The designing of the medical device is the central part in the making of innovative apparatus, implements, and tools used in the healthcare industry. Unsurprisingly, in its product development lifecycle – ‘design and development’ is the most challenging, complex, and multifaceted undertaking and must confront the required application requirements, specifications, and regulations while seamlessly addressing end-users needs and satisfaction. And that is what makes it a successful product. It’s, equally, a large-scale project involving thorough market research, analysis, expert involvement, prototype development, R&D, and more.
That’s why an increasing number of corporate to small and medium enterprises nowadays prefer joining hands with specialized medical device designer groups to maximize the possibility of their project success while protecting their trade secrets through a professional tie-up. So, if you’re one of the budding entrepreneurs and on the lookout for an expert design partner but wondering about how they would contribute to your venture making your end-product stand out in the highly competitive marketplace, continue reading – how they make it done!
It’s the primary phase of your medical device design project and is devoted to determining the fundamental requirements to enlighten the parameters for the design to meet the market needs. Regardless, it’s the mechanisms used to treat patients like MRI scanner, Infrared vascular imager, or Automated blood analyzer or implements used for rehabilitation purpose like walking device, mimic human organs, portable or wearable devices, the functionality of the end-product should stick to their specification. Even at this primary stage, concerns related to the manufacturing methods and accessibility of materials need to be taken into account to control costs and risk management.
Once the research and findings are in hand – engineers start formulating final specs for the device which typically involves mechanical, electrical (depends), and software parameters. This covers factors including device functionality, tolerance factors, safety features, and equal requirement of material. Precision in the specification development process is most essential to avoid the necessity of the potential costly late-stage amendments during the project.
When the specifications are in place, it’s the medical device designer team’s mechanical and electrical engineers initiate developing the design of the product. Accordingly, computer engineers formulate all physical aspects of the medical device with the adoption of traditional designing tools and the latest 3D-CAD software in collaboration with the designing team to have an eye to its consistency, aesthetic, and project cost.
Once the engineering stage of the device is completed, the next phase involves the formation of a prototype. The objective of developing prototypes is to convert the design into a model and make sure if it is up to the desired level. It also involves verification and validation of the end product. While verification entails ensuring if the specs meet the design process – validation focuses on the overall functionality of the device determining the precision of its function and ensure that it adheres to the needs of the client, the target audience, and FDA regulations.
Testing and Refinement
Throughout the testing process of the prototype, lacking areas are spotted, and accordingly, the design is once again returned to the designing team for refinement. The process may be repeated until it meets all specifications and passed through validation and verification.
Collaboration and Confidentiality
Once you begin the production and launch the product, your trusted medical designer team studies the market feedback in a collaborative environment while assuring 100% success of the project endeavor and making you enjoy leadership in the market. To ensure confidentiality and propriety market for the partner, the professional group undergoes a non-discloser agreement upfront -protecting your IP right.
Integrated Design Systems is one of the leading industrial product design and development companies in NYC that specializes in medical product design ( idsys.com/medical-devices/Medical-Device-Designer ), analytical and testing instruments design, plastics products design, ergonomic design services for consumer products. To know more, visit https://www.idsys.com/industrial-design-blog/.