Medical Device Design and Development
Medical device design is one of the most challenging of all designed products. It is also one of the most prestigious and sought-after market areas for industrial designers and medical device design firms. We’ve always been intrigued by medical products because of the numerous challenges they present at each phase, from concept inception and optimizing human factors; to safety, aesthetics, sophisticated technologies, and hundreds of other complex parameters.
Our development team at Integrated Design Systems staff is incredibly proud to have contributed to dozens of designs of products within the medical device industry throughout our 35+ year history. We have designed products ranging from intricate, autoclaved, handheld surgical devices to large room-sized MRI scanners to benchmark biochemical analyzers. You can view some of our accomplishments as a medical design firm on our Design Portfolio below.
Every product has been skillfully designed to comply with international regulatory requirements, including FDA approval and ISO standards. Our design engineering experience and staff of highly skilled medical device developers are why so many prestigious medical device companies have chosen us as their development partners.
In addition, we’ve participated in numerous on-site clinical studies and interviewed physicians and experts in various medical fields to accelerate the approval process. Our familiarity with patients’, physicians’, and support staffs’ needs provide us with a precious perspective in creating every medical device design. Furthermore, our in-depth understanding of numerous technologies, including optics, radiation, chemical analysis, and biomechanics, has proven to be indispensable in this market segment.
Medical device applications are often based on device technologies with short life cycles, which must be developed quickly and correctly. Design and development firms must therefore be proficient in material science as well as human factors and sound engineering principles to work efficiently. Medical device manufacturers are also faced with stringent regulatory compliances that must pass rigorous quality systems. All these challenges can only be professionally managed by a reputable design firm like Integrated Design Systems.
Medical device design projects are frequently associated with numerous specifications, and design considerations that require exceptional technical expertise and human factors experience. These are the reasons medical product design projects are segmented into many development phases as summarized below:
Phase 1 – Research, Site Visits, and Product Specifications
Phase 1 is typically dedicated to objectively evaluating the medical device’s ideal requirements and establishing a set of specifications based on user needs. Phase 1 often includes completion of the following tasks:
- Document how users will interact with the product
- Document what the clinician or physician will use the new technology
- Document the end user’s likes, dislikes, preferences, and recommendations
- Document key features for the product design to be included in the product specifications
- Prepare a comprehensive and objective questionnaire
- Accumulate raw data found during research and interaction with customers and patients
- Prepare a report to have a list of recommendations affecting specifications for design features
- User studies typically include interaction with the medical device to optimize size, ease of manipulation, ergonomic interaction, and operation sequence.
- Flow charts are prepared to outline all phases of data acquisition, processing, storage, and retrieval.
- In addition to gaining a comprehensive understanding of the product and technology, research also includes an analysis of competitive products and technologies.
- Video, digital images and notes are accumulated throughout this phase to document all the information
Phase 1 concludes with a formal report including all the gathered information, the analysis, conclusions, and product specifications
Move your company forward with our medical product design services. Your ideas, coupled with our expertise and connections, can become something invaluable to future generations.
Phase 2 – Optimize User Interface, Overall System Architecture and Concept Designs
Phase 2 focuses on interpreting the specifications defined in Phase 1 into several viable design concepts. These concepts usually include the following parameters:
- Optimizing overall product size and shape
- Defining locations of physical buttons and controls
- Button sizes, orientations, functions, forms, tactile response, and colors
- Display size and orientation
- Materials on the surface for gripping and ergonomics
- Features to minimize crevices for ease of cleaning
- Menus, graphics, and operator interface – touch screen vs. button activation
- Weight balance
- Optimized size and shape of hand grips
- Overall humans factors considerations
- Appearance and product branding
Phase 3 – Concept Refinement
A concept is selected from the previous phase and is further detailed in Phase 3. If the medical device includes electronics, the housing is detailed with specifications for buttons, part to part fits, colors, textures, materials, and overall form. One or more models are usually fabricated to verify the design with engineering and marketing development team members. Models are also presented to selected physicians for their opinions based on critical factors affecting the design and use. Design modifications are often made based on the feedback from these sources
Phase 4 – Engineering Details and Production Part Design
The accepted concept design completed in Phase 3 is fully detailed into a complete set of production 3D CAD files throughout Phase 4. Phase 4 is always the most time-consuming and tedious phase of development. It is also the most critical phase since the quality of the production part designs will affect everything associated with the final product. Our designers and engineers are experts in plastics materials, all primary manufacturing methods and are fully aware of DFM (design for manufacturing). Structural computer simulations are frequently completed during this phase to minimize design revisions and optimize strength to weight ratios in the final design. Functional prototypes are also fabricated during this phase to verify complex mechanical mechanisms.
In addition to structural optimization, IDS engineers are also experts in designing plastic parts for all the major molding processes. We can therefore optimize your investment budget with the optimal plastic processing method. Our comprehensive knowledge in plastic injection mold tool design enables us to deliver fully detailed CAD files optimized for the molder. This very high level of detail eliminates costly tooling revisions and production startup problems. The toolmaker inserts our CAD file into his tooling program and begins tool design. All draft, split lines, and radii are entirely defined in our CAD geometry.
Phase 5 – Engineering Prototype
It is customary for most of our designs to undergo a prototyping fabrication, evaluation, and refinement phase. The prototyping method depends on the part size, type of evaluation, application and cost. If the product is primarily plastic, a completely functional prototype of the designed plastic parts will be fabricated from the 3D CAD files completed in Phase 4. The prototype may be fabricated from more than one material if required. Our engineers verify the assembly and function of the prototype. After we have certified it complies with product specifications, minor design modifications are being made, and the design is finalized for production.
Phase 5 – Production Documentation and Final Design Review
Product documentation is a culminating critical step in the medical design and development process. Production control drawings establish the criteria by which your supply chain manufacturers must comply. The production control drawings contain specifications for all manufactured parts and components associated with the medical device. Production documents can be equated to a contract between you and your supplier.
Phase 6 – Final Production Design Review and Release
Although it’s always prudent to regularly interface with molders, toolmakers, and other critical manufacturers in your supply chain throughout the development process, a final design review is a necessary last step before officially releasing CAD files and documents for production. An honest and objective critical final design is always recommended at the end of any medical device development process. The production design should be scrutinized by tooling engineers, molders, manufacturing engineers, and service personnel. This final step offers the only opportunity for key project contributors to make suggestions for improvement before files are released for tooling. After this critical moment is passed, design changes will become much more costly and challenging to implement. Files are officially released after all parties have approved the design.
We implement all of these development phases in all our medical device design projects. This is why our services have been sought after by major medical device manufacturers like Becton Dickenson, Smith and Nephew and Hologic and startups and mid-sized medical device companies.
A quick glimpse of our edited portfolio shows you the range of the many medical devices and products we’ve designed and developed.
Medical Device Portfolios
Medical Device Portfolios
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