Life science event: Pearl Pathways presents “The Impact of Software in Medical Device Development” forum

Pearl Pathways, along with Barnes & Thornburg Law LLP and Indiana Medical Device Manufacturers Council (IMDMC), will host an educational forum on the morning of Tuesday April 11, 2017. Key topics impacting the medical device industry will be addressed and attendees will have the opportunity to network with other leaders in the Indiana life science community. You may find agenda and registration information below.


  • 8:30 – 9:00  Registration & Breakfast
  • 9:00 – 9:45  My Medical Device Has Software: What Are My Next Steps?
  • 10:00 – 10:45 Regulatory Landscapes, Considerations and Pitfalls: Emerging Trends for Embedded Software in Medical Devices and Capital Equipment.
  • 11:00 – 11:45 – PANEL DISCUSSION – Best Practices in Developing Medical Devices Containing Software
  • 11:45 – 12:00 Q&A and Networking


Session #1 will be led by Marshall Parker, Principal Software Engineer & Owner at Gale Force Software
Session #2 will be led by John Lockwood, RAC, CWA, CSQE, Senior Advisor at Pearl Pathways


Heidi Hancock Strunk, Senior Director, Quality & Regulatory Affairs at PTS Diagnostics
Cathy Wilburn, Director of Quality Assurance & Compliance at The RND Group
Marshall Parker, Principal Software Engineer & Owner at Gale Force Software
John Lockwood, RAC, CWA, CSQE, Senior Advisor at Pearl Pathways
*Moderated by Lynn Tyler, Intellectual Property Litigator & FDA Practice Chair at Barnes & Thornburg Law LLP


Tuesday April 11, 2017


Barnes & Thornburg Offices

11 S. Meridian Street

Indianapolis, IN 46204

Learn more and register now!


IMDMC life science event

Barnes & Thornburg life science event

Save the date: IMDMC Medical Device event at the Indiana Statehouse February 15, 2017

On February 15, 2017, the Indiana Medical Device Manufacturers Council (IMDMC) will host the annual Medical Device Exhibit and Breakfast at the Indiana Statehouse. This event provides the opportunity to interact with state and federal officials about the industry. To register for the event, click here.

The not-so-grim Terminator future: Startups turn to Artificial Intelligence to combat cancer

Artificial Intelligence (‘AI’) has been in the media spotlight for various reasons as of late. A debate is underway concerning the integration of AI in our businesses, phones, art, and nearly everything else one can imagine. Companies within the healthcare industry are finding creative ways to weaponize AI in the battle against cancer. A recent blog on CB Insights detailed the work being done by a few corporate giants in the oncology space. IBM’s Watson for Oncology, a cognitive computing system targeted to help physicians deliver evidence-based solutions for cancer patients, has already been implemented in Thailand and India and will soon be rolled out across 21 hospitals in China. DeepMind, an AI company acquired by Google, will begin testing the “use of machine learning to reduce the time it takes to plan radiotherapy treatment for hard-to-treat cancers of the head and neck.”

Staying true to the entrepreneurial spirit, startup companies are also taking advantage of AI to treat or research various forms of cancer. Twelve companies were highlighted in the CB Insights blog. Notable Labs provides a service aimed towards oncologists to better identify efficacious treatment options.  Some companies, like Pathway Genomics, hope to determine if early detection of cancer is possible through the use of a blood test kit. SkinVision has entered the mobile space to turn our smartphones into skin cancer monitors through the development of a software application that analyzes skin lesions.

Healthcare professionals and companies alike will be met with new challenges in the coming years as the number of cancer patients continues to rise. The use of AI by researchers and practitioners may present solutions to many of the difficult issues associated with diagnosing and treating cancer, but bringing these new technologies to market expeditiously and at a reasonable cost will still be an ongoing challenge for both small startups and large corporations. Leveraging expertise and services from organizations like Pearl Pathways will help drive product development through the arduous regulatory, clinical, and quality hurdles that medical device and pharmaceutical companies face. Doing so will help ensure that lifesaving technologies march towards commercialization and continue to help patients worldwide.

Contact us for a strategy teleconference to discuss your product development and regulatory challenges.

FDA is building NEST for medical device

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health recently posted an article on the FDA Voice stating that the FDA is examining the ways they work with hospitals regarding data collection for medical devices. Hospitals can contribute to the safe use of medical devices by participating in the National Evaluation System for health Technology (NEST).

NEST is being built to look at evidence across the total product lifecycle of medical devices — excellent information to be passed along to patients. Need assistance with your post market surveillance program? Contact Pearl Pathways to partner with you.

Visit Pearl Pathways booth at the IMDMC Conference October 27th

imdmcPearl Pathways is excited to be attending and exhibiting at the Indiana Medical Device Manufacturers Council (IMDMC) annual conference, October 27th at the Montage in Indianapolis.  The conference includes keynote speaker Senator Dan Coats and a full day of speakers, panel discussions and exhibits.  Join in for networking, collaboration and discussions in the industry.  We encourage you to stop by our booth and meet members of the Pearl Pathways team.

RAPS publication features chapter authored by Pearl staff

gretchens bookWe are proud to announce that Gretchen Parker PhD, RAC, CIP contributed a chapter to a recent publication entitled “Global Medical Device Regulatory Strategy” published by the Regulatory Affairs Professionals Society (RAPS, purchase required). This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices.

Discussions cover medical device types, basic strategy components, and assembling a core development team from multiple departments to create a strong, viable strategy to market a product in more than one jurisdiction. There is information on device design and development elements, setting up a quality management system, labeling strategies, and manufacturing information. Other chapters look at the Notified Body’s viewpoint on regulatory strategy and that of regulators.  Additional information is included in the book, including the use of standards that cover global regulatory processes and how patents apply to medical devices.

Further information about this publication may be found on the RAPS website.

What is your company doing about Cybersecurity for Medical Devices?

cybersecurityEarlier this year, FDA released recommendations for medical device manufacturers in managing cybersecurity risks related to safety, efficacy, and integrity of medical devices and patient health. If you haven’t already, take a look at this timely draft guidance from the FDA to learn more. The draft guidance addresses cybersecurity issues throughout the entire product lifecycle of a networked medical device that utilizes software (firmware) and includes the ever important postmarket management. Risk to device functionality or loss of important data due to a cybersecurity risk is a consideration that could result in bad outcomes for patients. Device manufacturers need to take a look at their own risk management programs and assure they have a comprehensive plan established.

Pearl Pathways looks forward to the opportunity to work with you and provide support to your ongoing successful product development activities including risk management program development as part of your overall Quality System. Contact us to set up a discussion.

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Slower roll-out of UDI System

FDA’s unique device identification (UDI) system, established in 2013 as a means to identify and track devices through distribution and use, is taking some time for implementation. The UDI system was expected to be implemented in stages over a seven-year period to allow for manufacturers to comply. In establishing this system, the goal is to have device data available electronically, to reduce medical errors, and to have more accurate reporting of adverse events for a more rapid solution to reported problems and FDA communications to the public.

This transition to UDI on the labeling is a costly and difficult change for the industry in its device labeling documentation. The rule requires a UDI be provided on the device label using automatic identification and data capture (AIDC) technology so that it can be automatically entered into an electronic patient record or other computer system for tracking. FDA is extending deadlines, according to Michael Mezher, RAPS. Read his entire article here for details on dates and specific devices included in the FDA extensions. The patient comes first and the extensions seem to be necessary to avoid any problems with patient access to devices.

Designing with attention to Human Factors…

While safety and efficacy is a predominate reason for using human factors tools in medical device design, a recent article in MDTmag written by Daniel Jenkins and Paul Draper, brings up the point that “Human Factors is not simply a tool for regulatory compliance” — fully integrating human factors tools and techniques into design and development brings a design to market that has a competitive advantage.

Jenkins and Draper suggest looking at the medical device as part of a system. By doing so, this guides the design development focusing on safety and effectiveness, while concurrently looking at the user interface, efficiency, usability, flexibility. When the user interface is examined, you may find those opportunities to build in features in the design like easy to read indicators, connections and guides to reduce the risk of error and adverse events in manufacturing and with the end user. Design teams taking this comprehensive approach will be best at bringing devices to market with new breakthrough features never before considered. To learn more, check out the Jenkins and Draper article here.

Need help with integrating human factors into your medical device development, or assistance in designing or executing a usability study? Contact our staff at Pearl for their expert advice.


What are the lessons learned from the dirty scopes investigation?

Our recent blog post, Medical Device “Emerging Signals”, updated about FDA’s intent to notify the public about “new information about a medical device used in clinical practice”. FDA’s intent to alert the public to the most current information known about a medical device to prevent potential risk to patients is a good concept — implementation requires cooperation from hospitals and medical device manufacturers.

In a blog entry posted January 13, 2016, Michael Mezher, RAPS, addressed a Senate report released on duodenoscopes that were found to be the source of infection in patients. In Mezher’s article, the report found hospitals did not report safety issues in a timely fashion to the medical device manufacturers who were then to report to FDA. Also, it was found that there were no reports in design changes that were made to the scope from the device manufacturers. The delays in reporting safety issues and design changes without review meant patients were at risk because the scopes were still in use.

Lessons learned – more oversight, guidance and improvements in reporting can be made for better outcomes. The report makes recommendations for the FDA to determine if a design change is necessary on the scopes, require unique device identifiers (UDIs) to improve device monitoring, and update guidance on when device manufacturers need to submit a new 510(k) for device modifications.  These recommendations were made in efforts to improve safety on medical devices.

FDA’s emerging signals draft guidance is a step to transparency and may result in less risk to patient health. The patient is counting on hospitals, device manufacturers and FDA working together responsibly.

To read Mezher’s complete article on, please click here. Contact us if you need regulatory filing assistance or quality system support to ensure your Medical Device Reporting (MDR) processes are compliant.