Alethea is a life sciences veteran with 30+ years of experience in quality assurance, risk management, regulatory submissions & strategy, patient safety, privacy, corporate compliance, and clinical operations. She provides invaluable insight into various growth stages of biopharmaceutical and medtech companies. Her true passion is helping sponsors and research sites mitigate the risks of clinical trials and facilitating transparent, accountable sponsor-CRO partnerships.
Alethea began her career in the early 1990’s in oncology research working for a governmentally funded adult cooperative group, and advanced through start-up organizations in the laboratory developed test (LDT) and biomarker space, and a class III medical device company in critical care. From the sponsor side, she moved to the services side in several contract research organizations (CROs) as an executive, and in 2018, founded her own firm to address significant unmet needs of her clients.
What first drew you to medtech? When did you first know you wanted to be in the industry?
I was first drawn to Medtech when I saw the rapid technological advances of electronic health records (EHR), clinical trial data collection systems, and the synergies that could be achieved with the streaming of continuous medtech data. I also became intrigued by signal detection with the deployment of AI and ML which could improve individual patient’s health.
What projects, past or present, have made you love what you do?
A few projects come to mind that are centered around software as a medical device (SaMD) technology. We are working with several sponsor manufacturers presently. One is a mapping tool to help neurosurgeons make precise surgical decisions for individual patients with brain cancer or epilepsy. Others are software biomarkers for predicting wound closure, delirium, and post-operative surgical problems. The addition to a physician’s toolkit is a pragmatic approach that can help solve a lot of nagging cost problems within our healthcare system.
What projects are you most looking forward to?
I am very proud of our association with special U.S. defense programs and sponsors with unique breakthrough technologies that have the potential to improve acute and chronic conditions of our military and civilian populations. I am also gearing up for Federated Medicine initiatives that show promise to reduce obstacles to direct patient care and maintain patient privacy in a trusted infrastructure. Enabling real-time learning, including in silico, is here to stay.
What are some of the barriers women face in today’s medtech industry?
As a business owner and entrepreneur, I do not see many barriers today. I believe that when you demonstrate consistently in words and in action, your core competencies and compassion, and you make trust the fundamental building block of your business model, that you will attract those who appreciate these values. For our customers, we pay attention to the 80/20 rule, or concepts of the Pareto Principle. We also remain authentic in our relationships. These types of business attributes appeal to people who crave honesty and integrity which has nothing to do with being a woman.
Why is it important for companies to be more inclusive and have more women in charge?
I believe the real answer to this issue is growing women to command and earn (not demand) positions that are higher in the hierarchical pyramid of an organization. There is a key difference between command versus demand. No one respects a woman who demands her place. Competency speaks on its own merit. I believe over time women will achieve these leadership roles, however, I am more encouraged with them as entrepreneurs of their own enterprises simply because their success rates have been independently proven.
Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome?
My biggest leadership challenge was during the start of the pandemic in 2020 when several projects stopped cold because my clients had to lay-off their work force or suspend their businesses due to the supply chain collapse. As someone who pays attention to new, emergent critical needs and regulatory reform, we could pivot rapidly to new work to keep my team employed, but also address some of the biggest crises at that particular moment. I did not allow any irrational fear to creep in and affect what we were doing. Instead, I embraced the challenge and could see beyond the uncertainty. As a result, we actually tripled our business because I refused to be married to or dependent upon a prescribed recipe for providing business services. My team now sees and appreciates that resiliency from the rear-view mirror. I also refused any of the government’s tax breaks to keep employees because I didn’t want or need help.
Talk about your leadership What is the most important lesson you have learned that has guided you in your career?
One of the most important leadership skills that I live by is to constantly learn and develop my ideas especially by reading information that is most uncomfortable or inconvenient. This could be political, historical, geopolitical, literary, philosophical, or even economical information. My core foundation is to understand business and personal risk in the real-world, and in doing so, my interests are quite diverse. The world has no scarcity of noise, intentionally, but it is up to the wiser person to filter out the noise and focus on finding the truth and adapting accordingly. Decision-making is not free of unintended consequences. The era that I grew up in, having been born in the 1960’s, gives me great responsibility and awareness to face obfuscation and cognitive dissonance head-on. This is especially true in not being a part of today’s group think society, but rather instead, championing critical thinking and reasoning. I am an advocate of positive, constructive debate. I am not afraid of disaffecting the extreme outliers, while getting along with most people, most of the time. There was a time in our medical congresses where two experts would each debate one of two sides of an issue. We desperately need to return to this. I teach the people around me that it is perfectly acceptable to hold different views or even changing views, that all views are necessary, and that it is in us all to work together to appreciate the grey areas. I am most attracted to the fiercely independent contrarian who thinks outside of the box and in doing so, cannot be predictable, bought-and-sold, nor labeled. One of the most preeminent business leaders I most respect is the late Paul O’Neill who was well known to prioritize the safety of his workers as Alcoa CEO, but also enable financial debate from multiple sides of an issue when he was U.S. Secretary of Treasury. His rejection of orthodoxy throughout his career is commendable.
In your opinion, what more can be done to promote the greater participation of young women in the medtech industry today?
It is imperative that successful men and women in life sciences and medtech become mentors to the younger generations, especially young women, and to encourage community service and citizenship. By doing so, we accelerate the development of the next generation of leaders and encourage innovation, purpose, and humility. The road to success is part inspiration and part perspiration which means that putting in time, blood, and sweat must not be underappreciated. Young women in medtech have to commit themselves to lifelong learning and being willing to turn their ideas and belief systems upside down.