Today, medical device companies face the ultimate dilemma: how to build a comprehensive product innovation program while avoiding slowdowns. The medical device industry is transitioning toward country-specific regulatory demands, in-country manufacturing and supply chains, and more affordable healthcare. With these industry shifts come increased complexity to develop design control.
What are design controls?
Design controls are a set of quality practices and procedures that ensure medical devices meet user needs and regulatory compliance. Each product requires different design input based on the intended use of the device and what class it belongs in – class I, II, or III. Design controls also provide traceability during the development process of a medical device. Manufacturers recognize the need to refer back to their design controls more frequently as adverse events, recalls and regulatory audits increase.
As regulatory oversight grows and devices become more complex, the need for a more direct line-of-sight into design controls throughout a product lifecycle will only increase. The need to refer back and re-use design controls will become more time-consuming and expensive. Moreover, error-free design control will not be possible. Failing to standardize the level of context at each step of the product lifecycle leaves data up for individual interpretation and human error. As a result, design control failure is the leading cause of regulatory audit failures and product recalls in the last five years.
Creating granular traceability through design control
To establish more consistent and traceable design controls, medical device companies need to move away from document-centric information models. They must move toward data-centric models with granular traceability. Companies can now rely on computers to catalog and codify information. This change will reduce the dependency on human recall. In addition, engineers will have more time for valuable design activities and productivity rather than administrative tasks. With the transformation of design control documentation, companies can automate the traceability of design control and provides benefits, such as:
- Readily apparent regulatory compliance
- Re-use and parallel authoring of design controls
- Multidisciplinary collaboration in design
- Final products that match their intended design
To advance patient health and ensure safe and efficacious medical devices, a comprehensive history of device design controls in context is key for all companies.