Background

Medtronic PLC is the world’s largest medical device manufacturer with over $20 billion in revenue, 53,000+ patents and over 85,000 employees. Medtronic’s operational headquarters are located in Fridley, Minnesota. Their calibration lab there serves multi-business groups in Minnesota in the areas of manufacturing, research and development, design, and operations.

Their calibration competencies cover a full range of physical dimensional and electronic measurements to include company customized measurement systems that test finished medical device products. They provide direct and indirect support to their global operations and lead an internal calibration community of over 40 business locations where they share best practices and lesson learned from internal and external audits. IndySoft has been supporting their calibration lab for over 15 years.

Our Interviewee – Walter Nowocin

In addition to Walter’s role as calibration laboratory manager for Medtronic he has an impressive resume of contributions and leadership in the engineering management community. He is currently the chair of the NCSL International Healthcare Metrology Committee, he was an associate editor of the 4th Edition of A Guide to the Engineering Management Body of Knowledge and he became an American Society for Engineering Management Fellow in 2017. Additionally, he is an adjunct instructor at St. Cloud State University teaching Innovation and Engineering Management courses for the Executive Masters in Engineering Management program.

Will you please tell us about yourself and how you got started in metrology?

I served 22 years in the United States Marine Corps as an electronics technician on A6-E Intruder Attack Jets and then the last 16 years as a PMEL (Precision Measurement Equipment Laboratory) technician, instructor, production supervisor, and calibration laboratory manager.

A funny story, when I was looking to reenlist and change jobs in 1982, I had to list my top three job choices. My first choice was Computer Programmer because computers were becoming more popular, my second choice was Air Traffic Radar Technician, and my third choice was something called PMEL that everybody wanted but no one knew what it really was. So of course with military logic I got my third choice. What a life changing decision that ended up being!

When I retired, I relocated to Minnesota where my wife Jill is from and ended up as a Calibration Laboratory Manager for Medtronic, PLC in 1999.

To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service. This is one of the six tenants of the Medtronic mission statement. Do you believe that Medtronic has a competitive advantage for having a clearly defined and documented approach to quality in the mission statement?

This is really a great question as we just finished celebrating our annual company tradition with our holiday program where we bring in patients to share their life-changing experiences with our devices. This is my highlight of the year because it really focuses on the impact each employee has on ensuring that what we do every day is of the highest quality. It is so rewarding knowing that what we do helps so many people ‘alleviate pain, restore health, and extend life.’

A few years ago, I had the great privilege of meeting with our founder Earle Bakken at his home on the island of Hawaii. In 45 minutes, Mr. Bakken shared with my wife and I all of the projects that he is working on despite being in his 80s. A very humbling experience. Mr. Bakken continues to inspire and provide the example of our mission even in retirement as he continues to work on projects that help so many people.

(I loved Walter’s story regarding their holiday program, so after our interview I did a social media search and found so many of Medtronic’s employees noting how their favorite day of the year is that of the Medtronic holiday program in which they honor the patients’ whose lives have been improved by Medtronic products. If you have a minute check out their hashtag #MDTProud. I also encourage everyone to take a moment to think about how your daily work and focus on quality truly does have an impact beyond just getting your tasks for the day accomplished. I love how Medtronic chooses to celebrate that!)

Today’s manufacturing processes are more demanding and tolerances are tighter than ever before, as the manager of the Metrology Department what have been some challenges you’ve had to overcome in respect to metrology planning, process control and maintenance cycles to ensure the effective application of metrology and measurement are being used?

Our calibration laboratory is the oldest, most established lab in Medtronic. As a result we have many practices, equipment, and processes that have been around for many years. We have worked real hard over the past five years to raise our quality bar to bring past measurement practices to updated requirements and to take advantage of current industry best practices; e.g. measurement uncertainty, measurement decision rules, improved TAR/TURs, etc. In the process, we have also helped our internal customers and process owners better understand how quality measurements help improve their quality results.

You were a part of the selection process when Medtronic came on as a customer of IndySoft in 2002, do you recall what the selection process was like and any of the factors that lead you to choose IndySoft over our competitors?

Our project started off as a one location project to replace an internally developed calibration maintenance software system, but we decided to expand our project to anyone else in Medtronic that wanted to explore replacing their own system. We ended up with 11 Medtronic locations that participated in the process; a true grass-roots effort.

IndySoft was hardly known by anyone when we first started our analysis; however it soon became apparent that it was going to be a strong contender. Ultimately IndySoft won out because of its streamlined interface, ease of customization, ease and powerful search capability, customer access, and the best attribute at the time, the Alarm Module, which allows users to establish a multiple array of criteria to send automatic notifications of database equipment status.

You mentioned IndySoft’s ease of customization. How has IndySoft’s built-in Custom Scripting helped you conform the software to your own needs at Medtronic?

With regulations constantly changing and with increasing focus on internal and external audits and inspections, we have been able to quickly implement continuous improvements and resolve compliance gaps in a relatively short time due to the customization capabilities of IndySoft. We are constantly analyzing our workflows to see how we can become even more efficient and effective for our lab and our customers. A solid CMMS is the foundation of a well performing calibration laboratory.

IndySoft now has ERP integration capabilities, do you think this is something that you see being able to take advantage of in the future?

I think ERP integration capability will allow IndySoft to address the current business trend of going in the direction of more ERP solutions and I am glad to see that it is available for use.

As the chair of the NCSLI Healthcare Metrology Committee, can you tell us about your work on the committee and some of the committee goals for 2018?

I have been the chair of the committee since 2012. One of our most important accomplishments has been updating the NCSLI Recommended Practice 6 – Calibration Quality Systems for the Healthcare Industries. This is an excellent guide and resource for new managers working in the bio-medical regulated industry.

Our goal for 2018 is to release the results of our 2017 committee membership survey where we can learn what are the best practices in metrology as it relates to bio-medical calibration practices. We want to continue to have two Bio-medical Technical Training Tracks at the annual NCSLI Workshop and Symposium with six presentations to share best practices and latest trends.

Additionally, I am looking to identify our next Chairperson for the committee so we can continue to provide guidance and best practices to calibration laboratory managers and practitioners for the future.

Walter, thank you so much for taking the time to share with us.