum seeks to provide a holistic, long term  overview on how well countries are leveraging their human capital and establishing workforces that are prepared for the demands of competitive economies. By providing a comprehensive framework for benchmarking
human capital, the Report highlights countries that are role models in investing in the health, education and talent of their people and providing an environment where these investments translate into productivity for the economy. In addition, through extensive additional information on the 122 countries covered, the Report
seeks to provide a fuller picture of the context within which human capital is operating in any particular country.

The Human Capital report provides benchmark assessments on a number of items for 122 countries around the world in four broad categories: Health and Wellness, Education, Workforce and Employment, and Enabling Environment.

While the U.S. ranks a respectable 16 out of 122 overall on the Human Capital Index, there are areas of concern and opportunities for improvement. For example, in the Education category, our rank in math and science education was only 44 out of 122 but on the positive side, the U.S. was number 1 in education gender gap.

In the Health and Wellness category, we ranked 106/122 in stress and 112 in obesity rate but we ranked number 3 in % of children under age 5 with stunting or wasting. In fact, the U.S. ranked 43 overall in Health and wellness, not impressive for a country that spends more on healthcare as a percentage of GDP than any country on the planet.

In Workforce and Employment, the U. S. ranked 76/112 in unemployment rate and only 49/112 in labor force participation rate for ages 15-64 but were number 5 in both capacity to attract talent and capacity for innovation.

Finally in the Enabling Environment category, the U.S. ranked low, number 88, in mobile internet use (surprising!) but high, number 3, in business and university R&D collaboration as well as number 3 in something called the Doing Business Index.

Takeaways: There are growing numbers of online resources that can be used to bolster a business plan or presentation. There is an incredible array of data being generated on a continuous basis. The researchers that compile, analyze, and present this data are doing all of us a great favor as we have tools to pinpoint clinical conditions and compare our society with others around the world.

Read more:

Want to Save Lives? You Need a Map of What’s Doing Us In – Wired Science.

GBD Compare.

America, we’re not fat, loud and lazy. We’re fat, diseased and stressed.

The Human Capital Report 2013 – The World Economic Forum.

Ranking the best places for healthcare startups

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image via CBinsights.com

Silicon Valley is Mecca for technology companies. When it comes to ranking the best places for healthcare startups, however, the global technology hub seems to be not as dominant.

A common method for ranking the best places for startups is to quantify the number of exits and aggregate valuation in a given time period. A recent report by CB Insights, an investor service focused on early stage companies and emerging industries, says that Massachusetts and not the Bay Area has been more successful in exits for VC-backed healthcare startups.

Healthcare startup categories included medical device, biotech, and pharmaceutical companies.

The analysis also shows that other regions are competitive as well. Southern California had the next highest number of exits in the same time period, 2012-present.

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The CBinsights report looked at the startup exit data in another way that highlights differences between the regions more clearly. They defined another metric, “Value Creation”. Value Creation is the ratio of the average exit value of a company in the region to the average VC investment in a company in that region. So bigger is better.

As seen in the table, New York comes out on top in this ranking while Silicon Valley lags at little more than half of the New York number. My home state of Washington is even lower on the list. This ranking may reveal why certain regions seem to have an easier time attracting venture capital investment than others. One last and very interesting note: the Value Creation metrics for technology companies are much higher than for healthcare companies. It starts to become clear why there is a dearth of capital investment in the healthcare space. If you are a VC, would you put your money in healthcare or technology?

Takeaways: Although no single city or region in the U.S. dominates when it comes to a great location for healthcare startups, there are a few conclusions that can be drawn from the report.

The East Coast  – Massachusetts in particular but also the New York/New Jersey/Pennsylvania tri-state areas are very strong in healthcare startups. Obvious reasons include major population centers for access to a talented and experienced employee pool, large numbers of world-class research universities and medical centers, and close proximity to financial hubs.

Of course, other locations such as Minneapolis, the San Francisco Bay Area (including Silicon Valley), Southern California, and the Seattle Metro area have their drawing power as well. Some of the additional factors include lifestyle, proximity to the FDA and other government officials, and being part of an industry “cluster” (medical device in Minneapolis, biotech in the Bay Area for example).

Read more:

Silicon Valley doesn’t dominate when it comes to VC-backed healthcare exits.

Silicon Valley is Second to Massachusetts for Venture Capital-backed Healthcare Exits.

Price Increases, Not Demand, Have Caused the Massive Hike in U.S. Health Spending

image via wikipedia.org
Life expectancy compared to healthcare spending from 1970 to 2008, in the US and the next 19 most wealthy countries by total GDP (wikipedia.org)

In the USA, we continue to pay more and get less for our healthcare expenditures than any developed country on Earth. What hasn’t been clear is why that is the case in the complex American healthcare system. A paper in the latest edition of the Journal of the American Medical Association by researchers at Johns Hopkins University and elsewhere asserts that price increases and not demand have caused the massive hike in U.S. health spending over the past few decades.

The researchers used publicly available data to identify trends in health care from 1980 to 2011. They examined and analyzed the source and use of funds, patients and providers, and finally the value created by the expenditures and health outcomes.

image via blogs.wsj.com

The researchers found that US health care expenditures have doubled since 1980 as a percentage of US gross domestic product (GDP), to well over 1/6 of the total economy. Growth in healthcare spending has far outpaced that of other OECD countries. Most of the OECD countries have either some form of single payer healthcare or public option health insurance along with government-imposed price controls on healthcare components. The U.S., of course, has none of these.

The article notes that annual growth in the rate of healthcare spending has decreased since 1970, and especially since 2002. That’s typical of large entities – Google and Microsoft experienced the same effect as they grew and aged. The average healthcare spending growth rate, however, stands at 3% per year. The 3% average annual growth in spending is more than overall GDP growth and is more than the average growth in any other industry. Moreover, the share of the healthcare system funded by government increased significantly, from 31.1% in 1980 to 42.3% in 2011.

Of course, as has been noted in this blog and elsewhere, all of this spending has resulted in lower life expectancies at birth as well as lower survival rates for many chronic diseases compared to other developed countries. The conventional wisdom has been that soaring demand for healthcare and the needs of the increasing elderly population have been responsible for the increases in spending, along with “inefficiencies” and the ever popular “defensive medicine”. Not so, according to this analysis:

The findings from this analysis contradict several common assumptions. Since 2000, price (especially of hospital charges [+4.2%/y], professional services [3.6%/y], drugs and devices [+4.0%/y], and administrative costs [+5.6%/y]), not demand for services or aging of the population, produced 91% of cost increases; (2) personal out-of-pocket spending on insurance premiums and co-payments have declined from 23% to 11%; and (3) chronic illnesses account for 84% of costs overall among the entire population, not only of the elderly.

So hospital charges, physicians’ fees, drugs, medical devices, and administrative costs (medical insurance) have all risen faster over the past ten or so years than the overall rate of increase in spending for healthcare. Also note that chronic diseases among the general population, not just the elderly, account for a whopping 84% of all healthcare costs. In fact, the study found that chronic conditions in people younger than 65 account for 2/3 of all health care costs. It’s clear to me what’s driving the increases, and it’s not in keeping with conventional wisdom.

Additionally, despite what most people perceive to be ever-increasing co-pays, premiums, and deductibles, out-of-pocket spending decreased more than 50% (as a portion of total spending) over the same period. That means most people are disconnected from the economic realities of healthcare spending. No wonder we can’t decide how to fix things – we can’t even figure out exactly what’s broken!

The article also points out that three broad trends are responsible for much of the changes over the time period in the study: consolidation of providers reducing competition, an emphasis on information technology that has yet to produce tangible benefits, and empowerment of the patient that has not always produced positive outcomes (think of direct-to-consumer advertising of pharmaceuticals).

Takeaways: the authors summarized it very well: “a national conversation, guided by the best data and information, aimed at explicit understanding of choices, trade-offs, and expectations, using broader definitions of health and value, is needed.

The current controversies surrounding the Affordable Care Act are a good example. Something had to be done about health insurance reform. Obamacare is a place to start and more evolutionary than revolutionary.

Anything as massive as our healthcare system will always be highly politicized and change will be controversial. Whether we can hope to have a conversation informed by data and information remains to be seen.

Read more:

Soaring Prices, Not Demand, Behind Massive Hike in U.S. Health Spending – US News and World Report.

JAMA Network | JAMA | The Anatomy of Health Care in the United States.

The artificial hip fiasco

http://en.wikipedia.org/wiki/Hip_replacement
image via wikipedia.org

Designing medical devices is hard work. Designing artificial joints is even harder. The ongoing artificial hip fiasco in the medical device industry is proof.

Artificial joints such as hips and knees are incredible technologies. They can take people out of wheelchairs and turn them into active adults. The crippling pain and infirmity of arthritis and other degenerative diseases are banished, at least for a while.

The requirements for these high tech medical devices are challenging. They are implants, subjected to full immersion in bodily fluids and subject to all of the stresses and biochemical processes of the human body. Ideally, the implant should last the rest of the patient’s life although that seems to be one of the most challenging requirements.

Implants such as artificial joints that must move may be the most difficult of all to design and to last in the body. Materials selection is particularly challenging. Metal implants must be sufficiently hard and tough to take the loading and repetitive motion of a patient’s joint for years and years. Ceramic implants must be fracture-resistant to impact loads and shocks, say from a jump or a fall. Polymer implants must be low friction but must not break up under mechanical stress or chemical attack. And coatings must not migrate to other parts of the body. Of course, none of the materials in the implants can be toxic.

Unfortunately, there does not appear to be an ideal combination of materials for hip implants. Interestingly as well (and I’m sure of substantial frustration to device engineers), there does not appear to be a reliable in vitro or in vivo model with which to perform wear and life testing. If there were a robust model, none of these implants would have made it to market without major revisions in materials and/or design.

Implant designs have failed mechanically through fracture and friction and more insidiously, have raised the potential for cancer and autoimmune disorders through migration of metals, coatings, and polymers to other areas of the body. In many cases, patients have undergone additional implant surgeries as a result of the failures. And these are not trivial operations.

A report today in Fierce Medical Devices indicated that Johnson & Johnson has settled 7,500 lawsuits for its metal-on-metal hip implants for a whopping $4 billion. That’s an average of $300,000 per implant and is in addition to other lawsuits settled in October. Other lawsuits against J&J are still pending as well as legal exposure outside the U.S. J&J announced recently that it will exit the metal-on-metal and ceramic-on-metal implant markets in 2014. I’m guessing that the legal settlements wiped out any profits made over the years and is probably going to cost untold numbers of jobs.

J&J’s competitors have problems too. According the the Fierce Medical article, Biomet, Stryker, and others are facing similar liability situations with respect to metal-on-metal implants.

The market for these devices is large and increasing. Hip implants are one of the most frequent orthopedic surgeries. As the population of seniors in the U.S. and other developed countries continues to grow while the baby boom generation ages, demand for procedures that maintain active lifestyles will continue to increase.

Takeaways: The onus is on medical device engineers to create valid in vitro and in vivo preclinical models and to test exhaustively before releasing to manufacturing. Engineers and researchers must also identify biomaterials and designs that are truly biocompatible and able to meet the demanding requirements that these implants must satisfy.

Give the track record of implants, engineers and medical device executives can expect increased scrutiny and skepticism from regulatory agencies, investors, physicians, and patients and their families.

Of course, it also means that there is an incredible opportunity awaiting the company or engineer that can solve this intractable issue.

Read more:

Report: J&J settles most metal hip lawsuits in $4B-plus accord – FierceMedicalDevices.

More Artificial Hip Concerns – NYTimes.com.