Developing Diagnostics and Point Of Care Equipment – Project Management and Systems Engineering: Two sides of the same coinBy Dr Rodrigo Zapiain - Last updated: Wednesday, November 16, 2016
In this series of blogs about systems engineering we have covered five key elements so far. 1) Understanding and analysis of project requirements, 2) Functional analysis, and system architecture definition 3) Design generation and detail design , 4) System integration and interface management and 5) System Verification and Validation. In this blog, I will cover the special influence the Systems Engineering approach has in the way projects are managed, and analyse the role of the person that brings everything together: the Systems Engineer. Lastly, I will reflect on the benefits that such approach can bring to the development of Point of Care devices and Diagnostics instrumentation.
Project Management and Systems Engineering
We have discussed the principles and main components of the Systems Engineering approach applied to the development of complex diagnostics instrumentation. The most important thing to realise is that Systems Engineering is as much a methodology as a way of thinking that needs to be embraced by all involved in this process. As the Royal Academy of Engineering states: “You can’t build an integrated system without an integrated organisation”.
The objective of Project Planning is to estimate budgets and schedules against which the execution of a project will be assessed. As the system is being designed, the project should also be designed. A good system architecture will naturally lead to an allocation of tasks and resources;This will help identify interdependencies that will direct the way the different work packages are structured. Projects need to be managed in conjunction with the engineering of the system, as both disciplines will determine how the technical work will be organised, how the different components of a system will be tested and integrated, and how risk will be evaluated and mitigated.
Just as a project plan is revised and adjusted as a project progresses, the Systems Engineering process is of an iterative nature, enabling learning and continuous improvement. As a project advances, engineers uncover the real requirements and evolving properties of a system. Complexity can lead to unforeseen circumstances requiring changes and revisions to the project plan. This is why both technical and management processes need to go hand in hand and collaborate in the decision-making process. It is here where the support of the Systems Engineer to the Project Manager becomes crucial.
Systems Engineer – Ring Master of the Circus
It is often said that in a traditional development project, most engineers command specialist knowledge of one discipline or one key area, and their input is critical to get things to work on a project. Equally, most project managers are said to know just enough about many things to enable them to deliver on time, performance and budgets. These two characteristic roles can be found in many projects.
Engineers that specialise in the design of integrated systems are sometimes called Systems Engineers. These people are a combination of the two roles mentioned above; they have a broad knowledge about every aspect of the system they are developing and deep expertise on at least one part of it. This allows them to gain the respect and interact effectively with the specialist engineers in the project whilst maintaining a holistic view of the overall project. They are the “glue” that binds all the different elements of a system together, providing the development team with system-level and project perspective and taking up the subsystem perspective of challenges and design implementation to senior managers.
In the light of all of this, it can be said that good Systems Engineers need the following:
- A comprehensive basis in the science of engineering
- Enough experience to have a hands-on role in the development process
- Analytical skills with a desire to understand and quantify problems
- Creative and innovative thinking to find ingenious solutions without getting distracted by details
- Appreciation of the multiple disciplines involved in systems design, both technical and non‑technical ones
- Strong and effective communications skills, allowing them to converse with all stakeholders
- Leadership skills to guide the project team, listen to them, learn from them and negotiate with them
Overall, the main quality Systems Engineers need to have is the ability to look beyond the remits of the project, insight to see the real problem and its solution, without being distracted by surface detail. A person with a systems mentality knows how the system fits in a larger context, how they behave, and how to manage them.
Where does all of this lead to?
As mentioned in the first discussion, modern Point of Care and Diagnostics Instrumentation have become complex, multidisciplinary systems requiring knowledge of several interdependent specialties, governed by increasingly tight and changing regulations. The Systems Engineering discipline emerged as an effective way to manage complexity and change, with the primary goal of reducing the risk associated with the development or modification of complex systems. As such, its use can provide an effective way to tackle the challenges encountered when developing a new diagnostic instrument or process. It offers and integral approach to design and development which brings the following benefits:
- Clarity and visibility over the whole problem
- Creative and innovative solutions
- Risk and cost reduction
- Improved performance
- Manage compliance with applicable Regulations
- Responsibilities clearly defined
- Constructive relationships between clients, users, and developers
- Identification of priorities and gaps in the development programme
- Disciplined and auditable processes
- Reduced timelines from lower-risk concurrent engineering
A study by the International Council on Systems Engineering on the return on investment from using Systems Engineering in projects reports increasing reductions in costs and schedule overruns with increasing Systems engineering efforts. This report suggests that Systems Engineering has a positive effect in controlling these two factors and reducing the uncertainty in a project execution.
At Cambridge Consultants we apply a Systems Engineering approach suitable for the scale of the project. Our own Medical Development Process, certified to ISO 13485, its flexible enough to be tailored to each development programme based on its size, allowing us to keep a discipline and methodical approach without having any of the overheads associated with these techniques. This translates into fast development of innovative Diagnostic Equipment for our Clients, and real, successful, and useful products for them and their customers.