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A Black Market for 3-D Printed Organs?

The rise in 3-D printing technologies has inched us closer than ever to a world where the press of a button could produce a functioning human heart or kidney--but what if this kind of power falls into the wrong hands?

Kristopher Sturgis

Shadowy FigureAs 3-D printing technologies advance alongside modern medicine, one of the grim realities of making advanced bioprinting devices available to the public means opening the door for criminals to take advantage of the power to create and manufacture human tissue, as Wired recently noted. 

As medical printing technologies slowly become a staple of modern medical facilities, how do we stop unlicensed and unlawful citizens from taking matters into their own hands to produce cheap, low-quality bioprinted organs?

Such a scenario isn't as farfetched as it sounds, according to Wired. There are literally scores of patients around the world in need of an organ transplant with no insurance, or no access to the appropriate channels for an organ transplant. What's to stop them from turning to the black market where they could simply request the organ of their choice to be printed at the push of a button for a fraction of the cost--especially if their life depends on it?

While such realities are as daunting as they are plausible, there still remains a laundry list of technical and regulatory hurdles that need to be addressed, which could buy enough time to address some of these issues. The mere fact that a black market for 3-D printed organs is even possible is a testament to the accelerated pace of bioprinting innovations.

Lately researchers have produced a bevy of different 3-D printed innovations, from 3-D printed cells using a bioprinter, to 4-D printed creations that involve materials that can transform and self-assemble. Researchers have been working tirelessly to unlock the secrets of 3-D bioprinting considering all the potential breakthroughs such a discovery would usher in.

Earlier this month, researchers from four different universities teamed up to create a new bioprinter that can preserve cells better than any traditional scaffold 3-D printing techniques. These traditional scaffold printers utilize a process that squirts bio-ink through a nozzle to create its objects in layers -- a process that can damage and kill cells. Instead, this new bioprinter builds structures by placing groups of cells in fine needle arrays based off of pre-designed 3-D data, allowing the cells to bond and fuse into tissue.

However, despite some of these leaps in bioprinting technologies, some of the major concerns --like the potential unsanctioned sale of 3-D printed human organs--remain a significant barrier to progress. Granted, any kind of black market for 3-D printed organs could be avoided by streamlining the process of bioprinting, making 3-D printed organs affordable enough to become a normal part of healthcare. This would allow the majority of patients, who have relatively comprehensive healthcare, to have reasonable access to 3-D bioprinting technologies, making them less likely to resort to any kind of black market organs.

The next challenge would be to curb the use of knock-off printed organs in the poorer areas of the world where money and resources are scarce, making it difficult for patients in need of organ transplants to have access to 3-D bioprinting technologies. As we've already seen in the past, patients in need of life-saving organs will resort to virtually any means necessary if it can deliver them the organ they need.

With such grim realities on the precipice of this kind of breakthrough, it seems that the use of advanced bioprinting techniques could be the opening of a new medical Pandora's box. While it still may not be clear whether or not 3-D printing technologies hold the key to solving all the issues surrounding organ donation, the promise of 3-D bioprinting solutions remains quite significant--and the impact could be rather historic. 

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

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[Image courtesy of Frasier Mummery per Creative Commons 2.0 license]

Will CE Mark for Boston Sci's Lotus Edge Impact the TAVR Market?

Will CE Mark for Boston Sci's Lotus Edge Impact the TAVR Market?

Lotus Edge, the next-generation transcatheter aortic valve (TAVR) from Boston Scientific, has received CE Mark for use in high-risk patients with severe aortic stenosis. With features that should maintain low rates of paravalvular leak and potentially offer a lower rate of required pacemaker implants, market watchers speculate this TAVR could possibly win share from Edwards Lifesciences and Medtronic, the two lead TAVR makers.

Learn how to "Overcome Barriers for Achieving Market Adoption" at BIOMEDevice San Jose, December 7-8.

Larry Biegelsen, Wells Fargo senior analyst, wrote in a September 19 research note that there have been 21 Lotus Edge procedures conducted in Australia, as well as a "handful in Europe." In its release, Boston Scientific noted that the valve will be available in certain European centers, with more sites to be added as implanters and sites are trained.

Boston Scientific's Lotus valve was known for low rates of paravalvular leak (PVL). PVL is considered a relatively common side effect of TAVR and while many cases are mild, it is taken seriously because it has been linked to higher mortality. The Lotus Edge is designed to continue these low PVL rates with its Adaptive Seal technology, the company release noted. According to the company, in the 1000-patient RESPOND post-market registry, 7.7% of patient had mild PVL, but none were severe and just 0.3% of patients had moderate PVL.

The Lotus Edge also includes a lower profile catheter with more flexibility.

On the other hand, the Lotus valve was also known for a relatively high pacemaker rate, a factor that negatively impacted its market penetration. Lotus Edge's design incorporates Depth Guard, the company release noted, which is supposed to cut the permanent pacer implant rate following the TAVR procedure. 

Biegelsen wrote in his note that Boston Scientific's management anticipates the Lotus Edge pacemaker implant rate to be on par with the low-teens rate of Edwards Lifesciences' Sapien 3 valve. Pointing out that this expectation is an improvement from recent management commentary predicting an eventual pacemaker rate in the mid-teens, he wrote that this could mean the company is seeing good early results from the Lotus Edge.

While data on the new valve won't be shown until the Transcatheter Cardiovascular Therapeutics conference at the end of October, Biegelsen added, "If the Lotus Edge pacemaker rate is comparable to the rate with Sapien 3, BSX may be able to take more share than the Street currently models." He wrote that according to discussions with physicians, any market share win may come more from Medtronic than Edwards, as the Medtronic CoreValve is a self-expanding TAVR, like the Lotus platform.

Calling the Lotus Edge "highly anticipated," Ian Meredith, MBBS, PhD, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, said in the release, "It retains many of its predecessor's unique and valuable proprietary features, including the ability to reposition the device precisely and prevent paravalvular leak, while incorporating new design characteristics such as a more flexible catheter for easier delivery and Depth Guard technology designed to reduce valve interaction with the conduction system of the heart during valve deployment."

[Image courtesy of BOSTON SCIENTIFIC CORP.]

FDA Seeks App to Prevent Overdose Deaths

The agency is holding a competition for a mobile health solution to reduce the epidemic of painkiller overdose deaths across the United States.

Chris Newmarker

Opioid Epidemic FDAFDA is calling on innovators from all disciplines to create a mobile phone app that can help people overdosing from prescription painkillers, heroin, and other opioids connect with people nearby who are carrying the prescription overdose antidote naloxone. (Nalaxone is sold under the brand name Narcan, among others.)

The 2016 Naloxone App Competition will provide a $40,000 prize to the highest scoring entrant, as well as potential access to NIDA Small Business Innovation Research (SBIR) grants. FDA is holding the competition with support from the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA).

"With a dramatic increase in the number of opioid overdose deaths in the U.S., there's a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose--or a bystander such as a friend or family member--with someone who carries and can administer the life-saving medication," FDA Commissioner Robert M. Califf, MD, said in a news release.

"Through this competition, we are tapping public health-focused innovators to help bring technological solutions to a real-world problem that is costing the U.S. thousands of lives each year," Califf said.

The need for more life-saving options is serious. Roughly 78 Americans die daily from an opioid overdose--with nearly half a million dead from drug overdoses between 2000 and 2014, according the U.S. Centers for Disease Control and Prevention. The CDC cites prescription opioid pain relievers as a driving factor in the 15-year increase in opioid overdose deaths. When access to the prescription painkillers is cut off, users sometimes turn to buying heroin and other opioids on the streets.

The U.S. painkillers epidemic received additional attention after it was revealed that the music legend Prince died in April due to an overdose of the painkiller fentanyl.

Overdose deaths could have been prevented if those suffering overdoses had immediately received naloxone to stop or reverse the effects. Prince, in fact, reportedly received Narcan during a previous episode just days before his death, when his private jet made an emergency landing in Illinois after he became unresponsive.

The app competition has an October 7 registration deadline. FDA will then hold a two-day code-a-thon October 19-20. The results of the code-a-thon will be open-source and publicly accessible. Collaboration will be encouraged. Competition participants will then have until November 7 to submit a video of a functional prototype along with a brief summary of their concept. Judges from FDA, NIDA, and SAMHSA will evaluate final submissions.

"Mobile phone applications have been developed to educate laypersons on how to recognize an overdose and administer naloxone, and to connect bystanders with individuals in need of other medical services, such as CPR. To date, however, no application is available to connect carriers of naloxone with nearby opioid overdose victims," said Peter Lurie, MD, associate commissioner for public health strategy and analysis at FDA.

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.

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[Graphic courtesy of FDA]

U.S. Medtech Is Gobbling Up Europe

The trend of American medical device companies buying their European counterparts may slow, but Europe is unlikely to hop into the driver's seat, a new report says.

Nancy Crotti

Knife Fork PlateWhen U.S. medtech companies acquire European firms, the deals tend to be worth much more than those of European firms taking over American concerns.

That's according to a report by EP Vantage, which chalked the imbalance up to the fact that European medtech companies are generally smaller and less well-funded than their U.S. counterparts. Excluding Medtronic's $50 billion purchase of Ireland's Covidien, the biggest U.S. to Europe deals to date include:

In a technically in-Europe deal, Medtronic also agreed in May to buy Smith & Nephew's gynecology unit for $350 million.

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.

The top five Europe-to-U.S. deals the service listed for 2010 to 2015 were:

  • Novartis' $51.6 billion staged takeover of Alcon, completed in 2010;
  • Endo International's purchase of American Medical Systems in 2011;
  • Covidien's $2.6 billion acquisition of ev3 in 2010;
  • Fresenius' $1.7 billion of Liberty Dialysis Holdings in 2012;
  • Grifols' $1.7 billion purchase of Novartis' blood transfusion business in 2013.

Endo later sold off the urology device business it landed through the American Medical Systems acquisition to Boston Scientific.

European venture capitalists may have begun to lose their reluctance to invest heavily in medtech, particularly early-stage companies. European VC has raised several large medtech-focused funds this year. In March, Geneva-based Endeavour Vision raised a $275 million fund solely for medtech, the news service noted. Swiss/Dutch device maker G-Therapeutics (Switzerland/Netherlands) put together $40.2 million for a spinal cord neurostimulation product, according to Ecole Polytechnique Federale de Lausanne in April. And VC fund Forbion (Netherlands/Germany) earmarked about 30% of a $208 million healthcare round for medtech that same month.

But it may be awhile before European medtech companies can really compete at the level of U.S. companies in terms of having the financial heft for making acquisitions. European companies also carry the cachet of lower tax rates than those domiciled in the U.S., making them more attractive for takeover. U.S.-based companies looking to save on their taxes are more likely to seek out takeover targets in Switzerland and the U.K., which each have lower corporate tax rates than the United States, the site said.

U.S. companies keep trying to complete these so-called tax inversion deals, despite the U.S. Treasury Department's efforts to curb the practice. DOJ won one in April, when Pfizer and Allergan called off their proposed $160 billion deal.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of Pixabay]

Boston Sci's Lotus Edge Wins CE Mark

The newest Lotus TAVI system includes a more flexible, lower profile catheter.

Chris Newmarker

Lotus Edge Boston SciBoston Scientific announced Monday that the Lotus Edge, the latest version of its transcatheter aortic valve implantation (TAVI) technology, has received its CE Mark.

The Lotus Edge is indicated in Europe for use in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. The plan is for the Lotus Edge to be used in select centers in Europe, with commercial site expansion accelerated as physicians become fully trained.

The Edge's advantage over the previous Lotus valve system include  a more flexibl catheter with a lower profile, designed to improve ease of use and accommodate the patient's anatomy. The Edge also includes the Depth Guard design element meant to reduce the need for a permanent pacemaker by further limiting valve interaction with the conduction system of the heart during deployment.

"The Lotus Edge valve system is designed to give physicians increased control during implantation, which can help provide a more precise, predictable procedure to ensure the best patient outcomes," Kevin Ballinger, president of interventional cardiology at Boston Scientific, said in a news release.

The original Lotus valve system received CE Mark in 2013. Boston Sci has touted its unique design that resembles a Chinese finger trap, even though it is made of nitinol instead of fiber. The design enables the Lotus to be collapsible, elongated, and very flexible, greatly improving control during implantation.

The valve received its CE Mark nearly three years ago. But it remains an investigational device in the United States, where Edwards Lifesciences and Medtronic are the dominant players, as well as Japan.

The Lotus valve system recently ran into some recall troubles in Europe, with Boston Sci pulling any valves made before March 2016 that had not been implanted already. There were no safety concerns for patients who already had the valve implanted. Rather, the recall involved the release mandrel breaks in the valves' delivery systems. The delivery system problem caused health providers to resheath and remove the device, prolonging the implant procedure. There were three deaths caused by catastrophic vessel trauma.

Starting in March, Boston Sci made a component change to correct the problem.

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

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[Lotus Edge image courtesy of Boston Scientific]

Gore Goes After Aortic Arch Disease

Gore Goes After Aortic Arch Disease

The Gore TAG Thoracic Branch Endoprosthesis (TBE) device, which is designed to treat lesions of the aortic arch and descending thoracic aorta less invasively, has entered a pivotal trial. W.L. Gore & Associates, Inc., the makers of the TBE, announced implants have begun, with the first TBE patient enrolled at the University of Michigan Frankel Cardiovascular Center.

This study is meaningful because if eventually approved, the TBE would be the first device to offer aortic arch treatment in a less-invasive manner. Instead of requiring open surgery, the TBE allows physicians to deliver the graft using a catheter inserted into the femoral artery. This endovascular repair approach is already popular for treating abdominal aortic aneurysms. 

As noted in the Gore press release, patients with aortic arch disease typically undergo either open surgery, a hybrid treatment with surgical revascularization, or procedures that use endovascular devices off label. FDA has granted Gore's TBE the Expedited Access Pathway designation, which is reserved for devices that address unmet needs and offer meaningful benefit for patients with life-threatening conditions.

Around the aortic arch, the aorta is divided into different "zones" by the braciocephalic artery (BCA), the left common carotid artery (LCCA), and the left subclavian artery (LSA). Zone 0 is the portion of the ascending aorta below the BCA, Zone 1 is located between the BCA and LCCA, and Zone 2 is the portion of the aortic arch between the LCCA and the LSA. The pivotal trial will include up to 435 patients at up to 40 U.S. sites and all of the patients need treatment for lesions in Zone 0-2.

Gore's device is an off-the-shelf device that includes a side branch component--necessary to ensure a branch vessel isn't blocked and continues to have normal blood flow. 

Himanshu Patel, MD, section head of adult cardiac surgery at the Frankel Center and co-national principal investigator who enrolled the first TBE patient in the trial, said in the release, "The conformability of the GORE® TAG® Device combined with the unique side branch design provides a less-invasive treatment of the aortic arch with opportunities for perfusion of the brachiocephalic, left common carotid, or left subclavian arteries."

"The first implant of the TBE in the pivotal study is the latest step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market," Ryan Takeuchi, Aortic business leader at Gore, said in the company release. "Following a legacy of 'firsts' for this device family, we are now the first to advance this therapy into the pivotal phase, allowing the treatment of challenging aortic arch pathologies with an off-the-shelf endovascular device."

[Image courtesy of W.L. GORE]

Balancing Usability with Cybersecurity in Medical Device Design

Balancing Usability with Cybersecurity in Medical Device Design

As device manufacturers try to improve cybersecurity, they need to consider how users might perceive and react to security measures.

T. Grant Leffingwell

Digital medical devices continue to grow in complexity and as such, cybersecurity is becoming increasingly important. Medical device manufacturers are developing sophisticated ways to ensure the digital integrity of their devices as well as the confidentiality of the information they contain or transmit.

With this increased focus on cybersecurity, it is imperative for manufacturers to consider how such security measures impact usability. This is especially important because poor usability in a medical device can result in harm.

It can be challenging to determine how to balance usability needs and cybersecurity concerns. One of the well-known ironies of product development is that the more secure you try to make something, the less secure it actually becomes. This occurs for a number of reasons, chief among them is the desire for users to circumvent anything that interferes with their natural workflows.

This behavior is especially prevalent with medical device users. Clinical users tend to have less patience for excessive security controls than do most others because they view burdensome security as an impediment to rapid, effective health care. Next time you visit a hospital, take note of how often you see security controls circumvented: computers that have passwords taped to their monitors, locked rolling carts with the combination lock number written on the frame, and so forth. It's not that healthcare professionals don't appreciate the value of secure systems--it's just that there is little tolerance for anything that interferes with their primary goal of patient care.

That's why, if you're developing a system that will need security controls, it's absolutely essential to conduct contextual research at the earliest opportunity. For instance, the user-shadowing observations that occur during an ethnographic study can help document those places in the process where security may be circumvented.

Another reminder is to consider "security fatigue." If users experience excessive and unnecessary controls, they quickly tire and become frustrated, leading to evasions and circumventions. How are they to know which controls really matter and which don't? By strategically employing security measures only when necessary, users will be more likely to cooperate with them.

Balancing usability with cybersecurity will continue to be a challenge, but studying your users early and placing their needs at the center of the development process is the best way to maximize your chances of making a system that is both usable and secure.

T. Grant Leffingwell is a principal research scientist and a certified usability analyst at Battelle.

[Image courtesy of DAN/FREEDIGITALPHOTOS.NET]

Enter the 2016 Dare-to-Dream Medtech Design Challenge

Enter the 2016 Dare-to-Dream Medtech Design Challenge

If financing weren't an issue, regulatory hurdles were absent, and reimbursement were guaranteed, what dream medical device would you design?

MD+DI is launching our fourth Dare-to-Dream Medtech Design Challenge, a contest of bold ideas and limitless possibilities.

The idea is simple: If financing weren't an issue, regulatory hurdles were absent, and reimbursement were guaranteed, what dream medical device would you design?

The grand prize winner gets $500, while the first and second runners-up will receive $250 and $100 respectively.

To enter, fill out the form below. Along with written answers to the questions, please submit a good-quality rendering or image of the device you are dreaming up.

MD+DI's editors will narrow the field to a maximum of 10 finalists, and our panel of esteemed judges will select the winners. 

Entries will be scored based  on the following criteria:

  • Creativity and design (25 points).
  • Market viability (35 points).
  • Potential impact on healthcare (40 points).
     

See here for the official rules of the competition, which is only open to entrants  based in the United States or Canada (excluding Puerto Rico and Quebec). The deadline for submission is October 14, 2016.

Here are our judges--please check back as we may add more judges: 

 

Bill Evans
Evans is founder and president of product design firm Bridge Design, a Ximedica Company, in San Francisco, which for more than 20 years has helped design products for the medical and life science industries. Evans is also a member of MD+DI's editorial advisory board.

 Dr. Stephanie Kreml

Dr. Kreml is the chief medical officer for Accordion Health where she works alongside data scientists to develop machine learning-based tools to enable healthcare organizations manage their patient populations. Before joining Accordion, she was a Principal at Popper and Company, a strategy consulting and transaction advisory firm for the medical technology and life sciences industries. Dr. Kreml serves as a juror for the Medical Design Excellence Awards and is an advisory panel member for Dell Medical School's Texas Health Catalyst program. Prior to medical school, she held engineering positions with Motorola and Texas Instruments. Dr. Kreml received her Doctor of Medicine from Baylor College of Medicine and her Bachelor of Science in Electrical Engineering from The University of Texas at Austin.

Wende Hutton

Hutton is a general partner at Canaan Partners, a venture capital firm in Menlo Park, CA. She has facilitated bringing more than a dozen medical devices and drugs to market. She sits on the board of several firms, including ReVision Optics, Chrono Therapeutics, and Glooko.

Good luck to all, and may the best dreamer win. To enter, please either click here or fill out the form below.

How to Develop Mobile Health Apps Built to Last

To survive past launch, mobile health products must show strong evidence across clinical outcomes, usability/workflow, security, scalability, and economic value.

Anand K. Iyer, PhD, MBA

Mobile health continues to attract startups and developers. The space is still new and exciting, and the needs it can help address are vast. So, how do you ensure that your company's mobile health application rises above the fray?

If your organization is developing a wellness app that helps consumers track fitness metrics and diet, then a focus on user experience and performance is critical. But for apps that monitor vital signs, track medications, give advice to patients, enable telehealth visits, or deliver clinical data to physicians at the point of care, there's so much more to consider.

Hear Anand Iyer's talk on "Building Evidence-Based Requirements for mHealth Products" at MD&M Minneapolis on September 22, 2016.

Often referred to as digital health therapeutics, these "heavier" solutions tackle chronic conditions such as hypertension and diabetes. They should aim to enhance patient engagement, increase interactions with a patient's healthcare team, and, ultimately, improve patient outcomes over time. To succeed in this realm, however, you need evidence across multiple domains.

It all begins with the domain of engagement. The first hurdle is getting a lot of people to download the app and start using it, so you have a basis to measure their progress. This might require some sort of enticement--a "try before you buy" offer (if yours is a paid or prescribed mHealth solution) or a gamification element that attracts the eyeballs.

But that's just the beginning. The following are some other domains to consider.

Outcomes

Whether your solution is designed to improve healthcare staff productivity or lower someone's cholesterol, you'll need to demonstrate its effectiveness. For chronic disease management applications, you'll need to collect and analyze patient data. There are two methods for obtaining clinical evidence: the gold-standard randomized control group study and--with the increasing proliferation of digital health solutions--the more nimble, yet highly effective micro-trial. Cash-strapped startups can start with the micro-trial, which may be less costly and faster. Consider all of the patient health data that's available today through apps and popular devices like the FitBit and the Samsung or Apple watches. By collecting anonymized data from users and applying some basic analytics tools, you can make useful connections between user outcomes and characteristics such as gender, weight, age, ethnicity, lifestyle (diet and exercise), income, and education. You might still wish to conduct a control study later, depending upon what you uncover in the micro-trials.

Workflow

Many digital health therapeutics can be more effective with interaction from healthcare staff. If you're going to ask an overworked physician to do something extra, the effort better provide immediate value to his/her job. This is what's so exciting about mHealth: If the solution is designed well, the doctor picks up the phone in his pocket or clicks the screen on the EMR, and sees a longitudinal and holistic picture of what's happened with the patient, thereby helping support clinical decisions and appropriate treatment pathways. If the solution can deliver new information to aid decision-making that wasn't readily available before, even better. The solution should integrate as many relevant data sets as possible so that the nurse or doctor doesn't have to login to yet another system. Look for opportunities to eliminate any provider usability barriers or negative impacts that your technology could have on provider workflow and profitability. Human factors testing with providers helps validate design against users' requirements with an eye on risk and where they struggle.

Security

Consumers often wonder why it's so hard for healthcare organizations to protect their data. The problem is, patient data resides in many places, within many different organizations. Therefore, mHealth solutions must incorporate multiple layers of security into the solution itself, while also enabling integration with other providers' systems in a secure way. While this is an industry collaboration issue as much as it is a technology issue, you don't want to be the vulnerable link in the chain.

Scalability and Extensibility

To gain market share and mind share, your app must attract a lot of users. The backend technology infrastructure for your solution must be able to flex with unpredictable demand without causing the app to run slow for everyone. Also, the application will have better long-term viability if it is applicable to more than one condition. No healthcare organization wants to amass a bunch of point solutions. Strive to develop a multi-purpose solution and one that also can run on many types of mobile internet devices.

Economic Value

There are several options for a profitable business model. One is risk sharing, in which the health plan or provider pays the vendor based upon improved outcomes and/or reduced costs for managing patient populations linked to using the technology. Prescribed solutions, such as WellDoc's BlueStar digital therapeutic for diabetes management, can be reimbursed through the health plan just as are other pharmaceuticals. Paid apps may be a tried-and-true third model, if your solution provides ample benefits to the consumer to justify the fees.

As you can see, there's no short road to bring to market a viable and valuable mHealth solution. Plan ahead and ensure you have the proper resources and timetable to address the necessary domains of evidence for your innovation, thereby giving it staying power.

Dr. Anand K. Iyer is chief strategy officer at WellDoc, a digital health technology company that develops mobile solutions to drive behavioral and clinical change in chronic disease. WellDoc has commercialized BlueStar, a digital therapeutic, for adults with type 2 diabetes.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Valves Balance Requirements for Small Size, High Performance

As medical devices get smaller, valves are evolving to suit OEMs' needs.

Frank Vinluan

This Koganei PVR media isolation valve has less than 35 mL
of dead space, which is important for ensuring accuracy and
repeatability in laboratory and testing equipment.

As medical devices get smaller and more mobile, medical device manufacturers continue to look for valves that are smaller yet also have high flow capacity. Meanwhile, they also want valves to consume as little power as possible. Those requirements are familiar to valves suppliers. But as medical technology increasingly finds a place by a patient's bedside, The Lee Co. (Westbrook, CT) is also seeing an additional requirement: valves that are quiet.

[See The Lee Co. (Booth #633) at BIOMEDevice San Jose, December 7-8, 2016]

"If you have an instrument that's next to your bed, you really don't want to hear clicking sounds in your instrument," explained Christopher Marchant, Lee's marketing manager. 

The Lee Co. makes this two-port high-density interface (HDI) solenoid valve for miniature fluidics applications in a smaller footprint. 

Valve technology is evolving in step with miniaturization trends in medical devices, an evolution that comes with growing pains. Space in medical devices is limited, but there are also limits to valve technology. Valves can only become so small before they bump up against the laws of physics, Marchant said. 

Koganei Corp. (Tokyo, Japan) also sees OEM requests for valves that are smaller and more energy efficient.

 [See Koganei Corp. (Booth #316) at BIOMEDevice San Jose, December 7-8, 2016]

In media isolation valves, which are used in testing or diagnostic equipment that call for high purity or the capability of isolating media, the company aims to reduce the dead space of air created when fluid flows through these types of valves. Reducing this dead volume is important for improving the accuracy and repeatability of laboratory testing equipment, explained William Miller, a U.S.-based sales manager for Koganei. Air in this dead space is one of the variables OEMs want to address to improve how a device or diagnostic instrument performs. 

"Purity has to be the key component," Miller said. "You can't have many different variables of contamination." 

Both Lee and Koganei supply valves for several different industries, but industrial applications don't overlap much with medical device valves, Miller said. Automotive companies, for example, focus on low prices. But medical device requirements for valves are more nuanced and complex. Medical OEMs ask questions about valves that are just not asked in the manufacturing sector, Miller added. 

But Lee has found some instances in which valve technology in non-medical applications is useful in medical products. For example, the company supplies high-speed dispensing valves that handle fluid quantities as small as nanoliters. That capability, adapted from inkjet printing, proved useful for medical and scientific applications that require high accuracy and precision, Marchant said. 

Regardless of the application, medical device makers are asking suppliers if they can eek out more life from their valves. Ideally, a valve's life expectancy matches the life expectancy of the device, Marchant said. But over hundreds of millions of cycles, valves can leak, compromising the life span of the component and the device. One way to increase a valve's life span is to use alternate materials that can provide a good seal that minimizes leakage. 

Lee monitors the market to see what medical OEMs need from valve suppliers. If the OEM wants to move forward on a particular project, Lee engineers can work with the OEM on design concepts and provide samples. Lee provides both stock and custom valves. In many cases, a stock valve is a starting point for discussing whether a custom solution is needed. 

Though Koganei was founded in 1934, the company is a relative newcomer to the United States. In 2015, the company decided to expand from Japan into North and South America, operating from a U.S. headquarters in Fremont, CA. Koganei is different than some other valves companies in that it sells products in the United States and Canada only through distributors. Those distributors tell Koganei which products or requirements medical OEMs are asking for. But that doesn't mean that Koganei doesn't work directly with medical device makers.

Working from a stock valve, an OEM may ask Koganei about adjusting a valve's power consumption or its flow rate. Sometimes those comments represent broad feedback about valves in devices, Miller said. But in other cases, a medical OEM is considering a product that would be proprietary to the OEM. If it's the latter rather than the former, Koganei and the OEM need to quickly clarify exactly what the device maker needs, Miller said. For example, if a device maker asks for valves that can handle liquid nitrogen, Koganei would decline that request because the supplier does not make on valves that operate under extreme cold. When a device's requirements go beyond what Koganei offers, the company suggests others with that expertise rather than proceed with a custom valve, Miller said. 

For Koganei, the typical sales cycle from the first meeting to prototyping and testing typically lasts 16 to 18 months. In that period, Koganei tries to understand as much as possible about the application in order to determine the best valve solution. Koganei will ask what media would be passed through the valve, as well as its temperature. That information helps the company determine what type of seal materials would be appropriate for the application. Koganei also needs to know what kind of duty cycle the OEM expects from the valve, whether it's 5 million cycles or 10 million cycles. Valve suppliers also need to know how a device will be assembled. For example, an OEM's plan to assemble the device in a Class 3 cleanroom may not modify a Koganei valve, but it could require the company to manufacture the valve differently than how it is currently made. 

It's important for medical device OEMs to convey clearly the exact problems that they are trying to solve, Marchant said. Understanding that problem can help a supplier find the valve solution. But sometimes, information does not flow freely. Even with non-disclosure agreements, some OEMs don't pass along key details about their devices. Marchant understands that there are proprietary aspects of devices that medical OEMs don't want to disclose. But he said that sometimes the valve supplier needs to know more, such as what is feeding the valve or how the valve will interact with other components in the device. 

"Not having that information minimizes how much support we can give them," he said.  

Frank Vinluan is a contributor to MD+DI. Reach him at [email protected]