Rediscovering Systems Engineering in the Medical Device Industry, Part One

During the past few years, systems engineers and the role of systems engineering have all but disappeared from the landscape of the medical device industry.

The impact on many organizations has been significant—slipped schedules, cost overruns, difficulty in component integration, limited focus on effective system risk management, numerous verification cycles due to late defect detection, and system designs that are evolutionary, rather than planned.

As today’s medical devices and systems become increasingly complex and interconnected, it is crucial for organizations to reassess their development team structures and actively re-incorporate the function and role of the systems engineer. The upside potential for incorporating systems engineering is significant and goes right to the bottom line of development costs for product realization.

So what is systems engineering? NASA’s Systems Engineering Handbook defines it as “a methodical, disciplined approach for the design, realization, technical management, operations and retirement of a system.” Furthermore, the International Council on Systems Engineering defines systems engineering as “an interdisciplinary approach and means to enable the realization of successful systems.”  Ultimately, I think Sarah A. Sheard of the Software Productivity Consortium said it best: “The systems engineer is the ‘owner of glue’ among subsystems, the seeker of issues that fall in the cracks, the ‘technical conscience’ of the program.”

Systems engineering was first recognized as a critical role by Bell Telephone Labs in the early 1940s and by the end of that decade it was adopted and became a mainstay of the U.S. Department of Defense. Since then, systems engineering has become a cornerstone in the aerospace and defense industries. However, it wasn’t until the late 1980s that the medical device industry began to recognize systems engineering as a critical role and incorporate it into development teams. By the late 1990s, the role had established a solid foothold.

This trend, however, seems to be making a dramatic reversal as more companies are relegating the systems engineer to system architecture, or abandoning the role completely. The reason behind this trend is not obvious. However, my work with many medical device and product manufacturers reveals a set of myths that may be driving the thinking in these organizations—ultimately contributing to this current trend.

The Myths Surrounding Systems Engineering
Myth 1: It’s all about requirements and architecture. While system architecting, the iterative process of translating user need into requirements and system structure, is an important role in the development of today’s increasingly complex, highly integrated systems, it is only a piece of the development puzzle. Similar to the foreman or prime contractor overseeing a new home construction project, it is the systems engineer who ensures that all the architectural pieces come together through the action of the various functional team members while confirming that the system is built in the right order to the specific plans established, and issues and risks are addressed in a timely manner.

Myth 2: Experienced teams don’t need systems engineering. While experienced teams are one of the critical cornerstones of effective product development, good engineers alone do not ensure effective product realization, especially as the products developed increase in scope and complexity. Experienced developers tend to focus on their part of the product and often can lose sight of the bigger picture. Thus, systems-level issues such as error budgeting, interface management, and system integration and testing often are unattended and missed.

Myth 3: Good planning and procedures are all you need. Although solid planning, structured by a well-defined system architecture and an effective set of development processes, certainly are key components in product development, they tend to be static or contained activities. A key function of systems engineering is to attend to the dynamics that occur during development. No matter how good your planning is, it is guaranteed that some part of the overall system will change or run into roadblocks. The role of the systems engineer is to act as the “technical facilitator” and ensure that changes are systematically assessed while attending to risks. In many cases, engineers will make trade-off decisions regarding component design or operation without taking into account the impact of these changes on the larger system. It is the role of the systems engineer to assess these changes and insure the overall needs and architectural intent of the system remain aligned.

Myth 4: My company is small. I can’t afford systems engineering. The need for systems engineering is not limited by company or the size of the development team. While it may be true that on small projects, by sheer will and effort, development teams can overcome the obstacles of not having a systems engineer, not having a person in this role comes at a cost. This cost usually is realized in slipped schedules, difficultly in integration activities and ultimately, increased development costs. For most organizations, the investment in systems engineering will more than pay for itself within the next product development life cycle, regardless of the size of the organization.

The Truth About Systems Engineering
Systems engineering is a challenging role that not only requires a broad diversity of cross-functional engineering skills, but also the ability to effectively facilitate the “hard” and sometimes difficult discussions that must occur between members of the development team. At its core, the systems engineer must be a technical facilitator who has enough technical skill and domain knowledge to identify technical risk, challenge design decisions, and bridge the gap between the functional elements of the product development process.

The systems engineer is the glue between the functional elements of a system as well as the watchdog and gatekeeper of the architectural intent and subsequent product realization. Without a qualified person active in this role, development teams struggle and this struggle is magnified as the size and complexity of the system grows. At some point, without systems engineering, large-scale systems simply become unrealizable.

Still not convinced of the value of the systems engineering role? Conduct this experiment: Assess the issues and challenges encountered during previous product realization efforts and tally the costs incurred. In most cases, many of the identified challenges, issues and costs could have been mitigated by a systems engineering approach. In my experience, it almost is guaranteed that organizations that invest in systems engineering will see an immediate return on their investment within the time frame of their next product development life cycle. 

Editor’s note: This column is the first installment in a four-part series. The second part will explore the critical roles and responsibilities of the systems engineer and why, in today’s product development landscape, manufacturers should reassess their need for systems engineering and the significant impact this can have on their bottom line and overall business.

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Christopher Miles serves as the vice president of the Consulting Services group at Foliage Inc., a product development company that partners with companies to address the business and technical challenges inherent in developing complex software intensive systems.. With more than 25 years of experience in the research, design, development and management of complex medical and biotechnology products, Miles has contributed to numerous U.S. patents, and directly collaborated on the commercialization of more than 20 new medical and biotechnology products. Foliage leverages more than 20 years of experience partnering with leading companies in the medical and life-sciences, aerospace and defense, and industrial equipment industries. The company is based in Burlington, Mass., with offices in California, the Netherlands and India. Foliage is part of Altran, a Paris, France-based innovation and high-tech engineering consulting firm.