13485cert

WANTED: Design Team Needs Über-Leader

In CE Mark, CE Medical, Change Control, Design & Development, Improvement, ISO 13485, ISO 14971, Medical CE, Medical Device on May 16, 2012 at 5:11 am

“Mona Superwoman” by Teddy Royannez (France)

Last November Eucomed published a position paper titled, “A new EU regulatory framework for medical devices: Six steps guaranteeing rapid access to safe medical technology while safeguarding innovation.” While I have serious doubts that any government will ever be able to “guarantee” anything other than its own continued existence, I have an idea of how industry can help.

The position paper identified six steps. Each of these steps has a comparable action that could be taken in every medical device company. My list of six steps is:

Only the best leaders

  1. Only one approach to design controls
  2. Stronger internal procedures
  3. Cross-pollination by independent reviewers
  4. Clear communication of project status to management
  5. Better project management skills

The most critical element to success is developing stronger design team leaders. Design teams are cross-functional teams that must comply with complex international regulations, while simultaneously the team must be creative and develop new products. This type of team is the most challenging type to manage. In order to be successful, design team leaders must be “Über-Leaders.”

The most critical skills are not technical skills, but team leadership skills. The role of a design team leader is to make sure that everyone is contributing without tromping on smaller personalities in the group. Unfortunately, there are more men in this role than women.

Why is this unfortunate? Because men suck at listening (takes one to know one).

We need a leader that will be strong but we also need someone that is in touch with the feelings of others and will use that skill to bring out the best of everyone on the team. This superwoman also needs to earn the respect of the male egos around the table. She needs to be an expert in ISO 14971, ISO 13485, Design Controls, Project Management, and managing meetings. Our beautiful heroine must also be a teacher, because some of our team members will not know everything—even if they pretend to.

The Über-Leader will always remind the team that Safety & Efficacy are paramount. As team leaders we must take the “high road” and do what’s right—even when it delays a project or fails to meet our boss’ unrealistic timetable. Superwoman must demand proof in the form of verification and validation data. It is never acceptable to go with an opinion.

She will remind us that compromise is the enemy, and we must be more creative to solve problems without taking shortcuts that jeopardize safety and efficacy. She will work harder on the project than anyone else on the team. She will keep us on schedule. She will whisper to get our attention, but she won’t be afraid to yell and kick our ass.

As Jim Croce says, “You don’t tug on Superman’s cape.” Superwoman is the only exception to this rule.

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  1. I would appreciate any feedback you might have on the 6 suggestions for improvement to the design and development process for medical devices. I might use your comment as the basis for my next blog posting.

  2. […] can do to improve design controls. While the last posting focused on better design team leaders (WANTED: Design Team Needs Über-Leader), this posting focuses on writing stronger procedures. I shared some of my thoughts on writing […]

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