Balan Understands the Realities of Development and Life Cycles
The time and resources expended on the research and development of a new device, or even a modification to an existing device is considerable. You can’t afford to go down blind allies. Taking a wrong turn during development is costly and could mean a product misses its narrow introduction window. Throwing resources into a project or concept development without having the best idea possible of its likelihood of success can also cost a fortune. We understand how the medical device life cycle works. Applying our Core Capabilities in Analytics, Engineering and Medical Opinion gathering will add positive value at every point of your process. We can interface at any point, from Concept Identification and R&D of new products to Improvement and Repositioning of existing ones.
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.