In the medical world the scope of a project can change with even the slightest of events. How do you ensure that the scope of a biomedical devices project remains manageable and focused, considering the constant influx of new requirements, changing stakeholder expectations, and evolving technological capabilities? Try to use a real life example to support your response i.e. Covid developments.
we can apply some strategy to ensure that the scope of a biomedical devices project remains manageable and focused, considering the constant influx of new requirements, changing stakeholder expectations, and evolving technological capabilities.
1. Clear Objectives: Clearly define the project objectives and goals. Ensure that everyone understands the project objectives and goals.
2. Stakeholder Engagement: Maintain open communication channels with stakeholders. Regularly engage with stakeholders to gather feedback.
3. Continuous Monitoring: Monitor project progress closely to identify any deviations from the original scope.
During covid the development of diagnostic tests, ventilators, and personal protective equipment (PPE) was very important. At that time, the strategy mentioned above should be followed to maintain the project manageable.
In the dynamic field of biomedical devices, managing project scope effectively is a daunting but essential task, particularly as new requirements and evolving technologies can shift the landscape almost overnight. A prime example of this was seen during the COVID-19 pandemic, where rapid developments in virus transmission knowledge necessitated swift adaptations in ventilator design and production. To keep projects like these focused and manageable amidst flux, it's crucial to establish a robust scope management process that includes clear initial project boundaries, regular stakeholder engagement to align expectations, and a flexible yet disciplined approach to incorporating new requirements. Additionally, gate reviews at critical milestones can help assess the impact of scope changes and ensure that any adjustments are necessary, beneficial, and sustainable. This iterative approach, with built-in checkpoints for reassessment and stakeholder feedback, helps ensure that the project remains on track even as the ground shifts.
Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company called Inovio. They were developing a DNA-based vaccine for COVID, which came at the risk of it being a brand new kind of vaccine that wasn't yet approved. INO were significantly slower than Moderna or Pfizer to receive data from clinical trials, so they pivoted over to a booster vaccine. This also did not get anywhere because the company ceased funding to this project. Regardless of the outcomes, the scope of the project changed significantly based on the market saturation and new information coming out about COVID. By identifying that the company had "no chance" at competing with larger companies like Moderna and Pfizer, they shifted their priorities to developing a booster vaccine. Without this pivot, it could have cost the company much more time and resources to develop something that was not really needed any more. External factors outside of the control of a company need to be managed with a priority, and this is why agile scope management should be prioritized.
That’s a really important question, especially in a field as dynamic and high-stakes as biomedical devices. To keep the project scope manageable and focused, one of the most effective strategies is to implement a strong change control process right from the start. This means having a formal system where any new requirement, whether it’s from a stakeholder or driven by tech changes, goes through an evaluation to assess its impact on timeline, cost, and compliance before it’s approved. Regular scope reviews with stakeholders also help keep everyone aligned on what's critical and what can wait.
A good real-life example is the rapid development of ventilators during the early stages of COVID-19. Many teams started with a basic ventilator design just to meet emergency demand. But as the pandemic evolved, so did stakeholder expectations—there was pressure to add features like real-time data tracking, remote monitoring, or compatibility with hospital systems. Teams that succeeded were the ones that stuck to their core mission first—getting a safe, functional device to patients—and treated additional features as phased updates, not scope changes midstream. They used modular design and agile planning to build in flexibility, but always kept the initial scope laser-focused on the most urgent need: saving lives.
You’re right, scope creep is common in biomedical projects. To manage it, it's crucial to set a clear project scope upfront and have a process for evaluating changes. Regular check ins and clear change management help keep things focused. Take the COVID-19 vaccine development as an example. The initial scope was to create a vaccine quickly, but as new variants emerged, the scope had to adjust. Teams stayed on track by evaluating changes carefully, prioritizing the primary goal, and using cross functional collaboration. The key is to keep the project focused while allowing flexibility for necessary changes.
