In a recent webcast with Medical Design & Outsourcing, Prabodh Mathur, a twenty-five year medical device development veteran and current chief product development officer at Axonics Modulation Inc., spoke about lean innovation. But during the discussion, Mathur surprised me with a talk about some difficult topics companies face when they are entering into new projects and offered some advice on how to deal with them.

“People tend to gravitate toward those aspects of a projects that they are very comfortable with, that they’re experts in,” he says. “Inevitably there are other aspects of the project that will be new or challenging to you or the team.”

Mathur uses his own company as an example, noting that his team had never done a full, permanently implantable device before creating a sacral neuromodulation system. Most of the members of his team didn’t have that expertise. Knowing that up front, he challenged them to make that list of all the things they did not know or felt were going to be risky to the project. “Then we dealt with them upfront.”

“This list is important because, if you deal with all the issues that are unknown to you, or that are not in your strong suit, then you can get them out of the way.”

For Mathur, that is part of a fail fast strategy that enables design and development to happen at a fast pace. So first, he says, deal with those challenges, and Mathur also notes that for his team, following regulatory standards helped. “They were great teaching tools.”

The second list Mathur says to make is the project risks, which might be more than just the product risks. “We are all taught, in the medical device business, to focus on product risks, sharp edges, things getting hot and cold, making patients uncomfortable.”

But, he says, “You also have to concentrate on the risks to your project. You’ve got to make that list.” Some of those line items might include long hours for team members, challenges to team dynamics, and even assessing how well a project fits with a company culture.

Once you have those two lists, he says, “Then you take your team and assign specific people and hold them accountable for retiring these open questions or risks. You do that up front because the execution part is the easy part.”