This article discusses the widening range of responsibility for regulatory professionals and the increasing importance of their role to an organization’s bottom line. The author covers the value of continuously developing new skills in addition to regulatory and scientific knowledge to more effectively interface with colleagues with a variety of expertise. She highlights the effects of increased regulatory scrutiny, such as through compliance with the European Union’s new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and emphasizes the benefit of developing good writing skills.
What do you do for a living?
Regulatory professionals know how difficult it can be to answer the question: “What do you do for a living?” It is a difficult to answer because we do a little bit of everything. Working within an industry whose main output is a biotechnological product—whether a device, drug or somewhere in-between—to be successful, a regulatory professional must be involved at every phase of developing, marketing and selling a product. Additionally, in a constantly changing global regulatory environment, the specialist is constantly responsible for and involved in ensuring the consistent quality of products on the market. Increased regulatory body scrutiny, combined with a high demand for newer and better healthcare products and technologies, requires even more highly trained regulatory professionals who are quickly becoming integral to an organization’s “bottom line.”
Regulatory’s Role in the Product Lifecycle
A medical device manufacturer (regardless of company size) will employ many professionals with various kinds of expertise, such as medical doctors, engineers and scientists, quality, risk and clinical specialists, sales and marketing team members, legal advisors and more. Developing a medical device from bench-to-bedside requires the integration of various specializations at every level of the product lifecycle, from initial development to the global regulatory submission/registration and postmarket phase. The regulatory professional’s responsibility is to continuously monitor and integrate the expertise of these professionals to align with regulatory requirements during all phases of product development. Through all phases, meeting objectives and deliverables, both strategic and tactical, is paramount. In the design phase, this can mean providing a team with the regulatory framework for shaping design inputs and outputs, strategically communicating potential market approval “go and no-go” situations based on product design decisions and working intimately with a core design team to process all the possible impacts of product changes as the device is developed and, often, incrementally innovated.
Once a device is on the market, the product vigilance (postmarket surveillance) process begins and continues until the product is removed from market. Thus, a regulatory professional’s responsibility for a device lasts until product “sunset.” This over-arching responsibility makes the regulatory professional’s role a crucial component of the product’s lifecycle, an expertise and function upon which companies are increasingly dependent to ensure safety and longevity of their medical device.
A Changing Landscape
As 2020 begins, reviewing the remarkably increased role of regulatory professionals throughout the industry over the past two decades reveals big changes. In the past, regulatory duties within a company did not necessarily unify within a specialized role; regulatory affairs may have been handled by employees from various functions within the company. The regulatory professional often arrived at his or her position from a variety of backgrounds, and not all backgrounds were strictly scientific. Currently, specialized formal degrees, certificate programs and trainings are available with increasing frequency, allowing for developing or honing specific regulatory skills for both new as well as continuing professionals.1 Some of these programs include Masters in Regulatory Affairs, such as those offered at, for example, George Washington University, Northeastern University, Johns Hopkins University and the University of Southern California. Available as well are Regulatory Affairs Certification (RAC) through RAPS. Regardless of the path toward learning the profession, a certain set of skills and skill characteristics, as well as the timing of regulatory changes (for example the implementation of the EU Medical Devices Regulation (MDR)), have demanded the regulatory professional to move from a transitory role within a company to occupying a clearly defined professional role, one now indispensable within organizations.
In the premarket Product Development Phase (PDP), global regulatory requirements, along with product standards and clinical guidelines, affect everything from design inputs to verification and validation testing. It is becoming increasingly both evident and imperative that regulatory professionals who are well-versed in both US and outside US (OUS) requirements should be involved in any core team for product design. They are necessary to provide guidance and input at the earliest phase, possibly forestalling any major issues down the line, such as special regulatory considerations for medicinal or animal tissue components, or the need to make a late design change to a product due to inherent safety requirements prescribed by a particular region’s regulatory requirements.
To think many steps ahead while simultaneously considering previous experience, such a specialist must be a highest-caliber systems thinker, able to synthesize information from many different sources and experts (for example, engineering and clinical) to be able to determine how decisions made in the PDP are to be shaped and adjusted to fulfill the regulatory requirements of placing products on the market. This type of thinking, across multiple domains, requires not only the general understanding of decisions and how they shape the product, such as what type of engineering testing is required to produce a viable physical product, but also requires the creative problem-solving capabilities for integrating the output of various expertise into clear, logical and sufficient technical documentation for a finished device, one intended to pass all regulatory checks and balances with “flying colors.”
New and Better Skills Needed
During the regulatory workflow, project management and organizational skills are also important for keeping open the channels of communication leading to evaluating the pros and cons of potential device changes before they enter the change control process. This can be accomplished by working with engineering, supply chain and sterilization departments to ensure required testing is being performed to appropriate regulatory specifications and standards. These tasks require a certain level of influence, although one may not be in a position of authority. Therefore, the regulatory professional needs to be able to develop trustworthy relationships with various experts, working diplomatically, while remaining firm on ethics and regulatory requirements. In other words, the rigidity of regulations must be balanced with flexibility, well developed people skills, patient-focused thinking and respect for others’ expertise. Additionally, demonstrating a willingness to step up into a leadership role, making decisions that would need to be justified to regulatory agencies, or having the “pushback” for having to say the difficult ‘’no’’ within an organization, while working on compromise and alternative solutions, is a daily challenge. Conflict resolution is paramount. While none of these skills are easy to develop, they are all key to success. Thus, it is important to work on developing relationships, learning how to speak persuasively and how to interact face-to-face versus relying on e-mail to solve problems. These skills require a very proactive and engaged, scientifically and technically minded individual.
Cross-Functional Communication
Today, the regulatory professional must be able to fully integrate and adapt to the knowledge held by a variety of individuals with technical and business expertise who work outside of the regulatory world. Excellent communication is the primary way of efficiently obtaining new and disparate pieces of information from various departments within the organization and connecting them in new ways to achieve the desired outcome—which is an effective final device, safe for the patient and marketable across multiple regions. This type of knowledge transfer to the regulatory department is crucial to device development and impossible without efficient cross-functional communication, as the medical device regulatory world is increasing in complexity and requires an increased need for deriving new patterns of problem solving rather than relying on familiar ones.
While experience in the regulatory workings of small and large companies is still the best teacher, a regulatory professional can work on ramping up regulatory skills by interacting with as many individuals as possible in various departments. First-hand experience, gained by visiting the manufacturing floor, observing or getting involved in device testing and updates, while continuously asking questions, helps foster a deeper understanding and a curiosity beneficial for one’s ability to process device changes quickly, to think creatively and to be able to answer questions from regulatory agencies.
Combining skills from the development phase while moving into the registration phase also necessitates a regulatory professional to apply scientific and technical knowledge together with writing skills to build narratives into regulatory submissions. As the requirements for these submissions differ from region to region, a specialist must acutely tailor any submission to a specific country’s requirements while, at the same time, translate complex technical terminology and scientific concepts related to the device into more simplified terms
Good Writing: More Important Than Ever
In addition to solid technical and scientific skills, writing global submissions requires medical writing skills. Beyond on-the-job experience, organizations, such as the European or American Medical Writers Association (EMWA/AMWA), offer networking and training programs to develop this skillset. There are also formally developed regulatory affairs programs and medical writing certificates/degrees offered by various universities, including the University of Southern California, the University of California, Irvine, the University of California, Santa Cruz as west coast examples, or the University of Georgia, the Johns Hopkins University and Northwestern University on the east coast. Formal training in scientific and technical writing also helps regulatory professionals develop a sense of theme and narration while focusing on formulating and presenting logical arguments to demonstrate scientific concepts, carry out template work or provide concise written responses to technically complex questions via enhanced critical thinking. A regulatory-centric program can tailor these medical writing skills specifically to global clinical and regulatory requirements, familiarizing the regulatory professional with both simultaneously.
Often, each regulatory submission will be different. Too, having multiple device types can provide additional challenges. A specialist must combine conceptual reasoning with technical writing skills to connect new ideas and work across contexts—essentially asking questions such as: Can what worked well in this submission also be applied to the next? What parallels exist between these two regions’ regulatory requirements, where the same effort can be applied unilaterally to shorten the time from submission to approval? Where are these devices similar and where are they different? With this kind of information, the specialist can spend less time on problems already seen in previous submissions while tackling any novel problems using analogous experience. These types of questions will lead the regulatory professional to interface at a yet deeper level with various departments across the organization. It is as important to know upfront the fundamental questions to ask of these highly skilled experts as it is to know the answers to those questions, which can then be efficiently transferred and applied by the specialist to the regulatory context. Very specific product knowledge and technical details are thus synthesized by the regulatory professional into submissions or responses in a manner that answers any query, saves time and fulfills the spirit of the regulations, and effectively shortens the time to market, simplifies the implementation of product changes within the organization and, all the while, maintains good relationships with regulatory agencies.
Interfacing With Regulatory Agencies
The latter aspect is where the regulatory professional balances another important role—interfacing with regulatory agencies, via not only submissions, but also during audits, answering questions and participating in various meetings. His or her skills are utilized in parallel, while also being bidirectional within the organization and without dealing directly with regulatory agencies. At any given time, depending on the size of the regulatory department and the organization itself, specialists handle this bidirectional flow of information for an entire product portfolio while also sustaining and maintaining ongoing changes to products on the market and handling postmarketing vigilance.
MDR/IVDR Impact
The variety of regulatory activities have led to an increased role for the regulatory professional in an organization, one which is continuously “ramping up” with no signs of slowing down. With the advent of the European Union’s 2020 revision the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the inter-organizational aspects of device design, submission and market maintenance are now more clearly highlighted in the legislation. Revisions put the regulatory professional’s responsibilities in the spotlight while providing opportunities to demonstrate new skills, but not without additional challenges. The added pressures of interoperability and the heightened requirements for technical documentation require a ramp-up in training as well as a change in company culture and mentality regarding regulatory issues. Especially in organizations where departmental “silos” may have sustained efforts previously, the specialist will now have to wear multiple hats and understand exactly how various changes across MDR/IVDR will impact the organization beyond its own functions and day-to-day activities. Many more documents are now required to be created and maintained, including clinical evaluation plans, PMS plans, periodic safety and update reports, implant cards and trending requirements for vigilance, to name a few. Regulatory will touch on these new processes and documents. Practically speaking, the everyday job requirements for the regulatory professional have increased at least two-fold or more. Changes in MDR will increase the number of required inter-departmental meetings, the number of Standard Operating Procedures (SOPs) that require input and implementation, and the number of people who will require approvals from regulatory. Efficient organization will be the only way to keep up with the constant changes, along with appropriate delegation, better time management and concise problem solving.
Two areas where the MDR has especially expanded the expected responsibilities of the regulatory professional include the understanding of the clinical and postmarket surveillance/clinical follow-up (PMS/PMCF) requirements. The requirements for clinical and PMS/PMCF as they relate to Europe need to be considered at the very inception of the PDP of a device—considerations for bringing a device to market in the EU can no longer be secondary. Clinical requirements for MDR, as well as postmarket requirements for the device, need to be strategically discussed as early as design input for a device to meet its General Safety and Performance Requirements (GSPRs). Any regulatory department has a responsibility to not only drive the organization toward increased involvement in such early discussions, but also to provide tactical support and training for the clinical or postmarket group on the variety of new requirements about which they need to be aware. In smaller organizations, the regulatory and clinical/postmarket professional or group of professionals may be one and the same so getting “up to speed” on these new responsibilities is especially important.
Closer Collaboration
Additionally, regulatory professionals must work much more closely with clinical and marketing specialists on the information provided in the Clinical Evaluation Report (CER) and the technical file and labeling/Instructions for Use (IFU) as there is an increased emphasis in MDR on consistency in technical documentation across departments. This means that the intended use, indications, clinical claims and benefits for any device on the market must be presented unambiguously and consistently as well as fully supported by clinical data across all documentation. The company website or marketing brochures must not present claims different than those in the CER. Once more, the IFU cannot have an intended use different than what is presented in the technical documentation. As device engineering and innovation is a continuous process, the regulatory professional will need to be closely involved to ensure that compliance is maintained.
Device usability is another area where regulatory professionals will now have to apply extra attention. The connection between the GSPRs of a device and usability need to be established early on. In order to claim conformance in a device’s GSPR checklist, the regulatory professional will need compliant usability documents. Usability requirements/human factors requirements should be built directly into user needs documents and translated to design inputs. Design inputs will then have to be verified and validated during performance testing; the regulatory professional will need to ensure this has indeed been done for the purpose of the GSPR checklist. If the device is already on the market, PMS data may provide signals regarding any additional needed usability aspects. This information will have to be fed through regulatory back to design and engineering, who will need to collaborate on any potential changes.
Conclusion
As discussed above, the regulatory professional now holds a well-defined role within an organization. In the medical device sphere alone, a single, sweeping global regulation change, such as MDR/IVDR, has significant impact on the reliance of an organization’s regulatory department. Once more, the global regulatory environment is not static. Skills, such as effective communication, conceptual reasoning, project management, creative problem solving, diplomacy, conflict resolution and clarity in scientific writing, are nonnegotiable for navigating the environment at every device design step. It is also important for both new and veteran regulatory professionals to continuously develop these skills in addition to their regulatory and scientific knowledge. In a world where daily interactions across time zones and cultures, together with easy access to information, has become the status quo. The indispensable regulatory professional has to be more than just a scientific expert; he or she must be a people and communications expert with a keen sense of organizational culture and the ability to connect and manage “threads” from all sides in order to propel ethical, safe medical device innovation to patients in need.
Reference
- Chisholm O. “Professional Development: Benefits of Obtaining Professional Qualifications.” Regulatory Focus. August 2019. Regulatory Affairs Professionals Society.
This article was published in Regulatory Focus.