Evolving Role of Regulatory Operations in Medical Device & Diagnostics
The expanding importance of Regulatory Operations
This article highlights the shift taking shape in the medical device and diagnostics industry and defines regulatory professionals’ increased impact on business decision-making as a result of new global regulations that require a complete regulatory transformation.
Introduction
Regulatory operations professionals in the medical device industry have reached a crossroads. Mounting challenges due to globalization, increased supply chain complexity and patient safety have made regulatory teams far more strategic to their organizations.
Where they used to be considered foot soldiers fighting in the trenches to satisfy health authority demands, regulatory professionals now have seats at the table with senior leadership because of their importance in helping organizations navigate a complicated compliance landscape.
Device companies have experienced more regulatory changes in the last two years than in the last 20, with major updates to ISO 13485:2019, the Medical Device Single Audit Program and the European Union Medical Devices Regulation (MDR), which came into effect on 25 May 2021.
Some health authorities are pressing organizations for detailed supply-chain tracking and in-depth monitoring of both raw materials and contract counting on regulatory professionals to find ways to be more efficient and effective in a more heavily regulated world.
Despite their newfound importance and greater responsibilities, regulatory teams struggle with the same resource constraints that have held them back for years. For instance, two-thirds of regulatory affairs departments remain small with fewer than 25 full-time employees.
Many also still rely on manually intensive and time-consuming processes, including spreadsheet collaboration, file sharing and email to perform key aspects of their jobs. With EU MDR, the role of the regulatory professional expands and forever changes. Rather than focusing primarily on new discoveries in the approval stage, regulatory teams also now need to stay on top of the intricate network of laws and guidelines globally.
To succeed, they need to look to transform regulatory operations based on the following four key pillars so they can continue to evolve and adapt to business, market and regulatory changes:
- 1. People
- 2. Operations
- 3. Product portfolios
- 4. Technology
People: Finding the Change Agents
Hiring the right people or re-allocating staff where they can best leverage skillsets that align with a medical device company’s new operating model is key to assuring teams are staffed to meet emerging challenges.
Once on board, arming these regulatory operations professionals with the time, tools and training to perform their jobs is critical.
However, many companies struggle to find and attract enough quality talent. In fact, when EU MDR deadline was less than six months away, two-thirds of medical device organizations had not yet started preparing, citing lack of internal resources as one of the top reasons for the delay.
Increasing headcount is a top priority for companies in addressing the long-term challenges of EU MDR. Forward-looking medical device companies understand the importance of having teams with the appropriate regulatory knowledge that can add strategic value to help the company keep pace with regulatory changes.
One of high-demand skills sought in regulatory professionals today is strong communications skills to effectively collaborate across functions, especially clinical, quality and safety. In order to ensure compliance with the EU MDR and other new guidelines, regulatory professionals must work more closely with clinical, quality, safety, commercial and manufacturing teams.
Operations: Preparing for Change
In order to efficiently handle regulatory change, companies need to establish an operating model that connects end-to-end processes across teams and regional affiliates. Regulatory professionals, with a stronger voice in the executive suite, can be instrumental in breaking down longstanding siloes that inhibit collaboration.
For example, EU MDR increases the requirements associated with a clinical, evidence-based approach to compliance. Device companies need to demonstrate the safety of an increased number of devices in their portfolios, regardless of when they were introduced.
EU MDR also requires a shift from passive postapproval management of the product based on specific milestones, such as renewal or audit dates, to active and ongoing management, monitoring and renewal of all documentation required by health authorities.
Ramping up an organization to deal with these changes seems overwhelming, but an operating model that brings together different functional units enables a collaborative approach to change. Regulatory professionals who consider their available resources and establish the right processes for this change will connect the right people, internally and among partners, to form strong project teams with minimal time, effort or stress.
Ramping up an organization to deal with these changes seems overwhelming, but an operating model that brings together different functional units enables a collaborative approach to change. Regulatory professionals who consider their available resources and establish the right processes can connect the right people, internally and among partners, to form strong project teams with minimal time, effort or stress.
Product Portfolio: Addressing Compliance
Medical device companies channel research and development dollars to specific therapeutic areas or patient groups where the company can make a significant impact. Regulatory operations professionals can provide crucial spending advice throughout the process, flagging potential challenges early and providing suggested solutions for achieving and maintaining compliance.
Today, successful product development must take regulatory compliance into consideration throughout the process of designing, developing and delivering new devices. When organizations view compliance as a footnote to the process, something that can be handled after a new product strategy has been defined, issues typically arise.
However, forward-looking regulatory teams prepare for regulations and alert organizations to transparency and records traceability requirements, i.e., clinical evidence, post-market studies and risk management plans across the device lifecycle and entire supply chain.
The next-generation regulatory operations professional will need to have comprehensive regulatory intelligence globally so they can, for instance, avoid a costly decision to develop a product for a new indication for China if the additional compliance requirements call for time-consuming, expensive testing.
As device companies are forced to be more discerning with product development strategies, regulatory teams offer valuable information concerning the cost of compliance that can impact global go-to market plans.
Technology: Unifying Regulatory Information Management
Most device companies are instead using disparate, manually based systems that limit visibility and agility. Regulatory processes span both documents and data; however, device companies are often using point solutions designed for an entirely different process or generic office solutions to manage either documents or data.
Additional solutions for project management, calendaring and communications add to the number of disconnected, inefficient solutions often found in regulatory departments. One global company had more than 150 separate systems managing various parts of the regulatory process.
Deploying a unified platform for Regulatory Information Management (RIM) can better connect business processes and people while providing real-time data and insights.
Advanced technology will enable regulatory operations professionals to keep up with a growing amount of global information, the quickening pace of regulatory change and the need to collaborate with more people. Unified RIM platforms facilitate better access, visibility and control over regulatory document and data processes.
A recent spinoff of Novartis, Alcon Laboratories, a leading manufacturer of ophthalmology medical devices, had been relying on manual processes, spreadsheets and file shares to track and share submission information.
The company, with operations in more than 70 countries, modernized its approach by standardizing on a unified cloud platform to streamline management of clinical, commercial and regulatory content and data for a single source of truth across its operations.
Lori Holder, director of global regulatory operations at Alcon and a 25-year medical device industry veteran, discussed Alcon’s journey to transformation during a RAPS webinar. She noted that her team is fortunate enough to be larger than most.
This has enabled the company to get ahead of pending regulations, which has been a huge priority for Alcon. Even so, Alcon has faced many of the same challenges confronting smaller organizations, especially trying to do more with less.
“Managing submissions was largely manual and handled by spreadsheet submission trackers that had to be constantly maintained and updated. With our unified approach, all that data is contained in one system.” – Lori Holder, Director of Global Regulatory Operations, Alcon
“As our systems grew older, it grew harder to get things done,” Holder said. “Managing submissions was largely manual and handled by spreadsheet submission trackers that had to be constantly maintained and updated. With our unified approach, all that data is contained in one system. We can take that information and upload templates, request funding and completely manage submissions without emailing back and forth. We are also able to collaborate on final drafts of submissions and submit them for approval electronically, so the corporate team doesn’t have to chase down approvals. I think this unified system will allow us to streamline our process and work smarter.”
Holder acknowledged, however, that the implementation of RIM technology and full regulatory transformation will take time and stressed the fact that such rollouts should be supplemented with solid data, quality procedures, strict policies, and best practices.
“Technology isn’t a magic wand,” she said. “It doesn’t resolve everything. You must still make sure you understand where the data in your system came from and how it will be used. Otherwise, you end up collecting similar data multiple times and lose your single source of truth.”
6 Criteria for RIM System Evaluation
- Ability to track product registrations and manage health authority interactions
- Enables organisations to make more informed decisions and response faster to health authorities
- Effectiveness in uniting contributors, partners, and affiliates in the cloud with a single and transparent destination for regulatory readiness
- Facilitates global and regional submission dossiers to harmonize planning and provide real-time visibility into submission readiness
- Provides end-to-end submission development on a single platform
- Speeds submission delivery without an excessive number of errors
Eyeing the Future
Tomorrow’s regulatory operations professionals will empower their organizations to thrive in a heavily regulated world. This will require professionals to step outside of the more familiar “reg-ops” role of the past to focus on the four key pillars of transformation: people, operations, product portfolio and technology.
And, while technology can be a great enabler, it’s the bright minds putting it into action that will ensure success. Regulatory transformation will not only help device companies succeed and get safe treatments to patients faster, but it will also yield professional success.
As an instrumental agent to transformation, regulatory operations professionals will garner greater influence on product development, go-to- market planning and overall business strategy.
No matter the approach, though, every medical device company should be looking toward the future and establishing their new business model for operating in this new regulatory landscape. The increased complexity of regulations such as EU MDR requires a new approach.
Organizations that embrace change and modern approaches now will significantly improve compliance and efficiency in how they go to market and compete.