Systems engineering and compliance in implantable pacemaker production

¶ … Systems Engineering Expertise

The balkanization of organizations often impedes progress towards complex, highly challenging objectives. The continual adoption of system engineering concepts, frameworks and theories taken together are making it possible for organizations to attain greater results based on closer collaboration [1]. The intent of this analysis is to evaluate how systems engineering creates a competitive advantage by selectively combining specific strengths of each functional area of department to create a more agile approach to delivering value to customers.

Analysis of Systems Engineering As A Catalyst Of Greater Innovation

The synchronization of supply chain, sourcing, supplier quality, production and services requires a systemic approach to optimizing the contributions of each. Add to this the need for compliance and quality management, and the critical need for systems engineering as a means to continually improve becomes clear. The greater the level of synchronization across the most constrained resources of any enterprise, the greater the overall performance along the quality and performance dimensions of the systemic processes [2].

The production of medical devices, aerospace and defense components, and other highly regulated products rely on systems engineering to engrain quality into every aspect of sourcing, production and service. The inclusion of quality management standards is an essential cost of doing business in the medical products industry as the Federal Drug Administration can audit a production line at any time. The role of industrial engineering expertise in the synchronization of development, production and marketing is critical for the ongoing operations of any highly regulated business. Systemic insights into the specific departments' contributions to each aspect of quality is also critically important in the production of all medical devices. They are especially critical in implantable pacemakers, there the FDAS closely monitors every producer of these devices.

The greatest benefit of industrial engineering expertise in the production of implantable pacemakers is the reduction of audit and fine risks. The FDA will often fine an implantable pacemaker for lack of reporting and traceability compliance for example, and can do this without announcing they are visiting a production center. To avert the risk of fines from not being ready for a visit from the FDA or being shut down entirely, the systemic integration of each process and sub-process in the sourcing, supply chain, production and marketing practices is critical. Industrial engineering that incorporates compliance and governance form the shop floor level through assembly and testing all must be propagated by a systems engineering-oriented series of disciplines. The use of industrial and system engineering to ensure compliance and most importantly, deliver implantable pacemakers that don't fail after being delivered to patients is paramount.