Rapid Response to Medical Device Challenges Requires Broad Expertise

When a problem is discovered with a medical technology—or a new opportunity arises—commercial organizations have to act fast. That’s why Battelle offers a Rapid Response program for our industry partners in the medical device, pharmaceutical and diagnostics sectors. To address challenges quickly and find the best possible solutions, we rely on specialized expertise and resources from across our organization.

Fast Solutions for Medical Device Manufacturing

Medical technologies are highly regulated, and issues must be addressed promptly to avoid problems with end-users or the FDA. A defective part can significantly raise the risk of breakage, malfunction or poor performance, potentially putting patients at risk. Manufacturing defects and device recalls cost tens of millions of dollars annually for medical device manufacturers.

Under Battelle’s Rapid Response program, we work quickly to resolve problems when they are identified so production can get back on track. For example, we worked to identify the root cause of a blistering problem on an injection-molded plastic part. Using a scanning electron microscope, Battelle’s Advanced Materials team was able to resolve the problem with the contract manufacturer in a matter of weeks. Read the full story here: A Rapid Resolution to a Medical Device Manufacturing Mystery. 

What’s the key to an effective Rapid Response? It’s not enough to be fast. Companies need to find the right resolution. The solution must not only be technically correct, but also practical and feasible within the constraints of their device design and their manufacturing processes. Getting there requires deep and broad expertise across all of the domains that touch medical device design and manufacturing.

Better Answers Come from a Broader Perspective

Battelle uses a holistic approach to technical troubleshooting that draws on expertise from across our entire organization. We have access to specialized equipment and world-class research teams in advanced materials, optics, electrical and mechanical engineering, physics, drug development, human factors and more. This allows us to augment our team with whatever specializations are needed to solve the problem, right here in house. Our long history of work across industries has given us unique capabilities that we can draw on to solve complex problems and work with out-of-the-ordinary devices and materials.

This means we work differently than a specialized medical device design agency, engineering shop or contract manufacturer. When you work with Battelle, you are tapping into the resources of the largest independent, non-profit research and development organization in the world. Whether the problem requires a scanning electron microscope, accelerating aging facilities, rapid prototyping capabilities or a user research lab, it’s all right here. We also have the expertise to work with devices with unusual characteristics, such as radioactivity or delivery of potentially dangerous or controlled drugs.

And our expertise is more than just theoretical. Our teams are made up of industry veterans, many of whom have been working with us for years or decades. In addition to scientific and technical expertise, we have extensive experience in medical device manufacturing processes and the regulatory environment. This unique combination of capabilities enables us to address complex questions around environmental impact, manufacturing process optimization or device usability. Whatever the challenge, we can bring together the right team to solve it.

Want to know more about our Rapid Response capabilities? Contact us [email protected] for a consultation.