Successful commercialization of medical devices require effective Design Control, DMR Management, Document Control and Change processes for product development. Efficient management of quality processes, e.g. Corrective Action and Preventive Action (CAPA), Training Management, Complaint Management, Non-Conforming Materials Reporting (NCMR), Supplier Qualification, etc. are essential for regulatory compliance and operations efficiency.
Executives need effective process metrics and trends so that they can measure and continually improve the operational effectiveness of their product’s commercialization.
Medical device companies are under increasing pressure to be ready for product commercialization from the ‘get go’ by being operationally efficient while being in compliance with global regulatory agencies.
In order to develop leading products in the Medical Device industry, companies must focus on innovation, and effective and efficient processes. As in other industries, companies must also meet the challenge of efficient use of capital.
Focusing on core competencies and partnering for product design and product manufacturing with other companies can often enable more efficient and cost-effective design processes, but this environment also creates a strong need for collaboration both within the enterprise as well as throughout the supply chain.
Areas that are of serious concern to medical device companies during the product development process are:
- DMR and Change Tracking
- Design History and Revision Tracking
- Synchronization of Product Information (e.g. Product Requirements, Design Specifications, Assembly Procedures, Validation Protocols, etc.)
- Efficient Real Collaboration between Design, Engineering, Manufacturing & Quality Departments
- Managing Standard Operating Procedures and Training
- Managing the Product Life Cycle from Conception to Obsolescence