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Tag: medical devices

  • Startup Aims to Manufacture Ventilators Using 3D Printers

    Startup Aims to Manufacture Ventilators Using 3D Printers

    A startup company is in the early stages of building a proof-of-concept that would allow local hospitals to employ 3D printers to manufacture ventilators and other medical equipment to help combat the COVID-19 pandemic.

    Veritx president James Regenor said company executives have already been involved in use cases in which the military has used 3D printers to create replacement parts on aircraft carriers at sea. That same concept could be applied to medical equipment using any number of 3D printing services that now operate in most municipalities. In fact, some hospitals attached to universities already probably have access to 3D printers.

    Veritx is in the process of looking for funding to help create a proof-of-concept (PoC) around an electronic file that would contain the schematics for printing out the parts that make up a ventilator. Those parts could then be assembled near a medical facility to provide a steady source of ventilators as needed, said Regenor.

    Those printers could also be employed to create splitters that would enable multiple patients to share the same ventilator or, if need be, convert other devices for pumping oxygen, such as scuba equipment, into a makeshift ventilator, he said.

    Regenor estimates a local 3D printing service could manufacture more than 1,000 ventilators a day. Alternatively, medical facilities could use 3D desktop printers to fill an immediate need.

    The issue that 3D printing could solve is that ventilator manufacturing is currently dominated by a handful of companies. As demand for ventilators escalates, many of these companies are having issues scaling up their manufacturing. That shortage of ventilators has resulted in a wide range of companies, including Ford and General Motors, offering to use their manufacturing lines to build ventilators. However, it may be months before any ventilators that might be manufactured by those companies become available because of the need to retool manufacturing lines. Ventilators created using 3D printers could, in theory, be available within hours or days of being ordered, at a much lower cost.

    The ventilator shortage is already a chronic issue in areas such as Italy and New York, where the COVID-19 pandemic is now raging. It’s likely to become an even bigger problem as the virus spreads to more rural areas where hospitals don’t tend to keep many ventilators on hand. State governments naturally will do their best to acquire as many ventilators as possible; however, competition is now fierce, with individual states and governments around the world outbidding each other for ventilators. The chances that smaller states will have the financial resources necessary to compete for ventilators are slim.

    It’s too early to say to what degree the current pandemic may be one of those seminal events that winds up boosting an emerging technology such as 3D printing. The one thing that is certain is manufacturers of 3D printers have a role to play in the current crisis that could transform the medical equipment industry in a most unexpected way.

    — Mike Vizard

  • DevSecOps: IoT Right and Nobody Dies

    DevSecOps: IoT Right and Nobody Dies

    Dr. Suzanne Schwartz, CDRH Associate Director for Science and Strategic Partnerships at the Food and Drug Administration (FDA), recently released a blog to update us on the FDA’s role in medical device cybersecurity.

    Cybersecurity risks in medical devices are nothing new. As far back as 2012, Sonatype published warnings of security risks in pacemakers that could lead to lethal attacks. Last year, Johnson & Johnson warned of cyber vulnerabilities in its insulin pumps. More recently, our “2017 State of the Software Supply Chain Report” shared details of pacemaker programming machines that were discovered to have more than 8,000 known software vulnerabilities (see page 37).

    When it comes to software in medical and other devices, cybersecurity will be a constant threat requiring constant vigilance. The encouraging guidance I read from the FDA blog was that cybersecurity should not be limited to devices already on the market, but that security needs build in throughout the product life cycle. Schwartz remarked:

    “It is the goal of FDA’s Center for Devices and Radiological Health to encourage a coordinated approach of vigilance, responsiveness, resilience, and recovery that fits our culture of continuous quality improvement.

    “This means taking a total product lifecycle approach, starting at the product design phase when we build in security to help foil potential risks, followed by having a plan in place for managing any risks that might emerge, and planning for how to reduce the likelihood of future risks.”

    In these two brief statements, Schwartz shares views that are common in many of today’s DevSecOps conversations. Perhaps she has been listening in?

    The first view is that we need to “emphasize the performance of the entire system and never pass a defect downstream” (Gene Kim’s first way of DevOps). Schwartz recommends that device manufacturers start by building security in at the earliest stages of the development life cycle. Security cannot be an afterthought.

    Schwartz also recognizes that even when precautions are taken early in the life cycle, risks can emerge over time as new vulnerabilities are discovered. When it comes to device security, vigilance must be continuous across the development life cycle and over the product’s life in the market. As we have said for years, software ages like milk, not wine. Constant vigilance improves our ability to identify risks, initiate feedback to development teams and remediate issues in the device’s software. The faster we can address risks when they appear, the safer we can make the lives of consumers who rely on them.

    I applaud the FDA’s guidance and its proactive stance here to work with device manufactures. What we don’t want is a knee-jerk reaction to medical device security after someone has died. What we need is for security to be ingrained in the planning, design, production and maintenance of medical devices our families rely upon.

    You can read the full blog from Schwartz on the FDA Voice.

    — Derek E. Weeks