29 September 2016 Lisa Weeks, Marketing Communications, MasterControl
|There's a treasure trove of PMS
data you're probably not using.
Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.
Look Beyond MDR
Most device makers associate postmarket intelligence with medical device reporting (MDR), a surveillance tool intended to collect reports of device-related adverse events, use errors, product quality issues, and device failures. However, MasterControl’s Mickey Garcia, a medical device expert with more than two decades of industry experience, encourages you to look beyond MDR and take advantage of the “treasure trove” of PMS data at your disposal to improve decision making, product design and time to market. He’s not alone. The FDA is conducting and supporting a range of initiatives to enhance the nation’s PMS capabilities for medical devices, most notably its National Medical Device Postmarket Surveillance System, also known as MDS.
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The FDA’s Plan for Improved Postmarket Surveillance
In a nutshell, the FDA’s vision for MDS is to create a public-private system that relies on the experiences of patients to not only produce safer devices but also make it easier to spot defective ones. In a 2012 report, the FDA asked the public for help in implementing a five-pronged plan, designed to strengthen the Agency’s current postmarket surveillance efforts and better manage risks.
- Step 1: Establish a multi-stakeholder Medical Device Postmarket Surveillance System Planning Board to identify the policies and procedures necessary to create an MDS;
- Step 2: Establish a unique identification (UDI) system and promote its incorporation into electronic health information;
- Step 3: Develop national and international registries for selected medical device products;
- Step 4: Modernize adverse event reporting and analysis through the use of digital records and a mobile app; and
- Step 5: Develop and use new methods for evidence generation, synthesis, and appraisal.(1)
How Long will it Take to Build the MDS?
In the meantime, device companies should examine their existing postmarket safety surveillance efforts and ask themselves this question: Am I using all of the data sources, algorithms and tools at my disposal? Chances are, you’re not.
“Despite having access to unprecedented data and technologies, few companies are truly exploring how to use big data to improve product safety and drive better health outcomes,” said Garcia. “That’s unfortunate because those who do stand to gain substantial business and operational benefits.”
Limitations of Current Device Data Sources
Although you can get device performance information from a variety of sources, each source has well-documented limitations. Let’s look at a few examples:
- EHRs: Medical records provide valuable patient health information. However, most records live in disparate databases. This makes it difficult to detect safety problems quickly or assess long-term device performance.
- mHealth: Interoperability challenges also limit the usefulness of the data patients track on their smartphones and other mobile devices. Presently, there is no cohesive or standardized way to collect and interpret the information. What’s more, in its current form, this patient-generated information provides little interpretable data on the performance of FDA-approved devices.
- Clinical studies: Clinical trials produce the best data available for health care decision making; however, they are often small and may not be a true representation of the patients who will be using the device.(2)
3 Phases of Postmarket Surveillance
Postmarket surveillance encompasses three phases: data collection, data analysis and data distribution, i.e., how to get the results of the information you have gathered to the people in your organization who can use it to improve processes and products.
Phase 1: Data Collection
Most of us are familiar with the data collection phase since we are obligated by regulators to provide customer complaint information. However, as mentioned above, complaints are only one source of postmarket feedback. Other valuable collection and monitoring sources include clinical studies, information from the health care system itself (e.g., electronic health records or EHR), patient-generated information (e.g., smart phones and mobile products), internal quality data (e.g., nonconformances), and even insurance claims.
Many of these source categories have subcategories. Customer complaints, for example, can encompass everything from a highly structured FDA MedWatch Form 3500A to a casually worded social media comment. Because customer complaints are the ultimate indicators of product quality, every complaint must be appropriately evaluated, investigated and, when necessary, corrected. Customer Complaints Management software is available to help companies reduce audit times and findings and decrease the risk of costly and embarrassing product recalls.
Phase 2: Data Analysis
After PMS data has been collected, it must be summarized and analyzed. Corrective and preventive action (CAPA) and risk analysis are key components of phase two. If a complaint or nonconformance is determined to be a systemic issue, you must delve into the CAPA process and conduct a root cause investigation. You must also perform a risk analysis. Finally, all of the data gleaned from the CAPA and risk processes must be summarized, categorized and coded so that it can be trended. This is typically done manually. Someone must categorize and code incident records, which can be tedious and time-consuming. These challenges have prompted many device makers to rely on automated CAPA and risk management software to track and trend critical quality events and risk-related information.
Phase 3: Data Distribution
During phase three, you must act on the results uncovered during the first two phases. The key to acting on the results is to bring the data to the “points of use” where it can be utilized to create knowledge bases, in addition to conducting the baseline MDR required by regulators.
Garcia advocates using the results to establish a product realization knowledge base, a resource that process and manufacturing engineers can regularly access for product and manufacturing information compiled from all postmarket data sources. He also advocates establishing a product design knowledge base and using it to improve the design of products currently on the market, as well as your next generation products in development.
Medical device companies that proactively address the increasing demands for product safety face significant challenges as well as great opportunities. By adopting an integrated, risk-based approach to postmarket surveillance, and taking advantage of the full gamut of device evaluation approaches available, your company can decrease its exposure recalls anddevelop an even stronger product portfolio.
What type of postmarket evaluation methods does your medical device company use? How are you using the results to improve product safety and efficacy? Leave a comment below.
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Her work has appeared in many industry publications, including Medical Product Manufacturing NEWS (MPMN), Medtech Pulse, Risk Insights, MD+DI, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech.
(1) Shuren, Jeffrey, M.D., J.D. and Gross, Thomas P., M.D., MPH, Moving Toward a National Medical Device Postmarket Surveillance System, 23 February 23, 2015.