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From rapid prototyping to commercial medical device prototyping

The medical device industry is growing as baby boomers reach retirement age and beyond, creating higher demand for mobility aids and diagnostic equipment. As demand grows, so do businesses that provide vital services for innovative development processes and technologies.
As with any manufacturing technique, rigorous procedures need to be followed to ensure the end result is of the highest quality and reliability in a medical setting. Here are some technologies used in general medical device manufacturing, as well as some innovative processes that could change the world.

How to design and develop medical devices?

Providing the right healthcare solutions to meet the needs of customers takes a lot of effort. The right healthcare solution requires everyone to be aligned, define a clear scope based on end-user needs, collaborate across teams, and adhere to specifications and requirements drawn from product definitions, all while mitigating risk and adhering to the best possible quality.

Product Concept and Conceptualization

Medtech innovation, like any other industry, starts with analyzing and identifying markets whose needs have not been developed or met, or where there are more efficient ways to meet those specific needs. These needs can be anything that provides a solution, such as new or better methods of health monitoring, enhanced care that provides a solution, equipment or technology for better management, or anything that supports health and human life.

Stage 1: Exterior Styling

The first stage of the product design process does not involve creating an actual, physical product. Instead, engineers and designers work together to create 2D and 3D rendered images and models that can be used to win initial funding and support further product designs.

Stage 2: Proof of Concept

The proof-of-concept phase includes the creation of an actual device prototype. Prototype It may not look exactly like the finished product, but it’s not necessary at this stage. The main goals of creating a proof-of-concept prototype are:
●Prove feasibility
●Investigate potential risks.
●Select components
●Provide feasible product demonstration to investors.

Stage 3: Alpha Prototype

Alpha prototypes are based on proof-of-concept prototypes that look and function more like final products. The purpose of the Alpha prototype is to find potential design flaws and modify the appearance of the product to meet the requirements and specifications of its inventor. There may be some limited user testing at this stage.

Stage4: Test the prototype

Beta prototypes are more refined than Alpha prototypes. At this stage of product design, equipment should meet industry safety standards. If approved, it can be used in preclinical testing.

Stage5: Pilot Production

So far, only one to five prototypes have been created per production stage. During pilot production, product design firms can order up to 100 prototypes. Products should be ready for soft launch, including further clinical trials and testing. Pre-production is primarily used for identification modeling, fabrication, and assembly.

Stage 6: Product Manufacturing

Once the device has completed the first five prototyping stages and passed clinical trials, mass production and market launch can begin.

responsible time management

Medical equipment is tightly controlled, which means that any mistake could send your product back to the drawing board. Professional assistance can help streamline the production process and create designs that won’t be rejected for safety reasons.
Avoiding mistakes isn’t just about saving time. High-quality design services in partnership with manufacturers can speed up overall production.
On the other hand, companies or industrial design freelancers without good time management skills may delay projects due to missed deadlines or their own mistakes.
Many of the top prototyping services are familiar with the medical field and keep a close eye on the cutting edge of technology. They may use their current knowledge of the medical industry to improve your design. They can also react ahead of time to changes in FDA regulations, so you end up not having to update your medical devices sooner than expected.
The end result is not only a product to market on time or ahead of schedule, but a higher quality product that will really help your customers and keep them safe.
When looking for a medical device rapid prototyping manufacturer, look for a company with good time management skills and have them provide you with such a product.

Confirm success

For your project to run smoothly, you need them to have an equipment design process from start to finish. Before choosing a product engineering services business, ask if they have a proven product design and testing process. It may be helpful to ask the partner company for an overview of the product life cycle.


Obviously, a product must be usable to be worth selling. For medical devices, small changes can have a big impact on their comfort or ease of use.

Risk Management

No matter how careful you are with medical equipment, problems can still occur. There is always some level of risk. The magnitude of the risk depends largely on the care and attention your design engineering services provide. A solid risk management strategy is critical to ensuring that project risk is as low as possible.


The development process itself is well defined, and steps are taken to show that they not only have a proven method, but know how to work with others. Medical device design often requires a lot of effort from many different people to be successful, so having a plan is important.
It is very important if your medical device design service has a detailed life cycle diagram, they may produce a product you can be proud of.

Your dedicated and experienced team

Elimold has a team of professional engineers, project managers and technicians. If you are a medical device engineering company, elimold can be your outsourced comprehensive service team. We have the skilled designers, engineers, technicians and project managers you need to take your medical device from concept to commercialization.
We have developed a proprietary Program Development Process (PDP) that is FDA, CE and ISO compliant. Complete documentation is key to regulatory approval and successful transfer to production. We are proud to say that our team and process allow us to bring your medical device to life 2x faster than building an in-house team.
We develop project plans within days of taking over the client, including realistic timelines, expected regulatory arrangements and full prototype-to-commercialization budgets. Clients will receive the latest project reports on a regular basis! We do not make critical design decisions without the involvement of our clients.
Whether you have an existing team that needs professional support or a new project that your current team doesn’t have time to tackle, elimold fits seamlessly into your company. By developing while seeking regulatory approval, we can rapidly commercialize your project.
Your success is our success.

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