This post is sponsored by Veeva Systems.
As medical products become more complex and medtech firms sell into more and more markets, post-market surveillance is an increasing challenge for the device and diagnostics industry. Recently, SmartBrief spoke with Carl Ning, senior director of Vault Quality Medical Device & Diagnostics at Veeva Systems to learn why companies struggle with post-market surveillance and how they can better respond to changing regulations.
Why is post-market surveillance a growing challenge for the industry?
Quality and regulatory have been some of the highest cost centers within the medtech industry for years, with post-market surveillance leading the way. It is a challenging environment – dealing with high transactional volumes and perceived unsavory topics such as alleged product deficiencies and patient safety issues.
In addition to the conventional challenges, the industry is adapting to evolving regulations. While EU MDR and IVDR are top of mind for many, we expect to experience additional downstream effects from the Medical Device Single Audit Program (MDSAP). During the rollout of MDSAP, the FDA had declared that MDSAP-certified facilities would be exempt from routine inspections. However, it has since indicated that MDSAP audits do not evaluate Field Actions sufficiently to ensure patient/product safety. The agency has redefined its internal definition of For Cause Inspections in a way that enables it to use Field Actions as a point of entry for inspections. As a result, we expect to see an increase in For Cause Inspections, with additional emphasis around post-market surveillance, after the COVID-19 pandemic subsides.
What are some of the reasons companies struggle to submit their AERs accurately and on time?
There are several recurring themes that are worth examining. One possibility is the use of homegrown spreadsheets and databases. This not only poses security concerns, it also introduces a bevy of functional errors with formulas, transcription, filtering and more – errors that can slow a company’s submission timelines.
Another possibility is the use of antiquated, on-premise solutions that either lack configuration capabilities or that have gone through so many customizations (i.e., source code changes) that it hinders additional changes necessary to adapt to new requirements. This can also impede an organization’s capability to upgrade and/or validate the solution – even with the vendor’s support. More often than one would imagine, an ROI calculation or pro/con assessment forces a company’s decision to remain on an unsupported version and operate at risk.
Solution design also plays a critical role in system usability. While the post-market surveillance process is perceived as complex, we must be careful in not translating verbatim every bit of nuance into the solution’s functional requirements. Doing so has led to many complex and over-engineered designs that may force an operator to sit idle (e.g., waiting for system automation to take place between entries) or to click for the sake of clicking (e.g., workflow steps that do not fulfill any business requirements).
What benefits are companies missing out on when they lack global visibility in PMS?
For a specialist who handles medical device or diagnostics complaints, timeliness is next to godliness. The greater the visibility, the higher capacity for submission timeliness. When visibility is balanced with a well-designed solution, an organization can better prioritize and allocate resources. This approach lessens reliance solely on resource increases as a means to increase capacity. Efficient solution designs organically maximize capacity, which enables an organization to free up bandwidth to focus on value-added initiatives that can improve patient safety and product innovation.
How can companies better manage PMS and respond to changing regulations?
While it is prudent for the design team to identify, prioritize and document the organization’s business requirements, it is also pragmatic to see what vendors have to offer from an out-of-the-box, best-practices perspective. Examining a vendor’s best-practices offering can be a great value-add, as it may provoke new thinking.
Understanding Good Design Practices is important in helping better manage PMS, but it’s a balancing act. End users tend to embrace solutions that are highly functional, but highly functional systems typically carry a higher degree of complexity and customization needs. When it comes to system maintainability (e.g., picklist values, integrations), expandability (e.g., how quickly one can deploy to additional sites), and system agility (i.e., the ability for a system to quickly adapt to business and/or regulatory changes), the solutions with a high degree of usability tend to be less agile.
What are some features companies should look for in a PMS management system?
Where possible, companies must attempt to balance administrator responsibilities versus end-user autonomy. The chosen solution should help reduce system administrators’ reliance on activities such as maintenance of picklist values and health authority reporting timelines, for example. The solution should also provide self-servicing, in-tool, ad hoc reporting capabilities to help maximize consumption of data and, in turn, accelerate the business decision making process. A seamless, automatic upgrade process -- and the accompanying validation artifacts -- are also critical in maximizing efficiency.
Companies should pay attention to any vendor-suggested streamlining – either by way of best-practices delivered applications, or lessons learned from past implementations. Taking such an approach will help an organization move away from the reactive mode of operations toward a proactive strategy.
Carl Ning is responsible for Veeva Vault Quality solutions strategy, with an emphasis on the medical device and diagnostics vertical. With over 20 years of experience delivering transformative solutions in the life sciences, consumer products, discrete manufacturing, and financial services industries, Ning has dedicated 15 of those years to quality management. He has been involved in over 100 quality/regulatory system design and implementation initiatives, and continually seeks ways to evolve solution designs to maximize value without sacrificing efficiency and compliance. He can be reached at email@example.com.