All you want to know about risk management and medical devices

24 May 2019


risk management

Interview with Bijan Elahi – Global Product Risk-Management Consultant and Educator at Medtronic

Bijan Elahi is an engineer, a teacher and an author with one goal: helping people to produce the safest medical products. Bijan has over 25 years of risk management experience. Recently we had the privilege to talk to Bijan, one of the pioneers in risk management in the medical device industry. We talked about his career, risk management and his first book Safety Risk Management for Medical Devices.

Bijan studied aerospace engineering at Iowa State University, and continued his education in electrical engineering at the University of Washington in Seattle, WA. He started his professional career in aerospace.  After the Space Shuttle Challenger accident in 1986, NASA formed a team of experts to analyse and oversee the NASA manned space program.  Bijan was one of the experts on that team.

During his time at NASA, Bijan began to advocate the importance of risk management in his speeches at many conferences. At one of these conferences, executives from a medical device company asked him to lend his expertise and help them in risk management of their medical device. His passion for helping humanity made this an easy decision and he began working with medical device businesses. As a frame of reference, when Bijan started in the medical device industry (1992) the standard ISO 14971 did not yet exist.

The early days of risk management

According to Bijan, in the early days before ISO 14971, companies wanted to make safer products, but didn’t know how to go about it. ISO 14971 helped create consistency in the way companies demonstrated the safety of their products.

One of the challenges in medical device product development is the differing mindsets of R&D and Risk Management.  While the R&D engineers’ focus is ‘How will this work?’ the Risk Managers’ focus is ‘What will go wrong?’.  This juxtaposition of thinking was, and still is, a great struggle.

Over the years, risk management has become increasingly more important. Promulgation of EU Medical Device Regulation has further magnified the role of risk management in medical device product development.

Current challenges facing risk managers

One of the main challenges in risk management is the determination of the acceptable level of risk.  It is well-known that the perception and tolerance of risk varies greatly from person to person.  Getting alignment on what is an acceptable level of risk is difficult. It can be confusing and lead to long and time-consuming debates.

How do you help people align more effectively?

“What I teach my students is that you should think critically and systematically.” Applying the preliminary hazard analysis, (PHA), helps you to do this. This semi-quantitative analysis is performed to:

  • identify all potential hazards and events that may lead to harm;
  • rank the identified hazards according to their level of risk;
  • identify required risk controls and follow-up actions.

These tools enable risk management managers to anticipate potential hazards and put in place mechanisms/controls to prevent or avoid harm.

Five years ago, Bijan started teaching risk management to doctoral student in medical systems engineering at Eindhoven University of Technology in the Netherlands. His classes attracted much attention from both academia and industry. These days, his students’ profile is no longer limited to university students. People from many MedTech companies, plus physicians and clinicians also attend Bijan’s courses. Bijan’s goal is to make risk management part of the DNA of medical product development – to ingrain it into the thought processes throughout the product development lifecycle.

If you could teach your students one thing about risk management, what would that be?

“I would like them to understand the language of risk management. Risk management has its own language. It may sound like English, but it is not. Words such as: Harm, Hazardous Situation, and Hazard don’t carry the same meaning as ordinary spoken English. Awareness and mastery of these terms and using them with care will prevent and avoid confusion and lengthy debates.”

Writing the book on risk management

While teaching at various universities, he was asked on numerous occasions to recommend a textbook on the subject of Medical Device Risk Management. “I was never able to find a book that contained all the information needed,” says Bijan, because risk management is still a relatively new field for the medical devices sector.”  During a conference, a friend of Bijan who works at Elsevier publishing recommended Bijan to her director. Elsevier publishing asked Bijan for a proposal.  Elsevier agreed that there was a gap in available books on this topic and asked that he write one. With the publisher’s greenlight Bijan started writing his first book.

“I started actively writing in November 2016 and finished the book in January 2018. It took me 14 months in total to write it. This effort was an incredible experience that I would recommend to anyone. The act of writing forced me to organize all of my experience and know-how and to document it in a systematic, coherent way that would be understandable by, and useful to others.” The book was released in July 2018 and has been available for purchase ever since.

Says Bijan, “I believe that the book’s success is thanks to it being both educational and practical. The main focus was to enable people to apply risk management in a sensible, practical way to medical device product development.”

You say that your book demystifies risk management.  What do you mean by that?

“Risk management is a multidisciplinary endeavour that touches on many areas such as: engineering, mathematics, logic, statistics, biology, psychology, law, toxicology, regulatory, etc. Nobody has deep knowledge in all of these areas. As a result, people approaching risk management can become confounded and thus shy away from the work.  My intention was to make risk management more understandable, accessible, and doable.”

risk management book

Medtech Safety

As mentioned before, Bijan enjoys sharing his risk management knowledge and experience. He does so by delivering courses and presentations at various educational institutions, international conferences, and medical technology companies. While his book offers broad knowledge in risk management, in many cases companies have more specific questions. To answer these, Bijan decided to start a consulting company called ‘Medtech Safety’. “I want to share my know-how. I can do this in general form by teaching, and via my consulting I can assist in more specific ways.”

During his extensive career, Bijan has had the privilege to work for various companies and gain extensive knowledge from these experiences. “I have enjoyed working for all of them. An unforgettable point in my career was when I saw my deep brain stimulator go into the brain of a human patient. While this was an incredible moment, I was the proudest when the patient experienced no complications afterwards and lived happily thereafter. It made me profoundly appreciate my decision to switch industries from aerospace to medical technology.”

“Contributing to the immediate and profound effect these technologies have on human life is an incredible journey. That is why I want to continue what I am doing. I want to elevate proficiency and confidence in risk management in all medical technology companies globally…to create safer medical products for this world.”


We want to thank Bijan Elahi for the interview and for sharing his knowledge. Do you also work in the risk management department, and would you like to share your experiences? Let us know and send an email to info@medicaldevicescommunity.com.