It is often said that the two most common phrases among safety, regulatory and quality professionals in the medical device industry are “it depends,” and “it’s complicated.”

This is with good reason, as a change to one process or standard for safety, regulatory or quality will often impact the other two. In addition, information pertinent to these processes tends to reside in disparate systems; product life management (PLM), quality management systems (QMS), and regulatory information management (RIM) solutions. That means information does not readily flow from one solution to another resulting in the need for manual intervention with change management and remediation strategies. In turn, this makes it difficult to determine the true cost of a change in terms of resources, time, or regulatory approval. Commercially and operationally the execution of a product change often needs to strike the balance between moving fast enough to adjust to unforeseen manufacturing change events and moving with conscious decision making and control to ensure the global market impact is understood before product changes are implemented.

In some cases, the impact of a change is minimal – minor updates to packaging, for example. However, there are several types of changes that can have a ripple effect throughout safety, regulatory and quality operations and in some cases, what is seen as a simple or non-significant change in one country can have a much bigger impact in activities in another country.

Different requirements for the US and the EU. The two geographies in which medical device makers typically define their first ‘go to market strategies’, the United States and the European Union, have different requirements for demonstrating evidence of compliance. They also use different medical device classification systems, which in turn come with their own requirements. This means manufacturers need to assess the impact of change separately for these two regions and ideally this impact assessment should be coordinated within a single change control workflow with bi-directional communication between safety, regulatory and quality systems that are managing the change activities and identifying the global impact assessment. In other words, a single global change process will trickle down to different actions based on the local authorities and regulation requirements, and these actions will be tracked back into the original change notification.

Submission pathways for subsequent approvals. After obtaining US 510(k) and EU CE approval, manufacturers typically seek approval from other markets such as Brazil, Saudi Arabia, Russia, China and Japan to name a few other important markets. Product testing, technical and clinical documentation, and country submission reviews for the various individual markets can take up to and beyond three years for the global approval of a product range.

In the context of change management, it can be difficult to complete a global impact assessment in a timely manner for manufacturing and/ or predict which safety, regulatory and quality requirements will need to change or what submission documentation needs to be redone. However, the more gaps there are between the submission and the impact of the change, the longer it takes to complete an application and receive regulatory approval. Hence a global single click change impact assessment does not serve the purpose and will simply fail to accommodate country specific regulatory requirements. It becomes important to classify the global change on the product level and then perform the impact assessments at the country specifications.

Development of next-generation solutions. Manufacturers increasingly seek to differentiate themselves by developing product solutions that incorporate a combination of medical equipment, software, consumables, pharmaceuticals, and other customized product elements. This leads to interdependent product development and safety, regulatory and quality timelines, which only gets more complicated as manufacturers begin to prepare products for launch in additional markets. The dependencies on the Drug related approvals for the combinational products cascade the delays.

The combination of medical devices and pharma. Another consequence of developing solutions instead of products is the blurring of the line where pharma regulations end, and medical device regulations begin. A common example is a syringe; a pre-filled syringe is regulated differently than one that is shipped empty and comes with a separate container of an injectable therapy. These solutions require their own strategic plans, requirement assessments, and workflows – and a greater degree of interconnectivity than medical devices or pharmaceutical products alone. Another example from the dental industry are fluoride pastes – depending upon the volume of fluoride in the paste the product could be classified as a device in some global markets and as a pharmaceutical product in others.

Midstream change controls. What if a product has been on the market in the US and EU for two years, and a company is seeking approval in new markets, but feedback from safety systems indicates that a design change is necessary? This has significant safety, regulatory and quality implications. After conducting a health hazard assessment, companies must consider what the change is, how significant the change is, the impact of the change in markets where the product is already registered, the time and cost to make the change, and the impact on pending product registration.

These types of changes are inevitable. As patient safety is every manufacturer’s priority, products will need to be changed to address known issues. Authorities also update quality standards and regulatory requirements on a frequent basis to better meet the needs of their markets and adapt to technology and product innovations.

Designing Change Management across Safety, Regulatory and Quality. As change is inevitable, so too is change management. The most effective strategies for change management in safety, regulatory and quality also boil down to two simple phrases: "control the controllable” and “automate the transactional.” In following these two strategies we allow safety, regulatory and quality industry professionals additional capacity to focus on technical elements of their roles.

To accomplish this, manufacturers must enable dynamic and bidirectional information flow among the solutions within their safety, regulatory and quality ecosystem – PLM, QMS, RIM and any others that add value. The ability to structure and share data leads to integrated workflows and business processes among safety, quality, and regulatory teams. To identify, track, and respond to change stimulus across the safety, regulatory and quality workflows and reflect data consistently across the ecosystem. Manufacturers can then identify requirements up front, complete regulatory event submissions faster, and drive continuous improvement in product quality and patient safety. By connecting the data across the various safety, regulatory and quality departments, greater intelligence is brought throughout the organization to speed efficiency. Through the use of automated, advanced technologies, teams are empowered to provide greater connected intelligence into predicting potential outcomes so proactive measures may be taken. As a result, firms will have an enhanced focus on patient, regulatory professionals and healthcare practitioner engagement.

To speak with an IQVIA expert, send a note to RegulatoryTechnology@iqvia.com.