Published: January 14, 2014
Steven Burdorf is President of CEA Medical Manufacturing, a contract manufacturer of final packaged critical care medical devices. Burdorf joined CEA Medical Manufacturing as chief operations officer in 2012, and was promoted to president two months ago. He began his career in the airline industry and worked in it for 15 years before moving into manufacturing. Most recently he was Vice President of Operations at Aesculap Inc. He has a degree in Business Administration and Economics from the University of North Dakota, and an MBA from the University of St. Thomas. He currently commutes to Colorado Springs from Minneapolis.
Question: What products does CEA Medical Manufacturing provide?
Answer: Primarily, we manufacture sterilized, single-use, electro mechanical devices and guide wire technologies that are used in three types of surgeries: Cardiovascular surgery, neurological surgery (and) gastrointestinal surgery.
Q: How many employees do you have?
A: We have 85 employees in Colorado. Manufacturing and production make up about 35 percent of those jobs and the other 65 percent are engineering, finance, supply chain and quality.
Q: What is the fastest growing part of your business and what are your plans for growth?
A: The fastest growing segment of our business is the electromechanical disposable finished devices. Our next focus will be balloon catheters. You have to focus on what you're good at, what you have invested in today that works well, what equipment you have, and the talent of the people you have. Balloon catheters support our mission and our competency, which is minimally invasive surgery.
Q: Did the recession affect your business?
A: I think it affected everyone, but it didn't have a notable impact on us like it did on the car industry. What actually affected not only CEA, but also all medical device companies, have been the changes in the Affordable Health Care Act, the medical device tax, and the uncertainty of how the environment within the federal government is changing. It has become very well known that the U.S. used to be the leading-edge country when it came to new device development, doing clinical trials and being first to market, but that is not the case today. The FDA has come back and said they really want to swing the pendulum the other way and get back to being a friendly, proactive organization so we can re-establish the leading-edge capability that we once had.
Q: What does CEA do better than the competition?
A: CEA has been in medical manufacturing 100 percent for 26 years. We are built on having strong relationships with our customers, and there is a strong dedication to meeting their needs with exceptional service as well as providing quality products. We also understand the rigor of the FDA requirements for documentation, validation and qualification. The challenges associated with the business are second nature to us and our customers are long-term.
Q: How does CEA serve the community?
A: CEA has made a commitment to be in this area and to grow, and I want to bring in some highly technical positions as a strong value-add to the business environment. But, what we need to do better is leverage some of the talent at the universities, UCCS and CC. I really want to see us capitalize on collaboration with both the colleges and the hospitals. I'm involved in a program with the University of Utah called the bench to bedside program. For instance, physicians who have ideas on how we could make a certain product that would improve patient safety give the idea to students at the university as a project. Then, someone like myself from private business becomes their mentor and guides them to make it a marketable situation and a viable product. I've started talking to the Business Alliance here as well as with some of the folks at the university, and there are plans to do that.
Q: What is your formula for success?
A: My advice to every company when I'm with them is the following, in order of priority:
Safety - safety of product, of equipment, and of facilities for employees and customers.
Quality - CEA's products have to be top quality that won't fail because you're dealing with a human life.
Throughput - This is the ability to deliver quickly, to design quickly, to manufacture quickly, to delivery on time when it's needed.
Cost - How do we deliver lower cost to our customers through lean practices and processes? If something is wrong with quality, we forget about cost and throughput and go from there.
Q: What experiences in your career have prepared you for success?
A: When I was with Northwest Airlines as the director of flight operations, I had responsibility for the movement of every airplane in the fleet worldwide. Because air travel is so impacted by external factors you can't control, I learned to make decisions in two seconds, and to train everyone to be decision makers. To be able to make quick decisions you need the following: a contingency plan, people who are decision makers and communicators, and an infrastructure that supports the decision making requirements of the situation at hand.
Q: What advice would you offer someone who is thinking about starting up a new entrepreneurial venture?
A: When you develop your business plan, do yourself a favor and do the following:
Seek feedback on your plan from an independent third party.
Double the amount of funds set aside for contingencies. Negative cash flow can easily last longer then you planned.
Edited for space and clarity.