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!

 

10 Principles of 3D Printing

3D printed bionic ear
image via American Chemical Society publications

Last week I attended an event, “From Trinkets to Body Parts: 3D Printing – Transforming Sci-Fi Fantasy Into Reality” sponsored by the Seattle MIT Enterprise Forum. The keynote speaker was Hod Lipson, PhD, Professor of Engineering at Cornell University. Prof. Lipson gave an informative and entertaining talk centered around his 10 principles of 3D printing.

There was also a panel of 3D printing industry experts and lots of Q&A with the large audience. It seems that there is much interest in 3D printing – a not-so-new technology whose time has come?

Prof. Lipson identified 10 key principles of 3D printing in his talk:

  1. Complexity is free
  2. Variety is free
  3. No assembly required
  4. Zero lead time
  5. Zero constraints
  6. Zero skill manufacturing
  7. Compact, portable manufacturing
  8. Less waste by-product
  9. Infinite shades of materials
  10. Precise repeatability

Here is my take on the 10 principles:

1. It’s as easy to 3D print a complicated piece as it is to 3D print a simple piece.
2. Every piece that you print can be different without increasing cost or cycle time.
3. The assembly process can be part of the printing process, e.g., a bicycle chain has been 3D printed.
4. Because there is no tooling and no setup, the only lead time is the time required to start the printer and send the digital file.
5. You can fabricate things using 3D printing that could not be made any other way.
6. Since there are no precision assembly tasks, printer operators do not require specialized skills.
7. 3D printers are relatively small, portable, and inexpensive compared to injection molding machines, milling machines, punch presses, and foundries.
8. The 3D printing process does not generate waste material. Neither does modern injection molding, but processes that remove material such as milling do generate considerable waste.
9. Not only can you combine colors in infinite shades, but you can combine materials to create unique mechanical properties.
10. Within the tolerance limits of the printer (0.1 mm for commercial grade printers), every piece printed is exactly like every other piece printed.

Prof. Lipson is also the author of a new book, Fabricated: the New World of 3D Printing.

There are drawbacks and limitations to 3D printing, of course. High volume production is better suited economically for injection molding. Surface finish can be rough, requiring secondary processing, although efforts are ongoing to improve surface finish and textures. Pieces may not have isotropic physical and mechanical properties.

Prof. Lipson identified an incredible range of materials that have been used as the raw material in 3D printing: plastic, of course, sand, concrete, various types of food, paper, steel and other metals, and even living cells.

Some products that have been 3D printed: a working gun, clothing, shoes, furniture, aircraft parts, artwork, food (might be what astronauts eat on their way to Mars and beyond), a working loudspeaker, batteries and electrical circuits, and body parts.

And here are some examples of 3D printing in healthcare and medical devices. Some are in research, some in active development, and others are commercially available:

  • Invisalign braces – custom made for each patient
  • Knee meniscus
  • Heart valve
  • Ear prosthetic
  • Organs – liver, kidney, heart

3D printing of human body parts and organs is also called “bioprinting” in this 2013 New York Times article, “At the Printer, Living Tissue”. The article is pessimistic about near term prospects for 3D printed organs, although it notes that there is much research and development being conducted. Others in technology think that breakthroughs are imminent: Functional 3D Printed Organs by 2014 > ENGINEERING.com. There is a startup bioprinting company, Organovo, developing an artificial liver. The liver in its first incarnation will be suitable for drug development and testing, not for human implantation. A research team at Princeton created a functional 3D printed ear, again, not suitable for implantation: Researchers create world’s first 3D-printed bionic organ | ExtremeTech.

Takeaways: 3D printing is becoming widely known and commercially acceptable. In the medical field, it can be used for rapid prototyping and even for fabrication of low volume production parts. As the “10 principles” indicate, you can save time and money in your medical device development projects by using 3D printing.

Renal Denervation – the next big bust?

Oops! Road SignOn November 1, I wrote a blog post about what seemed like an exciting new therapeutic market for medical devices, renal denervation to treat hypertension and lower high blood pressure:

Renal Denervation – the next big thing?

Fast forward to the present. Just 11 weeks later, it appears that this hot new market is in trouble.

First, this negative news from Medtronic:

Medtronic’s Hypertension Study Fails Taking Analysts By Surprise | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

The failure occurred in a large, randomized study being conducted at 87 medical centers in the U.S.

And then the company statement:

Medtronic CEO: Failure of Hypertension Clinical Trial Not An Execution Issue | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

followed by competitive reaction from St. Jude Medical:

St. Jude’s CEO is still betting on renal denervation, despite Medtronic’s setback – FierceMedicalDevices.

Most recently, Covidien has decided to exit the market. Covidien spent $60 million to acquire Maya Medical and additional millions on clinical studies. They stated that the market in the European Union was developing too slowly and that they would be taking a $20 million writedown on their assets:

Covidien Pulls Out of OneShot Renal Denervation Program Citing Slow Market Development | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

Medtronic famously spent $800 million to purchase Silicon Valley startup Ardian. Early clinical results were promising but when Medtronic tried to scale up the clinical studies for FDA approval, the results were disappointing. The company is in full “reboot” mode and is planning to convene a blue ribbon panel of experts to determine what went wrong and what to do now. I think I would have my resume updated and on the street if I were involved in this unpleasant set of circumstances.

Yet to be heard from are two other renal denervation market competitors: Boston Scientific, which spent $425 million to acquire Vessix in late 2012, and VC-funded startup Kona Medical which is developing a noninvasive ultrasound-based technology.

Takeaways: There is enormous pressure on medical device companies these days to identify, enter, and dominate new markets. Unproven therapies and technologies will always engender risk. Since most innovation is done at startups now, it will be interesting to see how risk mitigation occurs in future acquisitions or if there were any mitigations included in the Medtronic or Covidien deals.

If you are a startup executive or founder, you can look forward to more stringent diligence and a longer wait before investment or acquisition by strategic partners. There may also be more contingencies requiring technical and clinical milestones to be achieved before milestone payments are made. Make sure you have a good general counsel attorney and CFO. You are going to need them.