Martine Janicki

Winning Project Management Practices for Medical Device Development

In my last blog, I talked about risk management, extreme risk management from the device perspective, manufacturing perspective and project management perspective. Through the risk planning, risk engagement itself and mitigation implementation, I have learned that it is very important to communicate to team members, project owner and any other important stakeholders. Managing the expectations of all involved is now very high on my list of project priorities.

Most people are reasonable when provided information, even when it’s the delivery of bad news. A seasoned Project Manager should be able to inform and the future medical device users of the good, the bad and the ugly. I’m referring to time slippage, cost overruns, a component delivered in the wrong shape/ color / finish, a first article received with dimensions slightly off, an industrial design not adequately conveying corporate identity and so on. The key is to continue to talk to project stakeholders to prevent surprises. Active project management implies involving project sponsor, project owner and technical expert in decision-making in order to share responsibilities and provide clear visibility of project outcomes.

Here is a list of fundamental project management practice that I use and recommend to maintain the confidence of project sponsor and project owner.

1. Under promise and over deliver

Systematic progress of a medical device development project depends on an active Project Manager who supports team members, removes roadblocks and incorporates request changes in a timely manner. Any deviation from original device concept, lack of QMS documentation, inadequate effort estimates, unintended omission of statutory holidays in the schedule, resources or process inefficiencies will lead to time slippage and cost over-runs. As a seasoned Project Manager, I do everything in my power to attend to all project details and to keep the project on schedule and budget, but will communicate pessimistic delivery dates and higher than estimated costs to avoid disappointment.

2. Estimate, but remember they are just estimates 

Project sponsors are required to raise sufficient capital, coordinate regulatory submission, plan for distribution, and establish a target pricing structure. They will ask for cost estimates of device development, transfer to manufacturing and manufacturing of low and high volume. I use historical project data from the development of similar medical devices, facilitate brainstorming sessions to identify required tasks for the project goal, and make reasonable assumptions to develop duration and effort estimates. A certain amount of realism and contingency gets added to the estimates prior to communicating these estimates to the project owner.  However, these early estimates may under-represent the true costs of the project and device because of a design becoming more complex, material and process being refined, suppliers adjusting their costs, and assembly labor costs being higher to account for part inspection. Revised estimates need to be communicated clearly and on a regular basis in order not to shock or disappoint the project owner.  Costs could also decrease with increase clarity.

3. Show transparency, provide weekly status reports

There is comfort in knowing that tasks are progressively been executed. Control and monitoring is an important process in good project management practice. I have recently adopted a simple SharePoint task management system that I first populate with all major project tasks from the Gantt chart, and then add any required additional tasks. Part of my Project Manager function is to assign task owners and ask these team members to update the % completion on assigned tasks. I value having full visibility on tasks and ensure their progression is in line with target due dates. I provide this data to the project owner because I believe that everyone benefits from knowing what everybody else is doing. Information is power; the project is easier to coordinate and team members know when to focus on tasks on the critical path. From SharePoint task lists, I generate a weekly report that I sent to the project owner. The task list includes both StarFish and the client “to-do” tasks.

4. Dare to discuss business questions

I openly ask questions about the client’s strategic business and operational realities. How are you planning to finance the project? When are you planning to reach the market with your new medical device? What is your main competition? What technical aspect worries you the most? Who would you like to champion your team? It is the role of the Project Manager to help business Project owners to align the project deliverables to the business goals. Sharing important business decisions will keep priorities in perspective and everyone aligned.

5. Be sensitive to cultural difference

I am very sensitive to personal style, corporate culture and ethnic difference. What seems to be a responsive team in one city/region/state/country may be perceived as laid back and under-performing in another area.  A Project owner should expect flexibility, adaptability and open communication from the project team, regardless of circumstances. The key is education and sharing of values and believes. Let us know what you consider important – is it to be on budget? Have a certain COGS for your product? Reach milestones? Have a specific quality standard or brand?

6. Be available to discuss technical, resources, process issues and concerns

As a Project Manager, I play an important role in the success of the project’s concept development, technical excellence, and commercialization and that’s all possible because the lines of communication remain open. I want to ensure that I am available and open to all sort of easy, pleasant and difficult conversation with team members and project stakeholders.

Medical device design, development and manufacturing are no trivial business. The industry is heavily regulated and under quality assurance scrutiny. At StarFish Medical, we pride ourselves to be medical device technical experts and thrive on engaged and collaborative discussions whether related to lasers/ optics/ sensors, requirement / specifications documentation, cost of prototyping /components, or resources availability. In a culture of open communication, no topic is too difficult to discuss and vivid discussions are simply part of the day-to-day project operation.

Commercialization Consult


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