How To Kill A Unicorn: The cautionary tale of Theranos

A unicorn in startup jargon is an early stage tech company with a $1 billion+ valuation. Theranos is (was?) a Silicon Valley startup and a unicorn, focused on disrupting the enormous market of diagnostic blood testing.

Valuations are funny things. They are critically important to startup CEOs and investors but ultimately, they are subjective shared opinions based on complex models of present and future events. Startup CEOs and venture capital investors try very hard to keep their company’s’ valuations ever-increasing. Negative news or events can start a cascading cycle resulting in the dreaded “down round” of investment and even ejection from the unicorn club.

Theranos was a unicon, but no longer
Killing the unicorn, British Library

Background

CEO Elizabeth Holmes founded Theranos in 2004. As a 19-year old college student, Holmes pitched an idea to her Stanford professor and was advised to start a company. Through family and personal connections, venture capital money poured in, Holmes dropped out of Stanford and Theranos began its mission to change health care.

Theranos CEO Elizabeth Holmes
Theranos CEO Elizabeth Holmes – Inc. cover photo Oct. 2015

“…it doesn’t work…”

Alas, “mistakes were made” and the company and its executive team found itself in hot water with the FDA and the subject of a number of unflattering stories in The Wall Street Journal and elsewhere. The Theranos head of R&D committed suicide and left a note saying “it [the technology] doesn’t work.” Also, the company president recently resigned and CEO Holmes is banned from owning or operating a lab for two years. In addition, Theranos’s commercial partners, Safeway and Walgreen’s, terminated their agreements with the company.

That’s about as bleak a series of events as you can imagine, right? Well as the infomercial goes, wait, there’s more…

Negative reactions continued over the year since the WSJ story broke. In May 2016, Theranos announced that it had voided two years of results from its Edison device. Patients filed a class action lawsuit alleging they were adversely affected by Theranos’s business practices (specifically, faulty blood tests). Recently, the company announced layoffs of 40% of its labor force and closure of testing labs around the country. In October, 2016 Holmes announced that Theranos would shift its strategy toward development and manufacture of small, robotic diagnostic test equipment – a very crowded market.

In June, 2016, Forbes assessed the valuation of Theranos as $800 million and revised the estimated net worth of CEO Holmes from $4.5 billion at the company’s peak valuation (she has a 50% stake in Theranos but it’s all common stock) to zero.

Theranos valuation history
Theranos valuation history (based on public estimates)

What killed the unicorn? There are a number of bad decisions made by Theranos management and its Board of Directors. Here are 10 of the worst that I identified.

Bad Decisions

  1. Stack the Board of Directors with old, politically connected white guys (Henry Kissinger, George Shultz, Bill Frist, Sam Nunn) with little or no startup, technology, or diagnostics savvy.
  2. Create a cult of personality around the CEO. Make sure she appears on popular magazine covers and is interviewed frequently on TV shows.
  3. Create a not-so-subtle emphasis on the similarities between your attractive, young CEO and Steve Jobs: both are college dropouts, both wear a uniform of black turtlenecks, both are “visionary” leaders, both are/were young billionaires (only on paper in the case of Elizabeth Holmes)..
  4. Keep the founder as CEO, no matter if she has zero prior business or medical industry experience. Do not bring in a strong executive team with relevant industry experience to complement the CEO’s energy, vision, and talent.
  5. Hype your technology but shroud its technical details in secrecy. Worse, secretly use competitor’s technology for the vast majority of the tests performed.
  6. Do not conduct randomized clinical studies to demonstrate efficacy vs. industry “gold standard” technologies. Definitely  do not publish in peer-reviewed journals.
  7. Sign agreements with major commercial partners (Walgreens, Safeway) and conduct major PR campaigns announcing the deals before the technology is mature and proven.
  8. Pay no attention to FDA, CLIA, and GLP requirements. Refuse to learn from what happened to other startups that defied or ignored the FDA (see 23andme).
  9. Aggressively promote your muddled, multi-pronged, “disruptive” business model.
  10. Deny and deflect all bad news. Accuse The Wall Street Journal of conducting a witch hunt.

Takeaways

  1. The medical device/diagnostics industry is not the technology industry. Patients’ health and lives are affected by poor management, decisions, and/or business practices. Consequently, medical technology companies are heavily regulated and conservative regarding innovation. 
  2. If you must have an inexperienced person at the helm of the startup, compensate with a seasoned, accomplished Board of Directors with relevant experience and networks.
  3. Aim to solve one problem at a time. Prioritize. Theranos touted its “Nanotainer” finger stick technology, Edison diagnostic technology, and plans to disrupt healthcare by bringing diagnostic testing directly to patients through grocery and drug stores. That’s a lot of moving parts.
  4. Expect swift and deadly reactions from entrenched competitors (including complaints to the FDA and leaks to the media). Your disruptive business model is their existential threat.
  5. As the saying goes, sunlight is a powerful disinfectant. The first step to success in the medical technology industry is a strong intellectual property portfolio and properly maintained trade secrets that create solutions to real healthcare problems. But that strategy must coexist with a culture of regulatory compliance, stringent adherence to quality standards, and sponsorship/disclosure of peer reviewed randomized clinical studies. It’s a business model that has worked for many successful companies in the industry.

Will Theranos pull out of its nose dive, emerge as a disruptive company in the ultra-competitive medical diagnostics market, and regain its unicorn status? Maybe, but given its track record and penchant for acting more like a Silicon Valley tech startup than a medical technology company, I would not bet on it.

Postscript 12.15.16 The shareholder lawsuits have begun.

References

  1. From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth Of Theranos Founder Elizabeth Holmes [Forbes]
  2. The wildly hyped $9 billion blood test company that no one really understands [The Washington Post]
  3. An Open Letter From Elizabeth Holmes [Theranos company website]
  4. Theranos Attacks Wall Street Journal (Again) in a Rebuttal You’ll Need a Medical Degree to Understand [recode]
  5. Expecting Data From Theranos, Lab Experts Get New Product [Bloomberg]
  6. At Theranos, Many Strategies and Snags [The Wall Street Journal]
  7. Why the Next Steve Jobs Will Be a Woman [Inc.]
  8. Theranos throws in the towel on clinical labs, officially pivots to devices [Ars Technica]
  9. How Playing the Long Game Made Elizabeth Holmes a Billionaire [Inc.]
  10. Theranos’ Scandal Exposes the Problem With Tech’s Hype Cycle [Wired]
  11. Will Shareholder Lawsuit Trigger Theranos To Return Capital To Shareholders? [Forbes]

  12. Theranos Just Got Slammed With Another Lawsuit [Fortune]

3D Printing Parts from McMaster-Carr| Make:

McMaster-Carr Catalog 3D print
McMaster-Carr Catalog

McMaster-Carr, the industrial supply giant (http://www.mcmaster.com/), has been in business since 1901 but the company is fully embracing the digital age. McMaster previously released an iPad app of its massive paper catalog containing over 555,000 items. The company has gone one step further and is now offering 3D printing files of many of its parts.

Engineers and designers unsure about dimensions and compatibility of a particular part now have the option to download and print a 3D printing file of many parts in the McMaster -Carr catalog. The user can then try the printed part for fit before ordering “real” parts. This capability can save makers considerable time and expense.

It’s probably just a matter of time until 3D printing has the capability to duplicate manufactured parts in terms of materials and physical performance. Great to see a company that’s over 100 years old innovating and keeping up technologically with its customers.

Takeaways: If you are developing a new widget or prototyping a novel medical device, check the McMaster-Carr catalog, website, or iPad app if you are looking for readily available parts and you don’t want to wait or pay for custom prototypes. You can even check out a new part without the wait by downloading and 3D printing some parts.

If your company-startup or otherwise-is in a rut, look at McMaster-Carr for inspiration. If a 114 year-old company is still innovating and  differentiating itself via new technologies, your company can, too.

Pro Tip: You Can 3D Print Parts from McMaster-Carr | Make:
Link to Instructables set-by-step instructions

Neckties

ID-10081313In honor of Fathers’ Day and all of the neckties given as gifts that will be relegated to the back of Dad’s closet…

When I started my business career, neckties were mandatory attire. I didn’t enjoy wearing ties but I had fun picking out outlandish designs and sending subtle messages via tie designs (probably missed by everyone but me).

Then casual Fridays came along (initially, just in the summer!). My coworkers and I all celebrated the one work day when we didn’t have to tie the knot in the mirror and wear that hot, hated, neck-constricting piece of fabric.

A move to the Pacific Northwest revealed a much more relaxed attitude about neckwear: basically, no one wears ties here. Is the climate to blame? Is it Seattle’s famous informality where people attend the opera in t-shirts and cutoffs? I don’t know but the trend to the casual has been increasing and even accelerating in the 20 years I’ve been in the Northwest.

The no-tie movement seems to be gaining momentum all over the USA for at least a couple of decades, perhaps starting on the West Coast and marching eastward. From observations on business trips, the East Coast and particularly the northeast remain a bastion of tie wearing. It it a more buttoned-up culture than the pot-smoking, t-shirt and jeans-wearing liberals on the Left Coast?

Plus, many guys are either fashion-challenged or just don’t care about matching vs. clashing patterns and colors (apparently, their wives or girlfriends are not around when they dress in the morning). Those fashion (in)decisions inflict pain and suffering on people who have to look at the tie wearer.

Once upon a time, clip-on ties were a standing joke but I have a different perspective. I was wearing a traditional knotted tie on a visit to a vendor’s manufacturing plant. While examining a piece of automated equipment, my tie got caught in the machinery. I panicked as I was pulled toward the machinery but I managed to jerk the tie free before injuries occurred. My hosts and I had a big laugh at my expense and I decided to wear clip-on ties on future factory visits!

I did not know this but the origin of the necktie is French and…Croatian! More fascinating facts about ties here.

What do you think – have ties gone the way of spats, pocket watches, and felt hats (hipsters excluded, of course)? Take our ten second poll!

[yop_poll id=”2″ tr_id=”7734″]

Happy Fathers’ Day!

Image courtesy of stockimages, FreeDigitalPhotos.net.

Free Medical Device Launch Checklist – Protect Your Investment

free Medical Device Launch Checklist

So you (or your company) has developed a new medical device. You have invested millions of dollars and substantial time in engineering, obtained regulatory clearances, and set up manufacturing. It’s time to go to market, right? Turn it over to Marketing and Sales and wait for the orders to pour in. Are you sure that all relevant launch activities are being planned and accounted for? Perhaps you should protect your investment in your medical device product with this simple, easy to use, free Medical Device Launch Checklist.

Easy to use, downloadable PDF file: free Medical Device Launch Checklist

The Medical Device Launch Checklist from sanko::strategic consulting is free and easy to use. It contains 64 checkable launch items. Launch items include traditional marketing activities like pricing as well as easy to overlook issues such as expiration dating and localization. The Checklist gives you a brief description of the purpose of each item. It also shows you the department/corporate function with primary responsibility for the item. The file can be saved to monitor launch progress.

Anyone can use the Medical Device Launch Checklist. It is primarily intended for small and medium-size companies that may not have institutional systems and processes to control launch activities. It can also be used by anyone (Product Manager, Marketing Manager, Project Manager, startup CEO, et al) who wants to assure that nothing has been omitted from their launch plan.

You can use the Checklist to guide the development of a launch or marketing plan. The Checklist can also be used as a gateway document to assure that all activities are accounted for and either completed or in progress before authorizing product launch.

To obtain your personal copy of the free Medical Device Launch Checklist, click here and select the link for the free Medical Device Launch Checklist.

Think of it as cheap insurance to protect your multi-million dollar baby.

Image courtesy of arztsamui / FreeDigitalPhotos.net

Look Out, mHealth Startups, Here Come the Tech Companies!

mHealth Startups, the Tech Companies are coming!
Google’s prototype smart contact lens

It’s a good news/bad news situation for fledgling mHealth (aka mobile health or digital health) companies. The startups are working in a market that combines consumer technology with medical devices, meaning they are at the mercy of fads but subject to FDA regulation. The market is small but growing. The business opportunity has drawn the attention of some of the world’s largest technology companies including Google, Samsung, and now Apple. The traditional exit for technology and medical device startups has been acquisition by large players. The good news is that there are more large players in the market than ever – also good for market validation and prospective partnerships. Of course, big competitors can be bad news too. Look out indeed, mHealth startups, here come the tech companies!

Google

Google recently announced it is developing a contact lens that will monitor glucose levels in the tears of patients with diabetes. The device, developed partly at the University of Washington, could also provide patients with alarms when their levels are too high or too low. This is a natural to be combined with mobile technologies like smart phones and Google Glass devices. I’m sure the researchers are already identifying what else could be monitored via a smart contact lens.

Google Dips Into Med-Tech With Glucose-Monitoring Contact Lenses | Singularity Hub.

Official Blog: Introducing our smart contact lens project.

No one could have avoided the general hype and hysteria about Google Glass over the past year or so. And the device is still in beta! Notwithstanding all of the snarky comments about looking like a cyborg and potential privacy issues, there are a number of useful applications in healthcare for healthcare workers and for patients who adopt Google Glass technology. The prospect of a head-worn see-through display with always-on video and voice access to information and colleagues provides for powerful advantages once the bugs are worked out and applications developed.

How Google Glass could revolutionize medicine.

Apple

Now it looks like Apple is getting ready to enter the mHealth market. Recent reports have Apple hiring experienced medical device engineers with backgrounds in biosensors and wearable devices. Perhaps the long-rumored Apple smart watch will make its debut soon.

mHealth: Apple nabs up more medical sensor experts | Personnel Moves | MassDevice.

Samsung

Anyone who is familiar with consumer technology knows that wherever Apple is present, Samsung won’t be far behind. The archrivals have been battling each other in the smart phone and tablet markets for years and have also fought in patent courts around the world. Samsung beat Apple to market with its Galaxy Gear smartwatch in 2013. That device has received a lukewarm reception from consumers, and it doesn’t have any unique mHealth capability. Samsung is famous for iterating and improving its offerings, so I would not be surprised to see a second generation Galaxy Gear with mHealth apps and functionality.

Notably, Samsung applied for and received a 510(k) marketing clearance for its S Health app on its flagship Galaxy S4 smart phone. Also of note in mHealth, Samsung has invested several million dollars in mHealth startup Glooko, which develops apps and devices for diabetic monitoring.

Samsung Receives FDA Approval for the S Health Fitness Tracking App.

Will Samsung tap Glooko for S Health? | mobihealthnews.

Of course, just entering a market does not equate to dominance or even success. After four years of effort, in 2012 Google famously abandoned its Google Health attempt to provide consumers with personal health records. I think the biggest reason for the service’s demise was that it didn’t really “do” anything useful. The story of Google Health shows how industry outsiders may not understand the dynamics of the market.

10 Reasons why Google Health failed | mobihealthnews.

Takeaways: The presence of large competitors can be a little daunting but it’s generally positive. The presence of big companies like Google, Samsung, Apple, and others provides validation of market potential to investors and partners. They can also become partners and investors in your smaller company. Get to know their executives at trade shows and medical conferences and make them a part of your network.

Lastly, you have the advantage of being closer to the market and customers than the big guys – as well as being more nimble and able to identify and exploit opportunities and trends.

mHealth Startups, the Tech Companies are coming!

 

Beyond Mobile Health: Cyborg Health

http://img.gawkerassets.com/img/1986ypr6azxiojpg/ku-medium.jpg
image via io9.com

Mobile health devices have become cool fashion and fitness accessories. They will be under many Christmas trees this holiday season. They do have their limitations, however, mainly being passive devices that monitor activity levels. A number of new technologies tease at the next step in our connected future beyond mobile health: cyborg health?

My own definition of Cyborg is a human who is augmented in physical and/or mental performance by a permanent or semi-permanent device that has extra sensory and/or mechanical functions and logic or intelligence capability. Here are a few examples of cyborg-like devices and people.

Sony has invented what they have termed the SmartWig, a sensor-festooned hairpiece. The SmartWig can monitor pulse, blood pressure, brain activity, body temperature, and more. It will connect wirelessly to the wearer’s smartphone. Since it’s a hairpiece, it’s easy to add audio feedback via earbuds or bone conduction although Sony seems to think in its patent application that a vibration motor would be used to signal and communicate with the wearer.

Sony is famous for not commercializing its inventions but the SmartWig may be just the right combination of innovation and practicality to compel Sony to bring it to market.

Researchers in England are working on alleviating a serious condition that affects millions who have minimal or no bladder control as a consequence of injury or disease. Poor bladder control inhibits lifestyles, causes infections, and inflicts misery on patients and their families. The “Cyborg Bladder” will provide smart functionality as well as external capability to control one’s bladder.

The neuroprosthetic device concept, being studied in rats at the moment, integrates nerves with an electronic implant and an external control. The promise is that the system would monitor the bladder, preventing accidental urination and enabling voiding on command, functions that are nonexistent in many patients.

The last example may be the most interesting. A man in England has been wearing a head-mounted device to help him with his severe color-blindness, a condition called  achromatopsia. People with achromatopsia see completely in shades of gray with no ability to see any color. The British Cyborg device uses a camera to convert colors into sounds. The wearer “hears” the sound through bone conduction, thus “seeing” the colors of the objects being viewed.

The camera can detect wavelengths beyond human capability including infrared and ultraviolet, thereby giving the wearer super-normal “vision”. While other human cyborgs have been hassled by governments and businesses, the British Cyborg has a passport with a photo of him with his head mounted device in place, giving him some degree of legitimacy.

Takeaways: The line between science fiction and science fact is becoming increasingly blurred. Tech-savvy researchers and engineers have ever more sophisticated technology toolboxes with which to construct solutions to unsolved problems.

While some people may object to the notion of Cyborgs becoming prevalent in society – and the recent uproar about public use of Google Glass is a good example – people living with these chronic conditions may welcome the chance to become a bit of a ‘borg.

Companies seeking to enter these early markets should keep in mind that the Cyborg devices, much like prosthetics, are extremely personal products with which the user interacts constantly and over a long time. Good market and usability research and user input is essential before product development commences.

Read more :

Sony files patent for health-sensing SmartWig | mobihealthnews.

New Surgery Promises Cyborg Bladder | Singularity Hub.

The first person in the world to become a government-recognized cyborg.

 

More Disruptive Innovation? True 12 Lead ECG Heart Monitoring for Consumers

mobilECG conceptNot everyone has a need for a 12-lead ECG at home. But hey, a few years ago, no one thought they needed their own portable defibrillator, either. Now you can buy them from Amazon, Costco, and Walmart. A startup, mobilECG, is in the process of developing a device and software to provide true 12 lead ECG heart monitoring for consumers.

mobileECG is a group of young engineers in Hungary. They are developing a consumer-grade electrocardiograph that will interface with a PC, tablet, or smartphone and that will retail for “in the $300 range” in the summer of 2014 if everything goes according to plan. The device is not a toy. It will have full 12 lead capability and regulatory clearance in Europe and the U.S. when it is launched.

Other smartphone-based ECG devices like AliveCor generate single lead ECG data. That’s useful, but not nearly as useful in cardiac monitoring and diagnostics as a full 12-lead ECG. The AliveCor device retails for $199.

The mobileECG engineers say that the ambitious price target is possible for a number of reasons:

  • No separate device and cable. The ECG electronics are built inside the cable.
  • No retailers. You can buy the device directly from the manufacturer.
  • Low price margin.
  • Crowdfunding.

The company is attempting to  raise seed funding through crowdsourcing on indiegogo. Their ambitious target is to raise $230,000 by November 26. As of today, they have raised $5640. You can reserve your own mobileECG by pledging $289. This project may not be in the sweet spot for crowdsourcing but I admire their spirit!

Takeaways: Smart, ambitious people all over the world are working to solve all sorts of problems in medicine and healthcare. They are also availing themselves of the latest design, prototyping, and fundraising technologies including rapid design and prototyping, 3D printing, and crowdsourcing.

A $300 ECG may not be necessary in a U.S. medical clinic but it might be very welcome as an alternative to $3,000 ECGs in developing countries.

As with most truly disruptive technologies, mobilECG does not have all of the bells and whistles of professional electrocardiographs. They have an intriguing business model, however, and they have cloud-based communications built-in. This technology could make things very interesting in the cardiac monitoring market in the next few years!

Read more:

MobilECG Aims to Bring 12 Lead Electrocardiography to Consumers for True Heart Monitoring.

mobilECG – accessible clinical-grade electrocardiography | Indiegogo.

Mobile health news: Can this cool, cheap ECG device startup raise $230K in a month?.

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.

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

3 Surprising Ways to Instantly Improve Your Public Speaking Skills | Portent

We all do public speaking. Some of us do it willingly, some unwillingly. Some people like public speaking although if surveys are accurate, most of us dread it more than death or root canals.

If you are a startup CEO, making presentations is a huge part of your life. The same goes for people in roles such as product manager, marketing manager, director of marketing or sales, etc. Communicating information and making persuasive arguments are a vitally important part of your job, perhaps the most important part.

Here are three tips for more effective public speaking from the referenced article:

  • Don’t prowl the stage. Don’t hide behind a lectern, either. Map your spots for various points in the presentation and rehearse them along with the pitch.
  • Vary your voice speed. It makes you more interesting.
  • Realize that people process information in different ways. Design your presentation and adapt your style to accommodate the “why people,” the “what people,” the “how people,” and the “what-if?” people.

Here are a few “bonus tips” from the article:

  • Have one, concise, clear call to action at the end of your presentation. Tell people exactly what you want them to do.
  • No meta comments (“The projector cut off my slide.”). Keep them to yourself as they break the narrative and cause the audience to lose focus.
  • Edit your content beforehand. Your audience does not need to hear (and they won’t remember) everything about your topic.
  • Stop using PowerPoint as a crutch. The audience knows how to read. You add zero value by reading bullet points off a slide. My favorite quote from the article:

“Frank Sinatra once said “if you need anything more than a microphone and a spotlight, you’re an amateur.””

Takeaways: Public speaking and presentation skills are vitally important for just about any business professional. These simple tips and small accomodations can make you a more effective public speaker. Remember that your presentation is about your audience, not you.

Read more: 3 Surprising Ways to Instantly Improve Your Public Speaking Skills – Portent.

Health IT startups, “physicians” shouldn’t be a target market. Get more specific. | MedCity News

This is good advice and good practice for all medical device companies, not just startups. Market segmentation is difficult but, properly done, leads to successful launches.

Here are a few other ways to categorize and target physicians beyond medical specialty:

Career status: Resident, senior resident/fellow, young attending, mid-career attending, late career attending, emeritus.
Decision-maker status: Department head, Chief of practice, second-in-command, member of purchasing committee or similar group, “worker bee.”
Case load: low, medium, high, unbelievable.
Geographic region: There are clear differences around the USA in medical practice as well as from country to country.
Corporate affiliations: You may or may not want to target physicians with strong ties to your competitors. And the ties can be VERY strong!
Primary type of practice: Hospital, research/academic/teaching, private practice, VA/military, standalone surgery centers. There is a lot of overlap in this category with physicians working in multiple settings so it can be a bit fuzzy.
Technology adopter status: Innovator, Early Adopter, Early Majority, Late Majority, Laggard
Influencer/Key Opinion Leader/Notoriety Status: Prolific article author, leads or participates in numerous clinical trials, frequent speaker at medical conferences, frequently interviewed and/or quoted in news and media.

You can purchase lists of physicians with some demographic data relatively inexpensively. You should then create a database and augment that data regularly with information you or your commercial team finds. Before you make final decisions about targeting, be sure to talk with actual prospects and test your model!

As for what happens after a company has decided its target specialties, Kim offers this advice: “If we could do it over again, we would have spent at least six months to one year working on site or near-site with a handful of actual customers.”

Read more: Health IT startups, “physicians” shouldn’t be a target market. Get more specific. | MedCity News.

Life Science Innovation Northwest Conference 2013 – medical device startup perspective

I attended LSINW last Wednesday and Thursday July 10-11 as a poster presenter. I’m serving as acting CEO for a University of Washington startup we’ve named SimpleCirc. The simple, safe, swift, and inexpensive adult male circumcision device is intended to address the HIV/AIDS epidemic in Africa (you can download our poster here: SimpleCirc LSINW 2013 Poster)

The LSINW poster submission and conference admission process is a bit of a bargain. Not all posters are accepted, but the ones selected are placed prominently in the main hallway of the conference. Most of the conference attendees walk through the poster exhibits several times per day. There are many opportunities for interaction. The presenters are given coaching and two full-conference admissions for $175. That compares to $350-$1500 per person for full price admission. Needless to say, we took full advantage of every opportunity.

Overall, LSINW is very professionally produced and run by WBBA, the Washington Biotechnology and Biomedical Association. Printed materials are high quality, the presentation venues have up-to-date AV equipment and adequate staffing, the various presentations and panels run like clockwork, and the food/refreshments are more than adequate in quantity and quality. The conference schedule is made available in a brochure, a digital PDF file, and in a tablet/smartphone app called Guidebook (more about that later).

There was a cocktail/networking event at the end of the first day but the organizers also scheduled an event honoring local women in life sciences AND had a rock band made up of (amateur?) musicians in the Seattle life sciences scene. There was too much going on for me. The noise level was high and it was difficult to hear in that space.

A Life Science conference necessarily has a wide variety of attendees: small, medium, and large medical device company executives, biotech execs, a few pharma people, consultants, service providers, grant-making officials, physicians, researchers, and academics, angel investors, VCs, media, etc., etc. Not every person had an interest in what we’re doing but it is always fun and interesting to look for a connection.

LSINW created several tracks for the two-day agenda: Biopharmaceutical, Medical Technology, Emerging, Health Information Technology, and Innovation. There truly was something for everyone and I often found myself torn between two compelling but simultaneous presentations.

The Opening Keynote speaker, John Crowley, CEO of Amicus Therapeutics, was unable to attend due to a family emergency but the conference organizers came up with a last-minute substitute, Charles Baltic, Managing Director of Needham & Co. He was an OK speaker but I’m sure he repurposed an existing presentation – very heavy on info about financings and IPOs.

The first day lunch keynote speaker was Steven Burrill, CEO of Burrill & Co. He updated his talk about the state and future of healthcare in the USA from last year but it was entertaining and extremely interesting. I’m impressed with his presentation abilities. He blows through ~150 slides in under an hour and apart from looking at a monitor to see what slide was being displayed, never looked at a note the entire time.

The panel discussions were good. Most of the moderators were well-prepared with stimulating questions and the panels – usually (but not always) executives with Seattle connections. Most of the discussions were non-controversial with panel members sticking to relatively “safe” positions. That is, until the last panel, “Blood from a Stone – Who is Left in Life Science Investing Today?” moderated by Luke Timmerman of Xconomy who did a fine job by staying out of the spotlight.

Sparks flew as three panelists more or less representing the Venture Capitalist side of funding sources sparred with Gregory Simon of Poliwogg, a relatively new crowdsourcing site for angel investors. For sheer entertainment value, this was the best panel of the conference. The perspective of the VCs seemed to be that “we are smarter than everyone else” and the “average investor” needs to be protected from the risk of losing their entire investment. Excuse me, but I don’t believe any VC fund offers money-back guarantees.

Gregory Simon was entertaining, if a bit of an iconoclast. He did make a number of good points and also noted that very recent changes by the SEC have enabled crowdsourcing of angel investments – details are still forthcoming but it is very exciting from my perspective. There are few opportunities in Seattle for early stage device companies to get seed or Series A funding. Once those have been exhausted, it’s off to California and overcoming the challenges of being unknown and from out of town in order to raise capital.

An added bonus was the participation of James McIntire, Washington State Treasurer, giving the perspective of a pension fund trustee, and Tracey Mumford from the Michael J. Fox Foundation representing the “venture philanthropy” segment. As an attendee remarked during the audience Q&A, democratization in venture investing is coming whether or not you want it or are prepared for it. He also served up the example of the meltdown in the investment banking industry over credit default swaps and mortgage derivatives to show that “the smartest guys in the room” are not infallible.

I’ve attended a number of LSINW conferences, starting in the days when they were held at the Bell Harbor Conference Center on Elliot Bay in Seattle. The Washington State Convention Center is the perfect place for this meeting, in my opinion – centrally located downtown, spacious, clean and accessible. No, there are not great views but that may be the only drawback.

I mentioned the Guidebook app earlier. It’s a nice compendium of the various events – and it auto-updates whenever there is a revision (like the keynote speaker change). You can even make a schedule for the entire event. BUT, you can’t upload the schedule to your Google Calendar or Outlook calendar. And you couldn’t sync the schedule in your phone to your tablet or vice-versa. Also, there was another event called Biopartnering where interested parties could arrange brief get-to-know-you meetings. Unfortunately, that function could not be integrated with the Guidebook schedule, meaning I had to juggle three different schedules over two different devices. Not for the technology-challenged!

As for my perspective as a startup CEO, I’m often left wanting…more from these events. Many of the panel discussions focus on biotech or later stage financing like VC or IPO. I would like to see a panel of startup medical device CEOs who recently completed an angel round to share their experiences, do’s and don’ts. I would also like to see a stronger presence from Angel groups like WINGS.

On the other hand, Seattle is a small town when it comes to life sciences. You can get to just about anyone with one or two requests for referral or introduction. The LSINW conference is a great way to do that in person every year. If you are a startup CEO or are thinking about a startup, I strongly recommend that you attend next year, June 19-20, 2014.

The value of curmudgeons and why health systems and startups should engage them | MedCity News

We all tend to seek people who agree with our brilliant ideas. It’s human nature to avoid the naysayers and skeptics. There is a significant danger of group think if you apply this filter too energetically, however.

I’ve found that the best tactic for engaging physicians or nurses as advisory board members or informal advisors is to have a mix of ages and experience levels. Too often, the key opinion leaders are too busy to give practical advice – but they are needed for their names and tacit endorsements. And they will point out obvious blunders.

The younger physicians and residents are often extremely energetic and idealistic but can be naive about what it takes to bring about change in an often byzantine hospital or healthcare system. Sometimes they just don’t have enough practical experience to offer meaningful advice about adoption of a new technology, although they are extremely sharp about technology and the latest research.

It helps to engage one or two mid to late-career curmudgeons as the article suggests. These people have seen more than one battle and in many cases, more than one war, metaphorically speaking. If you can gain their trust, they will tell you the flaws in your go to market plan and what needs to change. Of course, it helps to develop a tougher hide before asking for feedback from “grizzled veterans” as you will quickly learn that your “brilliant ideas” are anything but!

“…anyone who wants to make changes from a hospital system to a scrappy startup would do well to bend the ear of a curmudgeon, be they a nurse, provider or health care professional affected by a proposed change or innovation they want to make. They may be surprised by the results.

Why? Because curmudgeons are more likely to express their opinion about whether a new system or initiative will or won’t work and why. If a new interface would interfere with workflows, for example, they will often be the first to speak up. They are frequently the toughest critics. You may not get showered with praise from them but if you engage them early on and make it clear their opinions are valued you may end up making your app, EHR, etc. much better than it might otherwise be.”

Read more: The value of curmudgeons and why health systems and startups should engage them | MedCity News.

“The one thing” – Medical Device Commercialization 101

This is the first in a series of posts in which I’ll discuss the many factors that go into a successful product development / commercialization / launch project.

I’ve given many lectures and presentations on product launches and marketing. When I ask this question at the beginning of the talk, I get a variety of answers. Keep in mind there are many things  businesses need but only one thing that is like oxygen to a living organism – that “every” business needs.

What’s the one thing every business needs? [scroll down]

MC900097903[1]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customers!

Yes, you may have unique products, superior intellectual property, a great development team, world-class executives, perhaps even a NASDAQ stock listing. You may have efficient manufacturing, excellent internal communications, terrific PR, a slick website, and a green headquarters building. You may have ISO and cGMP-compliant processes, strategic partnerships, and cash in the bank.

Until and unless you have identified who will buy your product and why, you do not have a business.

What’s with the double::colon?

I was looking for a new name for my consulting practice. All of the branding gurus say (and I agree) that if you are a sole proprietor you should use your name as part of your company brand so people recognize you.

I also want to use the word “strategic” because I add strategic value when I provide consulting services. Linking the two words together made sense.

I did some searching and discovered that the double colon is a mathematical/logical/programming symbol sort of meaning, “is a part of”, or “relates to.” So “sanko” relates to and is a part of “strategic.”

Anyway, it’s different and a conversation-starter. And I like it.

Hello world!

This blog is about medical device commercialization – from a business perspective. From the first spark of an idea through requirements definition to product development to launch and beyond, I’m writing to offer my take on the commercialization process.