Pearl 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.
We 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. https://www.raps.org/ProductDetail.aspx?ProductId=96813130
Earlier 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 If you haven’t already, take a look at this timely draft guidance from the FDA to learn more. The draft guidance addresses cybersecurity issues throughout the entire product lifecycle of a networked medical device that utilizes software (firmware) and includes the ever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.
Image courtesy of thomasdinnocenzi.wordpress.com
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.
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.
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 RAPS.org, 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.
The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about “emerging signals” regarding regulated medical devices. FDA defines an emerging signal as “new information about a medical device used in clinical practice: 1) that the Agency is monitoring or analyzing, 2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, 3) that has not yet been fully validated or confirmed, and 4) for which the Agency does not yet have specific recommendations.”
An “emerging signal” would alert the public to the most current information known about a medical device. The intent is to prevent potential risk to patients. Opponents to this idea are asking why the FDA would release information that has not been fully verified / investigated by the FDA. For more information, read Zachary Brennan’s article on RAPS.org.
Medical Device Tax suspended for two years = good news for Medical Device Companies and Patient Health
President Barack Obama recently signed a bill suspending the Medical Device Tax for two years. It took a great combined effort of many large and small medical device companies to make this happen, many from Indiana. This outcome greatly benefits all medical device companies. Hopefully, now the monies that companies would have earmarked toward taxes could now instead be put into new product development. This investment in R&D could also drive more jobs and ultimately more innovative solutions to improve patient health.
After learning of the suspension, Fred Hite, CFO of OrthoPediatrics of Warsaw, Indiana stated “Luckily now we’ll be able to go back and review that and remove the expense and cash that we had put in to the budget for the medical device tax and instead replace that with incremental programs developing new projects.”
Great news for medical device development. To read Varun Saxena’s full article about this topic in Fierce Medical Devices, click here. The Pearl Pathways team is ready to partner with your team on your new projects to improve patient health, contact us.
On February 3, 2016 the Indiana Medical Device Manufacturers Council (IMDMC) will be hosting 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.