Martine Janicki

Teamwork in Medical Device Development

What makes a project successful or not? A seasoned project manager, charismatic leader, low risk technology, spin on existing proven technology or the right discipline resource mix? Well, maybe it’s all of those and a bit of chance, but it’s most importantly the right attitude. Let me elaborate.

In my last blog, I covered the important elements of effective communication between the business leader, project manager and project team members. Attitude is a major contributor and blocker to communication. Think of a time when you are trying to deliver good news to a friend or colleague to notice that they were too busy or not so interested in your news…  how disappointing that feels. Think of a time when you had difficult news to deliver to a boss, a partner or a business leader to find out that they took the new rather well and started to think of solutions with you… what a great feeling that was! Attitude translates into body language whether it is understanding, empathy, curiosity, hostility, impatience, or indifference.

Several elements must be in place for a medical device to be successfully and systematically transformed from a concept to a commercial entity. Let’s classify these elements as follows:

  1. Creativity – open mind, innovation  and an ability to let intuition lead concept development
  2. Openness – consideration for  alternate solutions and opportunities
  3. Responsibility – commitment to the project  and dependability for tasks
  4. Respect – good listening skills and provision of space for individuals to express themselves
  5. Understanding – trust in individuals, their motivation and their ability to pursue
  6. Patience – promotion of persistence, building self-confidence
  7. Engagement – willingness to participate and encourage skill development in self and others

Despite the best project management framework and technique, some project risks turn into issues and these issues simply don’t go away. They must be managed and mitigated. The way a project manager and team members respond to issues can directly affect the duration and effectively of a resolution, potentially impacting the cost and duration of the project. There is a choice to be made when faced with problems: (1) choose to embrace the negative circumstance, tackle it and learn from it; (2) complain, accuse and feel sorry about the situation. The extra energy required to overcome negative mind set will directly translated in a tardy issue resolution. An effective project team lead will not only choose an optimistic outlook on the issue, but will convey a sense of challenge and enthusiasm, an opportunity for team members to work closely, collaborate and prove its effectively. We have all heard about the power of the sum over the individual, well that’s an important aspect of a medical device design project, particularly as it requires multiple disciplines such as mechanical engineering, electrical/electronic engineering, firmware engineering, industrial design and regulatory affairs.

In the past few months a non-design project at StarFish Medical became the largest and one of the most interesting projects to work on. That might come as a surprise considering that those working in medical device development love to design and solve technology solutions.  What was the key? people had a great attitude which translated into a fantastic team culture. The project started as a documentation development for IEC 60601-1 ed. 3 compliance and turned into a complex mathematical static load case analysis and challenging design review of an existing establish product.  The initial dooming documentation mandate was turned into a challenging design review.

A project does not succeed on its own. It evolves out of people’s hard work, focus and right approach. The project manager is key at providing the vision, but more importantly at reinforcing team engagement and building a positive team culture. It’s all in the attitude.

Commercialization Consult


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