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Controversial Essure Device Gets FDA Scrutiny

Thousands of women have complained to FDA about abdominal pain, headaches, and other complications after having the Essure coils implanted in their fallopian tubes.

Qmed Staff

U.S. FDA's Obstetrics and Gynecology Devices Panel heard sometimes emotional testimony on Thursday as a string of women blamed a Bayer's Essure contraceptive device for ruining their health, according to media reports.

Chandra Farmer, 33, said she experienced muscle weakness so severe that she collapsed in front of her kids; she finally had a hysterectomy to remove Essure last year, according to The New York Times. Gabriella Avina, who once worked for the company and helped explain Essure to women, said she's changed her mind after going through celiac disease and myasthenia gravis.

Planned Parenthood and the American College of Obstetricians and Gynecologists still back the device, saying there have been few problems overall.

Edio Zampaglione, Bayer's vice president for women's health care, tells NPR that complications are rare with the nickel-titanium alloy coils. "What we believe and feel is that these women represent the small percentage of women who have had a bad experience with it," Zampaglione says.

About 750,000 women have had Essure implanted since FDA approved it in 2002, according to The Associated Press.

FDA has received nearly 6000 reports of problems related to Essure, many listing multiple health problems. They include pain/abdominal pain (3353), menstruation irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936).

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

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A Tangled Web: The World of Synthetic Spider Silk

Who hasn't read a Spider-Man comic book and watched the web slinger save someone with his super strong homemade webbing? It turns out manmade silk that is stronger than steel is closer than we think.

Jordan Brandes

Bolt Threads
Engineered spider silk fibers wrapped around a roller. Image from Bolt Threads.

Easily marketable synthetic spider silk has been the holy grail of bioengineers for a long time and for good reason: it is five times stronger than steel and three times tougher than Kevlar.

Earlier this week, a California startup called Bolt Threads announced that it can use synthetic-biology techniques to engineer proteins that can be spun into fibers with properties they can alter depending on their customers' needs. More to the point, this is the first case of it being done on large scale.

Using real spiders has been considered impractical since the arachnids are, by nature, cannibalistic and therefore cannot be bred on a large scale. Several years ago, scientists even came up with genetically modified "spider goats" that produced spider silk in their milk. 

Scientists continue to find different methods to create spider silk in the lab. Recently, a startup has said they have come up with a new way to produce the material that is also able to improve its properties.

The team uses genetically engineered yeast brew silk proteins that are then spun into fibers. Thanks to customization the properties of the fibers can be adjusted by altering the temperature, tension and spinning process during creation. The company is hoping to put the high performance material in sport shirts and bras by 2016. Perhaps medical device applications will follow after that?

Though Dan Widmaier, PhD has been developing the company since 2009 along with his partner David Breslauer, PhD the concept is not a new one. Just a few years before Widmaier, in 2006, Kraig Biocraft Laboratories introduced their version of synthetic spider silk. Kraig acquired the exclusive right to use the patented genetic sequences for numerous fundamental spider proteins. In June of last year CEO Kim Thompson unveiled the first Monster Silk textile created for commercial use.

Overseas, the German-based AMSilk has been developing a globally unique fiber from recombinant spider silk and presented under the brand name Biosteel. The product can be manufactured as a monofilament or multifilament depending on client needs.

Like Bolt Threads, the spider silk for Biosteel is produced by synthetically producing proteins on to a fiber. Using biotechnology the raw material, initially in powder form, is produced in high quality and in greater qualities than could be achieved using biological spiders. The process is based on findings by Thomas Scheibel, PhD from the University of Bayreuth, which were further developed by AMSilk.

At the moment there is no synthetic spider silk on the market but the race is on among companies around the globe. Multiple companies are estimating prototypes to hit the market by the end of 2015 into early 2016 but whether or not that comes to fruition is anyone's guess.

Once mastered, scientists envision that "This integrated approach provides a general path towards de novo functional network materials with enhanced mechanical properties and beyond (optical, electrical or thermal) as we have experimentally verified," notes Shangcao Lin, PhD of MIT in his paper "Predictive Modelling-based Design and Experiments for Synthesis and Spinning of Bioinspired Silk Fibres" released last year.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

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Is AdvaMed's Leader Moving to a Pharma Trade Group?

Is AdvaMed's Leader Moving to a Pharma Trade Group?

Marie Thibault

Media outlets are reporting that Ubl may be leaving AdvaMed to head pharmaceutical trade group PhRMA.

Could the influential head of Advanced Medical Technology Association (AdvaMed), Stephen Ubl, be leaving the medical device manufacturer trade group for a top post at a pharmaceutical trade group? 

Politico Pro reports that Ubl, currently AdvaMed CEO, is expected to be named the new head of Pharmaceutical Research and Manufacturers of America (PhRMA). A source told the medical outlet that the announcement could be made as early as next week. A PhRMA spokesperson told MD+DI that "no decision has been made yet."

Back in April, John Castellani, president and CEO of PhRMA, announced he plans to retire on January 1, 2016. Castellani has headed the trade group since 2010. PhRMA spends far more on lobbying than AdvaMed does. The pharma group has spent about $10.3 million so far in 2015, according to the Center for Responsive Politics, while AdvaMed has spent $1.44 million over the same time period.

If true, the move would be a big change at AdvaMed, where Ubl has been the top executive for a decade. Back in 2013, MD+DI named him one of 10 people who changed the medtech industry. He is known as a powerful critic of the medical device tax and as MD+DI's Jamie Hartford wrote in 2013, "Ubl's ability to rally the industry behind this key issue has shifted the tone of Washington, DC politics in the medtech industry's favor."

AdvaMed declined to comment when MD+DI asked about the reports.  

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie 

[Image courtesy of ADVANCED MEDICAL TECHNOLOGY ASSOCIATION (ADVAMED)]

How Telemedicine Can Bend the Cost Curve

How Telemedicine Can Bend the Cost Curve

Arundhati Parmar

Telemedicine holds great potential as a way to treat and monitor patients effectively in the continuum of care as they move beyond the walls of a hospital into their home.

An analysis by PricewaterhouseCoopers shows that it also has the capacity to reduce the cost of managing certain chronic diseases. The infographic below based on a PwC report shows that introducing virtual care into the mix in diabetes management can significantly lower costs.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

7 Key Changes in the New EU In Vitro Diagnostic Medical Device Regulation

EU regulatory requirements could soon become stricter for in vitro diagnostic medical devices (IVDs), which cover a range of products that can be used for diagnosis, therapeutic drug monitoring, disease screening, assessment of medical interventions, and population screening.

Paula McCarthy

Paula McCarthyManufacturers ofIVDs need to comply with the IVD directive 98/79/EC in order to place their products on the market in the European Union. Amidst calls for stricter regulation of medical devices within the EU, the European Commission proposed a new IVD regulation in 2012. The stated aim of the revised legislation is to ensure better consistency and safer products, and ensure that advancements in technological and scientific progress that have occurred since the IVD directive was implemented is legislated for, while maintaining fair and free trade of devices throughout the EU. Since 2012, the proposed text of the regulation has undergone rounds of negotiation and revision, with the latest amendments being made by the European Council in June 2015. The next stage in the approval process is a 'trilogue' negotiation between the European Parliament, Council and Commission, after which the final text will be adopted, possibly in Q1 or Q2 of 2016.

In this piece, I will outline seven of the key changes to the legislation proposed as it stands, and discuss the industry impact of the regulation.

1. Classification System and Conformity Assessment

The new regulation proposes a classification system that constitutes a complete overhaul of the current classification system for IVDs. A rules system based on the internationally recognized Global Harmonisation Task Force (GHTF) classification principles is proposed to replace the current list system. IVDs are classified in accordance with the risk they pose to the individual and the risk they pose to public health. IVDs will be classified in to four classes in accordance with seven rules: Class A, B, C, and D; with Class A being the lowest risk and Class D being the highest risk.

It is estimated that under the new IVD classification system, over 80% of IVDs will be classified in the medium and higher risk categories (Class B, C, and D) and will require Notified Body involvement in the conformity assessment procedure. This is in contrast with the current IVD classification system, where approximately 80% of IVDs are classified in the low risk, self-certified category. Another significant departure from the current directive is that all devices that do not fit any of the classification rules are automatically classified as Class B, whereby a notified body will be required for conformity assessment. Under the current system, such devices are self-certified.

This change to the classification system is considerable and will no doubt impact greatly on the IVD industry, with increased time, complexity, and resources required to launch new products, as well as significant investment in transitioning current products to comply with the increased regulatory requirements.

2. Clinical Evidence

It is proposed that clinical evidence will be required to support the scientific validity of the analyte, the analytical performance and where applicable, the clinical performance of the device. A performance evaluation report that includes the scientific validity report, the analytical performance report, the clinical performance report and an assessment of these reports will be required. The report will need to be updated throughout the product lifecycle, and will be part of the technical documentation. The proposed clinical evidence requirement for IVDs is one of the most debated topics in the draft regulation, and has undergone much revision since the 2012 publication of the draft regulation.

3. Traceability

The proposed regulation mandates that IVDs (other than those for performance evaluation) must have a Unique Device Identification (UDI) on the device label. The UDI will be used for reporting incidents and field safety corrective actions. Similar to FDA UDI requirements, the UDI will consist of a production identifier and device identifier. A database will be established where the UDI of each device will be input.

4. Regulatory Responsibilities within the Supply Chain

The proposed regulation outlines new responsibilities for Importers and Distributors. Before making the device available on the market, importers and distributors will have to verify that the device: is CE marked and has a declaration of conformity; is accompanied by instructions for use; and has a Unique Device Identification (UDI). Additionally, importers will have to verify that the device is labeled in accordance with the regulation and is registered in the UDI database; as well as placing their name on the product label. Importers and distributors will be obliged to ensure that while the product is under their responsibility it is stored and transported correctly, and ensure that product complaints they receive are logged and forwarded to the manufacturer for investigation where necessary. Importers and distributors will be obliged to inform the competent authority if they have reason to believe that a device presents a serious risk or is falsified.

5. Notified Bodies

The proposed regulation contains detailed requirements for monitoring of the performance of notified bodies by national competent authorities; quality management system requirements; and training, education and experience requirements for notified body assessors. This focus on notified bodies should ensure better consistency in the application of the requirements of the regulations by manufacturers, and increase the standard of competency of notified bodies.

6. Vigilance and Post-Market Surveillance

A reduction in the timeline for reporting of a serious incident to the national competent authority to no later than 15 days from when the manufacturer (or representative) has become aware of the incident is proposed. An obligation for manufacturers to produce a Periodic Safety Update Report (PSUR) on at least an annual basis is proposed in the June 2015 revision of the draft regulation. The PSUR will summarize the device's post-market surveillance data and risk-benefit information. An electronic system will be set up where incidents, field safety corrective actions, periodic summary reports, PSURs and trend reports are input. Healthcare professionals (HCPs) and members of the public will have access to the electronic system at an appropriate level. This proposal constitutes an improvement in transparency, providing the public and HCPs with information to allow them to make more informed decisions about use of an IVD. However, there will be additional burden on industry in the provision of an annual PSUR and maintaining compliance with the 15 day timeline for reporting of safety issues.

7. Companion Diagnostics

A definition for a 'companion diagnostic' is provided in the proposed regulation. Companion diagnostic tests will be classified in Class C and will require notified body involvement in the conformity assessment. Additionally, such devices, when undergoing conformity assessment by the notified body, will need to go through a consultation procedure with the European Medicines Agency (EMA) or a medicinal products competent authority. The EMA or competent authority will give its opinion regarding the suitability of the device in relation to the medicinal product concerned. The proposed change in the regulation will be very significant for manufacturers of companion diagnostic tests. Under the current regulatory system, most companion diagnostic tests are classified in the lowest risk category, and are self-certified.

Industry Perspective

In a recently published Position Paper, the European Diagnostics Manufacturers Association (EDMA) raised concerns that the European Council's general approach of June 2015 contains a 'significant amount of technical anomalies' and states that 'the regulation as proposed would put an excessive and unnecessary administrative burden on small and medium-sized enterprises. It remains to be seen whether the concerns raised by EDMA will be addressed in the trilogue negotiations, and in the adoption of the final text.

Paula McCarthy is a senior regulatory affairs advisor for Acorn Regulatory.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

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Ex Machina: What Is the Risk of AI in Medtech?

The recent film Ex Machina could serve as a warning for the unforeseen consequences associated with future medical technology.

Brian Buntz

Are we beginning to create a cloud-based healthcare monitoring network that is reminiscent of NSA's warrantless surveillance program? A popular vision for the future of healthcare monitoring paints a picture of a vast network of iPatients, who play an active role in monitoring their own health metrics (or use technology that automates the process), and allow their smartphones to send their data into the cloud.

The main difference in this scenario and the NSA's surveillance program is that the data is for detecting and monitoring worrisome health conditions rather than for detecting potentially threatening security situations. In this case, doctors take on a role reminiscent to an NSA agent--leveraging cloud-based analytics to identify suspicious-looking health data patterns. A single doctor could even pull up a dashboard showing near real-time health data for a range of patients, and help identify which ones should be admitted to a hospital and which can rest at home.

But the doctor doesn't have to be alone in this task. Such a system could be used to help facilitate the diagnosis of all manner of urgent health problems. Certain processes like calling for an ambulance or reading a cath lab could be partly or entirely automated. Doctors could do more than use mobile monitoring technology to identify high-risk patients but also to contact them, recommending that they come in for further evaluation.

In the field of diagnosis, IBM is hoping its Watson platform will use its artificial intelligence capabilities to boost doctor's ability to, say, find out what is wrong with a patient admitted the ER or identify a tumor barely visible in an MRI. Cloud-based computing could scour immense troves of data to identify the sickest patients, suggest possible treatments, and help monitor them once therapy has begun.

A Warning from Ex Machina

While this vision may be exactly what our disjointed and inefficient healthcare system needs, it also opens up new risks as well. Such an intelligent health monitoring system may help us meet the needs of 21st century healthcare, but it may have unintended consequences as well.

What if, through a software glitch of some sort, an artificial intelligence system recommends against following a doctor's wise counsel? Or what about the security ramifications of having so much personal health data correlated to specific patients in the cloud?

The recent sci-fi flick Ex Machina serves as a warning of the bad that can happen when artificial intelligence systems begin to surpass human intellect.

The thesis of the film, directed by Alex Garland, is that technology developed to help humanity can backfire without the necessary safeguards. While his film focuses on artificial intelligence, it hints at the security risks of a range of fields including medical monitoring, the smart home, self-driving cars, and so forth.  

In the film, a technology titan named Nathan has created not only the world's most successful search engine but also artificially intelligent robots that can interact with humans naturally. His most recent robot, Ava, eventually becomes capable of manipulating its creator and his unassuming employee, Caleb, who was interacting with the robot to see if it could pass a modified version of the Turing Test.

Nathan's AI system came to be able to imitate human behavior after scouring vast troves of search engine data matched with data captured by smartphone sensors. For instance, by studying people's expressions while speaking on the phone, it was able to identify the patterns on conversation and tone intonations that are most likely to elicit a smile or a grimace. Those patterns were then actively used by the robot and eventually imitate those patterns when interacting with humans.  

The film also points to threats of the smart home, which has been touted as some for its potential to revolutionize the monitoring of the elderly. In Ex Machina, Ava learns to manipulate this system to suit her own purposes.

Which Is Riskier? AI or Hackers?

Even if such a potential outcome seems like it is far fetched, the notion of limiting human control of technology is risky. And linking vast amounts of patient data in the cloud carries with it security risks. Hackers are becoming more interested in personal health data (including identifying information such as names, social securities, etc.) because they can use that information for identify fraud, including using the data to obtain prescription drugs. Consequently, they are placing less value on obtaining data such as credit card numbers because the banks that issue them are getting better at detecting fraud and quickly shutting the cards down.

The notion that artificial intelligence represents a real risk if not implemented correctly also seems to be gaining ground as well. Recently PayPal and Tesla founder Elon Musk donated $10 million to an organization with the mission of lowering the potential risks posed by "human-level artificial intelligence." Stephen Hawking and Bill Gates have joined him warning about such risks.  

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

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Company Run by St. Jude Medical Founder Shuts Down

Former Kips Bay Medical CEO Manny Villafaña is on to his next venture. 

Manny Villafana
Manny Villafaña

Chris Newmarker

Kips Bay Medical shareholders this week voted to dissolve the company after a disappointing clinical trial of its mesh "sleeve" meant to aid in in coronary artery bypass graft surgery.

Manny Villafaña, who was Kips Bay's chairman and CEO until Tuesday, is a serial entrepreneur who playd an integral role in founding Minnesota's medical device hub. Speaking at MassDevice's Device Talks conference in the Twin Cities on Wednesday night, he recalled how the New York Yankees' great Mickey Mantle struck out a lot, but he always came back the next day and kept on swinging. 

"I'm not afraid to swing the bat," Villafaña said. 

The board of Plymouth, MN-based Kips Bay made the initial decision in June. With Tuesday's shareholder vote done, the company plans to file a certificate of dissolution with the Delaware Secretary of State on Thursday.

Villafaña recalled that fundraising was tough for Kips Bay, which started in 2007 as the Great Recession was ramping up. Meanwhile, FDA was raising the bar on what it expected Kips Bay to demonstrate. Villafaña and others at Kips Bay planned to demonstrate a percentage of success comparable to standard care.

"The FDA wanted a higher number of success for us, and that was a really tough bar to meet," Villafaña  said. 

Villafaña is a serial entrepreneur with decades of experience in the medical device industry. He started St. Jude Medical (Little Canada, MN) in 1976. St. Jude is now one of the largest medical device companies in the world.

Villafaña also launched Cardiac Pacemakers Inc., which is now part of Boston Scientific's Guidant business. 

With Kips Bay, the company had already reduced its headcount from 13 to eight employees in January, according to its most recent annual report. The decision to liquidate came after poor early angiographic results from a study in which Kips Bay's eSVS Mesh was implanted using the new surgical implant technique for the device. The nitinol mesh was supposed to wrap around saphenous vein grafts in order to support them.

The clinical feasibility study is now canceled.

Villafaña is still an enthusiastic medical device entrepreneur, though. He had to move up his talk at Device Talks so that he could make it to an 8:30 p.m. meeting related to a new undisclosed company he is starting. 

Villafaña recounted how he once witnessed a heart transplant in Spain. The old heart kept beating on the table and did not stop beating until the new heart started beating inside the patient. 

"When golf is as exciting as that, maybe I'll take on golf," Villafaña said.

Kips Bay Medical's heart was about to stop beating as Villafaña spoke, but it seems that a new venture is gaining a pulse. 

"I'm not ready to retire. I love what I do. I think I still have the energy. I think the brain is still working," Villafaña said. 

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

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MD&M Minneapolis Highlights

MD&M Minneapolis Highlights

Minnesota has long been the cradle of medical device innovation, and this year, during the state’s weeklong celebration of all things medtech, the MD&M Minneapolis conference and expo will roll into town with numerous opportunities for education and networking. If you’ll be in the Twin Cities area November 4–5, 2015, here are a few things you won’t want to miss at the event.

Advice from Industry

At MD&M Minneapolis, you’ll hear from experts at some of the most innovative medical device companies doing business today. You’ll learn about product development and commercialization from fellows at Boston Scientific, hear how Helius Medical’s CEO took a product from the drawing board to the market, and get the skinny on innovating with materials from an Olympus research engineer. Best of all, industry luminary John Abele, retired cofounder of Boston Scientific, will deliver a keynote on healthcare’s new patient value proposition and the role of technology in the industry today.

Business Buzz

Medtech’s business model is in the midst of an unprecedented shift. At MD&M Minneapolis, experts will help to make sense of the changing landscape with panels on emerging medical technologies and how information gathering, sharing, and ownership will affect the future of connected health. Attendees to this track will also hear about new business models that integrate services with medical device products and hear a case study on optimizing data, analysis, and feedback to improve medical innovation and patient outcomes.

Reimbursement Rundown

Reimbursement is undoubtedly one of the biggest challenges facing medtech today, so it’s fitting that the MD&M Minneapolis conference features an entire track to bring you up to speed. Attendees will hear from reimbursement experts on everything from evidence generation to strategies for obtaining a coveted CPT code. They’ll also get the lowdown on what’s next for the FDA-CMS parallel review pilot and hear how one company fared in its experience with the program.

Hands-On Innovation Instruction

Get your hands dirty in an interactive workshop run by Chicago-based Insight Product Development. In this three-part session, representatives from the award winning design innovation consultancy will cover identifying and assessing opportunities, driving innovation, and risk management.

Peer-to-Peer Networking

There’s no better place to interact with your industry colleagues than the MD&M Minneapolis expo. With more than 1000 exhibitors, you’ll have the chance to speak with suppliers and contract partners face-to-face. Through speed networking sessions, you can be paired with like-minded professionals for 10-minute mini-meetings. Or for a more casual atmosphere, join in the booth crawl and grab a drink while you troll the exhibitor booths. You can also rub shoulders with your industry colleagues—and learn something, too—at the Center Stage and Tech Theatre talks.

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie.

[image courtesy of TUOMAS_LEHTINEN/FREEDIGITALPHOTOS.NET]
 

Device Firm Receives 1 of 18 FDA Grants for Orphan Product Development

Device Firm Receives 1 of 18 FDA Grants for Orphan Product Development

Arundhati Parmar

On Monday, FDA awarded 18 research grants totaling more than $19 million to promote the development of products to fight rare diseases.

Only one of the 18 went to a device research project. A FDA spokeswoman clarified that typically more drug applications come through the agency's doors resulting in a higher proportion of grants being made to drug projects.

This year, the device firm that won one of the grants is Innovative BioTherapies, based in Ann Arbor, Michigan. The company will receive about $1.6 million over four years to study its Selective Cytopheretic Device for the treatment of pediatric patients with acute kidney injury. 

Innovative BioTherapies was founded in 2003 by Dr. H. David Humes, professor of medicine at the University of Michigan to commercialize intellectual property developed at the university. The company is funded by federal grants and contracts that focus on developing bioartificial organ based devices utilizing adult progenitor cells, biomaterials and MEMs technology, according to the company's website.

The Selective Cytopheretic Device is intended to treat acute inflammatory conditions that can be life-threatening. The SCD sequesters and deactivates those cells associated with the inflammation, and reduces their inflammatory activity.

"The FDA is in a unique position to help those who suffer from rare diseases by offering important incentives to promote the development of products, one of which is our grants program,” said Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development, in the news release. “The grants awarded this year support much-needed research in 17 different rare diseases, many of which have little, or no, available treatment options.”

The Orphan Products Grants Program was created in 1983 and since then has provided more than $350 million to fund more than 570 new clinical studies and supported the marketing approval of more than 50 products.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

To learn more about medical devices and trends in the marketplace, attend the two-day MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 

How Self-Driving Cars Can Steer Medical Devices to Success

How Self-Driving Cars Can Steer Medical Devices to Success

Medical device engineers can take lessons from the development of automated driving and apply them to the quest for closed-loop devices for diabetes, neurological disorders, and more.

Nigel Syrotuck

On the street, the statistics are staggering: 35,000 people will die and $450 billion dollars will be spent this year alone on car accidents in the United States. Errors like inattention, recklessness, and impairment will account for 90% of these accidents. Automation in driving is tackling this problem, and claims to reduce traffic accidents by 99%. Why shouldn’t automation in our healthcare system do the same, saving lives and money in the process?

The growing number of automated healthcare products marks a big step in the medical device industry. Operationally self-sustaining, these devices read an input and make their own decisions on how to react, without human input. This might seem worrisome at first glance, but the world is slowly coming to grips with the fact that software is often safer and more reliable than humans, despite added burdens like cyber security. The self-driving car is a great example of this: the math shows they’re safer, the engineers know they are more aware, and their accident record is far better than that of human drivers. Automated medical devices are poised to be the self-driving car of the medical industry, and we are all better off for it.

A much-anticipated device hitting the market is the Artificial Pancreas Device System (APDS), which is used to treat diabetes without any patient input. As an indicator of just how big and groundbreaking this market has the potential to be, FDA has issued specific guidance on it and Google just announced a deal with Dexcom to develop next-generation continuous glucose monitors (CGMs), which they claim will be about the size of a bandage. CGMs, which have been a successful product for a number of years, are essential in providing APDSs with the information they need to make decisions.

Another autonomous device is for Deep Brain Stimulation (DBS). This measures brain activity and responds with electrical signals, treating suffers of a variety of neurological disorders. Two of the main targets are essential tremors and Parkinson’s, but theoretically, any erroneous electrical disorders could be treated. Mass adoption of this device is held back by its riskiness, but future improvements could lead to this treatment being used more readily and patients getting a permanent solution.

An interesting topic of discussion when it comes to semi-automation is laziness (in the clinical sense). In the example of the self-driving car, if the car does 99% of the work the driver might become bored and distracted, not responding the 1% of the time he or she is needed. It is difficult to strike a balance to mitigate this issue, meaning in this example the technology must leapfrog from doing 1% of the work (for example, accident avoidance braking) to doing 100% of the work (full automation) without relying on the driver to step in. Most automated cars have a manual override function, but the vehicle doesn’t and can’t ever assume that feature will be used in times of trouble.

The analogue in closed loop digital health devices is user input. Let’s say for example you have an APDS, and you can use your smartphone to input your meal or exercise activity to add information. With this extra information, the device performance is improved. However, that information is not essential, so if the user doesn’t feel like inputting data they don’t. So why include this functionality at all? FDA has clearly declared human factors an essential component of good design for this reason: patient input in any form is an added source of risk. This creates a tricky, catch-22 scenario where the device should be able to function more effectively with user input in theory, but yet in reality is more likely to make mistakes. These devices must take the all-or-nothing approach that smart cars have, and go straight to 100% automation or risk the hazards of misuse.

What are the keys to success for automated device development?

  • Create a history of safety (consider marketing an early version as a wellness device)
  • Show they are more effective than human decision-based devices
  • Follow regulations on autonomous device and cyber security
  • Mitigate where required, and eliminate where possible, all risky user input

If autonomous devices follow the same road as self-driving cars then we are going to witness a jump in some crucial devices to 100% automation soon, creating a safer and more effective medical system. The real question the automotive market is trying to address right now is: despite the statistics showing that autonomous cars are safer, would you every buy one? If you were diabetic, would you ever switch to an ADPS? The way you answer this question will one day impact your life more than you might realize. 

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

Nigel Syrotuck is a mechanical engineer at StarFish Medical, a medical device design company headquartered in Victoria, British Columbia.

[Images courtesy of DAN/FREEDIGITALPHOTOS.NET and NIGEL SYROTUCK]