by GARR Staff
December 22, 2024
Change is an inevitable part of life. It happens when we least expect it and whether we are ready for it or not. Most people are averse to change simply because they don’t know the secret to dealing with it. The secret of change is to focus on building for the future instead of dwelling on the past. This means that in order to deal with the inevitable changes, we must innovate past the world of challenges that faces us, i.e. keep moving forward!
Regulatory Affairs is no stranger to change. Industry is always dealing with change in one way or another from various different avenues. Some examples are changing registrations in regions due to an update to regulations or sourcing obstacles from critical suppliers that result in a formulation or part switch out. Changes may also be industry imposed such as manufacturing changes to an alternate facility, cost saving initiatives or changes in the market that obsolete or change product lines. More recently, regulatory affairs professionals have experienced changes to US and global regulations, as well as an increased emphasis on emerging technologies.
A World of Challenges
In recent years, due to the increased awareness of patient safety issues and the recent pandemic, we have no doubt seen numerous changes in regulatory regulations, particularly in the medical products sector. In 2012, issues related to breast and hip implants in Europe were highlighted as unsafe and ineffective and brought attention to the need for increased patient safety and public health initiatives, surrounding medical devices, (Yallabandi et al. 2020). Following this, the EU Commission brought forth a proposal for a new medical device directive to regulate medical devices in Europe and EU MDR 2017/745 was officially published in 2017. The impact of these regulations, however, not only called for increased scrutiny in the approval process of devices but also imposed additional clinical and post marketing requirements for devices sold or marketed in the EU. Although there was a three-year grace period for implementation, which again was extended in 2023, it sent shockwaves throughout industry as manufacturers, importers and distributors hastened to understand the 175 pages of articles and annexes that still dominates the regulatory programs of many medical device organizations today.
Proactive Approach
So, what are regulatory professionals and leaders to do? Take a proactive approach, of course. In order to adopt a proactive instead of reactive mindset, we need to change the way we deal with change. We saw during the COVID-19 pandemic that access to simple medical devices like personal protective equipment to complex machines like respirators was essential in all countries around the world. While the need for industry to comply with regulations increase, we can no longer be in a reactive mode and still be successful. This calls for a different approach to the situation. Regulatory leaders need to do the thing that we do the best- adapt!
Here are a couple of behaviors that may be helpful.
- Anticipate: Buffer against Supply Shortages and Regulatory Hurdles.
- Establish: Change Management Mechanisms, Alternate Suppliers
- Embrace : AI and Technology Tools & Trends Analysis
- Develop: Adopt an Adaptable Leadership Style
Adaptive Regulatory Leadership
Adaptive Leadership not only involves finding solutions but producing a new way of doing things and setting a new standard. Someone who sets the trend instead of following it and rejects reactive behaviors and instead adopts a proactive mindset. Change is a natural phenomenon, and we are participants in change every day. As the seasons change, or the weather of the day changes from sunny skies to a rainy mess, we don’t throw our hands up and give in – most of us just grab an umbrella and be on our way. This is because we know what to do when it rains and have dealt with it before, so it is a change we are comfortable dealing with. Leaders need to apply this same mindset to twists and turns in their markets and empower their teams to recognize change and be open to dealing with challenges when they arise. As a leader, one has to not only be prepared to deal with whatever issues may arise but also should prepare their teams with the same mindset. This calls for a new way of thinking about regulatory affairs and a new way of working. This is the mindset of an adaptive regulatory leader, and the biggest asset of an adaptable leader is a flexible regulatory team. Additional helpful insights can be found in popular reads on adaptive leadership such as Adaptive Leadership in a Global Economy and The Practice of Adaptive Leadership: Tools and Tactics for Changing Your Organization and the World.
A Flexible Regulatory Team
One of the best ways to deal with changes is to expect them! As a regulatory leader, this includes preparing your team and coaching them in change management. Here are some pointers that can help.
- Build Your Team: Help your team to be receptive to change, new initiatives and adaptable.
- Collaborate: Be open to collaboration from peers and team members to creatively solve problems
- Be Proactive: Proactively research and utilize alternate regulatory pathways (FDA’s Breakthrough Pathway and Emerging Technology Pathway (ETP) and Green Pathways for Medical Devices in China.
- Creative Solutions: Analyze difficult scenarios and work as a team to creatively find solutions.
- Planning: Collect regulatory intelligence to anticipate future trends and prepare accordingly.
Change is hard but a little bit of planning can go a long way. Adopting a proactive mindset and a willingness to change may be just the thing to give you the edge over your competitors. Whatever the challenge, reading up on adaptive leadership and finding your own leadership style could prove fruitful and get you and your team over the next big curveball.
REFERENCES
Yallabandi, Sita Priya Darsini, Jaya Veluchuri, Ravi Kumar Juturi, Raga Deepika, and Sujatha Katru. 2020. “New Regulations on Medical Devices in European Union.” International Journal of Drug Regulatory Affairs 8 (September): 11–21. https://doi.org/10.22270/ijdra.v8i3.394.