Designing New Medical Products & Devices: A Step-by-Step Guide for Your Company

New medical products and devices that meet customer demands and is regulation-compliant takes great effort to develop. The new product design process requires everyone in the development team to be on the same page throughout the project, from discovering the needs in the market to the risk mitigation solution. Strict adherence to functional requirements and pre-determined specifications shall lead to quality medical products during the medical device design process.

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Designing new medical products & devices – step-by-step design phase

A product concept design company follows more or less the same development process and sequence of progression for medical products than other consumer electronic products for the most part. Some significant distinctions only occur approaching the end, during device classification and risk management steps.

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Initial Concept

The design development of every product starts with ideation, in which engineers develop a viable concept. During ideation, engineers and designers typically use hand-drawn sketches to figure out workable possibilities and determine the primary design objective. The ideation phase ends when the team eliminates all but one product concept.

After the final sketch, the team creates a mock-up and breadboard to build a proof of concept for the medical device design. The design might not resemble the final product, but it gives the R&D department a notion of technical feasibility and usability. A mock-up will demonstrate a few major components and how they should work. It is the most rudimentary form of product visualization services to present an idea. In some companies, a business plan for the product comes along at this early stage of development. Market research and fundraising initiatives begin when the concept is deemed probable. 

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3D Models and Renderings

Product designers draw a precise diagram of the medical device design using CAD software. They build 3D models of the final product and every component that makes up the new product design. Visual representations of all the components are necessary to showcase the product’s assembly and internal mechanism. PCB product designers will draw the main PCB and enclosure separately for an electronic device. If the individual components as made of different materials, the product designers should add annotations to mark the distinction.

Detailed 3D models provide a 360-degree view of the device on a computer screen. Component dimension and tolerances in assembly become apparent and can be further improved with image modification. Animated models can show the internal structure of every component and how the device should work when all parts are assembled.

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Simulation software takes the visualization further by showing how the device retains its functionality over time. A computer can also simulate a typical usage scenario to give an idea of durability and the regular maintenance schedule under heavy/light utilization. Although simulation results from the virtual world cannot be 100% accurate to real-life conditions, they are as close as engineers can get without testing the device on human subjects.

Product design engineers use simulation results as the groundwork for further improvement, which is why the 3D modeling phase takes up a large portion of the development timeline. A constant desire to eliminate room for improvement often sends the design project into a seemingly endless loop of upgrades and revisions. Improvements also concern the manufacturing process of the device. Engineers have to figure out the most efficient way to build the device, if possible, using readily-available materials without needing specialized equipment. In addition to solving the technical issues concerning functionality, the engineers must work around DFM (design for manufacturing) approach. 

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3D models are meant to represent the technical details of the device, including the shape, dimension, function, and inner workings. The final version of the models appears first as a 3D rendering. Based on the models, a 3D render studio applies the characteristics and textures of materials to the outer shell of the device, or medical device design. Patterns and colors come next, followed by lighting, shadows, and viewing angle. Render can be static or animated. The expected outcome is photorealistic imagery of a medical device, which represents its eventual appearance. The rendering stage should only happen when the 3D models are finalized.

Prototyping

All medical devices begin as a prototype before going to mass production. The development team needs several prototypes to test its performance in a real-world environment. The device must also be prototyped if it has custom components instead of commercially available off-the-shelf parts. Prototyping is not an isolated, one-off process, and it comes in a sequence of four stages, with every iteration being an improved version of the previous design:

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• Stage 1 – Alpha Prototype: a device version that doesn’t work. It only shows how the outer shell will look, but without any functional component on the inside. Think of it as a fancy mock-up with accurate dimensions. The purpose of an alpha prototype is to help engineers evaluate the form factor and cosmetic aspect. Most companies resort to design for additive manufacturing services to build prototypes to save time and cost.

• Stage 2 – Beta Prototype: a fully functional version of the device with an almost identical set of features and appearance as the final product. Beta prototypes capture the public’s interest, gather feedback, and eliminate potential flaws. Some designers use beta prototypes to seek opinions from the target customers. If there are features to add or remove, they would be minor details because changing the design at this point is overwhelmingly resource-demanding.

• Stage 3 – Pilot Prototype: at this stage of prototyping, the device closely resembles the final product. The specification, including materials and functionality, is an exact match to what the ultimate version will be. A pilot prototype of a medical device is intended for clinical trials.

• Stage 4 – Final Product: as the name suggests, it is the final version of the medical device and the result of multiple minor and major improvements over the previous prototype versions.

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Most consumer products can go directly to market launch once the electronic device design team concludes the prototyping phase with the final iteration. There are two more crucial steps for medical devices and medical device design: compliance with regulations and a risk management plan. 

Regulation

Before any medical device design may enter the market, it must meet regulatory requirements and standards. IEC is an international organization that publishes electrical, electronic, and related technologies standards. If your medical device relies on electrical components, it must be IEC compliant. Every country has regulatory bodies to set the standards for medical devices sold in their domestic market.

In the US, the main regulatory body is FDA; every medical device and product sold in the country must adhere to the design control guidelines issued by the agency. In addition, the FDA requires all medical devices to follow current good manufacturing practices (cGMP), which focuses on the safety aspect of medical devices and all pharmaceutical products. Other organizations also define the standards for consumer products in the US, including the American Society for Quality (ASQ), the Association for the Advancement of Medical Instrumentation (AAMI), and the American National Standards Institute (ANSI). 

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The authoritative organization for the European Union market is the European Committee for Standardization (CEN), which adopted the standard guidelines from the International Organization for Standardization (ISO). In Canada, the regulatory bodies are Health Canada and the Canadian Standards Association (CSA).

Risk management

In theory, risk management for a medical device is constant; it never ends. Despite meeting all regulatory standards, there is always a risk that the product causes harm or injury to the user if/when it stops working or malfunctions due to an unexpected issue. Even the most robust risk management practice cannot guarantee that the device will work and is 100% safe. Still, it helps your company minimize the chances of malfunction-related injuries.

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Well-planned risk management practice involves the process of identifying and preventing any instance of failure that may cause serious harm to users. A company must be able to control and mitigate the associated health risk of using the device. The level of risk depends on various factors, including but not limited to the technologies, materials, and design. Since every medical device is unique, the medical device designer and their company are responsible for ensuring that the product (i.e., medical device design) is safe for its intended use. In the event the device causes hazards to users, the company must be proactive in determining an acceptable solution. 

Once the device is considered regulatory-compliant with the respective regulatory standards, it is ready to launch. However, it’s critical to have an effective risk management and mitigation plan before the device gets into the hands of the initial user. Due to the complexity of medical device design and the requirements for meeting strict standards, the development process requires intensive engineering and a generous amount of financial resources. Every step of the development stage cannot be an isolated process but an integral part of a holistic approach to design.

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How Cad Crowd can assist

Continuous collaboration from the ideation stage to risk management ensures precision in every detail, minimizing the chances of mistakes and eliminating the potential for the unknown. Healthcare is both a highly competitive and exceedingly lucrative segment, and it can also be gratifying to create a new medical device design that can help someone. Ultimately, if the new medical device adds excellent value to end-users, it has all the potential to gain profitable market share. Freelance medical device design and development services are available to help companies create and launch new healthcare devices.

At Cad Crowd, we have a network of professional medical device designers who can help with any project. If you’re looking for a qualified professional to work with you to make a new device, let us know. Find out how it works today