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.

Beyond Mobile Health: Cyborg Health

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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.

 

Smaller, faster, lighter, cheaper medical devices

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image via singularityhub.com

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

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

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

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

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

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

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

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

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

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

Read more:

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

http://www.theranos.com/

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

http://tribogenics.com/

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

http://www.smartphonephysical.com/

 

Too good to be true…or just hype?

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image via getairo.com

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

 

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

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

From the Airo Health website:

NUTRITION

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

STRESS

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

SLEEP

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

EXERCISE

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

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

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

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

Good luck, Airo.

Read more:

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

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

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

The Clever Bottle vs. the Smart Pill

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image via clevercaprx.com

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

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

 

 

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

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

Hippocrates, Decorum

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

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

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

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

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

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

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

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

Read more:

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

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

Medication Adherence: WHO Cares?.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Read more:

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

GBD Compare.

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

The Human Capital Report 2013 – The World Economic Forum.