How Not to Get Led Down the Garden Path in Medical Device Development
Have you ever been advised to start down a path and then have the route changed after it’s too late to back out? During a recently completed a house renovation I was reminded of what it can feel like to be the client in a service relationship like that. In medical device development it happens all the time.
Setting aside dishonorable behavior, the major challenge is that medical device development is a complicated field. Between technology, IP, regulatory, product strategy, and clinical issues alone there are a dizzying range of possible ways to be surprised. One company we spoke to spent over a year in an unplanned 60601 regulatory compliance exercise. That caused a huge delay in their product launch with attendant budget issues.
There are ways to manage and communicate these risks without losing the essence of the development innovation or wasting money. Through discussions with our team and many decades of collective industry experience, I’ve identified six common issues that can cause medical device project relationships to go awry.
1) Risk communication. Sometimes when events happen that affect the risk of success the temptation is not to communicate them in the hope that everything will work out. Risk analysis as per ISO14971 is a great place to start so the right risks are put on the table. A commitment to communicate risk as it evolves is the other half of the equation. Among the types of risks to consider are financial, timeline, technical, clinical, operator and patient safety, and regulatory.
2) Level of planning (inadequate detail or too much detail). Having a plan with the right amount of details makes a huge difference in anticipating challenges. 10 lines on the Gantt chart is too few, 500 lines is too many. Too much detail and the plan can never be maintained as things change. Not enough detail and foreseeable outcomes and accountabilities are not anticipated.
3) Limited project management. If the plan is not updated and maintained as the situation evolves then unpleasant surprises are inevitable. We have found that a Project Management Officer has made a huge difference in balancing this process. It allows oversight of project managers and their plans while allowing our VP of Product Development to focus on the deeper engineering and client relationship issues.
4) Irregular communication. Sometimes the cause of a surprise is as simple as a lack of a regular scheduled meeting among the key people to discuss project progress. A warning sign is either client or service provider feeling frustrated they aren’t able to talk with the other party in a timely manner. A good rule of thumb is to have formal communication meetings set every 1-2 weeks.
5) Inexperience. An inexperienced team can sometimes minimize the effort required to do things and misprioritize their efforts. A common example is a lack of appreciation for how much work will be required to comply with design control standards. Another is miscalibrating where in the development cycle the project is. This one can have disastrous consequences across the organization. Having enough experienced people at the planning stage is critical in our experience to setting the right budget and timeline expectations and not missing critical elements.
6) Immature systems and checklists. Even the most experienced project manager forgets things. A mature Quality Management System with gates and time-tested checklists makes a huge difference. See Atul Gawande’s wonderful book, “The Checklist Manifesto” for the profound impact of doing this well in healthcare delivery.
One of the great knocks on our product development industry is that people can feel taken advantage of. I feel that we have systems to minimize this issue. I’d also recommend you consider them in your own development work. I’d love to hear from others on this important topic.