With increasing focus on patient safety by the FDA and other regulators, device companies face the challenge of improving the safety of their products. Given the increasing complexity of devices, manufacturers must look more broadly at device risks than they have in the past. They can no longer base safety surveillance just on passively acquired data or customer complaints. As changes are made to the 510(k) process, companies will be required to provide more data in conjunction with post-market safety. What’s needed — sooner, rather than later — is a consistent approach to post-market safety surveillance that incorporates medical input beginning with product development and continues through commercialization.

Global medical device companies face significant operational challenges to ensure monitoring and safety surveillance practices satisfy increased regulatory compliance requirements and new demands for transparency. These requirements will only increase in the near term, which means companies must avoid ‘static planning’ — planning to improve operations to meet current requirements, or focusing exclusively on ensuring compliance with procedures already in place. Developing an integrated, proactive approach to safety surveillance will require companies to change their organizational structure and improve processes to implement safety surveillance capabilities that are robust, sophisticated, proactive, efficient, and informed by clinical expertise.

Safety in Product Development

Manufacturers need to assess whether pre-clinical, clinical research, and broader product development insights about devices are systematically used in developing robust post-market surveillance strategies. This will mean a departure from the device industry’s historical engineering focus to include medical input in product development to assist in determining possible product safety issues and to prepare for post-market surveillance efforts. Planning for post-market safety surveillance includes creating a risk profile that takes product characteristics and associated medical risks into account. Medical input in developing product risk profiles will increasingly be necessary for complex devices in order to identify potential product health risks related to new technologies, materials and manufacturing, and to take patient and procedure related issues into account.

Developing a Surveillance Plan

Based on the risk profile, device manufacturers will be able to develop a post-market safety surveillance plan. The completed risk profile will guide specification of the information sources and signal assessment methods needed based on product risk. Increasingly, companies will need to expand the use of data registries, use new data sources and medical claims data, develop new analytical capabilities, and experiment with other kinds of surveillance activities such as social networks and clinical practice observations, in addition to traditional passive surveillance activities.

Building a Sustainable Framework

Most companies find that developing a systematic, consistent approach to safety surveillance which is proactive, efficient, and informed by clinical expertise is complex and challenging. Companies will need to determine how to redevelop their organizational structure to embed the appropriate capabilities, accountabilities, and processes needed to support this new approach. Developing this common strategy for safety, rather than defining requirements on a product-by-product basis, will allow device companies to ensure that their approach is consistent, while enabling a flexible approach to support multiple products.

Numerof’s Comprehensive Safety Surveillance Services

Numerof has made regulatory compliance one of our core practice areas because it is one of the most rapidly evolving aspects of healthcare. Requirements are growing more stringent, and the consequences of non-compliance more expensive; the very definition of adequate compliance structures and processes is a moving target. Numerof helps clients stay ahead in this increasingly challenging enforcement environment with proprietary risk management assessments, tools and processes and we can help you:

• Define quality and regulatory compliance priorities in light of business strategy and company performance
• Redesign roles, optimize staffing, develop policies and procedures, and develop integrated risk management processes for quality and safety surveillance groups
• Build an organizational framework that structures the involvement of development scientists, medical professionals, and others throughout the entire development and product lifecycle
• Design communication processes for early risk detection, and standardize data collection to improve data mining and analysis
• Build a consultative product safety/risk management function that anticipates and helps resolve internal clients’ business challenges
• Assess and redefine core processes and stakeholder relationships to satisfy evolving regulatory and legal requirements for transparency

Numerof has extensive experience in developing strategies and integrated approaches to the design and management of quality and compliance systems. Over the last 20 years Numerof has helped clients across the healthcare sector address both the “what” of strategy and the “how” of implementation. Our services are intended to help clients design and implement systems that enable strategically important performance in the organization. Whether you’re looking to enhance your current approach to post-marketing safety surveillance, or develop a better one, we can help.