Standing, fidgeting, coffee all good for you; sitting is still killing you

image via Lifehacker.com

Did you know that standing instead of sitting for just three hours per workday burns the same number of calories in a year as running ten marathons? That’s 30,000 calories or about eight pounds of fat. And that’s got to be the easiest way ever to keep the belly fat and love handles at bay.

It turns out that fidgeting is good for you as well according to a recent article in Michigan Today. Scientifically termed “nonpurposeful movement,” fidgeting generates nonexercise activity thermogenesis (NEAT for short), a fancy way of saying that you burn calories when you fidget – as many as 800 per day! So go ahead and ignore your parents, your teachers, and all of those other authority figures in your life who sternly admonished you to sit quietly and stop fidgeting.

Even though researchers have been back and forth on this one for years, the evidence is mounting that coffee is good for you too. I’m fairly sure the research is about plain old coffee, not the sugar and fat-laden confectionery treats Starbucks specializes in. According to a 2005 study, Americans get more antioxidants from coffee than from anything else in their diets. Actually, dates have more antioxidants than anything but we just don’t eat that many dates.

More coffee consumption benefits: a study published in 2006 that tracked 125,000 people over 22 years showed that those who drink at least one cup of coffee a day were 20 percent less likely to develop liver cirrhosis. And according to a study from The American Chemical Society, people who drink four or more cups of coffee a day reduce their chances of developing Type 2 diabetes by 50 percent. With every additional cup, the risk gets lowered by 7 percent.

In a development of particular interest to baby boomers, researchers from the University of South Florida and the University of Miami found that people older than 65 who had higher blood levels of caffeine developed Alzheimer’s disease two to four years later than others with lower caffeine.

Finally, according to The New York Times, coffee can make you a better athlete. Caffeine increases the number of fatty acids in the bloodstream, allowing athletes’ muscles to absorb and burn those fats for fuel. The body’s small reserves of carbohydrates are saved for later on in the exercise.

Update Feb. 13, 2015: Here’s a fascinating article on an incredible number of health benefits of coffee: 51 Scientific Reasons Coffee is Healthy (#49 is Life-Changing)

So much for things that can make you healthier. One of the single biggest activities (or inactivities) that negatively affects our health is the simple act of sitting. This infographic from MedicalBillingandCoding.org details the many ways that sitting is bad for you and in fact, is killing you. A few examples:

  • Sitting for more than 6 hours per day makes you more 40% more likely to die within 15 years than someone who sits less than 3 hours per day. That holds true even if you exercise.
  • Obese people sit for 2 1/2 hours per day more than thin people. Sitting burns zero calories.  One of every three Americans is clinically obese. You see where this is leading, don’t you?
  • People with sitting jobs have twice the rate of cardiovascular disease as people with standing jobs.
  • The human body has not evolved and is not designed for long periods of sitting.

Takeaway: Get on your feet, grab some coffee, and fidget away!

Read more:

BBC News – Calorie burner: How much better is standing up than sitting?

You are about to have a moving experience! | Michigan Today.

11 Reasons Why You Should Drink Coffee Every Day.

Sitting is Killing You – MedicalBillingAndCoding.org.

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

 

Cheney’s Defibrillator: Life Imitates Art, or Vice Versa?

http://graphics8.nytimes.com/images/2013/10/28/world/29heart2/29heart2-articleLarge.jpg
image via nytimes.com

Former U.S. Vice President Dick Cheney revealed in an interview with the CBS news magazine program 60 Minutes that he had his implantable cardioverter defibrillator (ICD) modified after implantation to turn off the wireless remote programming feature.

 

The skeptic in me wants to believe that Mr. Cheney was just drumming up publicity on his nationwide press tour to promote his latest book. Recent events in cyberspace, however, including the news that the U.S. National Security Agency has the ability to eavesdrop on the mobile phone conversations of the leaders of other countries has caused my to revise my beliefs. There are untold numbers of hackers around the world, all looking for a way to disrupt the status quo. So there is no shortage of motives for someone to try to hack the VP’s defibrillator.

[SPOILER ALERT] In the second season of the hit Showtime cable TV series Homeland (I’m a big fan, by the way), Nicholas Brody, the ex-prisoner-of-war/Marine Sergeant/Congressman/semi-terrorist cooperates with a Bin Laden-like figure to assassinate the Cheney-like Vice President by remotely manipulating his implanted defibrillator.

After Cheney made his revelation, there was much discussion about whether such an action was technically possible. The jury seems to be divided. It’s at least plausible enough to be the major plot point of Season 2 of Homeland. And apparently the possibility of hacker bad guys doing harm was the motivation for Cheney to deactivate the function in his device.

In the Homeland episode, Brody had to find a device code unique to the Vice President, then relay that to a remote hacker. The hacker executed some code that disrupted the device. The audience was not informed as to exactly how the bad code made its way to the implanted device. In real life, experts say that a programmer device must be in close proximity to the patient in order to wirelessly access the defibrillator. Apparently, Vice President Cheney wasn’t taking any chances!

Mr. Cheney had his defibrillator modified in 2007 while he was still in office. He has since undergone a heart transplant and presumably had the defibrillator removed.

Takeaways: As medical devices become increasingly complicated, the opportunities for negative outcomes – accidental and malicious – increase proportionally. Notwithstanding the dangers to the patient, this sort of negative publicity can have devastating consequences for a company, particularly an early stage company.

An ICD with wireless remote access obviously has the power to kill but other devices can be just as deadly. Be sure to conduct a thorough Failure Mode and Effects Analysis (FMEA) during the development process. Seriously consider involving computer experts, including security consultants, as additional resources. You should also consult key opinion leader physicians and patient groups to get objective third party viewpoints about risks and mitigations.

Lastly, have a disaster plan in effect for unthinkable scenarios like the one in Homeland. And make sure the CEO reviews and approves the plan.

Read more: 

Of Fact, Fiction and Cheney’s Defibrillator | The New York Times

Homeland | Showtime

“Dick Cheney’s Heart” |60 Minutes 

 

MedTech Startup Red Flags to Watch Out For and to Guard Against

Red flagIn an amusing series of articles and blog posts last week, biotech veterans and observers traded their favorite red flags that investors must watch for when considering biotech investment.

Most of these caveats also apply to medical device companies. On the flip side, startup CEOs should be forewarned and forearmed to not make the same mistakes when pitching and/or structuring their companies. They are on to you…

Here are a few of my favorite caveats:

[from Luke Timmerman at Xconomy]
  • Watch out for weak science or results that can’t be reproduced by third party researchers.
  • The company story is too complicated and can’t be reduced to an elevator pitch.
  • “There is no competition.”
  • No plan to demonstrate outcomes or show clinical and financial benefits to the healthcare system.
  • “Rent-a-luminaries” make up the Medical/Clinical/Scientific Advisory Boards.
[from David Sable, physician and venture capitalist]
  • CEO is clueless around investors
  • CEO is inflexible and won’t deviate from the rehearsed pitch
[from Christopher Henney, co-founder of Immunex, Icos, and Dendreon]
  • Too many VCs on the board
  • Family members in key management or board positions

I’m sure these three veterans have seen and/or interviewed dozens, if not hundreds of startup CEOs and their pitches.

Takeaways: Simple is best. Use a template to develop your pitch – they are easily found. Don’t deviate (at least not too much) from standard practices for startups in your industry segment and in your geographic area. It’s easier than ever to get a negative reputation. You may be able to get past one round with a sketchy pitch or objectionable governance. The stakes keep going up, however, and you risk everything by not being able to secure financing all the way to market launch. Do yourself and all of your stakeholders a huge favor and address the red flags before the investors see them.

Read more:

21 Red Flags to Watch for in a Biotech Company | Xconomy.

Six Red Flags to Watch Out For in a Biotech, From Dendreon Co-Founder Chris Henney | Xconomy.

A few more biotech red flags (h/t @ldtimmerman) – David Sable .

Verizon is a serious player in digital health

http://www.verizon.com/cs/groups/public/documents/adacct/logo_landing.pngIf you are a digital health entrepreneur, it can’t be good news that Verizon, one of the world’s largest telecommunications companies, has entered the healthcare market with a second FDA-cleared digital health product.

According to MedCity News, Verizon’s enterprise solutions division just announced its Converged Health Management platform after receiving FDA 510(k) marketing clearance in August.

The Converged Health Management platform will be marketed as a “B2B to C” product. Verizon says it will be white-labeled, meaning it will be sold to providers like hospitals and healthcare systems, payers, and large self-insured corporations and then marketed to consumers under the brands of the healthcare systems, etc.

Verizon also has an e-prescribing platform already on the market being sold in a similar way. That product is in use and growing rapidly. According to Dr. Peter Tippet, Verizon’s chief medical officer, the e-prescription platform has already transacted 40 million prescriptions this year. He also said that the e-prescription volume is doubling every 6 months, an impressive growth rate.

Verizon’s Converged Health Management platform will collect data from wireless medical devices – initially four types of devices: a blood pressure cuff, a scale, pulse oximeters and blood glucose meters. The data is sent automatically to cloud servers that are secure and HIPAA-compliant.

The patient can connect to the wireless medical devices with a smartphone, tablet, or PC. That’s important because they can be mobile and maintain their preferred lifestyles while remaining connected to the Verizon healthcare cloud.

Verizon has built algorithms into the platform to keep watch for patient health trends. Doctors can use the capabilities of real-time data access and two-way communications to express concerns or send reminders directly to the patient.

According to Verizon, the platform has been designed to work with or without biometric data. When used without real-time data, the platform can be used to manage chronic conditions like Crohn’s disease. It also has the ability to provide patients with a reward and even has elements of gamification. They seem to have anticipated a broad range of conditions and healthcare scenarios.

Additionally, Verizon implied that the platform will eventually connect to personal wellness devices like the trendy Fitbit and Jawbone products. According to the MedCity News article, Verizon purposely focused on achieving FDA clearance for the platform’s treatment capability first, reasoning that a treatment indication was more challenging to receive regulatory clearance than a wellness indication would be. Next step will be to get the platform cleared for wellness applications.

Verizon seems to be open to external apps running on its platform. Hospitals and device companies could find this to be valuable real estate.

The platform seems to be highly configurable and flexible to accommodate a broad range of customer and user preferences. Verizon really did its homework in product development.

Takeaways: The digital health market is a land grab scenario right now. Big companies like Verizon have the resources and market heft to occupy a large portion of the land. Medical device companies developing digital health products or startups with a single digital health offering in development must be nimble, flexible, and move quickly. It would also be prudent to approach Verizon and its big customers to find out if you can get your product into their platform ecosystem.

Read more:

Verizon launches FDA-approved platform to take over the patient engagement market – MedCity News.

Verizon demo video

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.

Hyping a digital health startup

http://graphics8.nytimes.com/images/2013/10/03/technology/bits03-healthtap/bits03-healthtap-tmagArticle.jpg
image via NY Times digital blog

HealthTap is a digital health app and website. It’s a useful way to get health and fitness information that is tailored to your interests. You can even get your specific questions answered by medical experts. I use it myself. In an effort to attract attention and even more users, however, HealthTap appears to have hyped or at least exaggerated its success.

HealthTap works by recruiting physicians (more than 50,000 participate) to answer questions posed by subscribers for free. The subscribers do not pay for the service. I’m not quite sure what their business model is, actually. The rationale for doctors to participate is that the physicians will be recognized (“thanked” in HealthTap parlance), their online reputation will be enhanced, and real life patients will come to them as a result.

After an interaction where a user asks a question and receives a response from a doctor, HealthTap asks the user to thank the doctor or HealthTap and prompts the user for more information. The extra information apparently includes responding with a click to a question like, “This answer saved my life.”

HealthTap keeps a record of all of the positive responses to the “saved my life” prompt and issued a press release when the tally got to 10,000. Nothing wrong with any of that, except there is no way to prove if the app/website/reply really did save a particular life.

As one physician commenter in the New York times article said, “after my third “This saved my life,” I investigated. It was for recommending antifungals for jock itch. Nice pat on the back, but lifesaving? Not!”

Although some of the the lifesaving claims may be legitimate, the touting of “10,000 lives saved so far” on HealthTap’s website seems vaguely desperate and hyped – not what I expect from a serious medical app.

HealthTap also provides a disclaimer on its website and app: “HealthTap does not provide medical advice, diagnosis or treatment.” The disclaimer is obviously there to avoid being treated as an FDA-regulated medical application. Of course, the FDA (and malpractice attorneys) will have the final say on that status. I don’t know how asking a specific medical question and having an answer provided by a physician avoids becoming medical advice.

HealthTap is competing with big players in the health information field. WebMD is the 800 pound gorilla and granddaddy of health information sites. I suppose the executives at HealthTap feel they have to be aggressive in order to create awareness and get users and doctors to take notice. Unfortunately, their real utility and service has been tainted by excessive marketing, in my opinion.

HealthTap appears to be a well-funded Silicon Valley startup. Its investors include luminaries like Eric Schmidt, Chairman of Google, Vinod Khosla, Esther Dyson, and more.

Postscript:  I removed the HealthTap app from my mobile phone because I thought the notifications it provided were too frequent and intrusive. I still receive an email every few days on the subjects I told HealthTap were important to me.

Takeaways: Yes, you need to be aggressive in marketing your startup. There is a lot of competition for mind share among similar startups all over the world, no matter how unique you believe your company/product/service to be.

No, you should not make up or exaggerate claims about your product. Perhaps it can be excused as puffery or marketing hype but healthcare companies are held to a higher standard than consumer products like beer or body wash.

Read more:

An App That Saved 10,000 Lives – NYTimes.com.

HealthTap.com

High tech medical device maker focuses on…China?

http://axialexchange.com/images/articles/Hypertension-Nutrition-Counseling.jpg
image via axialexchange.com

High blood pressure is a significant societal health problem all over the world. Kona Medical is trying to address the huge hypertension population with a noninvasive ultrasound device that might eliminate the need to take daily blood pressure medication. In a somewhat unorthodox move, the company is focusing initially on China.

 

Last year, Medtronic acquired Ardian, another startup that is focused on the same clinical condition. Ardian, based in the San Francisco Bay Area, was purchased for $800 million.

From axialexchange.com:

The statistics for hypertension are stunning. 30% of US adults have hypertension (high blood pressure). Another 30% of Americans are pre-hypertensive. Less than half of those people with hypertension have their condition under control.  A fifth don’t know they have it. The annual price tag for direct medical expenses related to high blood pressure is $131 billion. This is driven in part by the 55 million doctor visits that are prompted by high blood pressure. High blood pressure is present in most first heart attacks (69%), first strokes (77%), and in people with congestive heart failure (74%). High blood pressure was listed as a primary or contributing cause of death for about 348,000 Americans in 2008.

Recent medical research has shown that ablation (destruction) of the nerves around the renal arteries can reduce blood pressure in patients with hypertension. A number of medical device companies are racing to commercialize products based on their proprietary technologies in order to take a lead in this evolving market.

Ardian uses radio frequency ablation delivered via catheter to the area of the renal arteries. Kona is using focused external ultrasound to deliver the therapeutic energy – they are calling it “surround sound.” In a superficial assessment, it appears that Kona has the edge since their technology is completely noninvasive while the Ardian technology could at best be described as minimally invasive.

Of course, what should really matter is which technology works best with the fewest side effect, not how the therapy is delivered. The “best” technology doesn’t always prevail in the medical device industry, however. Sometimes first to market gets and keeps the largest share while in other situations the best marketing prevails.

Kona has previously raised $40 million in venture capital earlier this year and in 2012.

Kona’s latest announcement, to use a new investment of $10 million to launch their product in China, is somewhat confusing. Yes, there are vast numbers of people in China and untold numbers with hypertension. Most, however, probably do not have the type of health insurance that would pay for a high tech solution. In its press release, the company said that their therapy has the promise of being delivered in an outpatient setting. Outpatient hypertension therapy clinics – now that’s a disruptive concept!

China is not a traditional launch market for new medical devices. The company says that the latest investment, from a fund with deep ties to China, will be used exclusively to address the many clinical, regulatory, and intellectual property issues unique to China as a medical device market for Kona’s new therapy.

It will be interesting to see if Kona can successfully launch their product into the Chinese market while simultaneously commercializing for the traditional U.S. or E.U. markets without losing focus or depleting key resources.

Takeaways: Most companies commercializing novel medical devices pick a launch market and stick with it. There are any number of reasons to launch in the U.S. first. Other companies pick the European Union countries and some look to large, less regulated countries in South America.

While many development and commercialization tasks are the same no matter which initial market is selected, there are important differences. It’s usually best to choose the first, second, and perhaps third initial markets so that the launch components are not uniquely different and the company can use scarce resources for other commercialization tasks.

 Read more: Kona Medical raises $10M to reduce high blood pressure for people in China – GeekWire.

Kona Medical

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.

Teeny Tiny Pacemaker Fits Inside the Heart | IEEE Spectrum

http://spectrum.ieee.org/img/rsz_image_nanostim-euro_size_comparison-2-1381851816207.jpg
image via IEEE Spectrum

This leadless pacemaker is incredible technology. Not only did the company, Nanostim, reduce the size of the pacemaker by about 90% but it eliminated the often troublesome leads that are required in traditional pacemakers.

 

 

The stealthy company, based in the San Francisco Bay Area, was recently acquired by St. Jude Medical for $123-200 million (depending on milestones).

The new pacemaker has received European regulatory clearance but not FDA approval yet although it has received an FDA Investigational Device Exemption (IDE). A pivotal clinical trial is expected to begin soon in the U.S. while sales will begin in selected European countries very soon.

The device, about as big as a AAA battery, is implanted directly into the interior of the right ventricle of the heart. Electrodes on the exterior of the pacemaker provide electrical stimulation to the heart muscle. The device is implanted via a catheter inserted in the femoral artery. Removal occurs via the same route, only in reverse. Battery life is 9-13 years. The device has wireless communication capability so it can be programmed remotely.

Given the negative publicity and adverse events involving pacemaker lead fractures over the past years, leadless pacemakers appear to be an idea whose time has arrived. Of course, the idea has occurred to more than one inventor.

Here’s Medtronic’s take on the concept:

http://www.qmed.com/files/ck_images/large_Medtronic_leadless%20pacemaker.jpgMedtronic’s product concept is much smaller than a penny. Medtronic announced the device three years ago and said it would take 3-5 years before beginning human implants. They also said that the product concept included the ability to be programmed via a smartphone application.

 

image via qmed.com

 

 

Critics have pointed out that the Nanostim product and Medtronic device concept provide only single chamber pacing and are not rate-responsive – the most basic form of pacemaker.

It seems to me that the Nanostim device is classic disruptive technology. It provides a single function compared to the elaborate features of traditional pacemakers. It’s probably priced at a fraction of the price of complex pacemakers. As with other disruptive technologies, competitors ignore new entrants with low cost/performance at their peril. Given sufficient demand, I’m sure clinicians and engineers will figure out ways to make these “simple” devices perform all the functions of their bigger, older “brothers”.

On the positive side, no surgery is needed for implantation – a big plus with patients. And there are no potentially problematic leads to route. Other benefits from the patient’s standpoint are no activity restrictions, no surgical “pocket” for potential infections and no telltale bulge of the device under the collarbone. This could be one of those disruptive technologies where patient demand changes market dynamics.

The implantable pacemaker/defibrillator market is large, with 4 million active implants and 700,000 new implants occurring each year worldwide.

Takeaways: A leadless pacemaker is an obvious innovation to anyone who has worked in the cardiac stimulation field. Nanostim took the concept and ran with it while Medtronic took its time with what might be a technically superior solution.

While achieving lasting market share is more important than being first to market, Nanostim may be able to achieve both. Because they negotiated a strategic partnership with St. Jude Medical while the device was still in development, the company gained access to substantial resources, enhanced its credibility, and was able to reduce risk for investors by showing a clear path to exit. Nanostim also pursued the faster CE marking before FDA approval so that it could start selling the device sooner.

Read more:

Teeny Tiny Pacemaker Fits Inside the Heart – IEEE Spectrum.

News Release | Investor Relations | St. Jude Medical.

Weighing the Benefits of Medtronic’s Leadless Pacemaker | Qmed.

Medical Device Startup Fundraising: 5 keys for your pitch

Woman presentingIf you are leading a medical device startup, fundraising is your top priority. Here are five key points that you must address in every pitch that you make, no matter if it’s for a grant, seed investment from friends and family, angel investment, venture capital funding, or strategic partnerships with multinational medical device companies.

From the article:

  • Be clear on what your product is, right up front
  • Articulate the important problem you are solving
  • Define your customers
  • Spell out how you will create value with the $$ you are raising
  • Instill confidence in you and your team

Another way to look at the pitch is to think of it in terms of risk reduction. Most experienced investors talk about three main areas of risk in startup investing:

  • Technical Risk
  • Market Risk
  • Execution Risk

Investors will not move forward with an opportunity unless they believe that these key risks have been addressed and are below their personal threshold. Of course, you will never know that threshold so you must work to convince the investor that you have mitigated the three risks to the maximum extent possible.

Technical risk is all about the product or solution. Does your product solve the customer’s problem? Have you built a working prototype? Do you have an animal model? Have you performed animal testing? Are there important technical issues yet to be resolved? Do you have any intellectual property protection? Have you conducted a freedom to operate analysis? Does your product or solution depend on products or IP owned by other companies? Have you conducted beta testing? What’s your regulatory classification and plan? Are there more products in the pipeline?

Market risk is about the customer(s). Have you identified the problem? Is the problem a large one? Is the market opportunity big enough to justify the investment? Who are the customers? Why will they buy from you? What’s the competition (and don’t make the rookie mistake of saying that there is no competition)? Do you have evidence of demand? Do you have testimonials or at least interest from Key Opinion Leader customers? How do you plan to distribute and sell your product? How does your product or solution fit in today’s environment of managed care, healthcare reform, and evidence-based medicine? What’s your reimbursement strategy and plan?

Execution risk is about you and your team’s ability to convince investors that you can use their money to execute your plan. Does your team have the talent and experience to successfully commercialize your product? Do you have experienced and knowledgeable advisors, both business and clinical? Do you have a credible business model? What are your key milestones? What’s your exit strategy? Do you have a detailed pro forma income statement, especially for the period up to launch and for the two years after launch? Will you execute it exactly as conceived? Of course not, but you should be confident in your plan and your ability to execute. You should also have detailed contingency plans for the inevitable crisis when things go awry. 

Takeaways: Like many things, being successful at medical device fundraising requires being a great salesperson. Whether it’s a surgeon or an investor you’re selling to, put yourself in the place of that person. Be sure to address the five key points with details, evidence, and background information: product, problem, customer, milestones, team. Also keep in mind the risk tolerance of the investor. Your ability to communicate mitigation of technical risk, market risk, and execution risk will determine your success in fundraising.

Read more: Medical Device Startups: 5 essentials for your pitch deck | MassDevice.

Costliest 1 Percent Of Patients Account For 21 Percent Of U.S. Health Spending | Kaiser Health News

http://mhealthwatch.com/wp-content/uploads/2013/05/Infographic-Inside-Healthcare-Spending-in-America-300x231.jpgA recent U.S. government study revealed 1% of patients in the U.S. are responsible for a whopping 21% of healthcare spending. Wow, talk about a “target-rich environment.” We’re all familiar with the 80/20 rule where, in a given population, 20% of the group is typically responsible for 80% of costs, resources consumed or produced, etc. This news takes the 80/20 concept to a new level.

According to Kaiser Health News, the federal Agency for Healthcare Research and Quality report also said that just 5% of patients are responsible for 50% of all healthcare costs. On the other side of the ledger, the healthiest 5% of the population accounts for just 2.8% of spending.

The story behind the horrifying numbers: people with progressive, sometimes multiple chronic diseases such as kidney failure, diabetes, and COPD account for huge costs to the healthcare system. The patients in these groups even have a name: “super utilizers.” A different, not so flattering name is used in ERs everywhere: “frequent fliers.” On average, each super utilizer cost the healthcare system $88,000 in 2010.

In addition to overusing hospital emergency departments for their care, Kaiser said super utilizers suffer from a phenomenon called “extreme uncoordinated care” whereby they go to multiple, unrelated hospitals, (and all too often to the hospitals’ expensive ERs) for their care rather than a single outpatient clinic. The hospitals have no easy way to access patient records from other institutions to determine coexistent conditions and treatments. So they take the most direct path. They treat the immediate symptoms and discharge the patient.

In the past, hospitals could get away with just treating the patients’ symptoms and sending them on their way. With the advent of the Affordable Care Act (ACA), however, the incentives to the hospital are changing. Instead of a flat fee for service, the ACA provides penalties for high readmission rates and incentives for lowering readmissions within 30 days of treatment. From the article: “Hospitals have traditionally made more money readmitting patients than trying to prevent them from bouncing back.”

The ACA creates accountable care organizations (ACOs), groups of doctors, hospitals and clinics. The ACOs pool resources to treat Medicare and Medicaid patients more effectively and share in the savings. The ACOs work by creating and using coordinated care plans. The plans and their case managers have broad authority to do whatever it takes to help patients. By helping patients under the new ACA rules, the case managers help the hospitals increase their profitability.

The extra assistance to patients enabled by the coordinated care plans can include accompanying them to doctors’ appointments, paying for cab fare, buying food or furniture, phone calls and home visits to follow-up on prescription medication compliance, and more. These often simple interventions can have a significant effect on super utilizers. It is to be hoped that there will be a beneficial effect to the U.S. healthcare system as a result.

Takeaways: Healthcare financing is being reformed. That means healthcare delivery reform is coming as well. Hospitals are businesses, whether for profit or nonprofit. If their business models are threatened, they will respond to incentives and penalties to change. For medical device companies trying to introduce new products into this rapidly changing environment, realize that the traditional sales methods may work for a while longer. Realize also that the changes will affect purchasing decisions and procurement methods.

 

Read more: Costliest 1 Percent Of Patients Account For 21 Percent Of U.S. Health Spending – Kaiser Health News.

Mobile Health: Red Hot Market Opportunity

http://images.businessweek.com/ss/10/08/0823_mhealth/image/01_intro.jpg
Image from Business Week

Call it mobile health, digital health, eHealth, or”Consumer Health Technology” as Forbes does. By any name the emerging market sector is expanding rapidly and attracting lots of attention, entrepreneurs, and investors.

As I’ve previously written, the time for mobile health has arrived. We carry in our pockets mobile devices with more computing power than the Apollo 11 astronauts had when they landed on the moon. The devices themselves are bristling with sensors and wireless radios. Typical smartphones have temperature sensors, accelerometers, gyros, GPS sensors, ambient light sensors, microphones, touch sensors, and high resolution still and video cameras. They can communicate via Bluetooth, NFC, WiFi, and a number of cellular communications protocols. On-board storage can hold thousands of books and dozens of movies. Connected cloud storage provides effectively infinite storage capacity.

Innovative engineers are responsible for an ongoing explosion of single and multi-purpose external, wearable sensors that communicate wirelessly with smartphones. Smartphone manufacturers are increasingly integrating fitness tracking capabilities into their devices. For example, Apple’s latest iPhone included the M7 chip that can track user activities while minimally affecting battery life.

Application developers are creating sophisticated fitness and health tracking software using the aforementioned technologies. Applications are increasingly passive rather than active, meaning the user does not need to enter data. The apps and sensors detect activities and are able to collect activity data in the background. Others are working to connect the consumer devices and sensors with electronic medical and health records “in the cloud” for a variety of purposes.

There are two main segments in mobile health, regulated and unregulated applications. In the near term, there is tremendous growth and potential in the unregulated space because it’s a quick way to get to market. The consumer markets are very large but price-sensitive.

Of course, your mobile health startup will not be alone when you get there. Big players are either already in the market or they are entering rapidly. Nike, Weight Watchers, Aetna, Garmin, Apple, Samsung, and others are already battling to be the mobile health brand of choice. There are new entrants as well. Jawbone, BodyMedia, FitLinxx, and Fitbit are relatively new companies with trendy, stylish wearable devices.

Huffington Post reported that Berg Insight said 8.3 million wearables were sold last year, up from only 3.1 million in 2011. By 2017, that number is set to reach 64 million. mobihealthnews projects 13 million fitness-related wearables will be purchased just for corporate wellness plans by 2018.

For FDA-regulated devices and applications, the initial market is smaller but the potential is just as great. Regulatory clearances and approvals provide some barriers to entry but will ultimately serve to give early market entrants a head start and not much more. These devices promise to do much more than fitness tracking. They have the potential to monitor chronic diseases and overall health, to provide alerts for significant health-related events, to collect data for clinician use, and to provide specific health-related guidance using user-specific data.

In addition to FDA scrutiny, another significant issue is compliance with HIPAA laws regarding patient privacy. With what amounts to 24×7 data collection and connectivity, there will be enormous amounts of user-specific data in devices and in cloud databases. Companies will have to address data security preemptively or risk losing user trust.

I believe the benefits to the user and to the healthcare system far outweigh the risks and costs associated with these devices and applications.

For healthy individuals, mobile health can provide real time feedback into activities, fitness levels, sleep patterns, even diet information like nutrient balance and calorie consumption.

For aging individuals or those with chronic diseases, mobile health can monitor vital signs, check disease-specific conditions, provide reminders to take medications or perform physical therapy exercises, and send updates and alerts to family members and physicians.

For physicians, mobile health can provide another way to communicate with patients and can also check compliance with recommendations and prescriptions.

For the healthcare system, mobile health can contribute to healthcare Big Data, making it easier for researchers, drug and device companies, and policy makers to track, measure, and assess the health and activities of large populations.

Takeaways: Mobile health is a once-in-a-lifetime opportunity for entrepreneurs. If you have an idea, now is the time to commercialize it. If you are a software developer, find hardware partners. Likewise, if you have developed a sensor, team up with app developers to make a complete package. If you have an unformed idea, try to shape it around mobile health. Investors have taken notice. Rock Health is soliciting applications for funding at a variety of levels.

Read more:

Thinking of Starting a Business? Check Out Consumer Health Technology | Inc.com.

13M wearables to be used in corporate wellness plans by 2018 | mobihealthnews.

How highly sensitive, wearable thermometers could change digital health | mobihealthnews.

What health startups think of Apple’s new motion tracking chip | mobihealthnews.

Moves comes to Android, not afraid of Apple’s M7 | mobihealthnews.

Healthcare Startups Can Save Lives — And Rake in Big Money | Wired Business | Wired.com.

Health care and health insurance reforms are happening…at Walmart!?

Walmart logoHere’s an refreshing departure from all of the federal government gloom and doom news. Four hospitals around the U.S. including Virginia Mason Medical Center in Seattle have negotiated deals with large retailers Walmart and Lowe’s to provide comprehensive surgical care for knee and hip replacements to 1.4 million of the companies’ employees.

The kicker? Zero out-of-pocket costs, co-payments, deductibles, etc. But wait, there’s more. The arrangement, completely voluntary for employees by the way, provides travel, lodging, and living expenses for the patient and a caregiver.

The announcement expands a deal struck by the hospitals with Walmart in 2012 for heart and spinal surgeries along with organ transplants. The world-renowned Cleveland Clinic has been conducting a similar program, offering fixed-price cardiac procedures for a number of major corporations including Boeing.

The programs are attractive to the hospitals and corporations for a number of reasons. The corporations are self-insured. Reducing variability and uncertainty in healthcare costs is vitally important to the businesses. The corporations are large enough to be able to offer large volumes of patients for the high volume procedures.

The hospitals, already leading in terms of low complications and readmission rates, can use the guaranteed volumes to standardize procedures and improve quality even further. In exchange, I’m sure the partners agreed on large discounts to standard prices for the expensive procedures. And the patients, although not required to participate, get the sweeteners of no out of pocket cost and free travel. Sounds like a win for everyone.

In a separate development, Walmart announced that it was converting 35,000 part-time employees back to full-time status. Although that is a tiny fraction of Walmart’s 1.4 million employees, the latest action will result in those workers qualifying for employee-provided healthcare. Late in 2012, Walmart moved many full-time employees to part-time status in an action that was criticized as offloading their healthcare expenses on to taxpayers. Critics complained the workers earned so little that they would qualify for Medicaid health insurance through the new provisions of Obamacare.

Takeaways: While hardly novel, the agreements between the corporations and the hospitals are important because they have the potential to rein in out of control and spiraling healthcare costs. The hospitals will also be able to show exactly how they achieved their cost controls and quality improvements, giving them a competitive advantage and setting a great example for the rest of the country.

If you are developing a new device or technology, this should be a wake-up call. A key to cost control will be standardization. These hospitals will be highly resistant to adopt new technologies or purchase new medical devices unless you can show proof of positive effects on procedure costs, outcomes, and quality.

If you are in the healthcare insurance business, this disintermediation may not be a significant threat in the short term but be assured that other large corporations are watching or perhaps even conducting their own negotiations with high quality, high volume providers. The trend may prove to be a disruptive innovation in the long term.

Read more:

Walmart, Lowe’s strike deal with Virginia Mason on hip, knee surgeries | Local News | The Seattle Times.

Wal-Mart Returning To Full-Time Workers-Obamacare Not Such A Job Killer After All? – Forbes.

Digital health: what’s the business model?

image via svtechtalk.com

Connecting patients with each other, with clinicians and other providers, with insurers, and with healthcare companies via mobile apps on tablets and smartphones and on the web seems like a great idea. The unanswered question is can you make money doing it?

Articles have been written about how the Internet has enabled patients with chronic diseases and their families to connect with others with the same condition. The patients share stories about symptoms, treatment successes and failures, and try to support each other in what can be emotionally draining circumstances. That ability to connect with a vast community all over the country, perhaps even the world, was virtually impossible before the advent of the World Wide Web.

Other companies are trying to connect healthcare providers with their patients. Some are offering to connect patients with providers for online visits for a fee, effectively commoditizing the doctor-patient relationship.

Google famously shut its attempt at a personal health record site, Google Health, last year. Google Health required a lot of effort to use as it didn’t automatically connect with consumers’ Electronic Medical Records. That shortcoming left a small market of people who were OK with manually entering all of their health data. And that wasn’t a big enough user base for Google.

Healthcare companies, especially those with a B2C business model, are desperate to maintain relationships with consumers.

Providing apps and cloud storage can be costly. It’s not clear who will pay for the digital services.

Doctors and other providers have been incentivized into adopting EMR technology. It’s unlikely that they will invest in additional information technology for their patients.

It seems that consumers and patients love the free stuff. A few may be willing to pay for some services but many have grown to expect that someone else will foot the bill. And most non-healthcare smartphone and tablet apps are either free or at most a few dollars. That sets a low ceiling for any new health-related apps. It’s a tough way to grow a sizable healthcare or medical device company.

People have grown accustomed to paying almost nothing for their healthcare. Sure, there are co-pays and deductibles that have increased significantly in recent years but those are a small fraction of the cost of care. It will be a challenge to change this expectation for health-related apps and services.

In-app ads are probably not the way to go. If the ads are for healthcare-related items like prescription drugs, the patients will lose trust in the service. If the ads are specifically targeted to the patient’s medical condition, the service will be accused of spying on the patient.

Perhaps healthcare companies will regard the cost of developing and providing apps as a marketing expense.

It’s an interesting dilemma. Free apps and services will draw large numbers of users. But monetizing the app via ads turns off many people. Charging for the services drastically reduces the potential market. Absorbing the expense internally places the app/service on the list of things to be cut when the company’s overall business stagnates or declines.

Takeaways: There is enormous interest in apps and services for mobile health. If you are developing products or services in this space, be sure you know how you are going to make money. It’s not a market if you can’t monetize it.

The traditional medical device business model doesn’t seem to apply here. If you procure funding, develop a product, then show economic or health benefits, who do you sell to?

Perhaps partnering with noncompeting companies interested in the same population is a creative way around the problem. If you can deliver large numbers of consumers/patients via a sponsored app to a partner like a big pharmaceutical company, you may be able to avoid some of the pitfalls and objections.

It’s prudent to put a lot of effort now into developing a viable business model. After all, when you start pitching to investors, one of the first questions asked will be, “how do you plan to make money?”

Read more:

Will Any Health App Ever Really Succeed? | MIT Technology Review

Patients share tips online for managing diseases | SFGate.

Improving Patient Engagement Equal Parts Technology, Empathy | Computerworld

Patients Eager To Access Data Including Medical Imaging Through Online Portals (infographic) | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

A Cautionary Tale: Biotech firm Atossa recalls its only product | The Seattle Times

Atossa Genetics is an early stage biotechnology company in Seattle developing breast cancer diagnostic tests and medical devices using molecular diagnostic technology. The publicly traded company ran afoul of FDA regulations earlier this year and last week announced a voluntary recall of its products, causing its stock to tank.

The company bills itself as “the breast health company (TM).” Atossa is small, with only ten full-time employees (at least five of whom are senior management executives) according to Yahoo Finance.

Here’s a timeline of company events:

  • November 8, 2012 Atossa Genetics, Inc. Announces Initial Public Offering (NASDAQ exchange, IPO value $4 million). That’s not a typo. It really was $4 million, 800,000 shares at $5 per share.
  • February 21, 2013 Atossa Genetics, Inc. received a Warning Letter from the FDA regarding its Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System Collection Test. From the company’s press release:

“The FDA alleges in the Letter that following 510(k) clearance the Company changed the System in a manner that requires submission of an additional 510(k) notification to the FDA.”

  • March – September 2013 Atossa Genetics Inc. continues marketing its products, announcing numerous distribution and partnering agreements as well as supporting women’s health events.
  • September 18, 2013 The company’s stock closes up almost 21% in one day at $6.00 on volume of more than 8.4 million shares traded when it announces a distribution agreement with medical distributor McKesson.
  • October 4, 2013 Atossa Genetics Inc. initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. This voluntary recall includes the MASCT System Kit and Patient Sample Kit.
  • October 7, 2013 Atossa Genetics Inc. stock opens at $5.32 and quickly drops to $2.66 (down 50%) on the news of the voluntary recall. The stock closed today at $2.45, an all-time low.
  • October 7-8, 2013 At least six law firms have announced initiation of shareholder lawsuits in the aftermath of the recall.

Apparently, the company and the FDA disagreed on whether a new 510(k) was required after the company changed the Instructions for Use (IFU) on its product. The company seems to have decided to continue marketing without submitting a new 510(k). What happened next is unclear but the “voluntary” recall ensued.

The company told The Seattle Times that it currently has “sufficient cash for the next 8-12 months of operations without raising additional capital,” though it cautioned that the cost of the recall and other associated expenses is not yet known. Sales revenues were about half a million dollars for the first half of 2013. Atossa reported a $2.2 million loss for the same period.

According to The Seattle Times, Atossa is continuing to develop other diagnostic tests but “will be reassessing the regulatory status of these products … in light of our recent experience,” said CEO Quay. Seems like a prudent action given their recent history…

Takeaways: Do not disregard the FDA. They have the power to shut down your company. If you have a fundamental disagreement with FDA, hire a regulatory consultant and attorney and take their advice.

Make sure you have people with experience in commercializing medical devices, especially regulatory affairs, on your executive team and board of directors.

Think carefully before deciding that an IPO is your best financing option. There are very large fees to be paid and the reporting requirements (Sarbanes-Oxley, etc.) are much more revealing – and onerous – than anything required if you remain private and use VCs or angel investors as your sources of capital.

As the article points out, there are plenty of attorneys waiting to represent disgruntled shareholders. Perhaps you can prevail against all of this adversity but think of the opportunity costs in lost time and cash spent on lawyers and regulatory revisions instead of product development or marketing.

Read more: Biotech firm Atossa recalls its only product | Business & Technology | The Seattle Times.

Robotic surgery and Intuitive Surgical – justifiable targets or targets of envy?

http://mobile.bloomberg.com/image/index/pKISbwVuPwu-CpydsHPB-_ZzUeF8YNn3pSP_hdYcB-jmbFsMemtmA2YRxe7mpv9Ysm4SPHQUfdFCOkPclMKfZ9CUybeuQ86QqPvbWMC5B-eh3lqkPqkgukhgoIa-eGsGCD4Qr_KDqIxEgIvT52jCFi-wMjcy7J1OELQFhliwvoYa7eu81HQi3QHgaQ**Media attention on Intuitive Surgical is increasing. The Sunnyvale, California company is attracting much attention for its aggressive marketing and sales tactics. It’s also being scrutinized for what some critics say is an increased incidence of patient injuries during surgical use of the da Vinci System.

I’ve written about Intuitive Surgical in a previous blog post. Their products are very good and their marketing is stellar, perhaps too good if that’s possible. The ongoing controversies are whether the healthcare market needs as much robotic surgery as it is getting right now and whether inexperienced users and inappropriate use of the technology are responsible for increasing patient injuries or even death.

Intuitive has played the market situation perfectly as noted in the Bloomberg article. Their sales reps use da Vinci Systems to instill greed in hospital administrators by asserting that the hospital can increase market share by offering robotic surgery. Worse, they create fear by saying that other hospitals will increase their market share at the expense of the robot-deficient medical center.

Intuitive even heightens competition among surgeons in an effort to justify demand for additional installations. The surgeons are powerless to stop the marketing machine. One surgeon admitted that if he does not offer robotic surgery, his colleagues will, and he will lose patients to them.

One interesting, even frightening, item from the Bloomberg article is that many consumers, i.e. prospective patients, believe that the system is controlled by robots. In their minds, that’s what gives da Vinci a competitive advantage. So…low information consumers are heavily influencing  a market situation that affects everyone.

The MassDevice article highlights an ongoing dispute between Intuitive Surgical and analysts at hedge fund Citron Research. Citron alleges that adverse surgical events associated with the da Vinci System and reported through the FDA adverse event reporting system indicate a growing problem with injuries caused by the da Vinci System. Intuitive counters with its own analysis, saying that FDA reporting is unreliable and not suitable for time-based analysis. It further states that surgeons should rely on peer-based reviews before making decisions about the technology. From the article:

“”In the 1st 8 months of 2013, 2332 Adverse Event records were posted – compare to 4603 records posted in the entire 12 year period since the 1st Adverse Event tracking for da Vinci  appeared in MAUDE in 2000,” Citron wrote. “It is the opinion of Citron that the only reason there is not a national outcry is because the da Vinci robot has yet to kill or injure ‘the right person’ – like the next of kin of a congress member or a celebrity.”

Intuitive stock closed at $389.16 today, off 33.5% from its 52 week high.

Takeaways: If you plan to be a disruptive or hyper-aggressive medical device company, you need to have thick skin. There will always be plenty of critics and competitors taking potshots at you.

The extra risk with healthcare companies, of course, is that patients can get hurt and die as a result of action or inaction by the company.

You need to decide just how aggressive to be, and whether to define an ethical line over which the company and its employees will not cross. Of course shareholders and Board members may react negatively at any effort to put a damper on the money-making machine. Being responsible for installing that damper could cost a CEO, marketing, or sales executive his/her job.

As we move further into the era of outcomes-based decision-making, opportunities like robotic surgery for anything other than clinically justified reasons will diminish. Robotic surgery could be one of the few remaining “land grab” chances to make a lot of money with little competition. Let’s hope that patients and the rest of the healthcare system aren’t stuck with the bill.

Read more:

http://mobile.bloomberg.com/news/2013-10-08/robot-surgery-damaging-patients-rises-with-marketing.html

Citron puts Intuitive Surgical on blast over adverse events | MassDevice.

8 healthcare applications for Microsoft Kinect, 6 reasons not to pursue them

Microhttp://dri2.img.digitalrivercontent.net/Storefront/Company/msintl/images/English/en-INTL_Kinect_for_Windows_L6M-00001/en-INTL_L_Kinect_for_Windows_L6M-00001_mnco.jpgsoft’s Kinect is absolutely amazing technology. And Microsoft keeps improving it. Did you know that Kinect has multiple potential healthcare applications?

If you have an early teenage or “tween” kid, you probably have an Xbox gaming system. The Kinect sensor technology is perfect for all sorts of innovative interfaces for dance, exercise, and role-playing games.

The Kinect sensors and software have the ability to perform skeletal mapping on multiple people simultaneously, to detect 3D gestures and motions and facial and voice recognition. Kinect can even determine users’ heart rates! The device also has the ability to “see” in the dark with infrared camera technology.

The Microsoft Kinect is an amazing amalgam of sensor technology. I’m sure it has many useful and possibly disruptive applications in healthcare and other industries.

Here’s why you should not base your healthcare product or application on Microsoft’s Kinect:

  1. Single sourcing is risky for any startup business or new product development organization. You have no alternative way to duplicate  or replicate the Kinect functions if Kinect or its key functions are unavailable for any reason.
  2. Healthcare is not Microsoft’s core business – it could remove access at any time and/or de-emphasize it in any number of ways. In fact, Microsoft is in strategic transition right now and its long-time CEO, Steve Ballmer, announced recently that he will be retiring in 2014.
  3. You have no access to the device’s source code – access to that code might be necessary if you are developing an FDA Class II or Class III device.
  4. The Microsoft Kinect is based on a console or PC-centric world view. What about tablets and smartphones? Oh, and don’t expect to ever see an Android or iOS device with Kinect capability.
  5. Although Microsoft has made an SDK available for Kinect development on Windows operating systems, the installed base of 24 million Kinects is almost all in Xbox gaming systems. Microsoft is not interested in giving up valuable real estate on its premier gaming platform to comparatively low volume and low margin healthcare apps. If you develop a Kinect-dependent windows app, you will a). have to wait for an installed base to develop or b). take on the added risk of marketing Kinect hardware to create your own installed base.
  6. You will have little technical support from Microsoft simply because your business potential is small compared to their other ventures.

If those six reasons aren’t enough to give you pause, here are the healthcare market areas identified by MobiHealthNews that are particularly suited for Kinect-enabled applications.

  1. Fitness and Exergaming – games and exercises to get people off the couch and on their feet
  2. Physical Therapy  – conduct PT sessions, monitor recovery
  3. Surgery Support  – hands-free image manipulation
  4. Autism Screening and Therapy – not quite sure what the advantage is here. Perhaps some on the spectrum can’t relate as well to people?
  5. Virtual Visits and Virtual Nurses – automated nursing visits. I think this is a bad idea, as senior shut-ins crave human contact.
  6. Virtual Group Therapy – avatar-based online group talk sessions (I believe you can do this with Google Hangouts as well)
  7. Aging in Place and Fall Prevention – gait analysis and fall prediction
  8. Helping the Blind to Navigate and the Deaf to Communicate – using machine vision and text to speech

Takeaways: It’s incredibly risky to develop new technology that’s based on someone else’s proprietary technology. It’s even more risky if that proprietary technology is primarily focused on non-healthcare applications.

You should consider open source projects as an alternative. There are many open source projects all over the world. If it’s critically important to you, try organizing and starting an open source project to support your development work.

If you must use the proprietary technology, try to negotiate a development agreement that places key parts of the technology in escrow so it is still available to you in the event of a default to the agreement. This tactic doesn’t work with gigantic corporations like Microsoft but it may be effective with smaller partners.

Read more: Eight ways the Microsoft Kinect will change healthcare | mobihealthnews.

For Med Students, Love From the Drug Rep | NYTimes.com

No drug reps signDrug companies and medical device companies focus sales efforts on residents for one reason: because it works. The career-long profit from an eventual loyal physician could be tens or even hundreds of thousands of dollars for a medical device company. It’s also a “bottom-up” way to capture and defend market share.

Often done under the guide of education, healthcare companies’ marketing efforts are creative and relentless.  As the article indicates, many successful sales reps position themselves more as friends than as company representatives.

Inevitably, there have been abuses to the practice. In reaction, many hospitals have severely restricted or even banned contacts with medical students and residents. Some hospitals and medical practices no longer allow sales reps free access to facilities and staff. Some prohibit employees from accepting anything free from industry representatives.

A number of influential and outspoken physicians have written and spoken publicly about the issue, stating that they do not accept any freebies from industry, not even a pen. Their position is that any relationship with industry creates an uncomfortable conflict of interest, actual or perceived.

Of course, attempts to influence physicians and others under the guise of educational programs have been ongoing for many years. There are seminars, dinner meetings and conferences where doctors can earn continuing education credits. I know several physicians who significantly supplemented their professional practice income by speaking about specific drugs at dinner meetings.

Takeaways: Billions of dollars are spent annually on efforts to influence medical professionals. That’s a reasonable (but not necessarily ethical) business decision because many billions more are at stake in drug and medical device revenues and profits. If you are a pharma or medical device sales rep or marketing executive, your job and career are always on the line. Banning these practices just seems to drive them underground.

Perhaps a more rational approach would be to require full disclosure of any transactions (including lunchtime pizzas and the like) with a draconian penalty for concealment.

Read more: For Med Students, Love From the Drug Rep – NYTimes.com.

New Medical Devices May Be Extremely Effective at Preventing HIV Infections

One new medical device is an intravaginal polymer ring impregnated with an antiretroviral drug, tenofovir. If successfully commercialized, this new technology that combines a medical device with a drug could have a major positive effect in preventing HIV infections and reducing HIV transmission rates in developing countries.

As the article poignantly states,

It’s often said that the HIV/AIDS epidemic has a woman’s face. The proportion of women infected with HIV has been on the rise for a decade; in sub-Saharan Africa, women constitute 60 percent of people living with disease. While preventative drugs exist, they have often proven ineffective, especially in light of financial and cultural barriers in developing nations.

The device, called a TDF-IVR (tenofovir disoproxil fumarate intravaginal ring) can be worn for up to 30 days. It delivers a constant dose of tenofovir, lower than the typical dose of the same drug taken orally. Delivery methods such as oral dosage and vaginal gels have not proven to be effective for a variety of reasons including inconvenience and cost.

The ring also has the capability to be impregnated with other drugs such as contraceptives and other antivirals to prevent non-HIV sexually transmitted infections.

Recently completed primate studies showed that the TDF-IVR was 100% effective in preventing HIV transmission in female macaque monkeys. A Phase I human clinical study is being planned for November in New York to assess safety and side effects.

The device was developed at Northwestern University with support from the National Institute of Allergy and Infectious Diseases.

I’ve been working with a group of physicians and engineers at the University of Washington to develop a new medical device for adult male circumcision. Clinical studies sponsored by the World Health Organization demonstrated that circumcision can reduce a male’s risk of contracting HIV by as much as 75% – that’s about the same as a highly effective vaccine (which of course does not yet exist for HIV). Our device, called SimpleCirc, is designed to be used in low-resource settings by non-surgeon healthcare workers.

Perhaps the commercialization of these two technologies will begin to eradicate the scourge and epidemic of HIV/AIDS that is devastating sub-Saharan Africa.

Takeaways: When tackling an intractable problem, try different packaging or delivery concepts to address the issue. In the case of the drug-eluting ring, the drug was highly effective in other using other delivery techniques but cultural and logistical challenges limited overall effectiveness when delivered orally or as a single application gel.

In the case of the circumcision device, the design includes a kit with all materials and accessories to perform the procedure and the device itself is extremely simple, almost intuitive to use. In this way, the ability to perform circumcisions can be scaled up quickly and at low cost.

Read more: Study: New Medical Device Extremely Effective at Preventing Immunodeficiency Virus | News | McCormick School of Engineering | Northwestern University.

The world’s craziest toothbrush cleans your teeth in six seconds and is 3D printed | qz.com

Blizzident photo - world's craziest toothbrush
Blizzident photo – world’s craziest toothbrush

The Blizzident toothbrush may be the most innovative toothbrush ever developed. It is custom manufactured for each user and provides a complete teeth cleaning in 6 seconds. It even has the ability to floss between teeth and clean your tongue at the same time.

Blizzident took advantage of several technology trends in developing the Blizzident toothbrush. Mass customization, 3D scanning, and 3D printing enable the commercialization of a potentially disruptive product that would have been impossible or impractical to make only a few years ago.

Developed by an international team of dental experts, engineers, and computer scientists, the Blizzident toothbrush is commercially available today. Sold on the Blizzident website,   the device initial cost is $300. There is also a one-time expense of $75-200 for impressions and/or digitization of your teeth. According to Blizzident, the toothbrush will last twelve months. Replacements will cost $89 for refurbishment or $159 for an all-new device.

The Blizzident toothbrush can be fitted for kids, although a new scan is required each year because of the ongoing growth and changes in childrens’ teeth.

The toothbrush works by deploying hundreds of ultra-fine bristles that are angled to reach every nook and cranny of your teeth, including the all-important areas under the gumline. The user bites, chews, and grinds his/her teeth for six seconds, brushing all teeth and surfaces simultaneously. According to the company, that’s the equivalent of a three minute manual toothbrushing session. Clinical study results are promised but not yet available.

I have a dental checkup next week and I plan to ask my dentist what he thinks of this revolutionary technology. The somewhat steep price tag may discourage many people but it will probably decline over time. I’m sure there are sufficient numbers of people who are either gadget freaks or just really care about their teeth to make an initial market. It will be interesting to see how Blizzident’s awareness spreads. The story is compelling for both traditional media and for social media.

Takeaways: Who would have thought that the humble toothbrush could be improved upon “again”? A Seattle area company, Optiva, successfully innovated Sonicare, a “next generation” electric toothbrush back in the 1990s. Optiva was acquired by Philips Healthcare in 2000. In 2001, Sonicare was the best-selling electric toothbrush brand in the USA.

For startups, no idea should be considered too small to commercialize. Likewise, no existing product or technology should be thought of as too established to be improved upon. Mass customization is a compelling trend – people want things that uniquely fit them. 3D scanning and printing are powerful tools that make disruptive innovations and novel business models possible.

Read more: http://qz.com/129919/the-worlds-craziest-toothbrush-cleans-your-teeth-in-six-seconds-and-is-3d-printed/

http://www.blizzident.com/

Frazier Healthcare raises $377M venture fund, surpassing target | GeekWire

Wow, looks like a repeat of the 1990s! A new venture fund from Frazier Healthcare is seriously good news for the healthcare startup community. I hope it’s the beginning of a trend and that we’ll see a few more VCs make fund announcements.

For the past few years, VCs have been pretty much absent from the market. Angel investors were left as one of the few financing options for early stage medical device and biotech companies.

Perhaps we will see a return of past practices where angel investors concentrated on very early financing rounds and then VCs stepped in. Who knows? But I believe it’s on balance a positive development for the industry.

Takeaways: There is a lot of money out there “on the sidelines.” Frazier may be taking a leading role in revitalizing healthcare startup financing. At least it shows that a lot of wealthy individuals and fund managers believe in the future of healthcare as an investment opportunity. Startup CEOs, keep pitching!

Read more: Frazier Healthcare raises $377M venture fund, surpassing target – GeekWire.