by Michael Collasius
Diagnostic system development projects can be more prone to failure than you would think, given their strategic and financial importance for the company. Despite the eye-wateringly large amount of money that flows into these projects, relatively simple aspects are often overlooked. Regardless of the different conditions start-ups and large corporate organizations work under, the prerequisites for successful diagnostic system development are identical.
1. The project goals must be clear
The FDA asks for the “intended use” of a product for a very good reason. This defines why a product is being developed and who will benefit from it. However, the reality is often very different. Someone has a cool idea or finds a “disruptive” technology. The excitement is high, a decision is made and the project gets off to a great start. Everyone seems to be clear on what needs to be done and a large number of people work on something that relates to the original idea. So far so good. However, when things become more specific, the first problems are encountered. Some of these problems are addressed, others are not. The scope creeps again and again as new ideas are incorporated. The amount of work increases, the costs spiral out of control and project progress comes to a standstill.
The solution to prevent this happening is surprisingly simple. Make sure the project goal is clearly defined and all stakeholders understand it and agree on it. In many cases it can also be helpful to define what is out of scope. Here you can download a helpful FDA Checklist.
2. Understand the requirements
Surprisingly, but not uncommonly, the customer is left out of the product-development equation. Either because we think “we know” what the customer wants, or someone has a better idea of what the customer needs or there is no time to ask the customer as the new product is needed as a matter of urgency. This approach is fraught with danger as the project tends to fail even when development is successful. The product is launched, but nobody wants it or sales lag behind the original business case.
Talking to the customer and understanding their requirements is not only time well spent, but also money well spent. There is a very good reason why requirements management is a separate discipline. This ensures that customer needs are fully understood and and critical requirements are identified. Resolutely following a list of all aspects customers may have ever wished for makes a product expensive and possibly still misses out on what the customer really wanted.
3. Get the specifications right
Now that customer needs are clear, there is an infinite number of options and ways of implementing these requirements. Since everyone is on the same wavelength and timelines are short, the team immediately gets cracking and defines the solution, but the specifications are loosely defined or, even worse, not at all. This is the perfect recipe for disaster, as development will be a never-ending process or will not deliver what was intended. The other risk scenario is overly ambitious specifications. With this scenario the timelines will drag on, while development and manufacturing costs for the final product go through the roof.
Deriving the specifications from the requirements is time well spent and saves time in the long run. Make sure you know how to measure specification achievement and develop appropriate measurement tools for this. Well-defined, achievable specifications are a prerequisite for a profitable diagnostic testing business after product launch.
4. Project management and development process
Successful diagnostic platform development largely depends on disciplined implementation of the customer requirements and product specifications defined in the project goal. The development process is the collective, documented experience of an organization. It gives guidance on what needs to be done, puts actions into the right order and aligns activities across multiple disciplines. Although this all sounds very simple, it is not uncommon to “cut processes short” for faster timelines or “leaner, less cumbersome” procedures. Shortcuts will almost inevitably lead to longer timelines, higher costs, undermine the approval process and can ultimately lead to project failure.
5. Experienced team
Not being aware of what you don’t know poses the biggest risk to diagnostic system development projects. A multitude of disciplines need to be aligned in this kind of project and the costs can easily run into several hundred million US$. Typical tasks that need to be carried out include defining medical need and regulatory requirements as well as developing applications, chemistry, plastic disposables, mechanics, electronics and software. A particular danger that is easy to overlook is that all these disciplines work independently on the project, in some cases for up to two-thirds of the project time. The timelines, scope and cost are still within the project plan, but this can go awry when the individual pieces of the puzzle are put together to form an integrated diagnostic system. Usually, they are not ready at the same point in time and putting them together reveals unexpected challenges. This is the point when projects derail, timelines drag on or it turns out that the diagnostic system will never work.
An experienced team is aware of the risks, is familiar with these traps and has learned to identify the critical elements and take appropriate measures. If your organization does not have appropriate experience, seek professional advice. Assemble an independent advisory board and take their advice seriously.
6. Clearly assigned responsibility
You would think this is implicit, but in many cases responsibilities are not clearly assigned and documented. Smaller organizations tend not to assign responsibilities within projects, assuming the hierarchical structure in the organization will take care of everything. A misconception that results in double work, tasks fall through the cracks, potential problems became apparent too late, money is lost and, in the worst case scenario, the solvency of the company is jeopardized. Even in very small organizations, clear assignment of responsibilities helps to structure the project and achieve transparency at any given time. In larger organizations the situation is a little different.
While assignment of responsibilities is even more important for bigger companies, organizational deficits or a political environment prevents clear assignment of responsibilities and this kind of organizational setup is doomed to fail. Besides a clear project goal, clear role descriptions and assignments consistent with competencies and decision power plus appropriate workpackage breakdown are the most important building blocks for a successful diagnostic system project.
7. The most underestimated role, the project sponsor
While it is quite common to have a project manager, the role of a project sponsor is relatively unknown and is often seen as unnecessary or playing a secondary function. Although a project sponsor is not assigned in many cases, they are the most important function within a project, in addition to the project manager. This is the person who ordered the project, possibly as a delegate of an executive team, and pays for it. While the boundaries of a project manager are set by scope, time and cost, the project sponsor has the authority to make appropriate decisions if the project experiences obstacles that cannot be resolved within its scope.
The project sponsor is the most senior stakeholder manager defending the project within the organization and ensuring the businessgoals of the project.
The above building blocks do not cover all aspects of a successful system development project, but they form a great foundation. This kind of diagnostics development project is a very complex undertaking with many unknowns, even when the project is planned meticulously. Thus, it is extremely important to focus on the basics to prevent the project from failing.
It would be great to find out what kind of experiences you have had when developing a diagnostics system. Please feel free to email me and share this and also which factors were crucial for your project’s success.
I will also be presenting this topic at MEDICA TECH FORUM 2018 on Wednesday 14th November. More Info