As medical devices, software and technologies—and the risk management, regulations and recommendations concerning them—become more of a mainstream topic of conversation, we thought now would be a good time to round up a few newsworthy items. Check out key pieces from some recent articles and our takes on each, below.
Article quote: “Los Angeles-based startup AppliedVR has developed a platform with a library of interactive games and relaxing landscapes to draw users attention away from their pain, reducing dependence on pain medications with Samsung’s virtual reality hardware Gear VR. ‘Clinical findings from Cedars-Sinai and AppliedVR have shown that VR results in a 25 percent reduction in pain, in many cases obviating the need for narcotics, and a 60 percent reduction in stress and anxiety,’ says Dr. David Rhew, Samsung’s chief medical officer.”
Jama note: In a compelling example of convergence and collaboration between three different organizations—multi-national and multi-industry giant Samsung, therapeutic virtual reality startup AppliedVR, and Cedars-Sinai and other hospitals—we’re seeing the application of a disruptive technology as a solution to several types of debilitating patient problems. Programs and innovations such as these require collaboration across organizational and departmental boundaries to ensure traceability in clinical studies, and to capture requirements that exist outside traditional product development.
Article quote: “On Tuesday, Stephen Ubl, president of lobbying group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the industry is open to working with the Trump administration on ‘market-based reforms.’ ‘Our industry takes seriously the concerns raised about the affordability and accessibility of prescription medicines, Ubl said. ‘The current system needs to evolve to enable the private sector to lead the move to a value-driven health care system.’ Drug companies provide discounts on their drugs to companies that negotiate on behalf of insurers, and there is a growing discussion about the extent to which those rebates, granted in secret, trickle down to consumers.”
Jama note: At the same time that the Trump administration calls for pharmaceutical companies to make changes, medical industries face growing uncertainty as Congress puts the Affordable Care Act under its microscope. Consequently, many companies operate in “wait and see” mode, with the knowledge that change is coming but without the knowledge of what these changes are and how business will be impacted. While repealing certain regulations could benefit these companies by accelerating the time it takes to get products to market, the need for product safety still remains. As questions multiply and uncertainty mounts, the business value of capturing, managing and maintaining product requirements remains strong and will be increasingly important as companies navigate the changes ahead.
Article quote: “There are many benefits to having Internet-connected medical devices. They can monitor patients and transmit important data about them doctors. They also can provide remote control of medical devices such as pacemakers. Adjusting these devices through the Internet of Things can avoid additional surgeries or other procedures that carry the risk of infection. But remote control of such a sensitive piece of equipment can be a detriment. Anything connected to the Internet potentially is at risk of hacking — and when the device being hacked is a medical device, the risk could be fatal.”
Jama note: For every new opportunity the IoT creates, it seems a new reason to worry comes along with it, and there is no greater worry than when health and safety are at stake. As medical monitoring moves into the mainstream, enabling more efficient and responsive communication for patient care, we’re also approaching an era where trust in “the doctor knows best” isn’t enough. Doctors, hospitals and the patients using these devices will all share some degree of responsibility for security awareness. But the greatest pressure will be on medical device designers and manufacturers to design and build each new product, version and variant around changing definitions of patient safety and security. And for Internet-enabled medical technologies, good health begins with good requirements management.
- Medical Devices & Life Sciences Product Development News - February 16, 2017
- Best Practices for Developing Safety-Critical System Software Requirements - January 12, 2017
- Top 10 DO-178C Best Practices for Avionics Engineers & Managers - January 5, 2017