Bijan Elahi Meet The Innovators

A passionate, lifelong learner, the Medtronic Technical Fellow discusses the importance of med tech safety and risk management.

Bijan Elahi was born in Iran and came to the United States as a child. Always fascinated with technology, he studied both aerospace and electrical engineering in college. After spending time with NASA analyzing Space Shuttle systems for flight safety, he shifted gears and started a career in the medical technology industry. Recently named a Medtronic Technical Fellow1 — the company’s highest recognition for technical contributors — Elahi works in the corporate Design, Reliability, and Manufacturability group (DRM), focused on risk management, and is based in the Netherlands.

Q. You have said that safety risk management of medical devices is not a well understood process. Why is that, and what can we do to make it better understood?

Safety risk management is a complex multi-disciplinary endeavor. My goal is to simplify and clarify this activity so my colleagues can efficiently and confidently perform risk management of our products and be able to clearly explain it to regulatory bodies.

Q. What has been your biggest challenge so far?

My greatest ambition is building risk management into the DNA of Medtronic. I want people to think about risk from beginning to end and see it as value-added, not as a burden. I want them to think about how it helps to improve quality, save money, enhance reputation, and decrease field corrective actions.


I want people to think about risk from beginning to end and see it as value-added, not as a burden.

Bijan Elahi

Q. You also do some teaching, don’t you?

Yes, I love teaching. Right now, I teach a course in medical device risk management at Eindhoven University of Technology in the Netherlands. My students are doctoral students in engineering, physicians, and members of industry. I’m very proud to tell you that I recently received the System Safety Society's Educator of the Year Award for 2017. This award is in recognition of my contributions to the advancement of system safety through teaching.

Q. Has being an engineer made you a better educator — or has being an educator made you a better engineer?

This goes both ways. Being an engineer makes me a better teacher because I have real-life, fresh knowledge, and my students appreciate my examples. At the same time, teaching has helped me be a better engineer. It has given me greater clarity of thought. Questions from my students help me identify the dark corners in the knowledge space and shine light in them. 

Q. You’re also writing a book. What was the inspiration for that?

When I first started to teach risk management at the university, I was asked to recommend a text book on this subject. Although there were books on safety in the areas of aerospace and aviation, I could not find a book on medical device risk management. So, I decided to write one. I am hoping this book will elevate knowledge and skill in medical device risk management on a global scale, leading to better and safer medical products for all.


Simply doing the engineering analysis and math is not enough. We also need to know how our stakeholders such as patients, doctors, and regulatory bodies perceive the risks.

Bijan Elahi

Q. What critical skills are needed today to be better at risk management?

Risk management is interdisciplinary. One needs to be good in the hard sciences, such as engineering, statistics, math, and logic, as well as soft skills, such as psychology, behavioral science, and critical thinking. Risk perception and acceptance are subjective. People have different levels of tolerance for the same risk. Simply doing the engineering analysis and math is not enough. We also need to know how our stakeholders such as patients, doctors, and regulatory bodies perceive the risks.

Q. What are you proudest of?

I am proud of my colleagues in Medtronic. The sincere caring about the safety of our products, the effort and energy they put into it, the warm reception they give me when I try to help them with risk management warms my heart.

Q. What are the top three lessons you would teach someone just starting out in the business?

  1. Find your passion and follow it, but remember to live a balanced life.
  2. Work on both technical and soft skills.
  3. Use your time and talent wisely. It is your capital for success.

Q. What would surprise others to know about you?

I enjoy beauty and try to create beauty in everything, including my engineering work.

Q. What does the Medtronic Mission mean to you?

I am drawn to the part of our Mission about building on our areas of expertise through education and knowledge assimilation. I’m a great believer in continuous education and think of myself as a student for life. I learn from anyone, including my students. With information coming at us all the time, it takes open eyes and ears plus a receptive mind to capture it. Our Mission has wisdom. It is worthwhile to read it and internalize the message.


1

The Technical Fellows program was created in the 1980s to foster technical excellence within Medtronic by recognizing employees who contribute to the company through technical expertise, education, mentoring, and consulting efforts. Currently, there are more than 190 Technical Fellows within Medtronic.