Scott Arthur Nelson, who was scheduled to go on trial January 16 with five other men, entered the plea in U.S. District Court in Minneapolis. Still facing trial are Starkey’s former president, Jerry Ruzicka, and former human resources senior vice president Larry Miller, as well as two friends of Ruzicka—Jeffrey Taylor, former president of miniature parts supplier Sonion, and Lawrence Hagen, who also aided in the alleged conspiracy.
Nelson, Ruzicka and Miller were fired from Starkey in 2015. Original charges in the case, which covers a complex web of activity over a nine-year period, range from making financial transactions related to fraud proceedings to conspiring to commit money laundering, wire fraud, and mail fraud.
According to the original indictment, Starkey's founder, principal owner, and CEO Bill Austin created an affiliate called Northland USA in 2002 that acquired and operated retail hearing aid establishments. Ruzicka and Nelson were accused of forging Austin's signature in order to transfer Northland USA's assets to an entity they controlled, called Northland Hearing Centers. Ruzicka and Nelson ended up awarding themselves restricted stock, paying themselves and another individual $15 million to in exchange for terminating the restricted stock grants, the indictment says.
It also claims that Nelson took $200,000 and used it to buy a condominium where he could engage in a secret relationship with a Starkey employee, and another $250,000 to restore his investment account after buying a home in Prior Lake, MN.
Nelson, 58, had previously pleaded not guilty to the charges regarding Northland Hearing, according to a report in the Star Tribune of Minneapolis. Nelson now faces up to five years in jail, and the forfeiture of up to $2.53 million in stock sale and insurance proceeds, the newspaper reported.
Nelson will also be required to cooperate with federal authorities regarding Ruzicka and Miller. Jeff Longtain, the former president of Northland Hearing Center, previously entered a guilty plea, according to the Star Tribune.
Starkey Laboratories will “continue to follow the government's case with interest and believe today's news represents another step forward in resolving this matter," a Starkey spokesman wrote in an email to MD+DI. One of the largest hearing aid companies in the world, Starkey employs 5,000.
You could call it the Uber of spine surgery.
Xenco Medical recently debuted a smartphone app to speed delivery of the company’s spinal implants and sterile, disposable surgical instruments to the operating room.
The San Diego startup’s TraumaGPS app allows a surgeon to notify a Xenco technician of an upcoming procedure. The technician delivers a variety of the company’s implants and instruments, and works with the surgeon to determine which will be needed for a particular patient, explained Xenco founder and CEO Jason Haider.
Sterilization of metal instruments can delay surgery for hours.
“It’s a very cumbersome process and it’s very time-consuming for the hospitals,” Haider said. “The implants are carried on that tray for hundreds of procedures until that size is used. Even if they haven’t’ been used, they have to undergo sterilization every time.”
Using Xenco’s fiberglass-reinforced, injection-molded, polyetheretherketone (PEEK) instruments eliminates the need for in-hospital sterilization, and TraumaGPS can further reduce delays for trauma surgery, allowing for more efficient use of the OR, according to Haider.
“We can optimize it one step further and that is to let you know exactly when they’re going to arrive so you can get the patients ready and you’ll save another hour,” he said. “That was the idea behind the app. It was to capitalize on the surgery-ready quality of our system.”
To save hospitals on disposal costs, Xenco contracts with third parties to collect and repurpose its used plastic instruments into other products, such as asphalt. The company used materials science to develop the PEEK instruments not only for their disposability, but because repeated sterilization can affect metal instruments’ calibration, Haider said.
Most patients undergo scheduled spine surgery due to the effects of aging or smoking, but some arrive at the hospital with a traumatic injury. This is where the Xenco app can really make a difference, according to Haider.
“Those require immediate stabilization,” he said. “This was really the reason that we wanted to do what we do, which was come up with a solution that eliminates all of those logistics, eliminates the safety issues and also brings down the cost.”
Haider began his career developing software and hardware for rehabilitation of patients with traumatic brain injuries. That exposed him to the healthcare system and the spine, inspiring the formation of Xenco. The company spent its first four years on R&D, Haider said.
Six-year-old Xenco also makes traditional titanium spinal implants and instruments and its products are available nationwide.It has clearance to market in Europe, but except for its pedicle screws, it is focusing on the U.S. market for now.
Adding connectivity and smart functionality to drug-delivery devices will inevitably have an impact on the use process for the patient (whether this is the intention or not), and there are very specific patient-device dynamics that need to be considered to ensure that the implementation of this technology is successful across all patient populations. It may be time that we reconsider our traditional risk-based human factors approach and update it for this changing technology landscape by taking a more holistic approach to usability.
It has been suggested that some of the key driving forces for developing connected devices are tracking patient adherence, a move towards evidence-based treatment methods, and beating competitors to market.1 As a result of this, it is possible that user needs are not always being given the attention they deserve. Furthermore, while the barriers to the adoption of consumer technology are well known, these barriers are slightly different within the domain of medical technology, and may be particularly complex when the wide variety of patient demographics and specific disease and treatment types are added. Consequently, it is possible that user needs are also not understood as fully as they could be.
Recent research has gone tried to improve our understanding of the potential barriers to the adoption and long-term use of connected devices by patients, specifically with reference to connected inhalers for asthma treatment.2 It suggests that these barriers may include:
Furthermore, when the complexities of other diseases and patient demographics are considered, the number of these more subtle patient-device dynamic issues expands. For example, by introducing an app for HIV/AIDS medication to track and improve patient adherence (among other things), is it possible that we are lengthening the drug-taking process and drawing attention to an often “stigmatized” condition that a patient would rather put to the back of their mind? This is likely to put patients off using a device and could cause it to fail to be a success long-term. Or, by adding expensive technology to already expensive drugs, might patients perceive themselves as paying for (be it through their insurance provider or out of their own pocket) technology that they do not need? This could cause patients to switch to a competitor’s product. Additionally, by adding smart functionality to an auto-injector for the treatment of arthritis, could the initial learning curve associated with this new functionality prevent elderly patients from using the device? Again, this will inevitably impact negatively on the long-term success of the product.
Current Human Factors Methods
Human factors testing within medical devices has for a while now taken a risk-based approach to ensure the safety and efficacy of drug-delivery devices. While established methods such as simulated use of devices in a study setting can address some usability issues, it is possible that the more complex, yet subtle, patient-device dynamics fail to be identified.
Furthermore, while these drug-delivery devices may be deemed safe and effective to use, simply being “effective” is not necessarily enough to ensure their usability and long-term adoption by the target market. There is a risk that medical technology may follow the trend that we have seen in consumer health technologies such wrist-worn fitness monitors, where users often stop using them after a short period of time.
Marketing teams within pharma companies may give some consideration to these issues, but it is not common for them to work directly with human factors engineers to understand the subtle complexities of these patient-device dynamics. Furthermore, user experience designers may have input regarding the usability of software applications and graphical user interfaces, but just because something is easy and enjoyable to use does not necessarily mean that it will not highlight a social stigma with a disease or introduce a fear of failure to the patient.
It may be time that we reconsider our traditional risk-based human factors approach and introduce a more holistic approach to usability. So, what does this mean in practical terms? First, and above all, we must continue with a risk-based approach to human factors, and it is fundamental that all drug-delivery devices continue to be developed to be as safe and effective to use as possible. However, we should also consider non-risk-based usability and consumer insights above and beyond what is already considered by user experience designers and market researchers today.
There are a number of ways in which we could do this. Perhaps we no longer segment our participants in human factors studies solely by demographics that could impact their immediate interaction with a product, but by factors such as the extent to which they have come to terms with their disease, their willingness to adopt novel technology, or their fear of failure. Perhaps we put more emphasis on conducting our human factors studies in a longitudinal manner, asking participants to use connected drug-delivery devices over weeks or months. Or perhaps we carry out further standalone research grounded in psychology, sociology, and the behavioral sciences to build on the research already done and consider anecdotal evidence witnessed by many human factors engineers to develop our understanding of these complex patient-device dynamics.
Of course, in doing this we are going to have to overcome barriers regarding budgets, time-frames, and stakeholder buy-in, and we will have to develop and refine new processes and methods. However, if this leads to a more successful drug-delivery device, and subsequently better outcomes for patients, improved patient adherence, a wider market share, and ultimately a more successful product, then surely it is worthwhile.
Bacteria may need to find a new home inside the body, as researchers from Georgia Tech’s school of chemical and biomolecular engineering announced this week the development of a new electrochemical etching process that can be used on common stainless steel alloys to create a nanotextured surface with bacteria-killing spikes. If clinical studies continue to progress, the new process could have a big impact on implantable devices, providing a surface that can fight against microbial contamination.
The new process is still under investigation as researchers try to understand the specific means by which the material actually kills bacteria. Their theory is that tiny spikes and other nano-protrusions are etched onto the surface, which punctures bacterial membranes and destroys the bacteria inside. Julie Champion, an associate professor at Georgia Tech and one of the lead researchers on the project, told MD+DI that the new process is just a tweaked version of a commonly used process.
“The process is a variation on the commonly used technique of electropolishing, which smooths the surface,” she said. “It creates nanoscale valleys, which also leaves nanoscale peaks remaining, etched on the surface of any common form of stainless steel that is currently used. This technique could be applied to any current stainless steel implants, surgical tools, or even food processing equipment to prevent bacterial infection without the need for chemical coatings or antibiotics.”
Champion and her colleagues found that the nanotextured surface can kill both Gram-negative and Gram-positive bacteria, while not having any harmful effect on mammalian cells. As long as the surface does not harm cells, it can be used to protect implantable devices from bacteria — as cells must be able to adhere to implantable medical devices inside the body.
“Bacterial adhesion and growth on medical devices can lead to serious surgical and implant infections, which can be life-threatening, prevent healing and functional recovery, and incur substantial healthcare costs,” Champion says. “For example, by 2030, prosthetic joint arthroplasties are projected to increase to 3.8 million procedures per year, and the risk of infection is expected to triple for hip and knee arthroplasty, resulting in a cost of more than $1.62 billion. There is a critical need to prevent infection of implants and surgical materials. Our process to modify stainless steel implants and tools in a simple, scalable way could reduce infection, and revise surgery, mortality rates, and costs.”
The genesis of the project actually came from an idea to create a super-hydrophobic surface on stainless steel that could repel liquids. Once the team discovered this would require the use of a chemical coating — something they wanted to avoid — they decided to explore the use of a standard electrochemical process. Typically used to polish stainless steel, Champion and her colleagues thought that the electrochemical process could be used to roughen the surface at the nanometer scale.
Under microscopic examination, the surface showed protrusions 20 to 25 nanometers above the surface, much like a mountain range with sharp peaks and valleys. Even more importantly, because the process relies on a biophysical process rather than a chemical one, strains of bacteria will not be able to develop any kind of resistance to it.
As the group moves forward with their research, Champion says their next challenge is to continue to scale the process and prepare it for applications in the field of implantable medical device technologies.
“We need to demonstrate that it can be scaled to large implants and that the nanostructure can withstand the forces generated in the body,” she said. “After we demonstrate this, we need to test real nanotextured implants in animal models so that we can demonstrate prevention of infection and general performance of the implant. Since the process is simple and is not adding new components to the implants, there should be very little development needed to scale from animal model implants to human implants.”
One of the main changes to ISO 13485:2016 “Medical devices -- Quality management systems – Requirements for regulatory purposes” pertaining to suppliers is the “increased emphasis on use of a risk-based approach to supplier management,” Ron Schmitz, president of Grand Avenue Software, told MD+DI. “Medical device companies are increasingly required to not only analyze supplier-related risks during supplier qualification, but also to monitor their suppliers’ performance and feed the monitoring results back to a requalification process.”
Grand Avenue Software will be exhibiting at Booth #1612 at MD&M West 2018 in Anaheim February 6-8, 2018.
Schmitz highlighted some of the changes that were introduced within Section 7.4 Purchasing of the 2016 standard. “Per this section, suppliers are selected according to criteria that are based on performance and ability to deliver, as well as on the overall effect of the purchased product or service on the quality of the medical device. A new area of emphasis is that these criteria must be in proportion to the risks associated with the medical device.”
Companies across the medical product supply chain now need to work towards compliance, Schmitz said. “For all involved, that will include a review of current practices versus the requirements, followed by new practices and possibly new tools to close any gaps.”
To help companies comply, Grand Avenue Software has added a new Supplier Management module to its software suite. The web-based platform can be hosted in a secure Tier III data center or deployed on-premise on a company’s own servers. “The user experience is completely available from standard web browsers on both desktop and mobile devices, allowing users to access the system when visiting suppliers,” he says. “And companies may optionally allow their suppliers to participate in the same system so, for example, suppliers can easily train on new documents, implement and verify corrective actions, or get notified of revisions to existing documents.”
The Grand Avenue Supplier Management module includes automated workflows for supplier evaluation and approval. The module also allows companies to dynamically generate their Approved Supplier Lists (ASL) based on current supplier status, eliminating the maintenance of updating a static ASL as suppliers are qualified, updated, and removed. Detailed supplier histories are maintained by the system, helping companies easily find and see related CAPAs, nonconformities, and audits for each supplier.
Schmitz said that historically many companies kept track of supplier activity by manually entering information into spreadsheets. “It was difficult in that environment to keep track of what was needed from each supplier and when. The new standard heightens the need for effective tools to manage supplier information.”
Schmitz said that ISO 13485 changed to adapt to evolving trends in the marketplace. “Unlike when the 2003 version of ISO 13485 was published, almost any aspect of taking a medical device to market can now be outsourced,” he said. “Even though it is common today for medical device manufacturers to leverage design, production, and service suppliers from around the globe, device manufacturers are ultimately responsible for product quality.”
Above: Example of Supplier Performance/History
Please visit Grand Avenue Software at Booth #1612 at MD&M West February 6-8 for more details.
Each year, MD+DI’s editors gather to choose which company should be named the Medtech Company of the Year, and it’s always a heated debate. This year, we named nine finalists, but the decision to crown Abbott as our 2017 Medtech Company of the Year was unanimous. Our readers, however, had a different opinion.
While MD+DI’s editors chose Abbott for its ability to rise above challenges, Bigfoot Biomedical was the favorite among our readership. The Milpitas, CA-based firm is amalgamating other companies’ hardware plus its own software and algorithms to craft an artificial pancreas for patients with diabetes, and readers were impressed by this scrappy startup.
“The hopes of millions of diabetics are waiting on them,” one reader wrote. “They have a personal connection which motivates them product and price-wise[,] and they made a fantastic decision to switch from DexCom to Freestyle Libre as the continuous glucose monitor for their system, delaying the release by going with a superior product. That's what companies who CARE do.”
Many readers also cited Bigfoot’s patient focus as a reason for their choice.
“In the area of diabetes[,] there are many companies working to build this "artificial pancreas." What many of them don't comprehend is that their solutions are not easy for patients and their caregivers to manage. They involve multiple devices and complicated technology. Bigfoot Biomedical is working hard to make their solution easy to use, as well as accurate and dependable.”
While Bigfoot Biomedical was our readers’ first choice for the 2017 Medtech Company of the Year, garnering more than 25% of the vote, the runner-up, nabbing just over 20% of the tally, was ResMed. Respondents lauded the San Diego-based developer of devices to treat sleep apnea, chronic obstructive pulmonary disease, and other chronic respiratory diseases for its embrace of connected care.
“ResMed is the most connected medical device company in the world and is driving patient engagement in their own sleep therapy with patient[-]friendly apps and connectivity,” one respondent wrote.
Coming in at third in our readers’ choice polling, with 19% of the vote, was Nashua, NH-based iCAD Inc., which develops cancer detection and radiation therapy devices.
“iCAD has achieved some significant milestones this year[,] including FDA approval of the first and only concurrent-read AI solution for 3D mammograms,” one reader pointed out.
Around 14.5% of readers agreed with the editors’ choice, with many citing the company’s new blood glucose monitoring solution.
As one reader put it, “Freestyle [L]ibre. Nuff said…”
Percutaneous Coronary Intervention (PCI, or angioplasty with stent) is a common procedure used to treat patients with obstructive coronary artery disease, with an estimated 600,000 procedures performed annually in the United States. PCI has a low risk of complications for patients, but that's not the case for clinicians.
Patients receive a dose of radiation during a PCI procedure, which takes anywhere from 30 minutes to a few hours. Interventional cardiologists and cardiac catheterization laboratory personnel are exposed to ionizing radiation all day, every day. Protective measures, such as radiation safety caps, goggles, and lead garments and shielding, minimize exposure but don't completely protect clinicians from radiation's harmful effects.
"Protection garments aren't full body," said Dr. Alan Lumsden, chief of cardiovascular surgery at Houston Methodist DeBakey Heart & Vascular Center at Houston Methodist Hospital. "Even with radiation glasses you get scatter radiation on your face."
That scatter radiation, and other exposure, leads to an increased risk of cataracts, thyroid disease, brain tumors, heart abnormalities, and hair loss for clinicians. Wearing a heavy lead garment every day for hours on end also leads to back strain and other orthopedic injuries.
Robotic-assisted PCI promises to dramatically reduce radiation exposure, as well as improve precision during the procedure. "You get a very fine control of catheters and wires," Lumsden said.
Houston Methodist is one of 50 hospitals worldwide to date to adopt Corindus Vascular Robotics's CorPath System, the only FDA-approved device for robotic-assisted PCI. FDA cleared the latest Corindus System, CorPath GRX, in 2016, and an earlier version, the CorPath 200, was a 2015 Medical Design Excellence Awards winner.
During the recent Pumps & Pipes conference, a gathering of oil and gas, aerospace, and cardiology leaders held at Houston Methodist, the hospital's Dr. Colin M. Barker gave an example of how robotic PCI can improve patient outcome. An 83-year-old man presented with both left and right arterial blockages. During the manual procedure, PCI for the left artery failed. When the patient returned for a second PCI, doctors realized, after two-and-a-half hours of trying, the catheter couldn't make the 180-degree turns required to treat the lesion.
The CorPath system made the turns in five minutes. "You can literally map out where you want to go one millimeter at a time and move the wire down," Dr. Barker said.
CorPath's Active Guide Management enables robotic control of the guide catheter along with a guidewire and balloon or stent catheter. Because of its micromovement and guidewire rotation, clinicians more precisely position stents, which may lead to "less metal in patients' arteries," Corindus president/CEO Mark Toland said.
Its most dramatic benefit, however, is its ability to dramatically reduce radiation exposure. In a study published in Cardiovascular Revascularization Medicine, researchers from Spectrum Health's Meijer Heart Center in Grand Rapids, MI, found that robotic PCI reduced cranial radiation by 99%. Use of a suspended lead suit during manual PCI reduced cranial radiation by 97%.
The Corindus-sponsored PRECISE trial showed the average overall radiation exposure to interventional cardiologists dropped by 95.2% compared with manual procedures. "Surgeons sit behind a lead-lined cockpit that protects them from radiation, as well as potentially reducing orthopedic strain and fatigue," Toland said. "They can do an interventional procedure in the safe confines of a robotic system."
To make the system more marketable to hospitals, Corindus designed CorPath to be compatible with all catheter-based technology and imaging systems. Toland said designing a system that met multiple manufacturers' specifications posed its share of challenges, but it also led to tremendous opportunity.
"This made the approval process easier," Lumsden said. "It gave us the flexibility to choose catheters we're used to, which saves the hospital money in the long run."
Toland said Corindus plans to expand CorPath's functionality to treat other vascular beds, which could lead to a new treatment for stroke patients, for example. Corindus also plans to automate certain CorPath movements, as well as expand into performing remote procedures. If successful, remote operation would allow interventional cardiologists to potentially treat patients in rural areas that may not have access to top-tier clinicians.
The development of specialist robots is still in its infancy. However, devices such as the Corindus CorPath system show how these super-precise devices can benefit both sides of the operating table.
"Robotics are already here; they're part of our daily lives," Baker said during his Pumps & Pipes talk. "Working in the heart comes with a higher risk, but with the reward of this system, where your procedural success rate is going to be substantially higher, I think we have a game changer."
Martin Luther King Jr. said the ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy. The same can be said about the measure of a medical device and diagnostics company.
This year, one company stood out from the rest not just because of its accomplishments and impact on patient care, but because of the leadership it showed in spite of the obstacles it faced along the way.
Abbott didn't exactly have it easy in 2017. The company started out the year going toe-to-toe with Alere over a deal that seemed destined to fail. Abbott finally closed that acquisition in early October, allowing the company to move past the drama that plagued that relationship for much of 2016 and 2017.
Analysts were particularly concerned earlier this year about projected product launches out of the company's Sylmar, CA, facility (formerly run by St. Jude Medical), which was the center of an FDA investigation. Many wondered whether the agency's investigation would delay certain product approvals, such as the Full MagLev HeartMate 3 device.
"But we stuck to our guns on what our projections were," CEO Miles White said during Abbott's third-quarter earnings call in October. "The third quarter alone has been pretty gratifying in that we basically got every approval we forecasted within 30 days or so of when we forecasted it would happen."
The company launched more than 20 new products this year, including several in the third quarter.
In Diabetes Care, Abbott Crushed It
Among the most noteworthy of those approvals was that of the FreeStyle Libre glucose monitoring system as a replacement for blood glucose monitoring for adults with diabetes.
“We’re continually shaping the company to stay current and relevant," White told MD+DI via email this week in response to interview questions. "A big part of that is a strong product pipeline. We’re seeing some major contributions from new products, like FreeStyle Libre.”
The FreeStyle Libre approval was a major win for Americans with diabetes because it eliminates routine finger sticks, which have been the standard of glucose testing for more than 40 years. The blood glucose monitoring replacement indication, which came much earlier than most analysts had expected, allows patients and their doctors to make treatment decisions based on information from the FreeStyle Libre system, without the finger sticks. The approval of this indication came much earlier than most analysts expected.
“People with diabetes told us the biggest barrier to checking their glucose levels was the painful finger sticks," Robert Ford, Abbott's executive vice president of medical devices, told MD+DI. "FreeStyle Libre eliminates routine finger sticks and we’ve seen an increase in the number of times a day that people check their glucose levels with some better outcomes.”
Another big win came in July when Bigfoot Biomedical chose Abbott over DexCom as the technology partner for its initial launch. Bigfoot was also a finalist for MD+DI's Medtech Company of the Year, in part because the startup is taking on heavyweights like Medtronic and Tandem Diabetes in the race to develop an artificial pancreas for patients with type 1 diabetes. Bigfoot's approach involves cobbling together a closed-loop solution using its own algorithms and software combined with other companies' hardware.
"Our partnership with Bigfoot Biomedical brings together FreeStyle Libre glucose sensing technology with Bigfoot's insulin delivery solutions to develop new systems that will free people from the burden—and pain—of traditional diabetes care," Ford said.
Testing the Limits
One significant accomplishment that was perhaps overshadowed a bit by Abbott's other news this year was the European launch of the company's Alinity systems for the core laboratory. The company expects to bring those systems to the U.S. market next year.
The Alinity portfolio of testing instruments is expected to offer more efficiency, flexibility, and confidence to health systems and better enable doctors and nurses to get the results they need to improve decision-making and patient care. The systems are supported by Abbott's AlinIQ, a combination services and informatics solution designed to assist labs in achieving greater operational productivity with their existing resources.
"Healthcare systems around the world are under pressure, and they’re looking to us for solutions," Brian Blaser, Abbott's executive vice president of diagnostics products, told MD+DI. "In developing Alinity, our new family of diagnostics systems, we spent countless hours with our customers to design instruments that help them take lab testing and patient care to the next level.”
All of Abbott's 2017 accomplishments, especially its recent product launches, give the company strong momentum going into 2018.