Quality Assurance in a Medical Device Company
Ronnie Shalev is an emergency medicine physician and now the Director of Quality Assurance at a medical device company.
She was a community ER doctor for 14 years and describes being disillusioned. She felt she was “saving lives but not making an impact on patients or healthcare”, she felt “uneasy” and decided she did not want to continue in the ER until retirement.
A 2 ½ year journey led her to her current role. She started exploring other roles for physicians but was cautious not to move to another role where she would be unhappy. Utilization management (UM) was one area of exploration and she even went through the interview process where she likely would have been offered a job; after soul-searching she decided it was not the correct path for her and removed herself from the process.
For Ronnie, finding a company that she believed in and “could align with the mission” was a critical factor; being proud of where she worked and who she worked for was important. With this, she decided she could offer the most to a healthcare company. But, “no one would give me the time of day”. She came across many companies that were focused on rare disease or oncology and asked herself “why would they want an ER doctor and a community doctor?”
Ronnie’s mindset was critical for her success.
“I know there is a place for me”
She started networking in a health-tech incubator in Dallas, attending lectures and “meet & greet” events. At one event she met a female CEO of a health-tech company focused on healthcare navigation. She became a consultant to the CEO (while still working in the ER) on an unpaid basis. However, she gained a multitude of experience including business strategy, product lifecycle, protocols, international teams, care coordination, social media and marketing. Unfortunately, the position was not funded and she decided to start looking for a salaried role.
Networking is a common theme of these blogs… every physician I’ve interviewed raises networking as a critical step in their transition into the pharmaceutical/device industry.
Ronnie’s approach to networking was detailed and determined. She set a goal for herself; sending 3-10 emails/week with a goal of scheduling 3 phone calls per week. With each phone call, she aimed to obtain 2-3 more names to expand her network.
During this period, she also completed a BCMAS (Board Certified Medical Affairs Specialist). Although her experience was that most interviewers did not know about BCMAS, it was still a fruitful decision as she learned about clinical protocols, regulatory affairs, post-market surveillance, drug safety. It was more knowledge for her going into “industry”.
Another important observation that Ronnie has for physicians looking to transition to the pharmaceutical industry (this includes medical devices!) is that the physician MUST “connect the dots for people”. One needs to tell the interviewer how their experience as a physician translates to the skills needed for the role. Points such as translating her emergency medicine experience: “I am an expert in emergencies in multiple therapeutic areas” (making the connection of the therapeutic area experience she has). Also, explaining the importance of working in teams as a physician.
“People need you to connect dots for them to see it”
“Physicians don’t understand that they have so much to offer”
Ronnie’s role is an interesting one for a physician. One I have not featured in the blog previously.
Ronnie is a Director of Quality Assurance. What is Quality Assurance at her company?
She describes it is related to the safety of the devices that the company markets; but, not just safety of what is happening in patients, but also related to manufacturing. She and her team are responsible for evaluating any issues related to devices from safety, manufacturing, supply chain, etc that have caused an issue that must be investigated.
She has 75 employees in her reporting structure and they are a global team. They work together to identify emerging product issues, whether those are malfunctions or adverse events. They evaluate the information, “trend” and determine what functional area requires information for problem solving. Generally we agreed this is analogous to pharmacovigilance in the pharmaceutical industry.
I asked Ronnie what she loved about her job and she replied: it is “so interesting, there is always something going on”, I “work with so many teams”, there are “so many things I can work with and people to work with – completely different from medicine”.
Regarding the most challenging part of the transition, Ronnie reflected on her previous work in the ER where her hours were sporadic and she would have random days off; her work now is more standard with typical hours of 8am-5:30pm. With this, she has not yet figured out the balance of personal time, personal wellness.
I was also interested in her experience as a manager (reminder, she has 75 employees in her team!):
Ronnie reminisced about being scared and hiring an executive coach to help her with the transition. However, she realized it “was overkill” and that she has been managing teams for years. The difference is “they actually listen to me”; in the hospital, the team members were not her direct reports and did not necessarily have to do what she said. In her current role she realized that it was not as scary as she thought it was going to be.
Her final words of advice include:
“it will happen but you have to keep at it”
Be comfortable speaking in front of people; speaking in meetings, doing presentations
Figure out how you will add value to the company, but be humble.