SDM Aids Instrumentation Lab’s Health-Care Mission

Gene AchterJessica Levesque By Gene Achter and Jessica Levesque
October 19, 2010

Editor’s note: In this article, two executives from Instrumentation Laboratory — Gene Achter, vice president of advanced development and technology and chief technology officer, and Jessica Levesque, human resources manager — team up to describe how the company works with, and benefits from, its association with SDM.

Instrumentation Laboratory (IL) develops, manufactures, and markets in vitro diagnostic (IVD) systems. To put it in personal terms, when you visit a physician and a blood sample is drawn, IVD systems test the blood to provide analytical results that the physician uses to make clinical decisions—in effect, in vitro diagnostics provide the link between the patient’s vein and the physician’s brain.

At every stage of development and manufacture, our products integrate a wide range of disciplines, technologies, and subsystems. Systems thinking and effective system management techniques are essential for dealing with these complex interactions, hence our interest in MIT’s System Design and Management Program (SDM).

IL focuses on two main areas within diagnostics—hemostasis and immediate care. Hemostasis deals with clotting—the delicate balance between excessive bleeding and thrombotic events such as pulmonary embolism, heart attack, and stroke. Immediate care deals with blood gases, electrolytes, and similar parameters where time is of the essence.

The underlying physiology, biochemistry, and medical science define the parameters to be measured and the clinical relevance. The measurements are performed using electro-optical or electrochemical sensor systems, aided by biochemical and chemical reagents that selectively interact with components of the blood sample or calibrate the measurements. For example, some of the electrochemical sensors incorporate enzymes within polymer membranes deposited over metal electrodes. The engineering implementation includes mechanisms, electronics, thermal control, and multiple layers of software for user interface, direct control of the measurement processes, data analysis, and data connectivity to report the result to the physician.

IVD products are regulated to assure safety and efficacy. Our products are marketed worldwide, and must meet regulatory requirements and customer expectations in each country as well as differences in health-care delivery systems.

As you can see, our products and our operations are multidisciplinary and deal with multifaceted systems. However, most of our people focus on their primary disciplines—electronics, mechanics, biochemistry, and so forth. A few of us tend to be generalists, speaking everybody’s language to some extent and working to forge bonds between the disciplines. However, this intuitive approach is only part of the answer. IL looks to the SDM program to help us develop people who are well trained in systems thinking and the enlightened use of modern tools for system design and management.

Instrumentation Laboratory has been involved in the program for three years, and to date we have had six students earn SDM certificates. Of the six, two have gone on to enroll in the master’s program. We are planning to enroll at least more three students in the next session of the certificate program.

We encourage engineers from all IL disciplines to consider participating in the program. We run an internal application process, starting with an onsite Graduate Record Exam (GRE) prep course for potential students. Because some of our applicants have been out of school for several years, we thought this would help potential students remember how to study and would refresh the basic information that they will need to be successful at MIT.

Our selection process includes looking at the applicant’s work performance, years of experience and length of service, undergraduate major, GRE scores, and an essay that asks the applicant why they want to participate in the SDM program. In the past, SDM Industry Codirector John Grace (now retired) has helped us select students from the pool of applicants based on the aforementioned information. We found John’s assistance invaluable as he had insight as to which candidates were most likely to succeed based on his knowledge of the SDM program and the academic rigors it would present. We matched that information with what we knew about each candidate as an employee, and made our selections from there. We can easily say that not only did each student succeed in the program but every one maintained a high level of performance at work while participating in the program.

The affects of the SDM program on the scientists and engineers of Instrumentation Laboratory are still taking shape. In some areas, we see such evidence as diagrams left on a white board or a group gathering around a graduate who is explaining a systems concept. One of our graduates, Guy Criscenzo, explained the impact of the SDM on his thinking as follows: “The SDM program has provided me a system to increase the effectiveness and value of my system engineering capabilities by focusing all of my past product development knowledge and experiences using clear and concise principles, methods, and tools.” He went on to say, “The SDM program has changed everything, and product development will never be the same.”

Another one of our certificate graduates, Sassan Zelkha had this to say: “SDM’s certificate program has had a great impact on both my professional and personal life. Through the program, I have learned how to think globally while acting locally. I have become a systems thinker for life. I have also gained many valuable tools such as SDM, OPM (object process methodology), SysML (systems modeling language), and many others that are aiding me to be more effective system engineer.

“Another great benefit of this program is the interaction and connection made with many great minds such Professor (Edward F.) Crawley and other system engineers from different industries. The benefit of the program was so great that I decided to continue the program part time to get my master’s in SDM.”

Instrumentation Laboratory designs and manufactures complex medical instrumentation that is sold around the globe. Although so far only a small fraction of our staff have been trained in the SDM concepts, their efforts to impart that knowledge to others within the organization has already had a positive impact on how we do business.

Photo by L. Barry Hetherington

Photo by L. Barry Hetherington