Shannon Hoste is the president of Agilis Consulting Group and an assistant professor in the Quality Science Education program at Pathway for Patient Health. She is active on several standards and conference committees for medical devices and combination products.
Hoste formerly worked as team lead for human factors in FDA’s Center for Devices and Radiological Health (CDRH) and as a reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA, she led reviews of human factors data for medical device premarket submissions through 510(k), PMA and De Novo pathways, combination products through NDA, BLA, ANDA pathways, as well as data to support IND and IDE requests.
Outside of Shannon’s work for the FDA, she continues to build on her 25-plus-year career in the medical device, IVD and combination product industry as an R&D and quality engineer, manager and director. Over this time, she has worked within and directed project teams in all phases of product development from front end research to post-market support; as well as architecting process improvements for design controls, risk management, requirements management, software validation, system verification/validation and the incorporation of human factors and usability into overall product development processes.
Hoste earned a B.S. in mechanical engineering from the University of Toledo, an M.S. in management from Mount Vernon Nazarene University, and an M.S. in cognitive systems engineering from the Ohio State University.
What first drew you to medtech? When did you first know you wanted to be in the industry?
Hoste: It was a journey. At 17, armed with a Pell Grant and two jobs, I went to study mechanical engineering at my local university. I knew I wanted to use my “geek” skills and to help people. I considered medical school; however, I could not figure out how to make the financials work. At 19 I started working in the power transmission industry (conveyor systems for steel mills, sugar mills, etc.) This helped me be financially independent; however, I had not yet found my career passion. This came at 23, when I took a job at Battelle Memorial Institute working on medical device development within their Product Development Group.
As a mechanical engineer, I was working on material selection, mechanism design, design for manufacturability, etc. I found my calling in medtech. I knew it immediately. My journey did take a turn though. I was investigating field failures on devices that were fracturing due to, as it turns out, users lubricating their devices with butter and motor oil. This embrittled the plastics and voila: fracture. My analytical, engineer brain was frozen. I remember asking myself, how do I write requirements and predict risks when a user can do anything? How do I better understand the users?
From this question, being a learner, I started to walk from Battelle over to Ohio State and discovered cognitive systems engineering, or as I think of it, how humans and technology work together. This is where I could make a difference in the medtech industry! While common in aviation and nuclear science, use-related risk and human factors engineering were not common fixtures in medtech product development at this point in the 1990’s.
I took this to Intel, Stryker, FDA, Illumina, and now to our clients here at Agilis Consulting Group.
What projects, past or present, have made you love what you do?
Hoste: It is hard to pick one project. Looking back, I think I love what I do because of the people that I get to work with and what we can accomplish together.
At Intel in their Digital Health Group, we developed assistive technologies and a telemedicine platform. I led a project to validate this platform in eight countries and was able to see the impact this type of technology can have globally.
At the FDA, we released guidance around human factors/usability engineering and worked to help industry understand how to best manage use-related risk.
At Agilis, I work with an amazing team to support clients across the spectrum of medical device, pharma and life sciences.
What projects are you most looking forward to?
Hoste: I have learned that the drive that I had to use my ‘geek’ skills to help people doesn’t just apply to creating medical products. I look forward to any project where I can use my experience to help others, for example: Working on processes to streamline product development; teaching quality science principles to university students; or providing methods for development teams to better understand their users.
What are some of the barriers women face in today’s medtech industry, if any?
Hoste: I can’t speak for all women as I think we each have our own journey. I have found that many of my largest barriers have been within myself. Have I run into hurdles tied solely to being a woman in a male-dominated field? Of course. Every award ceremony I’ve been to, people approach my husband and ask what engineering award he is there to win. He is a special ed teacher and has been very kind to not take credit for my work. I have been told that a woman can’t do technical work. In these examples, the issue was in how this gave me pause and made me doubt my capabilities, the barrier would be if I failed to continue. For me, and many others I suspect, it is a constant battle to remember that I have a voice and I can and should contribute. At the end of the day, how can I best help others if I don’t show up and speak up?
Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome?
Hoste: Constructive confrontation. I was raised in a very non-confrontational family where the motto was if you don’t have something nice to say, don’t say anything at all. I was a pretty quiet kid. (Take that as you will.) It took me a while to realize that approaching challenges and “confrontations” with integrity and transparency leads not only to better results, but also to better relationships.
Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career?
Hoste: Ask questions, seek to understand before you jump to solutions.
In your opinion, what more can be done to promote greater participation of young women in the medtech industry today?
Hoste: We need to support each other. Many women (and probably men, too) are afraid of exploration and failure. There is a need to be right, smart, confident, etc. and this can lead to not doing something unless you feel like you know you’ll 100% succeed. This is a recipe for limited growth and mediocrity. To grow you need to try things that you may fail at. This is how we all learn, and nobody has it all together. Let’s celebrate our whole journeys, successes and failures alike, then we can all learn from each other and not be so afraid to fail at some audacious goal, because we could also succeed.
Why is it important for companies to be more inclusive and have more women in charge?
Hoste: Diversity fuels innovation: diversity of thought, perspective, approach, background, etc. One of my favorite quotes is by Dorothy Parker: “Creativity is a wild mind and a disciplined eye.” I see medical product innovation in this same light. It takes a diverse mix of knowledge and experience coming together under a disciplined process to create solutions to our biggest problems.