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Articles from 2017 In September


Supplier Stories for the Week of September 24

This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to marie.thibault@ubm.com with the subject line “Supplier Stories.”

Will All the Abbott-Alere Fuss Be Worth It?

Pixabay Will All the Abbott-Alere Fuss Be Worth It?

For better or for worse, Abbott and Alere are expected to officially tie the knot today.

Alere tied up several loose ends late last week to close the $5.3 billion deal that once seemed doomed. The company settled a Department of Justice investigation related to its triage cardiac and toxicology products, and the FTC said it would OK the transaction, provided that Alere sells its blood gas and cardiac marker testing systems, along with related facility divestitures.

Earlier this year the companies were going toe-to-toe over the initial $5.8 billion merger agreement. Abbott got cold feet after a series of revelations that included the DOJ investigation and the delayed filing of Alere’s annual financial statements.

Alere said the total combined payment to the DOJ and the participating states will be within the $35 million loss contingency reserve previously taken by the company.

Despite their rocky relationship, there are still upsides to the acquisition for Abbott. The company will now have a leading position in point-of-care testing, a fast-growing $7 billion segment of the $50 billion in vitro diagnostics market. Brian Blaser, executive vice president of diagnostics products at Abbott, said the combination gives the company the broadest point-of-care testing portfolio and will help Abbott meet the growing demand for fast, accurate, and actionable information.

The company noted that many healthcare systems are upping their reliance on these technologies to inform patient care decisions with easy-to-use tests that provide speed and accuracy, particularly in the outpatient setting. With the addition of Alere, Abbott said it has about $7 billion in diagnostics sales worldwide, including roughly $2.5 billion in point-of-care testing.

During Abbott’s second-quarter earnings call in July, CEO Miles White said he expects the acquisition to be neutral to earnings this year and that he wants to get the business on the path to integration as quickly as possible. “Assume it’s neutral, assume there is no accretion in 2017, and the question then rolls to 2018,” White told investors at that time.

Originally, Abbott had estimated somewhere in the neighborhood of $0.11 to $0.13 of accretion for the first full year, and while White said he didn’t have any reason as of July to change that projection, he wanted to have the business in Abbott’s hands for a few months before he re-confirms accretion estimates for 2018.

“I don’t intend to be conservative for cuteness or sandbagging or anything else,” he said. “But I would say, I want to get the business in our hands and evaluate that more directly than we’ve been able to over the last year and a half.”

After all, Abbott provided that estimate before knowing there would be divestitures for antitrust requirements, and before CMS revoked Alere’s Arriva Medical mail order diabetes testing supplies business.

The Human Experience: How Patients Inspire Innovation and Why Medtech Should Listen

HYENA REALITY/FREEDIGITALPHOTOS.NET The Human Experience: How Patients Inspire Innovation and Why Medtech Should Listen

Innovation has driven medtech to varying extents for decades. Healthcare relies on innovation in processes and procedures to improve operations and patient outcomes. Now, with an increased focus decreased spending and increased quality, innovation has never been more important.

As healthcare systems focus on outcomes rather than services, medtech companies are taking a more holistic approach to development. According to a PwC Health Research Institute report, as a "direct response to an increasingly modular, plug-and-play health ecosystem defined by consumer needs and desires," manufacturers and developers are evolving into problem solvers.

During The MedTech Conference, powered by AdvaMed, the healthcare and medtech communities joined forces to understand how patients inspire innovation. Discussions centered on patient-centered, outward-looking technology with an emphasis on data and patient engagement. The medtech CEO, physician, and hospital executive all consider innovation differently, but they all have the patient as the muse.

What Patient-Inspired Innovation Means

Todd Dunn, innovation director for Intermountain Healthcare, said during a conference panel that his organization created a new initiative to put empathy at the forefront of innovation. He said Proctor & Gamble's "immersion research," where executives spend time in people's homes to understand what matters to them, inspired him to approach innovation differently.

"I realized we were doing the wrong thing in healthcare," he said. "We weren't focusing in the context of where people live, work, learn, pray, and play." To change that, he helped create and now leads Design for People, which uses empathy as a tool to put people, not systems, at the center of design. Its team currently uses direct observation to assess endoscopy, allergy-immunology, and integrated care management programs.

Eric Stone, CEO and cofounder of Velano Vascular, which develops needle-free blood draw devices, agreed, noting that our healthcare system has historically treated problems rather than patients. "Many times the structure and process that leads to quality and safety dampens the reality of what the patient feels and experiences," he said. "It's the approach to treating the whole person and not just the disease that's essential."

Patient-Inspired Medtech in Action

Medical devices largely haven't delivered the outcomes hoped for, Dunn said. Now, as healthcare organizations shift to value-based reimbursement, device manufacturers must prove their products improve safety, quality, and outcomes.

"We need to measure whether we improve operational efficiency, and whether we ease the burden or improve the wellbeing of the person using that technology," said Bridget Duffy, MD, chief medical officer of Vocera Communications.

One way to improve wellbeing, and outcome, is by increasing patient engagement. New and established companies alike think "beyond the device," enhancing products with connectivity and offering features that benefit patients before, during, and after surgery.

St. Jude Medical recently introduced CardioMEMS™ HF, the first FDA-approved heart failure monitoring system. CardioMEMS uses a wireless sensor implanted in the pulmonary artery. The device uploads blood pressure readings, providing early warnings of heart failure. The system promises a 33% reduction in heart failure admissions, as well as an improvement in exercise capacity and quality of life.

In April 2016, Stryker launched JointCOACH, a digital patient engagement and education platform to help patients undergoing joint replacement surgery. JointCOACH is part of Stryker's Performance Solutions, a program that partners with hospitals, physicians and payors to improve results.

Stryker isn't the only major company to offer comprehensive solutions. According to the PwC report, five out of the top 10 medical device companies offer customized solutions independent of their product offerings, and seven have undergone organizational changes reflecting a shift toward service-based offerings.

Patient-Inspired Challenges

For all the benefits of taking a holistic approach, medtech faces no less challenge to get there. Duffy cited speed to adoption as an ongoing barrier. "We have so many antiquated and broken systems, in part because we've focused on the wrong thing," she said. "We need to listen to the patients, doctors, nurses, and frontline staff and cocreate design together."

Stone mentioned finding an ear willing to listen, with time to listen, as a hurdle when forming Velano Vascular. Lack of investment dollars also posed a challenge to development.

"We're looking to hospitals as investors, as well as high net worth individuals," he said. "Traditional VCs hesitate to invest because the runway for return is far longer and the actual returns appear to be smaller."

What Now?

Rather than look at patient-inspired innovation as a problem or an expensive change, medtech can see the shift as an opportunity to help people live healthier lives, which is really the only justification needed. "One opportunity we have as technology providers is to map the gaps in the human experience, from pre-arrival to post-discharge," said Duffy. "We can then find digital health solutions that restore those pieces to healthcare."

How Abbott's Big Win Crushed DexCom Shares

Abbott Laboratories How Abbott's Big Win Crushed DexCom Shares
FDA approved Abbott’s FreeStyle Libre glucose monitoring system, freeing diabetes patients from needlesticks.

The diabetes market has experienced two shake-ups in as many months – first with Bigfoot Biomedical and Abbott Laboratories’ partnership announcement in July, and now with FDA’s approval of Abbott’s FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring (BGM) for adults.

The approval is largely considered 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 BGM replacement indication means people with diabetes and their doctors can now make treatment decisions based on information from the FreeStyle Libre system, without the need for routine finger sticks. The approval of this indication came much earlier than most analysts expected.

“It was very interesting to us that the Libre was approved on a standalone basis. We don’t require it to be approved in order to embed it within our system,” Jeffrey Brewer, co-founder and CEO of Bigfoot Biomedical, told MD+DI. He explained that FDA reviews systems as a whole, rather than by individual components.

“That said, it’s great that the FDA has embraced what is a really big leap in technology,” Brewer said. “The idea that you don’t have to prick your finger and calibrate a sensor makes it so much safer, so much easier to use, and so much more patient-friendly.”

Brewer is all too familiar with the fears and frustrations of managing Type I diabetes. His son, Sean, was diagnosed with the disease in 2002 at the age of seven. Since then, Brewer has become a staple in the diabetes community, first as CEO of the Juvenile Diabetes Research Foundation, and now as a co-founder and CEO of Bigfoot Biomedical.

“My son’s life has been significantly diminished in its quality by having this stupid disease, Type I diabetes,” Brewer told MD+DI. “It’s just too hard. It’s not a reasonable expectation that people, all day long, should have to think about data and be their own doctor, giving themselves [insulin] and the right amount, which varies all the time.”

In July, Bigfoot took the industry by surprise by choosing Abbott over DexCom as its technology partner for its initial launch. DexCom’s shares crashed more than 36% this week after Abbott’s FDA approval was announced.

Steve Pacelli, executive vice president of strategy and corporate development at DexCom, told MD+DI the company could not comment on the recent news because it is currently in a quiet period. Management will provide an update on DexCom’s product pipeline during the company’s next earnings call, he said. During the company's previous earnings call on July 30, Pacelli said the company has been competing quite favorably in markets where it has robust reimbursement.

"Take Abbott in particular, in the markets where we're paid for, we're seeing quite a few Abbott customers shifting over to the DexCom platform," Pacelli said, adding that the company's clinical data "clearly demonstrates that our sensors are just much more accurate than anything else available on the market." 

For Bigfoot, the decision to partner with Abbott was easy. The FreeStyle Libre sensor is one piece, lasts up to 10 days, and is very simple to insert, Brewer said. The sensor is worn on the back of the upper arm and glucose readings can be captured using a small hand-held reader.

“It’s like a stamp. It’s just easy,” he said. “And that is a big thing for people who have a chronic disease that requires them to do so much planning and maintenance of the devices, and tests, and looking at data, and giving themselves a drug. Every bit of that sucks life and energy out, and it also is infused with a lot of fear because it’s a high-stakes thing, deciding how much insulin to give yourself.”

Libre requires less work on the patient’s part as it is, but Bigfoot plans to take that a step further by tying together sensors and insulin delivery (whether that’s through shots or pumps) in a smartphone-based solution that analyzes the data on the user’s behalf to help them manage their disease in as few steps as possible.

“Abbott is a company that thinks about that person, thinks about my son and making his life better, and Bigfoot is on top of that and going to do more,” Brewer said. “But we need more of that in healthcare. It’s not what the doctor imagines the patient needs that is the answer, it’s what the person can live with and use and feel good about.”

New Qualcomm Patch Can Monitor Patients for Cheaper than Lunch at a Fast Food Joint

Jamie Hartford/MD+DI Qualcomm biometric patch
Shown are the front (left) and back (right) sides of the biometric patch Qualcomm Life senior vice president and chief medical officer James Mault, MD, passed around during a panel discussion at the Medtech Conference hosted by AdvaMed on Tuesday. 

Qualcomm Life, the healthcare subsidiary of telecom giant Qualcomm Inc., yesterday announced that it has developed reference designs for single-use, connected, medical-grade biometric patches that will be commercially available in 2018.

Details in a press release about the patches were scant, but James Mault, MD, FACS, senior vice president and chief medical officer at Qualcomm Life provided a few specifics Tuesday during a panel discussion at the Medtech Conference hosted by industry trade group AdvaMed in San Jose.

The Bluetooth Low Energy–enabled patches have a seven-day battery life and can measure motion, heart rate, respiratory rate, and body temperature, Mault said. But more importantly, they can do it for “dirt cheap.”

“We’re talking about something that costs $3 instead of $100,” he said. “That changes everything and now makes it possible to stick one of these puppies on everybody that leaves the hospital, and you can mail one to everybody that’s not near the hospital, and you can know what’s going on with them. It will tell you whether they’re having symptoms of rheumatoid arthritis, or Parkinson’s, or MS.”

The patches will give providers access to near-real-time data, according to a press release.

“We have to go from a black hole to even a little bit of information that will start to tell us things we never dreamed of knowing,” Mault said.

Qualcomm has licensed the reference designs for the patches to electronics manufacturer Benchmark Electronics Inc., which will serve as the manufacturer of record for the devices and through which they will be commercially available next year.

Sustainable Pacemaker Research Accelerates

CAGS ACES/YOUTUBE Sustainable Pacemaker Research Accelerates
UConn's Islam Mosa explains his supercapacitor. Watch the YouTube video here.

One of the great "meta" areas of investigation for the scientific community is how to attain greater efficiency in sustainable energy creation and storage, from solar power arrays to car batteries to batteries for mobile phones and laptops.

To the quest for greater sustainability in these industries one can add cardiac pacemakers, and one pioneer of the technology says it could be ready for trials sooner rather than later.

"It's not far," M. Amin Karami, PhD, director of the Intelligent Dynamic Energy and Sensing Systems Lab at the State University of New York at Buffalo, said. "We can have the technology ready for animal tests and maybe even for human trials, in two years."

Karami supervised work by UB doctoral student Hooman Ansari, in which Ansari and colleagues recently created a piezoelectric energy harvester that converts the heart’s vibrational energy into electricity. The work, which was published in Smart Materials and Structures and the Journal of Intelligent Material Systems and Structures, is but one of several recently published experiments that illustrate the overall quest for sustainable systems has reached critical mass in cardiac device research. In fact, Karami came to the field through his earlier work on larger-scale energy harvesting systems, in aviation and bridge safety in particular.

In addition to the UB work, other recent advances include:

  • A project led by University of Connecticut researcher Islam Mosa. Mosa was exploring the suitability of a tiny device composed of graphene and the protein myoglobin as a biosensor, and serendipitously discovered it could serve as a biocompatible supercapacitor, or energy storage device, that uses serum as electrolyte. The device Mosa fabricated has three to 11 times the density of commercially available thin film electrochemical capacitors, without fear of toxicity. The supercapacitor is only one micron wide—about 1/10 the width of a human hair.
  • A leadless pacemaker designed by researchers at Rice University and the Texas Heart Institute, which harvests energy from radio frequency radiation transmitted from an external power source. In a prototype device presented at the IEEE International Microwave Symposium in June, the wireless power transmitter can be up to few centimeters away, according to information provided by Rice. The chip at the system’s heart receives power using microwaves, and the frequency of the pacing signals produced by the pacemaker can be adjusted by increasing or decreasing power transmitted to the receiving antenna.

The pursuit of longer-lived energy systems in pacemakers is especially important for patients, as procedures to replace the devices introduce risks for complications that more efficient—or, ideally, indefinitely sustainable devices—would not. In fact, British cardiologists John Dean and Neil Sulke, in a 2016 article in BMJ, called the current practices of replacing batteries in cardiac pacemakers and implantable defibrillators a "scandal," suggesting that with existing technology, engineers could design and build pacemakers that would last for 25 years or more.

How the researchers' new technologies may be integrated in the next steps of investigation presents intriguing possibilities. For instance, Mosa said the next step of his team's research will be to create an energy harvester that will work in tandem with the supercapacitor. He is considering several possibilities, including a thermoelectric device that would convert body heat to energy, and two piezoelectric approaches: one that would provide power to the storage device from a harvester implanted near a moving joint, and the other a heart-located approach similar to Ansari and Karami's version. Such a coupled device, Mosa thinks, would still be only about 1 centimeter square and only 11-15 microns thick, or slightly thicker than hair. He says it's an exciting time to be pursuing this type of research, and sees others' work as complementary more than competition.

"No, I don't think of it as competition," he said. "It's more like we need each other to complete this."

And, Karami said, he is already hearing interest among cardiac patients for devices like this.

"In the past, people have contacted us—I'm serious—and said, 'I want to go for my next pacemaker—should I wait?'" he said with a laugh. "Obviously, no. It wont happen earlier than five years at least, to be absolutely optimistic. But technologywise, we're not far."

Why Cybersecurity Must be Part of Medical Device Architecture

Image courtesy of MASTERCONTROL Why Cybersecurity Must be Part of Medical Device Architecture

Medical devices are no longer a stand-alone component in the healthcare ecosystem. More and more devices are network-connected, which often involves interaction through websites and the transmission of sensitive data through wireless components.

Network-connected medical devices promise an entirely new level of value for patients and doctors, but they also introduce new cybersecurity vulnerabilities that could affect clinical operations and put patient care at risk.

Medical device risk management processes need to be revamped to properly identify security vulnerabilities and include countermeasures to mitigate threats. This is no easy undertaking, as cybersecurity in medical devices is a multifaceted problem involving disparate factors. The complexity of cybersecurity along with the recent increase in cyberattacks in healthcare-related industries underscores the need for incorporating cybersecurity early in medical device design and development.

Threats vs. Vulnerabilities

Threat and vulnerability have often been used interchangeably when referring to cybersecurity, but they are not the same. A threat is a malicious action performed by a cyber actor to manipulate computer systems, steal data, or encrypt data and demand ransom for its release. A vulnerability is a weakness in a network, endpoint, device, or operating system that can be discovered and exploited to carry out a threat.

Preventing cybersecurity threats entirely is not possible. The focus of security measures is to reduce the number of vulnerabilities in order to increase the difficulty in breaching your network. If hacking your device or network requires a lot of time and effort, a cyber actor may abandon your site and search for a different target.

Common Vulnerabilities that Can Lead to Threats

More healthcare facilities are benefiting from advanced medical device technology. Still, the security vulnerabilities inherent in connected medical devices opens pathways for threats to the medical devices themselves, the data stored on the devices, and their surrounding network infrastructure. The following are a few vulnerabilities that are commonly exploited.

Hardcoded administrative passwords. These default passwords are used to permit privileged access to devices, such as for service technicians. These passwords cannot be changed by users or even the facility’s system administrator. Discovering these passwords is easy because the same password is often used in the code of multiple devices. If a hardcoded password is used in a system, a cyber actor can identify it and gain administrator access to the device and its data.

Unencrypted data transmitted through wireless connections. It’s common for medical devices to interface with web services that provide a graphical interface for configuring and interacting with the device. Data transmitted through a wireless connection can be intercepted from anywhere in the world. Unencrypted data can be stolen and even modified, resulting in a serious threat to a patient’s safety.

No authenticated access requirement. Medical devices that don’t require the login credentials of preauthorized users are highly vulnerable to cyberattacks. Internet of Things (IoT) technology allows cyber actors to access devices from remote locations, prevent connection to the device, or retrieve patient medication data.

Failure to scan application software for vulnerabilities. Software developers often use pre-written code, called a software library, when developing programs and applications. Medical device application software that includes a software library could have inherent vulnerabilities. Scanning tools are available online that can expose vulnerabilities in software code that hasn’t been tested prior to the device’s deployment.

Traditional Security Measures Are Not Fail-Safe

It might be tempting to trust traditional IT network cybersecurity tools such as antivirus software, intrusion detection systems, and firewalls to handle security for connected devices.

Network cybersecurity detection tools are critical components of IT security and must be kept up to date. Nevertheless, these tools alone cannot fully safeguard connected medical devices that lack embedded security controls.

Antivirus software. This software is designed to prevent, search for, detect, and remove software viruses and malware such as worms, Trojans, and adware. Antivirus software is adequate for catching and blocking viruses; however, cyber actors have the ability to test their malware against the latest antivirus software to learn how to bypass it.

Intrusion detection software. These tools detect and quarantine unauthorized entry to the network, preventing an intruder from accessing confidential data or injecting malware into the system. Cyber actors can sometimes get around these tools by using older malware technology. The network’s intrusion detection software either may not recognize the intrusion or classify it as a minor threat. With numerous threat attempts coming into a network, it’s easy for some intrusions to go undetected.

Firewalls. Firewalls form a barrier between trusted and untrusted network traffic. They often need to work in concert with intrusion detection software to adequately provide the right depth of network security. However, many medical devices are activated on an ad hoc basis so they are not permanently connected to the network. An organization’s firewall management technology may not have the flexibility to handle this type of variation in network traffic.

FDA’s Stance on Cybersecurity

FDA has acknowledged the severity of cybersecurity and has published various alerts and guidance documents regarding cybersecurity risks and patient safety. According to an FDA safety communication “Cybersecurity for Medical Devices and Hospital Networks,” medical device manufacturers should take steps to assure that appropriate safeguards are included in medical devices to reduce the risk of failure due to a cyberattack.

Per FDA’s safety communication, the extent of the safety controls needed in a medical device depend on these factors: the device’s intended use, the presence and intent of its electronic data interfaces, its intended environment, the type of cybersecurity vulnerabilities present, the likelihood the vulnerabilities will be exploited, and the probable risk of patient harm due to a cybersecurity breach.

Address Cybersecurity Challenges During the Design Stage

The need to identify security vulnerabilities and mitigate threats poses new challenges for medical device manufacturing. Security controls include their own risk assessments and requirements that need to harmonize with the device’s safety and efficacy.

Device functionality. Some security controls, such as encrypted data transmission and multilayered authentication are necessary to fend off unauthorized access. However, in some devices, these measures can slow down a medical device’s functionality and reduce its battery life.

Interoperability. The seamless interoperability of medical devices within a network infrastructure is valuable in healthcare environments. But increasing the number of integrated, connected devices increases vulnerabilities and risks of security breaches.

Maintenance and updates. Connected medical devices usually require frequent upgrades and patches, especially for security purposes. These processes need to include a secure method of installing the updated functionality. Certain functionality updates require regulatory recertification and validation, which can impact the timeframe of rolling out patches and updates in the production environment.

Incorporating security controls into a medical device is a gradual and painstaking process that requires careful planning and collaboration with cybersecurity experts. Security is a new stakeholder in medical device development that needs to be included in the device’s architectural risk assessment. Device manufacturers need to ensure that their device does not add more vulnerabilities to a facility’s network.

Two AI Startups Bag New Funds

Pixabay Two AI Startups Bag New Funds

Artificial Intelligence (AI) is easily one of the hottest areas of medical technology today, and investors are eager to place bets on companies that are turning to machine learning to help solve some of healthcare’s biggest problems. Two such companies announced funding rounds Wednesday.

An international syndicate of investors, including physicians, healthcare professionals, and medical device experts, kicked in $25 million to support Toronto, Ontario-based Analytics 4 Life, which is developing an AI-based cardiac diagnostic. The technology, under clinical investigation, is designed to help doctors assess the presence of coronary artery disease using intrinsic signals scanned from the body without radiation, contrast agents, or cardiac stress.

Meanwhile, Palo Alto, CA-based Cardinal Analytx Solutions clinched a $6.1 million financing to develop advanced machine learning solutions to improve healthcare by predicting costs. Cardinal Partners led the series A round, which also included Premera Blue Cross, and the Stanford-StartX Fund.

It All Starts with Feasibility

MASTER ISOLATED IMAGES/FREEDIGITALPHOTOS.NET It All Starts with Feasibility

Product development consists of different phases based on risk and reward, but the one constant in any development effort is feasibility.

A company may first perform feasibility activities to evaluate the technical or market viability of a product. At this early stage, only minimal funds may be lost if goals are not met. While financial commitment can range greatly depending on scope, the next phase of product development is typically a significant investment by the company. Defining and managing feasibility is critical to minimizing future project and product risks.

Successful feasibility studies greatly depend on having an overall strategy and process in place from the time of project inception. Having all key stakeholders agree on the specific objectives is crucial, as these key performance indicators (KPIs) will make or break the project and determine whether additional funds for continued feasibility or committed product development will be available. These measures of success should not be ambiguous. They must be clearly defined and may consist of title, description, testing approach, and acceptance criteria (minimum feasibility vs. commercial requirement).

KPIs should focus on technical metrics as well as operational and market-based indicators, and schedule is equally important to the feasibility study’s success. Can the feasibility of each KPI be determined in the allotted time? As limited budgets have become the norm, feasibility projects must be lean and efficient so the project team must always focus on the defined KPI level of scope.

Once KPIs are identified and approved, a project manager’s primary goal is to track to those measures. This is commonly done with a risk signal chart. Each KPI is scored based on the current risk level: demonstrated in feasibility, unlikely to demonstrate but confident to show in the next project phase, or unlikely to demonstrate but risk is acceptable.

Risk status should be frequently reviewed and evaluated with key stakeholders to show transparency on feasibility progress. While demonstrating KPIs is a primary goal of feasibility, it is also critical to keep decision makers engaged, which can be done by understanding the audience, their interests, and setting up ongoing, prototype demonstrations.

Feasibility studies are a critical tool for companies to stratify different product concepts based on their ability to result in a market-winning product. Successful feasibility study management and execution—demonstrating feasibility or lack thereof—is an essential process for product development companies and should not be undervalued.