The domain expertise required for a medical device development program should not be under-estimated. After all, the goal is to develop an innovative new medical device with proven clinical efficacy for a new market. Engineers, software developers, business analysts and regulatory advisers all play a unique role in the project team. Efficiently integrating a distributed team for medical device launch is paramount to success.
As a Project Management Officer (PMO), I oversee the management of several medical device projects (up to 20 at the moment) and facilitate project health check meetings with Project Managers to better address business, regulatory and technical needs of our clients.
This gives me a unique perspective across organizations, family of products, and core technologies (Ultrasound, Microfluidics, Digital Health, Optics, Cardiovascular, Ophthalmology and Technology Commercialization). Which in turn helps me formulate project risk mitigation plans to avoid duplication and waste, thus saving time and money for everyone.
Here is my list of recommendations for efficient distributed team integration:
1. Project Managers: Appoint a Project Manager (PM) and a Product Technology Leader (TL) for each of the collaborating organizations (a total of four people for a single client and service provider relationship). The PM manages the project environment, information sharing, quality of deliverables, while the TL focuses on functionality of the device, system integration and overall performance of prototype device.
2. Effective Communication: One individual can have dual roles in an organization, but there should be a clear line of communication between the Project Managers (a minimum of two people for a single client and service provider relationship). For product organizations without dedicated Project Managers in-house, consulting firms often have the ability to manage people for both organizations
3. Domain Expertise: Develop a work breakdown structure to identify required domain expertise. Figure out where that expertise will come from (in-house or consulting firm).
4. Estimated Effort: Assess the effort required for each domain expertise based on the complexity of the device, and determine availability of staff on hand to address required expertise.
5. Responsibility Chart: Formally document roles and responsibilities by creating a chart in your design plan that clearly shows who will do what. Make sure that design document ownership is clearly laid out.
6. Task List: Set-up a web-based task tracking tool (such as SharePoint) to provide visibility on task assignment and progress of execution for all team members. Clearly communicating and sharing project information is essential in establishing clarity. Consider formalizing the process by regularly producing a task tracking report and distributing written meeting notes.
When working with a consulting firm, be sure to fully utilize their tools and techniques for team integration. If the firm is well-established, their process has likely evolved and been validated by solving similar issues with other organizations.
Using my tips a good Project Manager can create harmony at the core of the team and deliver effective medical device development.
Martine Janicki leads the PMO at Starfish Medical and holds a PhD, PEng and a PMP certification. She follows her tips above and excels at efficiently integrating distributed teams for medical device launch.