The medical device development phase is a complicated stage, involving multiple aspects that need to be ascertained to achieve the best outcome. Unfortunately, several of these may be done in silos or later in the process, creating delays in moving to production. Waiting on certain teams to complete their portion can needlessly stall development.

As an alternative, tackling the multitude of tasks in tandem can keep the schedule on time, reducing unnecessary delays and expenses. One aspect of this that can be challenging is aligning the development, testing, and regulatory needs to result in a timely outcome that moves the project into production on schedule. One tactic to help ensure a smooth transition is integrating microbiology into the process early.

With this in mind, Dan Hickey, Ph.D., Lab Director and Lead Research Scientist at EXALTA, took time to share insights on how to optimize this process and offer best practices. In the following Q&A, Dr. Hickey identifies the biggest bottlenecks, the impact microbiology can play in the process, and how best to incorporate it to gain the greatest benefit from its early inclusion.

Sean Fenske: Orthopedic programs often face delays between development, testing, and regulatory readiness. Where do you see the biggest bottlenecks, and how does microbiology factor into them?

Dr. Dan Hickey: The biggest bottlenecks tend to occur at the handoff from development to testing, then in the interpretation of test results for…