Leading with Heart: Donielle Johnson Helping to Shape Patient-Focused Innovation

She believes every person deserves access to life-changing treatments and sees each regulatory challenge as an opportunity to help bring safe, effective technologies to patients. Her collaboration with NEST reflects that mission, as she helps shape real-world evidence strategies that make innovation more accessible, and her work not just impactful, but deeply meaningful.

Question: How did your career path lead you to Baxter?

Donielle: As a trained chemist, my professional journey has been centered around medical devices and combination products, with a particular focus on the intricate regulatory landscape of these products. The Advanced Surgery portfolio at Baxter, with its complex interplay of devices, drugs and biologics, initially drew me to the company.

However, it was the leadership team's genuine commitment to their people and the organization's Mission that truly resonated with me during the interview process. This alignment of values and dedication to making a meaningful impact in the healthcare industry ultimately sealed my decision to join Baxter.

Q: What does "Saving and Sustaining Lives" mean to you?

Donielle: For me, saving and sustaining lives is more than a mission statement - it's a deeply personal calling. My own experience with the loss of my mother to a curable disease has left an indelible mark on my life. I often reflect on the "what ifs", wondering if the cure had been available earlier, would my mother still be with me today.

This personal experience has instilled in me a profound sense of purpose. I believe that every individual deserves access to life-changing treatments and technologies that can improve their health and well-being. If I can contribute to the development or delivery of just one more lifesaving or life-enhancing solution, I know that my own life has been one of meaning and fulfillment.

Q: What do you love about your role, your team and the impact you get to make every day?

Donielle: In my role within regulatory affairs, I find myself at the fascinating intersection of science, law and communication. This unique position allows me to engage with a diverse range of disciplines, making every day an exciting new challenge.

One of the aspects I cherish most is the variety that comes with the job. No two days are ever the same, as I have the opportunity to follow a product's journey from discovery through to delivery and beyond. This comprehensive view enables me to appreciate the profound impact our work has on patients and to contribute to the development of the next big breakthrough in healthcare.

I am fortunate to work alongside exceptionally talented and dedicated teams at Baxter. Together, we are committed to driving our current portfolio forward while also exploring innovative ways to leverage our products to address unmet medical needs. This collaborative spirit fosters an environment where creativity and expertise thrive, ultimately enhancing our ability to make a meaningful difference in the lives of patients.

Q: What is the most challenging part of working for a healthcare company

Donielle: Working for a healthcare company can be an incredibly fulfilling experience, offering the opportunity to make a meaningful impact on people's lives. However, like any industry, it comes with its unique set of challenges. One notable balancing act is working toward equitable access to care for all patient and customer populations, while at the same time maintaining a sustainable business model.

Q: How did you become involved with NEST?

Donielle: My introduction to NEST began during my tenure at my previous employer, where I had the opportunity to work with a passionate advocate for the use of Real-World Evidence (RWE) in expanding indications for existing products. Her vision for leveraging RWE as a least burdensome approach resonated deeply with me, and I was inspired by the potential of this methodology to drive innovation in healthcare.

Fast forward to my time at Baxter, where we were exploring creative ways to expand indications within our product portfolio. We recognized the value of RWE in supporting our regulatory submissions and sought out NEST's expertise in navigating the FDA's RWE framework. As we collaborated on the project, I had the chance to engage with the NEST team and share my ideas on how to optimize our approach. The NEST team was receptive to my input, and I was subsequently invited to join their governance team. This opportunity will allow me to contribute to the development of RWE strategies and initiatives, that will assist bringing products to market with the least burdensome approach in new ways and backed by sound scientific data.

Q: What is going to be your role at NEST?

Donielle: I am on the NEST governance committee along with other key stakeholders from across the medical device ecosystem (e.g. industry, regulators, physicians, trade association members, etc.) and our primary responsibility is to identify and prioritize key initiatives to advance the quality and utility of RWE in support of safe, effective technologies for patients.

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