“Medical device manufacturers may put in procedures to design for manufacturability early in the development process, but the execution of that is critical. There must be a cultural solution to go along with it,” says Paul Orlando, Vice President, External Operations, Olympus. “It is absolutely critical for design and manufacturing to collaborate early and at the right time, both procedurally and intuitively,” he advises.

Orlando is a panelist at the marcus evans Medical Device Manufacturing Summit Spring 2017 and the Medical Device R&D Summit Spring 2017, taking place in Pasadena, California, June 19-20.

Is there a collaboration gap between design and manufacturing? How can it be closed?  

There is a collaboration gap, but the solution is not easy to achieve as it requires a cultural and procedural approach. Companies may put in a requirement to perform or ensure design for manufacturability during phase I or even earlier, but the execution is critical. There must be a culture of really believing in upfront early design for manufacturing and understanding it needs to come from company experts and suppliers. It is absolutely critical for design and manufacturing to collaborate early and at the right time, both procedurally and intuitively.

Without this collaboration, designs may be frozen or they might not be able to meet target pricing. It is difficult to make improvements after a design has been frozen or after the product has been launched.

Who can best lead this mindset shift? 

In my experience, a robust program management office, a strong program and managers to drive adherence to procedures and the culture lead to success. It should be common practice to ask questions and have indicators in place during project approval and reviews. If you have that knowledge with the people approving or running projects, it automatically takes place. We implement what we call “Stage zero” in our new product development process, which forces cross-functional collaboration earlier in the process.

What obstacles are common when setting up such a culture?

Unless you have credible people to start that culture shift, it is impossible to drive any change. There must be an understanding of that need at a high level. Then you must start with some pockets of experts who can demonstrate the success of the proper level of collaboration between manufacturing and R&D.

What trends should manufacturers prepare for?

In the past, it has been difficult for suppliers to provide design for manufacturing input because of resource constraints. Some suppliers actually charge a fee. Moving forward, having the resources available to provide that input without a guaranteed return will probably become the norm.

What is absolutely key for success?

It is the combination of procedures that formalize the requirement for collaboration, a strong program management office and process, a culture that believes in the criticality of design for manufacturing very early in the process, and the right subject matter experts. Not every project or product is the same, so there must be some flexibility in what resources should be deployed and how, which would come from having the right culture.