Aug 29, 2017

Medical Device Safety and Quality Data: Reduce Risk, Improve Patient Safety

Medical devices have received a lot of
negative attention lately.  Duodenoscopes
such as this are among the devices
receiving adverse event coverage.

by Nicolas Tasse-Guillen & Daniel Henrich, 

Reed Tech Life Sciences Team

Medical Devices in the Spotlight

Medical devices have received quite a bit of media attention recently and, unfortunately, much of that attention has been negative. High profile stories have appeared in major media outlets online, in print and on TV about adverse events resulting in patient harm from permanent contraception, power morcellators, duodenoscopes and other high-risk devices.

In many of these cases, media attention has been followed by intense government scrutiny. A Senate committee issued a report in 2016 regarding deadly drug-resistant bacterial infections spread through duodenoscopes. The report, Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, stated plainly that “FDA needs a more robust device safety surveillance system.” In conclusion, the committee issued several specific recommendations for FDA regarding the bolstering of agency device post-market surveillance programs.

FDA Data Collection Efforts

With this warrant from Congress, FDA has been diligently executing on its goals of making such improvements. The National Evaluation System for health Technology (NEST) and the Case for Quality are two examples of FDA initiatives aimed at better monitoring and reporting medical device safety and quality data.

Through the Unique Device Identification (UDI) program, FDA is building a framework to collect and connect industry data points, then leverage it to inform enforcement practices with the goal of improving patient safety. Through UDI and other FDA initiatives, more medical device data is being collected electronically now than ever before.

Some companies may be concerned about the cost of non-compliance with the FDA requirements. Based on a whitepaper from McKinsey and our own analysis of FDA data, Reed Tech estimates the cost to the medical device industry of FDA enforcement actions at $4 billion per year. However, the bigger question is what is the cost of poor quality for both manufacturers and patients.

Available Data Sources and the Importance of Industry Action

In light of these developments and mounting costs, industry must break the chain of negative media, congressional and FDA attention by being more proactive about leveraging available data to mitigate risk and improve patient safety. It has never been more important for device manufacturers to analyze the data surrounding the safety and quality of their products and to act on that intelligence.

The good news is that there has never been so much data to draw from. Publicly-accessible FDA databases (e.g., MAUDE, MedSun, and others) house a staggering number of adverse event reports, recall notices, warning letters, surveillance studies, safety alerts, inspection findings, and announcements about injunctions, seizures and consent decrees. In addition, other government agencies are compiling and publishing related data, such as the National Institutes of Health (NIH), which publishes clinical trial data on ClinicalTrials.gov.

Regulatory agencies outside the United States are also busy collecting data on their own device markets. Australia’s Therapeutic Goods Administration is one example of a non-U.S. regulatory body collecting and publishing adverse event reports. The EU’s European Council has just unveiled a new set of Medical Device Regulations (EUMDR), which includes an initiative to make a lot more device safety data available to the public on the web.

So, there is no shortage of data for device companies seeking to understand their products’ safety and quality data trends and compare them against competitors’ and industry averages.

Valuable Insights Are Achievable

A thorough and careful analysis of the data often yields valuable insights. For 
instance, analyzing adverse event reports by product type can tell you if there are specific failure modes more commonly associated with your product than with similar devices. Further investigation might show that the percentage of adverse event reports for your device indicating the issue of “material separation” has been climbing for the past several years, while your leading competitor’s product percentage has remained steady. In this case, you would be able to investigate this gap earlier and thoroughly to determine what the underlying cause of might be. Early intervention may bring material gains to patient safety.

This article is related to the Analyst Report:
To get the full details, please view your free Analyst Report.

Not So Fast – Barriers to Successful Analysis

But there are many obstacles to this type of meaningful analysis. The sheer volume of the data, its disparate locations and varying formats present formidable barriers.

As we researched the market for our own safety and quality analytics product, Reed Tech Navigator™ for Medical Devices, we found that most device professionals engaged in this type of analysis share the same challenges. A survey conducted by Reed Tech of device manufacturers in 2016 showed device professionals reporting the same problems over and over. Here are the top three:

  1.      1.   Difficult to search and retrieve meaningful results
  1.      2.   Time-intensive process requires combing through multiple sources
  1.      3.   Data is not normalized, standardized or connected, making trending and benchmarking difficult

Whether manually sifting through and manipulating data, building a software solution, hiring an outside consultant or purchasing an off-the-shelf solution, the approach you take must address these three barriers that stand between you and the actionable intelligence you need to succeed.

Reed Tech Navigator - a New, Simpler Approach

When creating Navigator™, Reed Tech took all of these items into consideration. Navigator starts by normalizing company and product names, making the datasets easily searchable and sortable. It then connects more than a dozen (and counting) data sources, even extracting standardized metrics from narrative text descriptions in reports. Finally, it presents the data in simple charts that give device professionals an immediate grasp on data trends.

Through the process of developing Navigator, the Reed Tech team learned a lot about medical device safety data and analysis. We recently partnered with the Medical Device Group on LinkedIn to present an educational webinar, Leveraging Big Data to Mitigate Medical Device Risks. To learn more, industry members can access this presentation on-demand for free, or contact Reed Tech through our website any time.

About Reed Tech Navigator™ for Medical Devices

Reed Tech Navigator is a new way to extract meaningful insights from medical device quality and safety data in a fraction of the time required to analyze the data sources manually. 

Navigator creates value for participants throughout the entire healthcare ecosystem, including device manufacturers, regulators, distributors, insurers, healthcare providers and investors by providing insights related to device safety and quality.
Navigator was recently named winner of a 2017 Connectiv Innovation Award by SIIA in the category of “Creating a Dynamic Customer Experience.”

Visit ReedTech.com/Navigator to watch a video and learn more.

Nicolas Tasse-Guillen is a Senior Product Manager in the Reed Tech Life Sciences group. Nick is a subject matter expert on creating user-friendly data-centric products. He has more than fifteen years of experience in product development working in the life sciences, healthcare, and information services industries. Nick holds a bachelor’s degree from Harvard University.

Daniel Henrich is Life Sciences Marketing Manager at Reed Tech. Dan specializes in understanding the challenges faced by medical device and pharmaceutical professionals and helping them understand how Reed Tech can help. Dan received his BA in Political Science from Temple University and MBA from West Chester University of Pennsylvania.


Watch Related Videos:

BioMimetic Therapeutics
How MasterControl Makes Your Job Easier

Download Free Resources
White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
Q&A: FDA Medical Device Investigator Offers Insights on Inspection
Q&A: Guidelines For The European Medical Device Vigilance System
Analyst Report: Risk Management: Best Practices for Medical Device Profitability
White Paper: Software Trends in the Medical Device Industry