In the Injectable bone growth factor syringes project, BoneFix is dependent on FactoSet’s expertise in biologics, while FactoSet relies on BoneFix’s market reach and distribution capabilities. However, achieving a seamless partnership requires effective communication and shared responsibility.
Project teams in medical device development often include scientists, engineers, regulatory specialists, and business leaders. Each group has varying priorities - scientists want the best formulation, regulatory teams need compliance, and executives focus on time-to-market. Managing these competing priorities requires strong leadership and a clear decision-making framework.
What strategies can be used to ensure that all stakeholders (both internal and external) stay aligned? How can project managers balance technical, regulatory, and business goals without causing delays?
I think this is a great point because the biomedical industry is highly cross-functional as you've mentioned. To ensure alignment among stakeholders in a partnership, project managers need to establish clear communication channels, set shared milestones, and create cross-functional teams. Regular meetings, structured updates, and collaborative decision-making can help balance technical, regulatory, and business priorities. Additionally, leveraging project management tools to track progress and fostering a culture of transparency and accountability will ensure all teams are focused on shared objectives.
A major strategy to ensure that all stakeholders stay aligned is by everyone acknowledging who is responsible for certain tasks in a project. Tools can be used in parallel like a Gantt chart and a RACI (Responsible, Accountable, Consulted, Informed) matrix. The Gantt chart will map out the project timeline and help categorize which tasks have slack and which tasks are on the critical path. The RACI matrix then comes into play by keep members in the project responsible for what they are assigned. It will also define who is accountable for the potential outcomes when the task is complete. Then finally, seeing if there needs to be consultations for certain scenarios and who needs to be informed of the outcomes from the task.
I think the way project managers can balance technical, regulatory, and business goals without causing delays is having a clear understanding with early start, early finish, late start, and or late finish dates. Also, utilizing a risk management team can help create contingency plans when technical, regulatory, and business issues appear. The risk management team can help the project team adapt and pivot quickly to overcome these issues. As a result, the project will be able to get back on track and achieve technical, regulatory, and business goals.
