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Ensuring Your Connected Medical Device Is Safe, Secure, and Usable

Ensuring Your Connected Medical Device Is Safe, Secure, and Usable

A GE Healthcare executive offers practical advice on balancing patient safety, security, and usability for connected medical devices, including what to know about security in the cloud environment.

Blame it on the headlines, filled with news about ransomware attacks at hospitals, reports of hacking risks for various medical devices, and stories of hospital networks being breached via medical devices running old versions of operating systems. Perhaps because of increased awareness or a trend toward connected devices, the importance of connected medical device security has hit home for many manufacturers and health systems. 

Now, the industry's questions have seemingly shifted from "Do I need to worry about cybersecurity?" to "How can I ensure security while balancing other device requirements?" 

Steve Abrahamson, director of product security programs at GE Healthcare, tackled the issues of patient safety, device security, and usability during a session at BIOMEDevice San Jose titled "The Backdoor: Legacy Device Vulnerabilities and Risk." Audience members asked Abrahamson to address how best to balance device security and usability, security in the cloud environment, and factors to consider for point-of-care devices.

Hear from more industry experts at MD&M West in Anaheim, CA, Feb. 7-9.

Asked about how to ensure a medical device is both secure and usable, Abrahamson first pointed out that patient safety comes before either of those considerations. He noted that a security control like an automatic log off would not make sense for a critical care medical device and that because such prevention measures should not be implemented in order to preserve patient safety, users need to be aware of alternative measures.

"Patient safety risk always trumps security risk or malicious activity risk," Abrahamson said. "If you think a security feature creates a safety risk, don't put it in there."

Usability is the third consideration. Abrahamson noted that there is a trend toward prioritizing security over usability when necessary. Referencing the widespread trend of physicians having less control over hospital device purchases, he said, "it's shifting to where the security have a lot more say in what that hospital system is going to buy or not buy."

While pointing out that the balance between usability and security is determined on a per-customer basis, "the landscape is shifting to where security is getting a little bit more important than usability in some cases--but usability is still very critical," Abrahamson said.

When a device is used at the point of care, its also necessary to remember just how open and public a hospital environment can be. One key point of advice is reducing the protected health information (PHI) that the device gathers. Abrahamson recommended that device manufacturers consider how many identifiers or what pieces of data are being collected and making sure that every piece is actually necessary. In addition, it's important to check that the data flow--which devices or databases are receiving that PHI--is also limited to what's needed. 

"You apply principles and minimize risk by minimizing identifiers in unnecessary collection and unnecessary data flows where there's not a specific use case," Abrahamson said. He added, "Just be cognizant of the risks, minimize them where you can, and then apply controls or compensating controls recommended to your customer where you can't mitigate them."

A major component of medical devices becoming more "connected" is knowing how to work in a cloud environment. Abrahamson noted that GE Healthcare is "going big into the cloud," as are many medical product companies. He offered a few bits of advice, including understanding your cloud provider's security practices and remembering that cloud providers are responsible for the security of the cloud environment--not the security of your specific application. 

"[Cloud providers] can make sure the walls are solid, but you still own the lock that's on the door," Abrahamson emphasized.

[Image courtesy of DAN/FREEDIGITALPHOTOS.NET]

FDA Clears New Tool for Patients with Type 2 Diabetes

FDA has given patients with Type 2 diabetes a new management option by clearing the integration of a blood glucose monitoring system and a diabetes management platform. The integration is the result of a partnership between WellDoc and Johnson & Johnson's LifeScan.

FDA has just cleared the product of a partnership between a mobile health company and a veteran medical device company. The two companies partnered to integrate a blood glucose monitoring system with digital diabetes management technology to give patients with Type 2 diabetes a new tool for managing the disease.

The partnership between LifeScan, Inc., a Johnson & Johnson Diabetes Care Company, and mHealth company WellDoc, Inc. resulted in the integration of LifeScan's OneTouch Verio Flex blood glucose monitoring system with WellDoc's BlueStar platform. That integrated product has now been cleared by FDA.

Patients with Type 2 diabetes can have their data from the OneTouch Verio Flex blood glucose monitoring system sent to the BlueStar platform in order to receive feedback and coaching that aligns with their treatment regimen via the WellDoc technology, according to a company press release. This integrated tool is in addition to the OneTouch Reveal web and mobile app.

According to the release, the two companies are focusing on giving patients with Type 2 diabetes access to the integrate platform through health insurance plans.

"Our partnership with WellDoc highlights our sustained commitment in helping to drive better health outcomes by building a more connected patient experience. Integrating digital solutions such as OneTouch Reveal mobile app and BlueStar will help patients self-manage their diabetes and create value for health care providers," Valerie Asbury, worldwide president of LifeScan, said in the release.

WellDoc and LifeScan announced this specific partnership in September 2016, with the intention of integrating their technologies to "create a comprehensive, data-driven, and payer-reimbursed program for Type 2 diabetes management." The relationship between the two companies began in March 2016, when WellDoc and LifeScan announced a strategic collaboration and Johnson & Johnson Innovation-JJDC, Inc. invested in WellDoc as part of a $29.5 million Series B financing round.

WellDoc CEO Kevin McRaith said in a September press release, "Together, WellDoc and LifeScan will provide those living with Type 2 diabetes a best-in-class diabetes management solution with robus data analytics powered by BlueStar's patented clinical and behavioral engine. We will facilitate national adoption of this innovative first-in-class digital health solution."

Don't miss MD&M West in Anaheim, February 7-9, 2017.

[Image courtesy of PR NEWSWIRE]

Surgical Robotics Newcomer Explores Universal Robot Concept

Cambridge Medical Robotics's Versius can be used to perform colorectal, pelvic, and upper abdominal procedures. 

Amanda Pedersen

The Versius system features light-weight robotic arms and
5-mm instruments.

 

A new venture-backed company that wants to add a touch of versatility and dexterity to the surgical robotics space said its Versius system performed "exactly as expected" in an initial round of cadaveric trials. Cambridge Medical Robotics Ltd. (CMR) said 32 surgeons have given the system a test run so far in 11 usability studies conducted in October and November.

Don't miss the MD&M West conference and expo, February 7-9, 2017.

Luke Hares, technology director of the Cambridge, England-based company, said the studies validated the universal surgical robot concept that CMR has been developing using a number of robotic arms in a flexible, modular system. The idea, Hares said, is to provide the "versatility and dexterity necessary to support the majority of laparoscopic procedures."

The Versius system is comprised of a surgeon console, light-weight robotic arms, and a range of wristed 5-mm instruments, according to CMR. The technology also uses 3-D high-definition imagery and is designed to incorporate force feedback to provide surgeons with life-like sensitivity.

Backed by ABB Technology Ventures, LGT Global, Cambridge Innovation Capital, and Escala Capital, the firm joins a number of other companies that are developing a new generation of surgical robots aimed at overcoming key limitations of current robotics technology such as size and expense. To date, the field has primarily been dominated by Intuitive Surgical, which sells the da Vinci system.

Mark Slack, CMR's medical director, said the first round of trials confirmed the ability of the system to perform surgery in the upper abdomen, and for colorectal and pelvic surgery. The next phase of development will include a study of individual operations to further assess the capability of the system and the performance of the graspers, scissors, electrocautery, and needle drivers, he said.

"We will continue with a series of studies to further assess and perfect the system while also exploring new operations previously difficult to perform with robotic surgery," Slack said.
 

Amanda Pedersen is Qmed's news editor. Reach her at amanda.pedersen@ubm.com.

[image courtesy of CAMBRIDGE MEDICAL ROBOTICS]

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AdvaMed Goes Digital

The medical technology trade group announced this week the launch of a new sector within the association, known as AdvaMed Digital, that will provide specialized expertise to companies in the flourishing digital health sector.

Kristopher Sturgis

Medical technology trade association AdvaMed announced this week the creation of a new digital health sector that aims to utilize the group's experience to meet the emerging needs of digital health companies.

Scott Whitaker, AdvaMed president and CEO, said in a press release this week that the association plans to be an essential resource for digital health companies in the future.

Learn digital health lessons to empower your device design at the MD&M West conference on February 7, 2016. 

"This new frontier of care promises incredible benefits for patients and efficiencies for health care systems," Whitaker said in a press release. "But only if public policies are in place that promote innovation along with high standards for patient safety, and companies understand how to navigate the regulatory and reimbursement systems still being developed. That's why AdvaMed Digital is an essential resource for digital health companies, and a key stakeholder in shaping the policy environment for this emerging area of health care."

AdvaMed Digital will strive to become the home for technology developers and manufacturers that are looking to drive new opportunities in the digital health space through innovative new technologies and systems. The new digital health sector will aim to help companies examine and explore digital health trends and solutions, engage with policy makers and stakeholders, address critical public policy issues, and advocate for the advancement of new digital health solutions that can benefit patients, according to the organization.

"From mobile devices that provide individuals personalized healthcare information, to harnessing big data to find solutions for entire patient populations, digital health companies are transforming how we think about health care every day," Whitaker said.

AdvaMed has been undergoing some changes recently, most significantly when its CEO of 10 years stepped down last year to take up the position of president and CEO of Pharmaceutical Research and Manufacturers of America. Whitaker was named the company's new CEO in February of this year and has already begun to shape the direction of the company with this week's announcement.

AdvaMed believes that this new digital health sector will enable the group to continue to be an industry leader on a variety of different issues within the digital health space, from software regulation to cybersecurity. AdvaMed Digital plans to provide members with important new opportunities for networking, as well as a chance to explore and gather new insights on the future of digital health technologies.

The association will be hosting its inaugural Digital MedTech Conference in March of next year in San Francisco. The conference will seek to bring together experts from FDA and individuals from the venture capitalist community to discuss a range of different topics. Among the different panels will be informative discussions on the future of digital healthcare, new FDA regulatory proposals, and the growing role of data informatics that drive healthcare decision-making. 

As for the new AdvaMed Digital, the initiative plans to convene with member companies and key stakeholders beginning in 2017, as well as hold annual meetings and conferences that can provide member companies access to AdvaMed's robust network of expertise and products. 

Kristopher Sturgis is a contributor to Qmed.

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[image courtesy of PIXABAY]

Michigan Company Recalls Single-Lumen Catheters

The Class I recall is just the latest in a series of catheter recalls for U.S. companies.

Nancy Crotti

A Michigan company is recalling certain single-lumen catheters due to the potential for excess material to separate from the catheter and enter a patient's bloodstream.

Don't miss the MD&M West conference and expo, February 7-9, 2016.

Centurion Medical Products of Williamston, MI, initiated the recall of 1000 Centurion Convenience Kits containing its Multi-Med single-lumen catheters, FDA announced in the Class I recall notice. The kits were distributed in the U.S. between May 23 and October 18, 2016, and are marked with the codes ECVC1680, ECVC4785, M11620HKIC, M11620HKICNL, M11620HS, M11620KC, M11620KCNL, M12013K, and M12013KNL.

The central venous catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process, according to FDA. If this occurs, the excess material may separate from the catheter during use and could enter the patient's bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.

The agency did not reveal whether any patients were harmed by the Centurion catheters. A review of adverse event reports related to Centurion products revealed one instance in which a patient suffered atrial fibrillation possibly related to a cracked catheter with a different model number, but no reports on the recalled product.

The company notified customers in October of the voluntary recall. A list of the affected lot numbers can be found on the FDA website. Centurion did not respond to requests for comment.

Other manufacturers' catheters have been subject to several previous recalls due to the potential for materials breaking off the devices and entering a patient's bloodstream.

FDA cited a similar danger from the manufacturing process in a September recall of nearly 16,000 catheters made by Vascular Solutions of Maple Grove, MN. Nearly 6,000 of the recalled Twin-Pass catheters were distributed in the United States between October 2014 and September 2016.

The largest such recall in 2016 involved Cook Medical, which voluntarily recalled all of its catheters with Beacon Tip technology--about 4.1 million units globally--in April because of complaints of the tips splitting or fracturing during procedures. That recall expanded on a much smaller 2015 recall that involved 95,167 devices. Officials of the Bloomington, IN, company said they recalled all lots to assure patient safety.

Nancy Crotti is a contributor to Qmed

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[image courtesy of IDEA GO/FREEDIGITALPHOTOS.NET]

Major M&A Deals of 2016

Zimmer-Biomet took on big purchases too. The company announced a $1 billion acquisition (6.0x sales of $165 million) of LDR Holding, adding to its spine product line with products that include the Mobi-C cervical disc replacement (CDR) device, which was (at the time) the only device that had FDA approval for both one- and two-level treatment indications. In July, Zimmer announced the acquisition of Medtech SA, offering immediate entry into the surgical robotic market, with the CE-Marked and FDA-cleared Rosa Brain system for robotic-assisted neurosurgery.[Image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]

These were some of the biggest business transactions of the year in the medical device industry. Take a look back at the transformational—and sometimes controversial—mergers and acquisitions of 2016.

2016 was another year of multi-billion dollar mergers and acquisitions.

Some major players took on new technologies while other doubled down on the businesses they know best. Yet it wasn't all smooth sailing for these companies. A couple of the announced transactions haven't gone as planned and controversies filled headlines, according to sister publication MD+DI.

Take a closer look at some of the biggest device deals of 2016.

Learn about the new world of services, value-based care, and risk-sharing at MD&M West, February 7–9, 2017, in Anaheim, CA.



[Image courtesy of PUBLICDOMAINPICTURES/PIXABAY]

Despite Device Industry Pushback, FDA Finalizes Emerging Signals Guidance

Despite Device Industry Pushback, FDA Finalizes Emerging Signals Guidance

Almost a year after its draft guidance proposing public notification of emerging signals for postmarket medical devices, FDA is issuing final guidance putting the policy in place. The agency intends for emerging signals to give patients and physicians the latest information about the risks and benefits of medical devices on the market, but device manufacturers and industry groups voiced their opposition to the idea earlier this year. 

The December 14 final guidance appears to be identical to the draft guidance that was released at the end of 2015In it, FDA sets out the process for evaluating available information about a medical device and determining whether there is an emerging signal. The agency defines an emerging signal as evidence of "a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events" that could be meaningful to patient management or the device's benefit-risk profile.  

Learn about "Fitting New Technologies into Old Regulation Paradigms: Don't Let FDA Regulation Hold You Back!" at MD&M West in Anaheim, CA, February 7-9.

FDA plans to determine what is an emerging signal by collecting information, working with device manufacturers, conducting an expert review, bringing in other stakeholders, including oversight by management, according to the guidance document.

FDA makes clear in the final guidance that "Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal." According to the document, public notification of an emerging signal would take place when there is evidence of a new causal assocation but more analysis or time is needed for FDA to make a decision, or if FDA has already decided a causal relationship is there but needs more advice or time to determine next steps.

A number of members of the Patient, Consumer, and Public Health Coalition offered their support of emerging signals during the public comment period on the draft guidance. They wrote that "the draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations."

Device makers, on the other hand, were not as supportive of the specifics of the emerging signals guidance. In a comment letter, Stephen Ferguson, board chairman of Cook Group Inc., wrote that while the company supports the idea of better postmarket surveillance, an emerging signal could harm the reputation of safe devices and potentially encourage unfounded lawsuits. He wrote:

"The impact of an 'Early Communication' will be very similar to that of a recall but have a great impact . . . public notice of emerging signals that are not fully vetted with cast a shadow not only over a specific lot of devices or over a particular device from a particular manufacturer. Instead, it will throw into doubt all devices of the same type from all manufacturers. Further, there is no doubt that the plaintiffs bar will be advertising to find patients who have been treated with the products in question in order to provide the basis for lawsuits, many of which will be frivolous."

In a February 9, 2016 Lawflash notice regarding the draft guidance, lawyers from Morgan Lewis wrote, "Given FDA's intent to release benefit-risk information to the public earlier in the process, medical device manufacturers will need to closely monitor any Emerging Signals associated with their own devices to ensure that FDA has all the appropriate information regarding the risk-benefit profile of such devices. Release of unconfirmed or incomplete information could increase medical device manufacturers' liability exposure."

The draft guidance also drew opposition from The 510(k) Coalition, the Medical Imaging and Technology Alliance (MITA), GE Healthcare, the Medical Device Manufacturers Association (MDMA), and the Advanced Medical Technology Association (AdvaMed), among others. These stakeholders pointed to the potentially "confusing" nature of the notifications, wrote that they felt more details were needed on the data, timelines, and decision-making standards to be used by FDA, and urged closer involvement with the device manufacturers throughout the evaluation process.

In the final guidance, FDA does note that it intends to reach out to device companies before publishing a public notification, "unless time does not permit because of the risk of patient harm or it is not feasible . . ."

MITA wrote in its comment on the draft guidance, "It is important that the Agency engage manufacturers while the available information is being reviewed to determine if public notification of an emerging signal is required. Such consultation would ensure that manufacturers are afforded due process as well as ensure that the Agency is, in fact, relying on all potential sources on information." 

[Image courtesy of GERALT/PIXABAY]

Postmarket Surveillance: The Truth Is Never Simple (Part 1—Regulatory Requirements and Data Sources)

Postmarket Surveillance: The Truth Is Never Simple (Part 1—Regulatory Requirements and Data Sources)

In the first installment of this three-part article series, experts detail the requirements for complying with medical device postmarket surveillance regulations and describe potential sources for postmarket data.

Kevin Ong, PhD, PE, Michael Frohbergh, PhD, Jennifer Stevenson, Esq., and John Constance, Esq.

Editor's note: This is the first installment in a three-part series detailing the ins and outs of medical device postmarket surveillance. Read Part 2 and Part 3.

As the age of the average American continues to tick upward and obesity-related conditions like diabetes and heart disease balloon in young and old alike, the need for medical devices has surged. Trailing this proliferation of device use in a more diverse and demanding patient population is the significant increase in the risk of product complaints. Even after releasing a medical device onto the market, manufacturers must keep abreast of complaints, not only to satisfy federal statutory and regulatory requirements, but also to ensure that they do not find themselves the target of product liability litigation.

This series of articles summarizes a manufacturer's obligations in complying with postmarket surveillance regulations and details the potential sources for postmarket data. It also previews the future of medical device surveillance and provides guidance to manufacturers seeking to balance their business demands with these strictly regulated surveillance requirements. Finally, the series examines how postmarket surveillance is currently used in litigation and what impact FDA's postmarket surveillance initiatives may have on future legal proceedings.     

Regulatory Requirements for Postmarket Surveillance

In the United States, FDA has regulatory requirements regarding postmarket surveillance for the medical device industry. Postmarket surveillance utilizes assessments of products throughout their lifecycle in order to track performance and identify areas in need of improvement or modification. Specifically, the postmarket surveillance requirements include: 1) medical device reporting (MDR); 2) Section 522 postmarket surveillance studies; and 3) postmarket studies ordered at the time of approval (premarket approval "PMA" studies, humanitarian device exemptions (HDE), or product development protocols (PDP)).   

FDA requires that manufacturers, importers, and distributors report certain types of product-related complaints in the form of MDRs. Product complaints may involve the identity, quality, durability, reliability, safety, efficacy, or intended performance of a drug product, consumer product, or medical device. They contain large volume, spontaneous feedback, and a direct contact between reporter/patient and call center. This information can be received from any source by an employee who becomes aware of the incident.

Learn about "Postmarket Surveillance: What's Behind the Medtech Recall Epidemic?" at MD&M West in Anaheim, CA, February 7-9.

Events that must be reported include death or serious injuries that may have been caused by or contributed to by the device, issues requiring the need for medical intervention to prevent or preclude serious injury or death, and malfunctions of the device that, should they recur, could cause or contribute to death or serious injury. Key information that, if available, is reported includes the device information, event dates, detailed descriptions of the event, hospital and healthcare professional information, and patient information. These reports are searchable through FDA's Manufacturer and User Facility Device Experience (MAUDE) website.

Under Section 522 of the Federal Food, Drug & Cosmetic Act, FDA can order postmarket surveillance of a Class II or Class III device if: 1) its failure may reasonably likely have serious adverse health consequences; 2) it is expected to have significant use in pediatric populations; 3) it is intended to be implanted in the body for more than one year; or 4) it is intended to be a life-sustaining or life-supporting device used outside a device user facility. For example, FDA ordered Section 522 studies of metal-on-metal total hip implants when concerns were raised regarding the effects of metal ions from the implants entering the bloodstream.

FDA may also request post-approval studies as a condition to the approval of a PMA, HDE, or PDP application to help assure continued safety and effectiveness of the approved device. A post-approval study may be clinical or non-clinical and is intended to gather specific information to address questions about the postmarket performance of, or experience with, an approved medical device. FDA and the manufacturer typically reach agreement on the protocols for post-approval studies during the application review process.  

Failure or refusal to comply with a 522 order or post-approval study requirements can lead to corrective or punitive regulatory actions, such as product seizure, injunction, prosecution, or civil money penalties.

FDA may also initiate tracking systems, in which manufacturers must adopt methods of monitoring Class II or III devices. The purpose is to ensure that manufacturers of certain devices can promptly locate devices in commercial distribution and remove them from the market and/or notify patients in the event of serious health risks. Devices that meet any of the following three criteria are required to be tracked by the manufacturer: 1) the failure of the device would reasonably likely have serious adverse health consequences; 2) the device is intended to be implanted in the human body for more than one year; and 3) the device is a life-sustaining or life-supporting device used outside a device user facility. FDA maintains a comprehensive list of products that must be tracked.

Postmarket Surveillance Data Sources

While FDA requires MDRs and may order tracking, 522 postmarket surveillance, or post-approval studies, it is important to recognize the strengths and limitations of these data sources, as well as of other methods for collecting information about the performance of a product. For example, although MDR data is proactive and spontaneous feedback from the field, these data alone cannot be used to establish rates of events, evaluate a change in event rates over time, or compare event rates between devices. They can also contain duplicates and limited and irrelevant information.     

Proactive monitoring of product performance using postmarket surveillance resources other than those required by FDA can mitigate risk by providing timely, systematic, and prioritized assessments of product safety. These assessments may then assist the manufacturer in actively identifying potential safety signals. A list of potential data sources is identified in Table 1.

Table 1. Potential data sources for postmarket surveillance

As a regulatory requirement, manufacturers are expected to receive, review, and evaluate complaints. If a complaint indicates a risk of serious injury or death, it constitutes a reportable event that must be submitted through an MDR. Complaints provide spontaneous feedback and a direct contact between reporter/user/patient and call center. Because of the open line of communication and the ability for multiple sources to report complaints, manufacturers can be inundated with a large volume of information, much of which may be superfluous. Moreover, complaints can suffer from inconsistent reporting and issues with event rate determination.   

Postmarket surveillance data can also be obtained through registries. Medical device registries are organized systems that use observational study methods to collect uniform data (clinical or other) to evaluate specified outcomes for a population. Registries can be set up by hospitals, manufacturers, medical societies, and government agencies, or as part of a 522 study.  They often include data elements such as patient characteristics, hospital/surgeon information, device type, and procedural parameters. However, registries are not clinical trials. Registry patients are observed as they present for care and treatments are not specified, in contrast to clinical trials that have strict protocols and controlled settings, with smaller and homogenous patient groups. Although the registries contain clinical data and allow the determination of an outcome rate within the studied population, they typically provide limited clinical outcome measures and cannot be used to link the device and outcome. Still, registries can provide additional detailed information about patients, procedures, and devices not routinely collected by electronic health records, administrative data, or claims data (described later). 

The widespread use of social media serves as another avenue for collecting user feedback on product experiences. Manufacturers can search multiple social media platforms to seek timely field data. However, inconsistent and unsubstantiated reporting is likely, because this information is unilaterally provided by users for non-medical purposes and the users' true identities may be unknown. The anecdotal nature of the information is prone to bias and it can also be time consuming to filter through all the "noise" to realize any relevant details. 

Excised/explanted or returned products are physical evidence which, when appropriately analyzed, can help validate or corroborate clinical observations or reports. Yet, depending on what information is provided with the returned product, there may be insufficient patient/clinical details to fully analyze the device. Furthermore, there may be uncertainty with the chain of custody and how the device was handled and/or altered prior to receipt by the manufacturer.

Scientific literature is widely used to inform patients, healthcare professionals, and manufacturers of product performance. The literature should be considered in terms of the hierarchy of study quality. At one end of the spectrum are with randomized controlled trials, the gold standard of scientific research. On the other end are case reports, from which scientific conclusions should not be drawn due to limitations such as small sample size and the possibility of bias. However, no matter the method, a study must be closely scrutinized to determine whether it was appropriately conducted. For the most part, scientific literature is subject to independent peer review and tracks the evolving standard of care. But the advent of pay-to-publish and open access journals calls into question the robustness of the peer review process. Due to the time lag between article submission, peer review, and publication, scientific literature also suffers from a lack of timeliness. 

Taking their strengths and limitations into account, these types of data sources can aid in proactive postmarket surveillance.

Kevin Ong, PhD, PE, is a principal engineer in the biomedical engineering practice at Exponent, Inc, an engineering and scientific consulting firm. 

Michael Frohbergh, PhD is an associate in the biomedical engineering practice at Exponent, Inc. 

Jennifer Stevenson, Esq. is a partner at Shook, Hardy & Bacon, LLP in Kansas City.

John Constance, Esq. is an associate at Shook, Hardy & Bacon, LLP in Washington, DC.
 
[Image courtesy of CLKER-FREE-VECTOR-IMAGES/PIXABAY]

IBM Watson-Enabled Robot Could Help the Elderly Age in Place

Rice University and IBM have teamed up to develop a state-of-the-art robotic assistant that can help monitor and assist elderly patients and their caregivers unlike ever before.

Kristopher Sturgis


IBM MERA can measure heart and respiratory rates.

IBM announced this week the creation of the new IBM Multipurpose Eldercare Robot Assistant (MERA), the first-of-its-kind Watson-enabled technology designed to assist the elderly and their caregivers. IBM announced the project in collaboration with Sole Cooperativa, an Italian-based independent healthcare provider that can implement sensor technologies into the device to monitor the daily activities of elderly residents.

The project sprung up out of IBM's "Aging in Place" research environment at their ThinkLab in Austin, TX, where researchers have been working on innovative solutions that can improve eldercare. The group's aim is to take advantage of the latest in cognitive-powered technologies and combine them with motion, falling, and audio sensor technologies to improve healthcare and wellness therapies for elderly patients in various environments.

Running on the IBM Cloud, the IBM MERA leverages IBM Watson technology with CameraVitals, a new technology designed by researchers at Rice University that can calculate vital signs by recording video of a person's face. These new technologies were designed to enable the new robot to gather fast, noninvasive readings on a patient's heart and breathing measurements multiple times a day. The camera can also be used to view if a patient falls and can relay that information back to a caregiver for assistance.

The new robot prototype is the latest device that aims to fuse together medtech innovation with the Watson supercomputer. Over the summer Murthy Devarakonda, an IBM research scientist, spoke about plans to begin introducing many of Watson's features into various medical device technologies, like machine learning and speech to text functions. The idea now is that Watson can also be used to monitor physical and environmental changes to provide a more detailed profile of each patient and their conditions.

The number of individuals aged 60 or older is projected to increase by 56% worldwide by 2030, according to the United Nations. IBM says that such a rapidly growing demographic indicates a strong need to invest in technologies that can care for and protect the aging population of the world. This new IBM MERA technology was designed to combine real-time data generated by sensors with advanced cognitive computing--all in an effort to provide clinicians and caregivers with information on how to provide the best care for their elderly patients.

IBM's recent partnership with Sole Cooperative signals the intent to create opportunities that can leverage the Internet of Things with IBM's cognitive computing technologies, so that the robot can identify changes in physical conditions and anomalies in environmental readings. These kinds of readings could be used to identify potentially dangerous situations, like a rise in carbon-monoxide or carbon dioxide levels in the room. The robot assistant can constantly monitor atmospheric readings to identify these conditions and notify a caregiver to take action if needed.

IBM says that all of these design features will be incorporated to help elderly residents live safely and independently for as long as possible. The robot technology will help provide a plethora of data on the patient's routines and surroundings to help users and their caregivers identify potential risks, and perhaps most importantly, deliver a higher level of personalized care that can extend and even improve their quality of life on a daily basis.

Kristopher Sturgis is a contributor to Qmed.

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[image courtesy of IBM RESEARCH]