Medical device design and development is not just about creating a solution, it is about successfully addressing the need of customers while fulfilling their compliance needs.
Fremont, CA: The design and development phase of a medical device is critical to its success. A medical device that is imprecisely described and constructed will be unable to meet regulatory requirements and reach the market. Or, under the worst-case scenario, even if it complies, it will fail to deliver the stated capabilities and benefits in accordance with market expectations, resulting in lower market adoption than well-designed solutions. Medical device design and development encompasses more than envisioning a solution, prototyping it, and mass manufacturing it for commercialization.
Here’s how to design and develop a medtech device:
Product Ideation and Conceptualization
As with other industries, Medtech innovation begins with assessing and defining the market, determining whether demand is untapped or unfulfilled, or whether a more efficient way to serve those specific needs exists. These requirements could include anything that provides a solution, such as a new or improved method of monitoring health, enhanced care delivery solutions, gadgets or technology that facilitate administration, or anything else that promotes health and human life. In an ideal world, product ideation and conceptualization would begin with the identification of needs, followed by device classification, and then the idea would be sent to the discovery phase.
Addressing Regulation and Compliance Need
To enter the market, a medical device must comply with a number of regulatory requirements, which are governed by both regional and worldwide standards. Medical device standards assist in describing and evaluating the requirements for biomedical materials, tools, and equipment design and performance parameters. These medical device standards enable organizations involved in the field of medical devices, such as product manufacturers, laboratories, and others, to check and assess such equipment and devices to verify that they meet specified quality and usability requirements.
Design Control Regulations
Medical device manufacturers must adhere to Design Control criteria because regulatory authorities such as the FDA, the European Commission, and Health Canada seek to guarantee that medical devices are safe for potential users before they are marketed. Professionals with technical and non-technical backgrounds, such as business administration, life science, engineering, computer science, and the arts, are necessary to execute the design control of medical devices properly. The design controls guideline is a quality system method that spans the whole lifecycle of a medical device, from conception to manufacture, distribution, usage, maintenance, and obsolescence.
Testing-Verification and Validation
Each medical device must meet functional, usability, and reliability criteria in order to gain a profitable market share. Apart from these factors, end users consider the effectiveness and safety of equipment they employ to address a specific ailment or condition, which may be life-threatening. This is why iterative testing of these medical devices with verification and validation becomes critical. Verification and validation of medical devices during the design phase ensure that the device is compatible with the needs of the intended users and that it provides the intended solution. Additionally, it assists in determining whether or not all standards are met. It aids in regulatory compliance as well as the development of the highest-quality products and production procedures.
Risk Management Procedures
Medical device risk management methods are governed by the globally recognized compliance standard ISO 149711:2007 Medical Devices - "Risk Management for Medical Devices." Apart from this, risk management policies should be included throughout the design and development process of medical devices and should be related to design control aspects as well.