Guest Column | May 14, 2021

The One Trait A Medtech QA/RA Professional Can't Succeed Without

By Isabel Osorio, MDR Consultants Inc.


In the medical device industry, whether you are a quality and/or regulatory professional working for a member of industry, you are an employee of a registrar and/or certification body, or you are a consultant for the medical device industry like myself, our lives are pretty busy and seem chaotic at times due to the amount of information we have to manage.

We hear stories and read studies showing that professionals who are successful and hold top positions in our industry possess certain traits. They say we are smart, committed to our jobs, perseverant, focused, determined, detail-oriented, stubborn, and argumentative, and that we enjoy an almost magical ability to persuade others. But if we think about these traits, we realize that those could describe many professionals working in an infinite number of areas. So, what is it that makes us unique and a good fit for this industry?

This was one of the first questions I asked myself when I transitioned from industry into a regulatory body. As a lead auditor and training manager for a certification body, I was given an open door to assess the quality management systems (QMS) of hundreds of medical device clients (big and small) each year. This not only gave me the ability to obtain a deep understanding of the level of success of process implementation, but it also allowed me to study and understand the people behind these successes.

It became very clear from the beginning of my new role that a company’s QMS success, measured in level of compliance and/or conformance depending on applicable audit criteria, is directly dependent on the perception of the applicable requirements (guidance documents, standards, regulations, etc.) by its employees. If the organization’s culture reflected a perception of these requirements as burdensome and/or something that should be done to simply comply and conform with an external imposition, then the QMS’s processes almost always were very complex and tedious, required several layers of oversight, and often resulted in a high number of failures that could be directly linked to human errors. On the contrary, if an organization’s culture emphasized that the requirements governing their QMS process were welcomed and that each employee’s outputs within that QMS was essential for that process to be maintained, then the resulting QMS processes would be leaner and easier to follow and would also yield fewer human errors. How is that difference made and ensured?

The answer, I discovered, stems from the personality of the people in the top quality assurance (QA)/regulatory affairs (RA) positions: us. Our personal perception of standards and regulations is embedded throughout our organization through each process that we participate in, create, document, design, implement, teach, review, edit, and approve. If we pay close attention, a QMS process can show you the priorities and personalities of the people who created it. In small companies, these processes are attributable to one or a few employees. In larger organizations, they are often developed by a larger group. If you observe and study the auditors you interact with from certification bodies, their priorities and personalities will also come through in their work.

From years of studying top QA/RA management personnel through interviews and direct observation during my audits, I have identified one distinct characteristic in the individuals who stood out from the rest. They are empaths.

Empathy is what allows us to face a tsunami of information without hesitation because we understand its value to our specific organization and to those we serve, our patients. Our lives are buried in an ocean of information — information we love and know by heart because we understand its importance to our industry. We understand that all this information was not created to make our lives harder; it was created to provide us with tools to ensure our processes are controlled. By monitoring key process indicators, we can understand how our organization is performing and measure the quality level of our devices.

This trait also arms us with a unique perspective — one that allows us to take on the herculean task of studying the requirements diligently in order to translate them into provisions within our processes and system. Because we understand the applicable requirements’ importance, for us, this is not simply a job that has to be performed. Rather, it becomes a responsibility that must be ensured. We understand that regardless of the many layers of requirements we face, we need to translate them into easy-to-follow processes. Then, we teach, assign, and disseminate the process throughout the organization while ensuring that each employee understands its importance to the organization and to their specific tasks and related outputs. Finally, we monitor the process so that our system of control is maintained over time.

Empathy is the key differentiator in climbing to the top of the medical device industry because it offers the ability to create and influence a corporate culture permissive and conducive to developing devices that meaningfully impact patients’ lives. If we want to succeed, we need to recognize this important personality trait in ourselves and others, and continue to nourish it. Empathy is the key to our success, so we must promote and disseminate it. To do this, we must demonstrate to each of our team members the importance of their individual contribution to the intended use of our devices. The key to achieve this is to create a tangible relationship between the products we make and the experience of an end user who benefited from that product. One of the most successful examples I have seen is a training program that provides first-hand testimonials of patients. Having first-hand exposure to patients telling their stories of how your devices have impacted their treatment, recovery, rehabilitation, etc. is crucial and powerful. By connecting an individual’s work outputs to process implementation and on to a human outcome, your team members’ empathy will have a chance to shine and their attitudes toward their jobs will change for the better.

Beyond our daily tasks, processes, and our corporate or personal success, we also know that at any moment, any of us can become a patient in need of our devices. Through the nurturing of our own personality traits, we could be saving our own lives and the lives of those we love.

Always remember that your professional success and the traits that allow you to climb the corporate mountain is what allows you to successfully disseminate a sense of responsibility and awareness throughout your organization. However, above all, remember that by nourishing your empathy, you could be saving your own life and those who you love the most.

About The Author:

IsabelIsabel Osorio is the president and founder of MDR Consulting Inc., a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. With more than 15 years of experience, her career began as a member of industry while serving in senior leadership roles and then transitioned into serving in leadership roles for regulatory and certification bodies. These roles provided her with an extensive knowledge of medical device management systems and medical device regulations worldwide (e.g., ISO 13485:2016, ISO 14971:2019, EU MDD, EU MDR, MDSAP). Isabel holds a B.S. in biomedical engineering from Florida International University. You can reach her at .