A Corporate Refugee Bares All
Written by Frank Freedman
Illustrated by Robb Miller
www.acorporaterefugeebaresall.com
Please Don’t Come Anymore
What Was Happening:I was hired in 1979 to be Medtronic’s Director of Clinical Research and bring much needed change to the department. I implemented project management, standard operating procedures and many other changes. Within a year, the department’s corporate image changed from a “liability” to an asset.
What I Learned: Sometimes the job requires a manager to be a coach. If you take the time to do so, it can be a labor of love.
The clinical research department’s role was to obtain the clinical experience required to support the needs of many other departments (design, marketing, regulatory affairs, etc.), before a new pacemaker or pacing lead could be sold. It was no secret that this department was in disarray, when I became its director. On my very first day as director, I was greeted with a continuing stream of telephone complaints, some angrily expressed using four-letter expletives.
The professional staff was constantly subjected to criticism from others at Medtronic about what type of clinical experience was needed and how to obtain it. Frankly, they were demoralized when I took over.
Critical changes were necessary. That was why I was hired. I quickly convened a staff meeting to listen to their concerns and begin the process of making substantial changes. But I honestly did not have any specific ideas about what changes were necessary. It was hard to know if I would need a protective suit of amour, a big box of Kleenex or both to get through this meeting.
One by one, the staff told me about problems they faced. To their surprise (and mine), after a moment’s thought I announced that they would now lead their clinical research studies differently. Those in charge of clinical studies would operate as “clinical study managers.” This was a totally foreign concept to them. It was not how the department previously operated. As clinical study managers, their job would be to seek consensus from product development team members about what clinical experience was needed, what physicians to use as investigators and how to conduct the study. But if consensus was not possible, the clinical study manager alone would make the final decisions. It may have been the first use of project management to lead clinical studies in the Twin Cities or the entire medical device industry.
They expressed great reluctance to accept their new role. I was pointedly told that my approach was not how things were done. I countered by reminding them how difficult their jobs currently were … constantly reacting to criticism and unreasonable requests. Managing clinical research studies, rather than reacting to circumstances, would make them far more productive and make their jobs easier.
I decided to use the pending Spectrax® Pacemaker Clinical Study as the vehicle to introduce the corporation to the new way clinical research would be conducted. Spectrax was a revolutionary new type of pacemaker, one that could improve patient outcomes and boost the corporation’s bottom line. Its leader, Tim Lathrop, was now the Spectrax “clinical study manager.” Tim was a smart, popular scientist who had an engaging smile and warm personality. I don’t think he had led any project in his life. Meetings he convened about the Spectrax clinical study were always disasters.
I also told Tim that I expected him to get at least 95 percent of clinical data expected from the Spectrax clinical study. In the past, getting far less clinical data returned sufficed because very little was required to evaluate older pacemaker models. Getting 95 percent of the data returned to us was critical for two compelling reasons: New FDA regulations would require it before approving Spectrax sales in the U.S. Marketing was depending upon it to support a planned, aggressive Spectrax sales campaign.
Tim understood why I picked the Spectrax clinical study to proactively introduce these changes to the corporation. But he was very hesitant to assume his new responsibilities. A colleague and I became his coaching staff. We talked with Tim daily to make him comfortable about assuming them. Each day for about a week, Tim left Medtronic more and more confident that he could assume this new role as “clinical study manager.” Each morning he would return to work with uncertainty about his ability to do so. We stopped coaching him when he started seeing the bigger picture. The corporation could no longer tolerate clinical studies whose outcomes were marginally useful due to confusion about what clinical experience was needed and how to obtain it.
To completely allay his fears, I sent a memo to the Spectrax development team about Tim’s new role as a clinical study manager and his new responsibilities. I informed them that I planned to accompany Tim at the next team meeting in case any questions arose. At the meeting, I started to explain his new role and responsibilities. To his credit, he took over explaining his new responsibilities and how the Spectrax clinical study would be conducted.
After the meeting, Tim’s first words to me were: “Please don’t come to any more of these meetings. If you do, that could detract from my authority.” He might have expected me to be angry. Instead and with a big smile, I shook his hand and exclaimed, “Congratulations … You are where I need you to be.”
All subsequent meetings Tim convened about the Spectrax clinical study were very productive. He became an outstanding clinical study manager.
The Spectrax Clinical Research Study was one of the most successful, effective studies ever performed at Medtronic. It drew praises from all across the company. I was especially pleased that my expectations for data were met; more than 95 percent of expected data was obtained for this study. This study reset the bar for clinical research study excellence, primarily using a project management approach to pursue it. Tim’s success using my new approach for conducting clinical studies was a real “high.”
But Daddy ...
What I Learned: Very little is required to show a big interest in someone.
I happened to see Tim Lathrop talking to his young son one day. His son proudly showed him a gold star he earned from his teacher on a picture he drew. Tim congratulated his son, reached into his pocket and gave him a quarter as a reward. It was a special moment between a parent and a child.
I remembered this special moment a few weeks later when I reviewed the first draft of Tim’s Spectrax Clinical Study Report. I made a relatively large number of editorial changes and comments in red ink throughout the report. Since I remembered the special moment when Tim praised his son’s drawing, I printed “Great Job” in big bold letters and pasted a large red star I bought specifically for this occasion on the title page. Would Tim show it to his son? How would his son react?
Tim told me about his son’s response to seeing “Great Job” and the star on the title page. His son gave Tim a nickel from his piggy bank and praised Tim. But he became confused when he looked through Tim’s report. “Daddy,” he asked “how come you got a red star when you made so many mistakes?’
Tim was very pleased that I remembered this touching incident. He took great delight in telling others what happened after his son saw his report