With its many moving parts to direct and risks to navigate, managing a new medical device project can be a challenging undertaking. Because of the stringent quality requirements in the medical device industry, project management principles such as project structure, setting goals, tracking status, risk management, and resource management are especially important, and leading this charge is integrity. So, what exactly is integrity, and why should it be a critical part of project management?
Defining Integrity in Medical Device Project Management
Integrity is all about “honoring your word.” This includes identifying and conveying clear expectations, taking ownership of one’s role and tasks, communicating when you are unable to keep your word, and clearing up the resulting mess. – Tom Waddell, CEO of Waddell Group
Integrity in relation to a system or an object is the quality or state of being complete; unbroken condition; wholeness; soundness. The lower the integrity of a system, the lower its workability (ability to perform a task) which in turn leads to lower performance (results achieved from said task).
As a bicycle wheel loses spokes, it will first lose its ability to carry weight, then at some point ceases to function at all. This same concept applies when it comes to project management. Reducing the integrity of a project management system and its components (the people and processes) leads to the reduction in efficiency and efficacy (workability) which in turn reduces output and worsens expected results (performance). As an example, when the project manager cannot be counted on to do what they have promised on time, they are creating a culture of “it’s ok to not be on time with my tasks.” This will undoubtedly reduce team performance in the long run. At the Waddell Group, we focus on integrity in relation to 4 important components of the project management system, with “the company” and “the project” being the focus of this article:
- The company
- The project
- The team
- The project manager/team members
Integrity in Relation to the Company
The project manager needs to be cognizant of how the project aligns with company values. The project needs to fit inside whatever predetermined mission the company is committed to. If you’re a company committed to producing cutting-edge technology for cardiac health, vapor pens do not align with your mission.
The profitability of a project is important. Companies have different expectations of profitability. If the project is creating a product, it should be profitable at the level the company requires. A pharma company will have a higher profit margin as compared to a retailer for medical devices, but they may also have higher development costs. Medical device companies in Minnesota often seek greater than 50% gross margins. Although that’s good profitability, they have to make up for a lot of spent development dollars. And that sometimes takes years.
It all goes back to the ‘why’ behind the project. Is it fixing something, reducing losses, adding a new feature suite, or increasing market share? It also means being aware of how the project impacts the company as a whole. How does it impact other product initiatives? How does it align with the availability of corporate resources? What about its impact on other avenues of income? How does it play globally?
Ensuring that everyone is aware of the ‘why’ of a project will make sure that the resources (including time) are allocated properly. And that the project is correctly prioritized in relation to other projects running concurrently. For that, you need to be aware of the trade-offs.
Integrity in Relation to a Project
To uphold integrity when it comes to each individual project, we should first go back to the ‘why’ this particular project is being done. What’s the outcome expected when carrying out this project? Is it:
- improve the safety of the procedure?
- improve patient comfort?
- meet a new need in the market?
Once you understand the ‘why’ as a project manager, you must make sure that this message is properly conveyed to your team. Every action, decision, and suggestion that the team members make should align with this intent. For example, if the ‘why’ of your product is to improve clinician throughput (speed of procedure), a feature focused on improving patient comfort adds no overall value to the project. We also need to make sure that the intent of the project fits inside the mission of the organization or company.
Speed, Cost, and Quality Trade-off in Medical Device Project Management
The diagram above represents the trade-off between speed, cost, and quality. It demonstrates that if you want to focus on only one element, you will have to make sacrifices in the other two as compensation. Since quality is nonnegotiable in the medical device industry, there’s always a constant trade-off between speed and cost.
Let’s say we need to add new features to a product as fast as possible to catch up to the competition. If we do that, we’ll be able to increase our market share. We might need to invest more money in the project to get the work done faster. Thus trading time for money. What if an engineer comes to you with a feature that they’d love to incorporate in the project? What would be the trade-off then? This reminds me of a joke I heard before, “It only takes one engineer to turn a locomotive into a slow-comotive.”
A good project manager needs to know the answer to, ‘What’s the trade-off?’. Does it bring you closer to your ‘why’? Remain protective of your current revenue? Would it lead to advancements? Will the quality still be maintained? Does the trade-off justify investing more money in the project? You need to convey that importance, the why, and the priorities to your team members and stick to them – over and over again.
Ready to dive into your new project with integrity but don’t know where to start? Feel free to reach out and schedule a free 15 min discovery call now. Don’t forget to share this article if you think it’ll be useful to your company, friends, colleagues, or team members. If you want to learn more about how integrity increases performance for individuals, teams, and organizations as a whole, then have a look at the latest research.
Next up: How can you maintain your integrity as a project manager and ask your team to do the same?