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Regulatory affairs is a critical function within every orthopedic company. It covers a product’s lifecycle, provides direction on the latest regulations and standards and interacts with every department within an organization. Sharon Starowicz knows this firsthand. Her tenured career in orthopedics has involved working with device companies and industry associations, providing guidance and shaping policies.
Starowicz’s regulatory expertise has appeared on these pages multiple times. Here, we’ve asked her to reflect on her professional journey and insights gained from working at and with regulatory bodies.
You started your career at FDA. How did that help when you moved to industry?
Starowicz: My first professional job after graduate school was working at FDA as a biomedical engineer and scientific reviewer within the division that regulated orthopedic medical devices. Although I would like to say this was a planned career move, it happened quite by accident as I was exploring job opportunities in the Washington, D.C. area. Who would have imagined that it would be the start of a rewarding career in regulatory affairs and orthopedics?
My time at FDA helped me develop a knowledge of regulations and policy, and understand how they are applied to the review of orthopedic devices. It gave me an appreciation for the critical job of FDA reviewers and how they must carefully balance their role in protecting public health to ensure that safe and effective devices reach the market. They must also understand the practical implications (time and cost) associated with testing and clinical data requirements. I developed insight into the internal review process at FDA, and the importance of effective communication. Other experiences I gained — learning how to work in a team environment, balancing a diverse and often unplanned workload, and seeking areas of common ground and collaboration among FDA, the professional community and industry experts — were invaluable as I moved to industry.
You still have close ties to FDA. Do you have any advice for regulatory or non-regulatory professionals on working with FDA?
Starowicz: The FDA review process is often a bit of a mystery to those in industry. Keep in mind that you have likely spent months or even years developing your product and are familiar with every detail of its design and function, while FDA reviewers see product submissions for the first time — often with a stack of other submissions on their desks. As you approach the FDA submission, put yourself in the shoes of the reviewer and don’t assume they have an automatic understanding of your product.
“Tell the story” of your device or technology and present information in a clear, consistent and complete way. Take highly detailed and technical information, and boil it down to the most salient points in a way that can be easily understood by someone seeing it for the first time. Anticipate and proactively address FDA’s questions and work with product development teams to offer testing, provide additional data or seek alternative solutions. When conflicts arise, remember that FDA reviewers are trying to fulfill their role in the best way possible. Do not be adversarial, and try to find common ground.
What initially attracted you to regulatory affairs?
Starowicz: Regulatory affairs touches all aspects of a business and provides a unique understanding of how different processes interact and tie together. As a result, it affords the opportunity to work closely with associates in different functional areas across the business. It combines engineering and scientific principles with policy and the law, and requires both strategic thinking and practical application. There are rarely black-and-white answers or ways to approach business challenges. You need to explore alternatives using a risk-based approach and make recommendations based on sound regulatory science.
Regulatory affairs professionals must be knowledgeable about differing regulations, requirements and time-to-market expectations within each country or region where products are sold. They must effectively communicate this information to product development teams and executive management. Regulatory affairs also touches the lifecycle of every product. Postmarket design and manufacturing changes must be continually assessed and managed on a global basis to ensure that local market requirements are met before product introduction. Many moving parts require regulatory affairs professionals to be at the table and engaged early and often as nimble and strategic business partners.
What are ways that the regulatory landscape has improved during your career?
Starowicz: I have seen a positive and encouraging trend toward greater communication between industry and the regulators, through public/private partnerships and other forums, to address mutual issues of concern and strategic priority. Regulators are more receptive to industry input and collaboration to tackle important issues facing the ecosystem. I’ve observed an increased emphasis on education. Programs such as FDA Vendor Days and the FDA Experiential Learning Program provide excellent opportunities for FDA staff to “touch and feel” the products they regulate and to develop a more in-depth knowledge of new technologies and business processes. FDA outreach programs also ensure that industry and other stakeholders are up to date on new initiatives and requirements.
You’ve spent the latter part of your career focused on regulatory policy. How would you like to see the regulatory landscape improve?
Starowicz: There are several ways to improve the regulatory landscape in the short and long terms. These opportunities include the global convergence of regulatory requirements, such as the work being pursued by the International Medical Device Regulators Forum (IMDRF) to promote global harmonization. Additional efforts should focus on greater use of real-world data and evidence in regulatory decision-making, the application of a risk-based approach to regulation and the overall simplification of regulatory processes.
Movements are underway in each of these areas to achieve meaningful change. This is encouraging, but it will require continued focus and engagement on the part of many stakeholders. Global regulators, industry professionals and experts in clinical, research and testing communities must work together to seek alternative ways to address regulatory requirements, while at the same time encouraging timely patient access to safe and effective products.
You’ve worked for more than 30 years in orthopedics and spent most of them with J&J/DePuy Synthes. Do you have any advice for younger generations on finding success in the field?
Starowicz: Thanks for reminding me — it has been a long time! Establish a network of mentors within and outside of your functional area, especially those with diverse experience, perspectives and even personalities. Mentors help you grow professionally and serve as sounding boards when challenges and conflicts arise along the way.
Consider yourself an integral team member and hold yourself accountable to the collective team’s success or failure. You will likely work with many different product development teams and should immerse yourself in the products, assess unmet clinical needs -from both a patient and clinician perspective, and understand the market dynamics and competitive landscape.
Be open to different projects, assignments and taking on different roles, which could lead in various directions. What appears as a disconnect in your career trajectory may actually afford the opportunity to gain valuable experience and subject matter expertise. This has been true for me and for many of my colleagues. There is not a single prescribed career path. I have helped colleagues transition into regulatory affairs from other disciplines, and they have gone on to have success in this field.
Finally, do not be content with the status quo and always seek ways to improve processes, share information and offer solutions when communicating challenges.
I’m sure you have many career highlights, but is there one aspect of which you’re the most proud?
Starowicz: I am grateful for my involvement in the collaborative industry effort through the Orthopaedic Surgical Manufacturers Association (OSMA) to classify posterior cervical spine systems. These systems have become the clinical standard of care but, because of their restrictive regulatory status at the time, companies were precluded from training on their proper use. OSMA formed a task force to prepare and submit a classification petition to FDA, including supportive data. The task force worked closely with the clinical community, as well as with FDA staff, and presented the results at an FDA panel meeting. This work culminated in the successful publication of an appropriate risk-based classification for posterior cervical spine systems.
Although it took several years to come to fruition, this collaborative effort in service to patients represented a significant milestone for orthopedics. It was a unique opportunity to work closely with industry, physicians and FDA colleagues who shared a common goal, and it’s a great example of how meaningful change can come about through focus, persistence and effort.
Is there anything else you’d like to add?
Starowicz: From my earliest days at FDA, I would have never imagined how fulfilling a regulatory career in orthopedics would be. I am so grateful for the many experiences I have had, the many colleagues whom I have had the pleasure of working with and learning from, and the lasting friendships developed through the years. I look forward to the next steps of the journey through my continued involvement in OSMA and other industry, regulatory and professional forums, and will continue to leverage my experience to bring forth future opportunities to improve and transform the orthopedic ecosystem.
