The Medical Device Plug-and-Play Interoperability & Cybersecurity (MD PnP) Program


 

Contact: Colin Gorman, Program Manager

cgorman@mgh.harvard.edu

The Medical Device Plug-and-Play Interoperability & Cybersecurity (MD PnP) Program was founded in 2004 with the mission of improving patient care by leading the development and adoption of safe, secure, and effective digital health and interoperability solutions. Since then, the MD PnP Program has been recognized internationally as a leader continuously pushing the frontier of medical device interoperability, cybersecurity, and informatics research and innovation. Our team of subject matter experts in clinical, computer science, and bioengineering are dedicated to solving complex socio-technical problems that impede digital healthcare innovations.

The MD PnP Program is based at the Massachusetts General Hospital (MGH), one of the nation’s best clinical, research, and teaching hospitals; and affiliated with Mass General Brigham (MGB) health system, a network of leading healthcare delivery organizations in New England. The Program is also a member of Consortia for Improving Medicine with Innovation & Technology (CIMIT), a network of world-class academic and medical institutions partnering with industry and government to foster collaboration and accelerate innovative healthcare technologies.

Working with our sponsors and partners in both public and private sectors, we have established a holistic sandbox environment with a wide range of medical devices and equipment, a sophisticated yet highly configurable network infrastructure, and a rich repository of tools and techniques. This sandbox environment creates vendor-neutral labs for prototyping, design optimization, and assessment of medical devices, digital health solutions, and health IT technologies in simulated care settings.

The MD PnP Program has collaborated with government agencies, hospitals, and medical device companies of all sizes for pre-clinical/pre-deployment testing and assessment of medical devices, digital health solutions, and hospital IT.  We are also a service provider to MGB for pre-procurement medical device assessment. In addition, our sandbox environment is ideal for startups and other companies to rapidly prototype and test novel technologies in close-to-reality deployment settings, as we have demonstrated in projects in support of pressing national needs, such as Ebola Virus Disease and the COVID-19 pandemic. 

We welcome collaborators and customers to take advantage of our sandbox environment and our world-class expertise to expedite research, development, and verification of innovative medical technologies.

     


How can you collaborate with the MD PnP Program?  Here are a few ideas:

1. Technical and Clinical Risk Assessment of Digital Health Solutions

  • Rapid proof-of-concept prototyping
  • Systematic technical and clinical risk assessment
  • Safety and essential performance assessment

2.  Interoperability Capability Assessment of Digital Health Solutions

  • Test interoperability capabilities per FDA’s medical interoperability guidance
  • Assess interoperability design, development, verification and disclosure

3.  Pre-Deployment and Integration Testing of Digital Health Solutions in a Virtual Hospital Setting

  • ​Early detection and mitigation of issues related to network integration and conformance to hospital networking standards
  • Compliance to hospital procurement, configuration, and maintenance requirements
  • Guidance on refinement and optimization of product offerings to minimize or reduce risks in clinical deployment and integration

4.  Cybersecurity Risk Assessment of Medical Devices and Digital Health Products

  • Assess cybersecurity threats and vulnerabilities and evaluate their safety implications
  • Assess operational viability and effectiveness of security controls and remediation solutions for security threats and vulnerabilities