MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

How Smart Clothing Is Made—Advantages & Challenges

Van den Brand pointed out that while his team works on wearable devices as well as smart clothing, garments do offer advantages in certain cases.

"The big advantage of a garment is that it covers a large part of your body which also means that sensing . . . measures over a large part of the human body. If you want to measure a really high-quality ECG signal . . . you have access to the full front and back of the body. You can just choose the optimal size and location of the electrodes while with a wristband that's just not possible," Van den Brand said.

He added, "If you want to monitor running, the way that people move their legs and the joints in their legs . . . you have to do that in clothing by integrating sensors into clothing."

Two of the main challenges in developing smart clothing is ensuring the electronics still work after repeated washing and that the clothing isn't bulky or inflexible as a result of being "smart."

Van den Brand explained, "The biggest challenge is washability . . . Clothing is known to degrade when you wash it multiple times. Electronics doesn't have a degradation mechanism. It works or it doesn't work. To make the electronics so reliable that it survives the washing machine--that's the number one challenge."

He continued, "People accept electronics integrated into clothing, but they don't accept that it's bulky. To really make it have the mechanical properties of clothing, that's clearly the second challenge."

             

[Image courtesy of IMEC & HOLST CENTRE]

Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

How Intel and Teva Are Tackling Huntington's Disease

The two companies want a mobile health solution for continuously monitoring and analyzing key symptoms of the devastating neurological disease.

Chris Newmarker

HuntingtomTeva Pharmaceutical Industries and Intel Corp. have announced a collaboration to create a wearable device and machine learning platform for better monitoring of Huntington's disease, in the hopes of better understanding the disease's progression.

In the process, the companies might be able to better evaluate treatments for the disease. The inherited disease results in the progressive breakdown of nerve cells in the brain, broadly impacting functional abilities and eventually leading to death. Researchers estimate that the disease affected four to 15 out of 100,000 people of European descent, according to Wikipedia.

To better understand Huntington's disease, Teva in collaboration with Intel will have people with the disease use a combo of a smartphone and a smartwatch with sensors able to continuously measure general functioning and movement. Data will be wirelessly streamed to the open-source Intel Trusted Analytics Platform (TAP), initially developed in collaboration with The Michael J. Fox Foundation for use in Parkinson's disease research.

Proprietary algorithms will crunch the Huntington's disease patient data in near real-time to produce motor symptom severity scores.

(See Lori-Ann Woodard, senior manager of quality compliance for combination products at Teva, discuss connected combination devices at BIOMEDevice San Jose, December 7-8, 2016.)

"Current measurement of symptoms is largely based on observation when the patient sees the doctor. This technology now provides us with an opportunity to have continuous monitoring," Michael Hayden, Teva's global R&D and chief scientific officer, said in a news release.

A machine learning platform could "help drive the pharmaceutical industry towards faster, better clinical trials, potentially leading to new treatments for patients," said Jason Waxman, corporate vice president and general manager of the Datacenter Solutions Group at Intel.

The study is expected to start near the end of 2016 in U.S. and Canadian centers. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image by Frank Gaillard - Own work, CC BY-SA 3.0]

How Smart Clothing Is Made

How Smart Clothing Is Made

Someday, we all might wear our heart (rhythms) on our sleeves. Smart clothing is becoming a reality, thanks to major advancements in technology. Here are the hurdles researchers have cleared to make smart garments possible. 

Wearables research being conducted by imec and the Holst Centre in Eindhoven, Netherlands is focused on creating smart textiles. The possibilities of this research are exciting. As imec pointed out, "Textile[s] are the perfect platform for wearable electronics: you may forget to wear your smart watch, but you will never forget to wear your (sensor) T-shirt."

MD+DI spoke with Jeroen Van den Brand, program manager at the Holst Centre about the work on smart garments. He explained a few of the challenges that researchers are solving.

Read on for more about how smart clothing is made.

 

Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

[Image courtesy of IMEC & HOLST CENTRE]

 

Adaptive Trial Design Can Save Device Makers Time and Money

Adaptive Trial Design Can Save Device Makers Time and Money

FDA has made it clear that manufacturers truly can use adaptive design in medical device trials. An expert shares the benefits of adaptive design and offers advice to companies considering it.

In late July, FDA issued its final guidance on using adaptive designs for medical device trials, a followup to the agency's draft guidance on the topic in May 2015. MD+DI asked Vicki Anastasi, vice president and global head of Medical Devices & Diagnostics Research at ICON plc to discuss adaptive design in more detail. Here, she makes clear FDA's acceptance of adaptive design, how the strategy can bring multiple benefits to device makers, and how to get started.

This Q&A has been edited slightly.

MD+DI: Did anything in FDA's final guidance stand out to you as being different from the draft guidance or particularly meaningful/impactful?

Vicki Anastasi: The guidance provides the first explicit indication that the FDA is ready and equipped to handle the use of adaptive designs in medical device clinical trials. In the guidance, the FDA clearly encourages industry to understand the utility of adaptive trials in addressing the inefficiencies in current study designs, and it provides an overview of how to incorporate adaptive elements into protocols submitted to the FDA.

Learn about "Developing Devices That Generate Data for Evidence-Based Medicine" at the MD&M Minneapolis Conference, September 21-22.

To the FDA, adaptive design is not a new concept; in fact, the CDRH has been evaluating adaptive designs for over ten years. Between 2007 and 2012, they received 120 submissions that included adaptive elements. The guidance makes it clear that regulators support this approach. It should lead to a rapid change in how manufacturers design studies across their portfolios.

I'd think that FDA setting out draft guidance on adaptive trial designs last year might have spurred more medical device companies to try an adaptive design. Did this happen? Have you noticed any changes in how device companies are approaching their trial designs or consideration of an adaptive trial design?

Yes, we have since received many more inquiries from device manufacturers about the utility of adaptive designs in their trials. Companies that adopted adaptive designs have found them to be beneficial.

For example, a manufacturer developing an electrostimulation device approached us to design a trial that supported registration of the device as early as possible. We suggested and designed an adaptive trial that would not only yield useful results quickly, but also protect the company against potential delays and risks. The design specified two prospectively planned interim analyses. We set thresholds for the sham control response rate and observed a treatment effect at the first and second interim analyses, respectively, that allowed the manufacturer opportunities to right-size study enrollment for optimal statistical power or to terminate the study early on efficacy or futility grounds.

At the second interim analysis, after enrolling only half of the total planned number of patients, ICON identified a response rate much lower than the prospectively planned threshold. The manufacturer deemed the device ineffective and then, with the $1.9 million of funds and five months of time that would have otherwise been spent on the ineffective device, they accelerated development of an improved treatment regime and delivery methodology that would be more efficient to prove in a future clinical study.

In another case, a company came to us after being encouraged by positive data on a disc replacement device from a non-inferiority trial. These data had spurred a desire to conduct an additional superiority trial, which would be a rare claim in that indication. However, they found that it would be cost-prohibitive to start a new superiority trial from scratch with new protocols, a new recruitment strategy, and new sites.

To reduce costs and save time, ICON supported negotiations with FDA to allow a midstream change to the non-inferiority trial that would allow the simultaneous collection of superiority data. ICON designed and executed an adaptive design to collect both non-inferiority and superiority data using a single, patient-sparing, efficient trial. This strategy ended up saving the manufacturer $5 million and accelerated their go-to-market timeline with a stronger value proposition.

What questions, if any, still remain for you after the final guidance?

We have seen many presentations and spoken to many regulators over the years, and their support of adaptive designs is clear.

The one remaining question is, how may the trials in your portfolio benefit from adaptive designs? And, how quickly will your organization or its competitors integrate adaptive across a portfolio?

From a commercial point of view, the value of adaptive design is greatest when applied at a portfolio level. This is, namely, by mitigating the risk that errant trial parameters could cause an effective device to fail or suffer delays, and by augmenting opportunities to ensure that limited resources are directed to the most productive products.

Achieving the portfolio-level benefits of adaptive design requires establishing a checkpoint early in every product's lifecycle to assess the relevancy of various adaptive designs for its clinical development programme. While not all trials are appropriate for adaptive design--for example, fast-enrolling trials that last only a few weeks would logistically preclude an interim analysis--most device trials would benefit from simulations to identify risks that may arise over the course of a trial and development of designs that optimally addresses those risks.

It is important to note that this review process does require an upfront investment of time as well as access to statisticians and other experts who are specifically knowledgeable in device-relevant adaptive trials. These preparations are important, as the strategies and operational processes used for pharmaceuticals do not necessarily translate to benefits in device development. This early investment, however, is offset by adaptations that, for example, compress study duration through combined pilot and pivotal studies, adjust the sample size to preserve statistical significance, or prevent an overpowered design from continuing to recruit unnecessary subjects.

What advice do you have for device companies considering or still uncertain about using an adaptive trial design?

No matter how big or how small a manufacturer is, adaptive designs are achievable. Adaptive designs are especially significant for smaller manufacturers because a trial's outcome can have an outsized effect on their success as a company.

In terms of concerns manufacturers should have, it's important to heed FDA's guidance and the requirements they note for conducting an adaptive trial. For example, regulators stress that manufacturers need to update their infrastructure, from their monitoring and data management systems to how they work with IRBs [Institutional Review Boards] to maintain data integrity. Clinical trial management systems need to be purpose-built to handle data more securely. They also require that if manufacturers use an adaptive design, they must use statistical software that can perform Bayesian analyses.

Image courtesy of NOKHOOG_BUCHACHON/FREEDIGITALPHOTOS.NET] 

3 Recent Acquisitions in Medtech's Ortho Space

Zimmer Biomet and Stryker are among the companies buying.

Chris Newmarker

10 Hot Medtech Industry Trends

Medical Device Industry Trends

The M&A frenzy in the medical device industry may be losing a bit of steam, but that hasn't stopped medical device companies from engaging in smaller deals to snap up new technologies and capabilities. 

Here are three recent deals in the orthopedics space that stand out:

1. Zimmer Biomet Picks Up 3-D Range-of-Motion Simulation Tech 

The Warsaw, IN-based ortho giant recently announced that it is buying Clinical Graphics for an undisclosed sum. Clinical Graphics's 3D range-of-motion simulation technology shows promise when it comes to informing treatment decisions for common hip conditions requiring early intervention. "3D imaging represents the next generation of treating joint pain, and we're excited to team up with Clinical Graphics and integrate our technologies to further enhance the clinical utility of our market leading hip portfolio," Dan Williamson, group president of joint reconstruction at Zimmer Biomet, said in a news release

2. Stryker Buys Tech for Extremety Procedures

Stryker meanwhile has agreed to buy the assets of Restore Surgical (Houston), which does business as Instratek. The deal, expected to close in the fourth quarter of 2016, allows Stryker to acquire a portfolio of pstaple and hammertoe implants, as well as minimally invasive soft tissue recession instrumentation used in foot, ankle and upper extremity procedures. "This acquisition supports our commitment to growth in extremities with products that complement our existing portfolio, strengthen our leadership in the forefoot segment and provide immediate access into minimally invasive soft tissue recession procedures," David Floyd, Stryker's orthopedics group president, said in a news release.

3. Stryker Purchases Sports Injury Tech

Stryker also recently announced that its endoscopy division has bought Ivy Sports Medicine and its minimally invasive meniscal repair platform. The deal also includes Ivy Sports Medicine's FDA-approved collagen meniscus implant, an all-inside repair device, as well as an inside-out meniscal suturing platform for treating the sports knee injury. "This is an area of sports medicine where there is continued opportunity to address unmet customer needs. The Ivy portfolio provides a unique platform for us to build upon as we seek to continue advancing the treatment of meniscal injuries," Matt Moreau, vice president and general manager of Stryker's sports medicine business, said in a news release. 

Product Development Models Driving Innovation

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapolis on September 21. Qmed readers get 20% off with promo code Qmed16.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.

Smart Fabric Generates Energy From Sunshine and Motion

The new garment has solar cells woven into the material to harvest energy from the sun and body motion. The resulting electricity could power wearable mobile health technologies.

Kristopher Sturgis

Georgia Tech Energy Harvesting FabricResearchers from Georgia Tech's school of materials science and engineering have developed a new hybrid fabric material that can generate electricity while remaining flexible and thin--making the fabric perfect for wearable technologies. Zhong Lin Wang, professor at Georgia Tech and one of the lead authors on the work, describes the material as a power source for wearable devices.

"The hybrid power textile is ultra-thin and flexible," Wang said. "Holding a single layered interlaced structure, the hybrid power textile shows an ultra-thinness with superior flexibility, and could be fabricated into various cloths. It is highly deformable, breathable, and adaptive to human surface curves and biomechanical movement."

The material itself is assembled on lightweight, flexible polymer fibers that are environmentally friendly. The fabric was created using a commercial textile machine that weaves together solar cells with fiber-based triboelectric nanogenerators. These nanogenerators use a combination of the triboelectric effect and electrostatic induction to generate small amounts of electrical power harvested from the user's motion.

"The triboelectric generator makes use of the triboelectric effect to create surprising amounts of electric power by rubbing or touching two different materials together," Wang said. "When the materials are in contact, electrons flow from one material to the other. By continuously repeating the process, an alternating current can be produced."

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

With the wearables market growing exponentially, the demand for flexible, stretchy power sources continues to grow with it. Earlier this year researchers from the University of Illinois developed a new flexible power system that was designed to bend and stretch with virtually any wearable fabric. Power systems like these having been springing up more and more as emerging wearable technologies begin to veer away from the rigid components that power traditional electronics.

With this in mind, Wang and his colleagues set out to create a fabric material that can not only be worn comfortably and discreetly, but can also harness enough energy to power a bevy of different electronic devices.

"This hybrid power textile presents a novel solution in a fabric form, delivering sufficient power for practical applications," Wang says. "Such as directly charging a commercial cell phone in a wearable manner. This all-solid hybrid power textile has a size of 4 cm by 5 cm and is capable of sustainably and stably delivering an average output power of 0.5 mW in a wide range of loading resistances--and this output power can be dramatically enhanced with the fabric area scaled up."

The group's latest tests have indicated that the fabric can withstand rigorous use, as they continue to explore the material's long term durability. Wang says the group also plans to further enhance the material for industrial uses, and eventually encapsulate the fabric to help protect the electrical components from rain and moisture--all in an effort to prepare the fabric to power any virtually any wearable device. 

Kristopher Sturgis is a contributor to Qmed.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Georgia Tech]

How a 'Smart' Vibrator Caused an Uproar

Standard Innovation Corp.'s We-Vibe can be run off a smartphone app, including remotely. So what could go wrong?

Chris Newmarker

We-VibeAn Illinois woman has anonymously filed a class action lawsuit in federal court over a connected sex toy, claiming that its maker Standard Innovation Corp. collected her usage information without her knowledge.

The We-Vibe is fully operated through the We-Connect app downloaded over the Apple App Store or Google Play that allows smartphone control of the device, including remote control over a lover's smartphone. However, most people would have not bought the We-Vibe had they known that Standard Innovation--which is run out of Ottawa, Canada--was monitoring, collecting and transmitting their usage information to servers in Canada, according to lawyers for the woman listed as "N.P." in the lawsuit, filed September 2 in U.S. District Court in Illinois.

Standard Innovation, according to the lawsuit, concealed its actual data collection policies from its customers. Collecting such usage information without knowledge or consent is "highly offensive to a reasonable person as it reveals intimate private details about their sexual behavior that they believed were confidential," N.P.'s lawyers at Edelson say.

While certainly an attention-getting story, the lawsuit could also serve as a warning for makers of connected devices in general, including in the health and medical device field.  Fitbit, in fact, garnered some negative publicity in 2011 when its users' activity logs, made public by default at the time, included the publicly accessible sex-ercise habits of about 200 users, as Forbes related at the time

For its part, Standard Innovation has posted an online statement promising an update of the We-Connect app that will include a new in-app communication regarding Standard Innovation's privacy and data practices, and a new feature allowing users of the We-Vibe and We-Connect to control how their data is used. The company also has external expert reviewing its data practices.

"There's been no allegation that any of our customers' data has been compromised. However, given the intimate nature of our products, the privacy and security of our customers' data is of utmost importance to our company. Accordingly, we take concerns about customer privacy and our data practices seriously," Standard Innovation said in a statement shared with Qmed. The company declined to discuss the lawsuit, saying it has not been served yet.

The lawsuit comes about a month after security experts going by the names followr and g0ldfisk raised concerns about the We-Vibe during the Defcon hacking event in Las Vegas. As related by CNET, followr and g0ldfisk noted that real-time information collected included device temperature and vibration intensity. The researchers figured this out by taking the vibrator apart, as well as taking a close look at the product's terms and conditions. 

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Standard Innovation Corp.]

Coalition Prods FDA for New Approach to Digital World

Coalition Prods FDA for New Approach to Digital World

A group petitions FDA for an overhaul of the agency's approach to medical products. Will FDA be able to transform itself?

Jim Dickinson

FDA is not known for anticipatory forward thinking, or for its ease in handling fast-moving technology. Yet that is precisely what an extraordinary petition from the Clinical Decision Support Coalition asks for in accommodating the new world of personalized medicine and its enabling digital medical devices.

It may be the most challenging petition the agency has ever received. It presents what to my mind is an irrefutable--and urgent--case for FDA to wholly reinvent its approach to therapeutics.

The 11-page document, plus a 12-page appendix that's devoted to three supporting case studies, asks FDA to break its timeworn mold of taking a case-by-case approach to regulatory change and instead take a cue from the University of Illinois--"completely upending the traditional medical school curriculum [by combining] medicine and engineering into a single program, with systems thinking throughout in order to train a new breed of physician."

Hear Bradley Merrill Thompson, general counsel for the Clinical Decision Support Coalition, discuss "FDA Regulations Impacting Connected Health Devices and IoT" at BIOMEDevice San Jose, Dec. 7-8.

The coalition, representing software providers, IT infrastructure manufacturers, healthcare providers, medical device and pharmaceutical manufacturers, trade groups, and members of the clinical community, said that "factors driving the combination of pharmaceuticals and digital health products" include:

  • advancements in wearable sensor technology that allow sensing and electronically sharing a huge array of body signals of relevance to treating patients;
  • evolution of the Healthcare Internet of Things, allowing for the stitching together of many different electronic constituent parts to allow for a more unified assessment of patient status and monitoring;
  • advancements in medicine that allow an understanding of disease progression; and
  • advancements in pharmaceutical care that provide a better understanding of how disease progression can be studied and used to more effectively choose the timing and selection of pharmaceutical ingredients.

The coalition's petition asserts that "All of these advancements, taken together, mean that a new model is emerging for treating disease that considers treatment strategies based on systems made up of many components, not just pills in isolation."

FDA's leaders have, in an ad hoc way, talked about this concept for almost a decade, under the rubric of "personalized medicine."

The coalition seeks to jolt the agency as a whole from this relatively unfocused posture to a dramatically more dynamic and narrowly focused one.

Its petition asserts that companies involved in the fusion of pharmaceutical and digital technologies can no longer reasonably be expected to go individually to FDA, as in the past, for case-by-case discussions on the way forward.

Besides the delay this creates in decision-making at both the inquiring company and the agency, the petition says "there is never a written record produced" of such discussions. Although FDA usually makes its own informal memoranda of meeting for internal use, these are not routinely shared (produced) in written form for the company.

"Oral advice from one or even a handful of FDA employees does not mean that the advice given will remain true," the petition says, adding that this "is not a fair system. It replaces the rule of law with the rule of people. If everything is up to the agency in its discretion, there is very little practical oversight of the agency."

There can be little doubt that, institutionally, FDA likes it this way.

Since it physically and procedurally cocooned its employees away from the news media over a decade ago, the agency--like all others in the government--has become steadily more opaque, notwithstanding President Obama's election promise to make his the "most transparent government in history" (hence all the talk about the virtues of "transparency" in the current election campaign!).

It is my observation that since roving journalists and public-interest activists left the agency's hallways and cafeterias, FDA employees in general have come to like transparency even less than their managers and politicians do, although nobody openly argues against it.

Likewise, the petition's authors do not belabor the point--but neither do they shirk it.

FDA's present system of dealing with the concerns the petitioners present "can be very unfair," they write. "It does not assure that different companies asking comparable questions are receiving harmonized answers. Among other things, the answers then tend to vary depending on which individual FDA official an industry person contacts . . ."

To remedy a process that does not work, the petition says FDA should eschew its comfortable broad approach and instead "begin to develop guidance, using the good guidance processes, on very narrow specific questions based on a specific set of facts. For lack of a better name, we call this 'case study guidance.'"

This is the core of the petition, built on input from the coalitions members and other entities that have identified topics "where case study guidance is needed . . . to identify common use cases that present common issues."

This resulted, the petition says, in the development of "three scenarios that typify in a very real way the issues that all these companies are facing."

The petition goes on to formally ask FDA for "a very focused" response to each of 26 specific questions "involving three very detailed use cases in areas of tremendous importance to the industry"--multiple sclerosis treatment, relapsing MS treatment, and gastrointestinal stromal tumor.

In presenting these questions, the petition says it has already had the benefit of FDA input, and invites more in the agency's ultimate response. The 26 questions are included in the appendix detailing the three case studies.

The petition concludes with brief explanations of the coalition's expected advantages to FDA, industry, and patients from issuance of the requested case study guidance.

For FDA, it says the agency will avoid committing broad answers to an entire technological field, as well as saving "substantial financial resources by publicly disclosing its responses to case study guidance requests, because it will not have to answer the same questions over and over again."

For industry, the petition foresees faster answers to questions in an important therapeutic area (digital pharmaceutical products) that is currently being impeded by an opaque FDA regulatory process, as well as fairness in the process.

For patients, the petition says, there is the obvious advantage of access to new and innovative products in the shortest possible time as well as the introduction of transparency to a process that is a mystery to the public. "It is all behind closed doors and under the veil of secrecy," as the petition terms it.

But for an agency that has luxuriated for so long in its introspective freedom from transparency to the outside world, the coalition's multiple arguments may be tough to embrace--something the petition seems to anticipate.

It acknowledges that "creating guidance in this space is a difficult task for FDA. For starters, it is hard to anticipate which direction the technology will go within the general area of software used in tandem with pharmaceutical products . . . Guidance that FDA issues could have unintended consequences if it is applied to scenarios that FDA has not previously thought about, because they did not exist . . . Moreover, to put it simply, this is hard stuff. If it was not difficult, and if it did not require judgment, industry would be able to figure out the rules based simply on the statutes and regulations. But alas, there are many different issues raised by these scenarios."

Too tough for an antiquated FDA?

Jim Dickinson is MD+DI's contributing editor.

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Regulatory Missteps Threaten Medical Device Innovation

Regulatory Missteps Threaten Medical Device Innovation

Changes to the U.S. patent system over the past several years are hurting the medical device industry.

Eb Bright

For generations here in the United States, patents have been the engine of innovation. Whether it's individual inventors, companies, or researchers at universities, the protections provided by patents for those attempting to make the world a better place have driven improvements that have bolstered our economy, addressed medical crises, and improved our lives. Over the course of time, patents have evolved in parallel with technological advancements from manufactured products to software technology. 

We have seen a seismic shift in patent development, too, as a greater proportion of patents are focused on software in the 21st century.  We find ourselves in a Golden Age of invention--with key new technologies making our lives better, making our day-to-day processes more efficient, and, in the medical field, helping to improve the quality of life and save lives through invention.

Unfortunately, a decade of changes caused by court decisions, Congressional missteps, and the predatory behavior of a few bad actors has threatened the U.S. patent system, a lifeblood of our economy. Nowhere is this more clear than in the medical device industry, where new inventions are being put on hold, innovation is suffering, and the impact of these decisions are being seen every day.

Learn about "Securing Intellectual Property Protection for 3-D Printed Models & Devices" at the MD&M Minneapolis Conference, September 21-22.

For those of us in the medical device industry, the ability to protect our inventions and pursue new innovation has been critical. In the last several decades, we've seen some notable developments in medical devices. Many heart surgeries transformed from opening a patient's chest for surgery to using catheters inserted through small openings making recovery time shorter and less painful; sinus surgery and prostate surgery transformed from operating room surgeries to procedures performed in doctor's offices saving time and money for the healthcare system, patients and employers; leukemia, breast and colon cancer transformed by genetically-personalized diagnosis and treatment--or as it is most commonly referred, "personalized medicine." These strides were made possible because inventors and their investors knew that their inventions could not be stolen and replaced by cheap knockoffs.

Bright

The system that has been working so well now finds itself in dire straits. Years of congressional underfunding and redirected dollars have severely hobbled large portions of the U.S. Patent and Trademark Office, leading to a broken examination process and a generation of questionable patents being approved in new technological areas. Combine that with a decade of shifting jurisprudence and acute U.S. Supreme Court decisions that have blown a hole in the patent system--most notably via the eBay, Mayo, Myriad, and Alice decisions--and we've been left with a broken protection scheme that has consequences for everyone from giant corporate behemoths to individual inventors tinkering in their garages.

The impact on small companies, universities, and individual inventors is insidious. Take the Myriad decision, for example. The stocks of the largest biotech companies GlaxoSmithKline, Merck, and Amgen rose sharply after the Supreme Court's decision. Those companies no longer have to worry about small company or university patents on isolated genes from stopping them using their market dominance and manufacturing resources to be in essence generic drug manufacturers without paying or paying less for the new discovery of others.

The economic effects of these situations is tangible. As the Patent Office has become more favorable to those challenging patents in an effort to make money off other people's work, it's created broad apprehension among investors and the business community writ large. I'll give a hypothetical: let's say a large company wants to license or acquire a patented invention that will make the lives of patients better. In the past that transaction would have been straightforward--meaning patients would get the updated services they need; now the decision is fraught with uncertainty. Many in the business community are afraid to enter into such agreements, wary that they may be licensing or acquiring something that is ultimately invalidated. Why pay for something when you could wait and possibly get it for free, or you could challenge yourself, knowing the Patent Office was preconditioned to rule in your favor?

The current environment has had a deleterious effect on universities, individual inventors and startups who historically have supplied to or partnered with larger corporations in order to move innovation from the drawing board to the doctor's office. That's no longer the case.

It's clear the current system is working for no one except those who want money for nothing. America's inventive spirit has been the lifeblood of our economic growth for generations, moving us from horse-drawn carriages to electric cars in just over a century. Missteps by the courts, Congress, and the Patent Office have threatened to drive that underground, unwittingly rewarding a few large corporations happy to profit off the work of others at no cost to themselves. That's not the American way.

Eb Bright, JD, MBA is a former patent attorney and current President & General Counsel at ExploraMed, a medical device incubator.

[Images courtesy of KHUNASPIX/FREEDIGITALPHOTOS.NET and EB BRIGHT]

High-Speed CLIP Printing

    Arrow  back3-D Printing Carbon

Google last year invested $100 million in Carbon to commercialize its high-speed CLIP (Continuous Liquid Interface Production) process, which uses ultra high-performance urethanes.

The technology was actually inspired by the movie Terminator 2 and the way the next generation T-1000 robot assassin rises out of a puddle of material. CLIP promises printing speeds 25 to 100 times faster than conventional 3-D printers.

Johnson and Johnson has already forged a medical device partnership with the company, which unveiled its first commercially available CLIP printer, the M1, in April. 

The 10 Most Promising Medical Technologies of 2016 >>

See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image courtesy of Carbon]