Engineering and Health Care Expertise Combine to Provide Unparalleled Support
Our fundamental knowledge of medical device components, extensive experience with medical device development and manufacturing, and close collaboration with practicing physicians allows Balan to provide engineering solutions not found elsewhere. Balan engineers will assist you with your device specifications, sourcing needs, testing, safety and quality control, troubleshooting, performance modeling, technology enhancement and training requirements. Balan’s unique engineering/physician partnership provides clinical context and engineering expertise to reduce programmatic risk in your device development process.
Balan engineers excel in implantable device power sources, including batteries and capacitors, while our physicians lend clinical insight into optimal performance requirements. Let the Balan engineering team support your device development program.
Case Study: Implantable Device Performing Poorly in Phase I Trials
The manager of R&D for a medical device manufacturer had a serious issue with a new line of implantable units. These units were performing poorly in Phase I trials. Data from testing seemed to implicate an internal component. This issue was delaying the regulatory submission and subsequent market introduction of the new device.
The R&D Manager realized he needed to engage a resource to augment the skills of his internal team in order to resolve the problems quickly. After being selected for the job Balan’s Engineering Team reviewed the client’s data and documentation in order to gain an understanding of the device’s intended use and market. Balan suggested modified testing procedures and statistical data analysis to better define the root cause.
Once the joint team was sure that the source of the problem was identified the performance of alternatives to the faulty component were evaluated from comparable applications and a set of specifications to meet the required needs of the device were prepared. These same specifications were also reviewed in a clinical context to assure they met or exceeded requirements for future trials.
In this particular case Balan identified an appropriate technology from a commercial, non-medical source that met the client’s needs. Balan then assisted in the design of a comprehensive testing plan to qualify the device’s performance using the new technology. The result of this effort was a cost-effective improvement that brought the project back on schedule.