Medical Device Design
Medical device design and development is a crucial step for the success of the product. A medical / medical device that does not comply with the necessary criteria in its design cannot meet the legal requirements and cannot be put on the market. Even if the necessary conditions are met and its suitability is approved, it will not be able to fulfill the functions defined according to the needs of the market and will not be able to provide the expected benefits. Compared to well-designed products, it will not be able to create the desired effect in the market and even stopping production will be on the agenda in a short time.
The success of medical device design projects depends on technological, clinical, commercial and legal criteria. Because well-designed medical devices;
• should be in line with technological trends,
• must pass clinical tests and provide the desired values,
• must show success in commercial matters such as product marketing, sales, advertising, etc.,
• must comply with national and international legal regulations.
Due to the extensive regulations in the industry, the design of medical devices presents significant challenges in terms of both engineering and regulation. This necessitates professional support for the follow-up of legal regulations as well as technical studies during the medical device design process. Subjects such as tests, records, reports, production method, validation, repair and maintenance procedures of a medical device are at least as important as technical studies. The scope of medical device design is expanding even more, especially if a unique product is to be introduced to the market.
Medical Device Design Stages
Like all product categories, medical devices are made to eliminate a medical problem or reduce its effects to an acceptable level. In this case, the first stage of design is feasibility studies. In summary, the following issues should be addressed in a feasibility process:
• Medical problem and clinical needs
• Critical features of the product
• Legal regulations related to medical device
• Intellectual property of the product
• The market or markets that the product addresses
• Competitors in the market
Another important step in the medical device design process is planning. For this, a realistic, comprehensive and consistent plan should be made. The project schedule and budget should be determined in detail. Documents to be edited should be revealed and followed up regularly. The following documents must be prepared at the planning stage:
• User needs and design inputs
• Product overview and design concept
• Production, packaging and labeling strategies
• Risk assessment
• Tests to be made
The next step in medical device design is design and development. The main activities carried out at this stage should be:
• Approval of design input requirements
• Device design and identification of user risks
• Making changes in the design to produce with a suitable, low cost and fast production method
• Creation of samples using expected production methods
• Testing to what extent the produced samples meet the targeted criteria
Testing and analysis on the products obtained and product approval is the next step of medical device design. With the engineering evaluations, it is determined whether the device design service and studies meet the product requirements. After the completion of this stage, the design team can also obtain statistically significant results about the functionality and safety of the product.
The step in which external support is most needed for medical device design is the validation phase. Extensive system and user testing demonstrates whether the design satisfies the client´s clinical needs. Upon completion of this phase, a project team has documented evidence of product usability and resolved the stated clinical need.
The final stage of medical device design is the transfer of the device to production. To produce to the quantities required for sale, production procedures must be demonstrated to consistently and reliably produce the commercial product. For many medical products, regulatory approval is also mandatory before being placed on the market. With the completion of this stage, the device is ready for routine production and sale.
In the Medical Device Design Process, Azan Consulting Is With You
Aşan Danışmanlık provides support to companies in medical device design at all stages. In this context, companies
• approval of the design in accordance with legal regulations
• testing and analysis processes
• beginner and advanced training
• certification services
• CE document
• ISO 13485 and other certification studies related to medical devices
• market research
• risk analysis
• feasibility report studies
and many other issues from Aşan Danışmanlık. Aşan Consulting service is also provided as a second product in medical product design, sales and sales prices.