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.

Jumper Cables for Your Brain

http://graphics8.nytimes.com/images/2013/11/03/magazine/03brain1/mag-03brain-t_CA0-articleLarge.jpgA novel therapy that improves mental performance in healthy people is being called “jumper cables for your brain.” The scientific name for the therapy is transcranial direct-current stimulation, tDCS for short.

A similar yet very different treatment, electroconvulsive therapy (ECT), formerly called electroshock therapy, doesn’t have a positive image in most peoples’ minds. Popular culture including movies and TV has convinced most of us that it’s used to treat crazy people, usually with extremely undesirable outcomes, and that the people giving the treatment are either mad scientists or evil government agents.

ECT does have a place in modern neuroscience, however. It is often the last resort therapy for patients with intractable depression and other conditions that do not respond to drug treatments.

tDCS uses very low voltage and very little current to achieve its effect, less than 1% of the enegy used in ECT. The tDCS devices being studied today use a 9 volt battery for power. tDCS researchers have been using currents in the range of 300 to 500 microamps. In contrast, ECT uses much more current, about 2000 times as much. According to an article in Wikipedia, “Typically, the electrical stimulus used in ECT is about 800 milliamps…”

 Researchers have identified a myriad of benefits for the novel therapy. From the article in The New York Times:

Scientific papers published in leading peer-reviewed journals since 2005 have shown that tDCS can improve the speed or accuracy with which people perform [a computerized] attention-switching task. Other studies have found it can improve everything from working memory to long-term memory, math calculations, reading ability, solving difficult problems, piano playing, complex verbal thought, planning, visual memory, the ability to categorize, the capacity for insight, post-stroke paralysis and aphasia, chronic pain and even depression. Effects have been shown to last for weeks or months.

“tDCS will not make you superhuman, but it may allow you to work at your maximum capacity,” said Felipe Fregni, the Brazilian physician and neurophysiologist who runs Harvard’s Laboratory of Neuromodulation at the Spaulding Rehabilitation Hospital. “It helps you achieve your personal best level of functioning. Let’s say you didn’t sleep well the night before. Or perhaps you’re depressed, or you suffered a stroke. It helps your brain reach its peak performance.”

No one is really sure why the therapy works although there are theories. The brain is essentially a very complex electrochemical computer. Applying a weak electrical field to neurons while performing a task seems to make the neurons fire easier and to remember the task for some time. Unfortunately, researchers have not yet identified the specific mechanism that is responsible for the improvements. As a result, research funding has been sparse because peer reviewers for funding agencies in the U.S. government remain skeptical.

A number of companies are pursuing commercialization of tDCS technology and are engaged with the U.S. FDA on the regulatory approval process. ECT devices are categorized as Class III or pre-market approval (PMA). It remains to be seen if the new, lower power devices also fall into the PMA category. A less restrictive FDA classification would mean a greater market potential and benefits to ordinary healthy people who are looking for a little mental advantage. I would definitely consider trying one of these devices in exchange for a few of those mental benefits!

Takeaways: There are many processes and body functions that are not fully understood or characterized. When researchers continue to investigate these promising areas despite a lack of funding, it might mean that there is an opportunity for collaboration and eventual commercialization.

Of course, something like tDCS, “brain enhancement technology” comes with risks. What might be the long term effect of the therapy on the brain? What about effects on children and adolescents?

Finally, it will be imperative to separate the new technology from the stigma of electroconvulsive therapy in order to appeal to healthy consumers.

Read more:

Jumper Cables for the Mind | New York Times Magazine

GLNT gets another patent to treat Parkinson’s for transcranial direct current stimulation during sleep.

Renal Denervation – the next big thing?

blood pressure checkIt seems like every big medical device company is working on a technology for renal denervation to treat high blood pressure.

Development and market availability of a therapy for hypertension (high blood pressure) is a big deal. Here are some facts about hypertension from the World Heart Federation:

  • Globally, nearly one billion people have high blood pressure (hypertension); of these, two-thirds are in developing countries.
  • Hypertension is one of the most important causes of premature death worldwide and the problem is growing; in 2025, an estimated 1.56 billion adults will be living with hypertension.
  • Hypertension is the leading cause of cardiovascular disease worldwide.
  • People with hypertension are more likely to develop complications of diabetes.

Some additional facts about hypertension in the USA from the Centers for Disease Control:

  • 67 million American adults (31%) have high blood pressure—that’s 1 in every 3 American adults.
  • 69% of people who have a first heart attack, 77% of people who have a first stroke, and 74% of people with chronic heart failure have high blood pressure. High blood pressure is also a major risk factor for kidney disease.
  • More than 348,000 American deaths in 2009 included high blood pressure as a primary or contributing cause.
  • High blood pressure costs the nation $47.5 billion annually in direct medical expenses and$3.5 billion each year in lost productivity.
  • About half (47%) of people with high blood pressure have their condition under control.

Hypertension is treated currently with drugs of course. According to a report from ADS Reports, the global market for antihypertensive drugs was $29.9 billion in 2010 and is projected to reach $33 billion in 2017. That’s a huge target for interventional therapy.

I wrote about Bellevue, WA-based Kona Medical a couple of weeks ago receiving a $10 million investment specifically earmarked for their market entry into China, obviously one of the biggest potential markets.

Kona recently announced interim results from two ongoing clinical trials. It reported an average systolic blood pressure reduction of 29 mmHg at 6 months in their first study and a three-month drop of 19.4 mmHg in the second study using a dosing pattern that reduced therapy time from 13 to three minutes.

Kona’s results are significant because its therapy is completely noninvasive. It uses high intensity focused ultrasound on the surface of the skin to deliver energy to ablate the renal nerves.

Other companies developing renal denervation technologies include St. Jude Medical, Boston Scientific, and Medtronic. Each has chosen a different energy modality to deliver the therapy.

MedCityNews reports that St. Jude is using a multi-electrode catheter to deliver electrical energy to the renal nerve sites. The company reported results from a clinical study: at 18 months, 77 percent of the 46 patients treated with St. Jude’s technology, the EnligHTN system, had responded to therapy. St. Jude’s system total ablation time is about four minutes, according to a company statement.

The Boston Scientific therapy uses bipolar (electrical) energy to deliver therapy. After 12 months, the company reported a “clinically-meaningful decrease in office systolic blood pressure” in 85 percent of the 139 patients treated. The Boston Scientific therapy requires a brief 30-second treatment time.

Medtronic seems to have a head start in the market. In early 2011, it finalized its purchase of Ardian, a Silicon Valley startup that was working on a novel therapy for hypertension since 2003. The Medtronic RDN system therapy uses radio frequency energy delivered via a catheter to the renal arteries/nerves. Medtronic’s Symplicity renal denervation system has a CE mark and is commercially available outside the U.S. Medtronic has a number of completed and ongoing clinical studies, all of which have resulted in conclusions that the therapy is safe and effective.

Takeaways: New markets are one area where startups can compete on a level playing field with huge, multinational companies. They can be more nimble, take more risks, and can pivot when things don’t go according to plan. In the case of renal denervation, Kona seems to have a decided advantage with its noninvasive technology and treatment. Of course, Medtronic has a years-long head start and we all know the “best” technology doesn’t always prevail, right?

Read more:

Two top medical device companies announce promising renal denervation tech results – MedCity News.

Kona notches solid results for novel renal denervation tech – FierceMedicalDevices.

 

 

How many calories were in that cheeseburger?

CheeseburgerA Canadian startup has developed technology that may disrupt the mobile health tracking market. Airo Health is commercializing a nutrition tracker that can passively detect and inform the wearer exactly how many calories were consumed in the user’s last meal.

The nutrition tracker uses a light emitter and detector in a wristband and fairly sophisticated software in a smartphone app to measure metabolites in the bloodstream. The metabolites are released during and after the user’s meal.

The Airo device also detects the user’s heartbeat and uses that information to assess activity and fitness levels. All of this analysis starts with sensors in a small, unobtrusive wristband.

According to the company co-founder, Abhilash Jayakumar, Airo received US$81,400 in seed funding from the Canadian federal government and the University of Waterloo. The company says it is planning a commercial launch in the fall of 2014 – that’s just a year or so away. Airo has not yet built production prototypes, so their launch date is most likely optimistic.

In an interview with MobiHealthNews, Jayakumar said the sensor bracelet is detecting accurate calorie intakes about 80% of the time. That’s an exciting development, but the lead times for consumer electronics make a full commercial launch in a year improbable at best.

The fledgling startup has done impressive work with very little funding. They are taking digital health and the “quantified self” movement to a new level. Competitors are no doubt already starting development of their own passive calorie tracking technology. What would really be disruptive is an app to make you not eat that cheeseburger in the first place!

Takeaways: Mobile health sensors and applications are getting progressively more sophisticated. It remains to be seen if there is a sizeable market for these devices and apps but they are capable of measuring things in real time that were previously available only in a doctor’s office by appointment. The commercial availability of a Star Trek-like Tricorder device may be only a few years away.

Most of the personal fitness devices are targeted at healthy people. There is a large opportunity as well in monitoring people with chronic diseases or those recovering from surgery.

Read more:

AIRO ups the ante with passive nutrition tracking

 

Riboflavin: not just for breakfast anymore

image via wikipedia

Riboflavin, also known as vitamin B2, is a micronutrient and food additive commonly found in breakfast cereals and other processed foods. It’s yellow or yellowish orange in color and is sometimes used as a food coloring. Now it’s being researched for use as a biocompatible “ink” ingredient for 3D printed implants and other structures to be placed in the human body.

3D printing has enormous potential to enable mass customization of medical products. Think of having an implant crafted to fit you and only you. How about 3D printing structures on demand rather than ordering from a manufacturer?

Conformis, an othopedic medical device company, makes individualized metal joint implants from imaging studies using a milling machine. The milling machine creates a custom-made prosthesis for knee replacement surgery. Patients have to wait about 7 weeks for their prosthesis to be made, however. 3D printing promises to be much faster since the machines are small and relatively inexpensive.

One issue has been the biological incompatibility of most of the polymers used in 3D printing. In typical use, a spool of polymer “ink” in the form of a long thread is fed through a 3D printer nozzle. Tiny dots of polymer are melted and laid down on a two dimensional surface and built up vertically until the piece being manufactured is complete.

Now according to Fierce Medical Devices, researchers at North Carolina State University, the University of North Carolina at Chapel Hill, and Laser Zentrum Hannover have used riboflavin as a nontoxic polymerization agent to 3D print structures that could one day become implantable medical devices.

While there is much more research and development to be done before this becomes a practical commercial technique, the technology is possible today. Next step is for a hungry startup or tech-savvy medical device company to commercialize this work. Perhaps when you have a surgery performed in 5-10 years, there will be a 3D printer in the next room churning out an implant “just for you.”

Takeaways: trends like mass customization and technologies like 3D printing are converging. Even in the relatively slow-moving healthcare industry with FDA regulation, there is a need for new, different, better ways of treating patients. 3D printed devices are yet another disruptive technology. At first, they will be crude and not very useful. As time goes on and the technologies evolve, however, they will have a significant effect.

Read more:

Study Finds Natural Compound Can Be Used for 3-D Printing of Medical Implants – FierceMedicalDevices.

Vitamin B2 may help build a safer 3-D medical implant – FierceMedicalDevices 

Knee Replacement, Knee Pain, Customized Knee | ConforMIS.

 Riboflavin – Wikipedia, the free encyclopedia.

 

In search of a better mousetrap…EHR system, that is

http://www.mddionline.com/sites/www.mddionline.com/files/image/01310/ehrdoc.jpg
image via mddionline.com

There has been enormous emphasis in the past few years on getting physicians to adopt electronic health records (EHRs). The HITECH Act (Health Information Technology for Economic and Clinical Health Act) part of the American Recovery and Reinvestment Act of 2008, established financial incentives for medical practices and hospitals to adopt EHRs that met specific “meaningful use” criteria. According to a recent survey, physicians are dissatisfied with their EHRs and are looking to switch.

The HITECH Act was an early effort of the Obama administration to use information technology to begin to rein in out of control healthcare costs by using data to make more informed decisions.

The Department of Health and Human Services (HHS) announced recently it has exceeded its goal of 50% of doctor offices and 80% of eligible hospitals having electronic health records (EHRs) by the end of 2013.

There are thousands of EHR products from hundreds of vendors: 3721 EHR products for ambulatory care and 1282 EHR products for inpatient care listed on the HealthIT.gov website as certified EHR solutions. Many entered the field opportunistically when it became apparent that large numbers of physicians, medical practices, and hospitals would be purchasing EHRs in response to the HITECH Act incentives.

According to research conducted by EHR software reviewer Software Advice, it appears that many physicians are unhappy with their new EHR systems: 31.2%  of medical providers are replacing their EHRs today, compared to 21.0% in 2012. That’s a 48.6 percent increase. The main reason for replacement? More than 60% of physicians reported dissatisfaction with their current system. There are multiple reasons for their unhappiness: 26% said their EHR lacks key product features while 14% said it was too cumbersome to use and 12% said their current EHR was too costly.

Adopting a new EHR is a big investment in capital and resources. The switching costs are quite high because transitioning to a new system is complicated and time-consuming.

Takeaways: There remains a significant opportunity for an EHR developer to capture revenue and market share given the high levels of dissatisfaction with current solutions. Companies already in the market should reassess their offerings and work with customers to improve usability and user interfaces, to improve connectivity with other systems, and to provide the features that users need. Startups should try to differentiate their products in the same ways.

It all starts with understanding customer requirements.

Read more:

Why Physicians are Ditching Your EHR System | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

The Impact of the HITECH Act on EHR Implementations IndustryView | 2013.

HITECH Act – the Health Information Technology Act | Policy Researchers & Implementers | HealthIT.gov.

Prosthetic Hands May Soon Gain the Sense of Touch

Someday in the not too distant future, amputees with prosthetic hands may gain the sense of touch.
image via discovery.com

This research being conducted at the University of Chicago could be a major advance in robotics and prosthetic technology. Amputees today have no way to “feel” their prosthesis except to watch it as it moves. Someday in the not too distant future, amputees with prosthetic hands may gain the sense of touch.

Using monkeys, the researchers first identified specific areas of the brain that corresponded with their fingers. Then the scientists connected electronic strain gages in the prosthetic hand to those specific areas in the brain. Using software, the scientists were able to successfully identify a “contact event” at the prosthetic hand from the monkey’s brain and to create a sense of pressure.

An important next step would be to control the prosthetic hand with the brain and to be able to apply force with feedback so the brain can sense what and with how much force the hand is touching.

The research work was partially funded by the U.S. government’s Defense Advanced Research Projects Agency (DARPA). DARPA is well-known for sponsoring high risk, long term research activity. The wars in Iraq and Afghanistan have resulted in large numbers of U.S. military amputees, creating an ongoing and increasing need for improved prosthetic technologies.

Takeaways: There are non-obvious sources of funding early technology development work. DARPA is a great example but there are plenty of others. In the government, NIH, CDC, and NSF have ongoing research grant programs. There are other military programs as well, for example, TATRC. Yes, there is competition for these grant dollars so you need to make a strong case for the technology and the problems it solves. There is also the possibility that the researchers have no intention of commercializing their technology. In that case, it is possible for a company to license and commercialize the technology on its own.

        Read more: How to Give Prosthetic Hands Touch Sense : Discovery News.