As medical device developers compete to push the boundaries on designing and building innovative, connected medical devices, the market continues to boom. It doesn’t look to be slowing down anytime soon, either. KPMG estimates that global annual sales of medical devices will rise by over 5 percent a year to reach nearly $800 billion by 2030.
Modern medical device makers are hyper focused on building innovative, connected solutions for the next generation of care. That continued innovation opens the door for new, lower cost technologies for early intervention and at-home care. But it also opens the door for more risk.
In the past, medical device software was generally used to control programs to simply switch the equipment on and off and display readings. Today, software and its functions dominate much of the features, making devices far more integrated, complex, and connected-and growing more so every year.
Growing Concern for the Security of Connected Medical Devices
While smart devices provide opportunities for instantaneous results and early medical intervention, connected medical devices are also more vulnerable to both deliberate attacks and undirected malware.
A survey released in October 2018 of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18 percent of provider organizations had connected medical devices impacted by malware or ransomware in the last 18 months.
The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
Read this case study to see how RBC Medical Innovations leveraged Jama Connect to unify processes and enhance traceability.
Modernizing Requirements Management to Reduce Risk
The reliance on connected medical devices isn’t going to ebb, and the increased complexity will only make the management and reporting of interconnected information across product definition and verification more difficult and inefficient. This inefficiency is only exacerbated by the use of document-based requirements management, which introduces more risk into the process.
To achieve better results with projects of mounting complexity, teams must get a stronger handle on their process and avoid gaps in development. A better solution for requirements traceability can do just that.
Traceability, normally a sub-discipline of requirements management, ensures that engineering design aligns with the identified needs of users and patients; manages scope by ensuring alignment between engineering work and actual user needs; confirms that device needs are addressed at all levels through gap analysis; and connects the design of the device directly to the verification.
Requirements Traceability is No Longer Optional
Small teams building simple products may be able to get by initially with spreadsheets, documents, and emails, but with the rise of software-driven, connected medical devices and increasing system complexity, requirements traceability quickly becomes too convoluted to be handled manually.
The reality is that the more complicated or distributed the product development process becomes, the more opportunities for error are introduced. Excel just can’t account for the wide array of risks and requirements involved in medical device development.
In fact, according to Stericycle’s Recall Index, software issues were consistently one of the top causes of medical device recalls through 2017 and 2018.
Today’s medical devices are so much more than metal and plastic – they’re incredibly complex, connected devices that require complete hardware and software traceability.
Medical device development contains too many scope changes, remote team members and reviewers, and requirements to be easily managed in documents and emails. Using Excel or an internally developed requirements management solution or system diverts scarce resources and availability away from the important tasks of product development. Instead, team members have to focus on attempting to assemble and maintain traceability, usually resulting in the trace being hastily thrown together in the end for the design history file (DHF).
Traceability increases efficiency, drives alignment, and mitigates organizational risk. And with Jama Connect, teams can link and decompose high-level requirements to more detailed system and sub-system requirements, including associated risks and hazards, to ensure proper verification and validation before release.
Until fairly recently, you might not have considered vehicles to be major cybersecurity targets. But with the rise in connected and autonomous cars, hackers and other cyber criminals can break into the systems that run these vehicles and wreak havoc.
“With all of the connectivity available comes cyber risk,” says Faye Francy, executive director of the Automotive Information Sharing and Analysis Center(Auto-ISAC), an industry-driven community to share and analyze intelligence about emerging cybersecurity risks to vehicles.
Technology has a long tradition of racing ahead of oversight, and the automotive industry is still catching up to the speed of change. Updates to the ISO 26262 functional safety standard were recently made in December 2018 and touch on cybersecurity, but expect to see more emphasis on this topic in the future. That’ll be especially true as automotive connectivity and complexity escalates, and the development of autonomous vehicles (addressed by another safety standard, ISO/PAS 21448, or Safety Of The Intended Functionality (SOTIF), which has incidentally sparked its own upcoming conference in Germany) progresses.
As an additional resource, Auto-ISAC aims to enhance vehicle cybersecurity capabilities across the global automotive industry, including light- and heavy-duty vehicle original equipment manufacturers (OEMs), suppliers and the commercial vehicle sector.
“The Auto-ISAC is the go-to organization that facilitates cybersecurity resiliency for the global automotive industry,” Francy says. Automakers worldwide joined together in 2015 to form the nonprofit community to address growing vehicle cybersecurity risks.
A Shared Responsibility
The focus of Auto-ISAC is to foster collaboration for mitigating the risks of cyber attacks and to create a safe, efficient, secure and resilient global connected vehicle ecosystem,” Francy says. Members use a secure intelligence-sharing portal to anonymously share information that helps them more effectively respond to cyber threats, vulnerabilities and incidents.
The 49 members includes all major automakers across North America, Europe, and Asia, as well as suppliers to the heavy-duty trucking and commercial vehicle sector. In 2017, the Auto-ISAC established a Strategic Partnership Program to enable ongoing coordination with key stakeholders including partners, government regulatory agencies and law enforcement.
One of the key accomplishments of the Auto-ISAC is its Best Practices initiative, which focuses on developing guidelines organizations can use to advance their vehicle cybersecurity programs, Francy says. The members conceive, write and develop Best Practice guides that are in various stages of review.
The guides cover organizational and technical aspects of vehicle cybersecurity including incident response, collaboration and engagement with third parties, governance, risk management, security by design, threat detection and protection, and training and awareness.
“These guides are released to the community to help the automotive industry stakeholders mature,” Francy says. Currently there are three guides available to the public on the Auto-ISAC Web site: Incident Response, Third Party Collaboration, and Engagement and Governance.
Evolving Recommendations
The digital age has introduced connected, advanced automotive capabilities for consumers, such as driver assist, navigation and hands-free calling. But this also introduces the possibility of risk such as hacker attacks.
“We have moved from a more physical analog attack surface to a digital, networked environment,” Francy says. “This provides different opportunities for the bad actors, due to the increase in innovative technologies and the interconnectedness” of the ecosystem.
Fortunately, the industry has taken a number of actions to identify and thwart cyber threats, including implementing security features in every stage of the design and manufacturing process, collaborating with public and private research groups to share solutions, and participating in multiple cyber forums on emerging issues. There is, of course, much more work to be done.
Automotive companies can learn from the Auto-ISAC leadership as it builds and leads a community of best practices, Francy says. The organization conducts an annual tabletop exercise, quarterly workshops and monthly analyst calls with members. It also leads virtual, monthly community calls and runs an annual Vehicle Cybersecurity Summit.
Auto-ISAC partnership programs “are developed to cultivate relationships beyond our membership, with the common goal to enhance vehicle cybersecurity and develop a vibrant and robust information-sharing community,” Francy says.
Learn how a Fortune 100 semiconductor company is meeting the challenges of functional safety standards for its automotive-related technology with Jama Connect by downloading our paper.
Author Bob Violino is a freelance writer who covers a variety of technology and business topics. Follow him on Twitter.
Rendering of the experimental X-59 QueSST, courtesy NASA.
It was a mind-bending year for some of the most innovative companies on the planet. From relentless advances in autonomous driving to Starman orbiting Mars to getting a firmer handle on the future of agriculture, there were some dizzyingly inspirational moments in 2018.
To recap the busy year, we compiled a far-from-comprehensive list of some of the most notable moments from product development teams that are pushing the boundaries of what’s possible and solving problems that will improve the quality of life for millions…sometimes with help from Jama.
Lyft demonstrating its driverless technology, powered by partner Aptiv, at CES 2018.
Tesla, Waymo, Lyft and Panasonic take differing data strategies to advance autonomous driving
Human drivers have plenty of information about how other drivers behave on the road, and driverless cars need that data too. Tesla and Waymo, which started life as Google’s self-driving car project, are at the forefront of this effort to collect and process enough data to develop a reliable autonomous vehicle.
The two companies are taking very different approaches to the challenge, reported The Verge in April: Tesla, leveraging the hundreds of thousands of cars it already has on the road, is collecting real-world data about how vehicles perform with its current semi-autonomous system, Autopilot. Waymo, meanwhile, is using robust computer simulations to drive the development of a small real-world fleet of autonomous cars.
Elsewhere, in a decisive step in the direction of self-driving cars, Jama customer Lyft acquired London-based augmented reality (AR) startup Blue Vision Labs. Blue Vision has developed a way of using street-level imagery to build “collaborative, interactive reality layers” using images captured by smartphone cameras, reports TechCrunch. This technology is crucial to Lyft’s vision for autonomous vehicles, which was on display earlier this year at CES 2018 (pictured above). Both Lyft and arch-competitor Uber are expected to file IPOs in the first half of 2019.
Not to be left out, Panasonic North America announced in August that it was developing a cloud-based data platform called C-V2X (V2X stands for “vehicles to everything”) that pushes traffic information out to users, such as the Colorado Department of Transportation — which we interviewed earlier this year. Cars with C-V2X technology, according to The Denver Post, send out signals 10 times a second to roadside sensors, conveying information about speed and direction from internal sensors such as breaks and airbags. Transportation workers can use Panasonic’s data platform to monitor the road grid and spot problems before they snowball. The system can also deliver customized, time-sensitive messages directly into equipped vehicles.
NVIDIA digs deeper into autonomous driving
During his January keynote at CES 2018, NVIDIA founder and CEO Jensen Huang spoke about the importance of traceability in developing functional safety systems for the autonomous car market. With what Huang calls an “extraordinarily complex” development process, traceability is crucial to achieving safety and functionality. That way, Huang says, “If something were to happen, we could trace it all the way back to its source to improve and mitigate risk in the future.” We may not be used to thinking about traceability as a central concern for semiconductor companies like NVIDIA, but Huang’s keynote reminds us that, as product development grows increasingly complex, traceability is relevant for everyone.
In November, self-driving car startup Optimus Ride announced that it had selected NVIDIA’s Drive AGX Xavier as its development platform of choice for autonomous vehicles. A purpose-built platform for developing autonomous driving systems, Xavier is an open, scalable software/hardware solution designed to streamline development and production for companies working on driverless cars. Optimus Ride founder and CEO Ryan Chin says the company will use Xavier to create Level 4 autonomous vehicles, meaning the cars will operate in specific conditions and locations with limited human oversight and input. (In other words, yes, you can take a nap – as long as the car is on normal, mapped roads.)
Also in November, NVIDIA announced three new deals with Chinese electric car companies to develop technology for autonomous vehicles. These companies – Xpeng Motors, Singulato Motors and SF Motors – join other customers of Nvidia’s Xavier platform, including Uber, Volkswagen, Mercedes and Audi. Xpeng will begin building Level 3 autonomous capabilities into vehicles in 2020. A vehicle with Level 3 autonomy can drive by itself, but the driver must stay alert and ready to take control. Singulato and Volvo – yet another Xavier customer – are also planning to release Level 4 cars in the next two years.
Innovative aerospace company makes history
In June, Lockheed Martin and NASA — a Jama Connect customer — announced they were building an experimental supersonic plane designed to shed the deafening sonic booms normally associated with super-fast airplanes. Peter Coen, project manager for NASA’s Commercial Supersonic Technology Project, described the X-59 QueSST as “a research aircraft flown by a single pilot” in a statement sent to Newsweek. The X-59 QueSST isn’t designed for commercial use, but as a research craft, Coen hopes it will “open the door a to future generation of quiet supersonic travel.” The X-59 QueSST is set to hit the skies in late 2022.
In February, aanother customer of Jama Connect made history by launching the world’s most powerful operational rocket. The successful launch set the stage for faster, cheaper launches of national security satellites and other cargo.
Sowing the future of agriculture around the world with tech
Agricultural technology (agri-tech) is booming in Africa, with investments in agri-tech startups surging by 110% since 2016, according to Forbes. In fact, there were more than 80 agri-tech startups operating in Africa at the beginning of 2018, says Forbes, and over half of those were launched in the last two years.
The reasons for the boom were summed up by Tom Jackson, cofounder of Disrupt Africa: “Everyone knows how important the agricultural sector is across Africa, but until very recently it remained relatively untouched by tech innovators,” he told Forbes. “That is suddenly changing as entrepreneurs and investors realize the scale of the challenges facing farmers, and spot opportunities to reach huge addressable markets.” Kenya, Nigeria and Ghana are the current leaders in the agri-tech market.
And speaking of agriculture: By the year 2050, according to a Duke University researcher, we will need to double our current food production to feed the estimated 9.6 billion people on Earth. Part of the answer lies in “precision agriculture,” which involves integrating technology and farming to maximize production, increase efficiency and minimize waste.
For instance, drones are being developed that are equipped with sophisticated sensors can be flown over thousands of acres to gather data on pest damage, crop stress, yield and other factors. Farmers can use drone-captured images to monitor what’s going on and make adjustments where necessary. Some drones can even plant and water crops, while others help farmers determine how much pesticide or fertilizer is needed.
The Apple Watch Series 4 boasts improved fitness and health capabilities. Image courtesy Apple.
Apple, startups prove wearable medical device market extremely healthy
Wearable health-tracking devices have soared in popularity over the last decade as fitness enthusiasts look to quantify their exercise and health goals. But the technology is also finding a welcome home in the medical community, where patients with chronic conditions can use it to monitor their day-to-day health. As we reported in March, MIT spinoff Empatica’s smart watch, The Embrace, was granted FDA clearance to detect the most severe kinds of seizures for patients with epilepsy, while tracking the frequency and duration of the seizures. In fact, Empatica was able to get the product off the ground thanks to a 2015 Indiegogo campaign that raised $800,000, more than 500% of its funding goal.
On a similar note, the Apple Watch 4 released in September was cleared as a Class II medical device by the FDA. As Forbes reports, the watch offers fall detection and three new heart monitoring capabilities: low heart rate alert, heart rhythm detection and a personal electrocardiogram (ECG) monitor. Apple COO Jeff Williams stressed the watch’s potential as a health “guardian,” and noted that Apple Watch 4 is the first ECG product offered over-the-counter directly to customers.
Other wearable medical devices to hit the market this year, per Internet of Business, include sensors for monitoring recovery in stroke patients. Coordinating care for patients recovering from strokes is complex and daunting, and has traditionally required equipment that comes with a tangle of wires – making it tough for patients to resume daily activity and be at home. Northwestern University has developed stretchable, comfortable sensors that are subtle and noninvasive. These wearables give both doctors and patient precise data about all parts of the body without cumbersome wires.
IIoT leveraged for disaster prevention
Companies pioneering Industrial Internet of Things (IIoT) infrastructure are developing ways to prevent industrial disasters through automation, reports PC Magazine. IIoT platforms offer real-time embedded systems, virtualization and AI designed to save lives – and billions of dollars in disaster damage. With these platforms, plant owners and operators can react more quickly in emergencies, thereby protecting the safety of their employees, the surrounding population and the planet.
Ultimately, says Jim Douglas, president and CEO of Wind River, told PC Magazine that IIoT technology is leading us toward automation: “The next wave is machines that are either fully autonomous or partially autonomous…you can have people be more focused on higher-level tasks and let the robots do the lower-level tasks.”
To learn more about how Jama helps organizations thrive in critical product markets by reducing risk and providing a single source of truth, download Frost & Sullivan’s recent executive brief,“Safeguarding Regulated Products Amidst Growing Complexity.”
