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How to choose a medical device product design and development company

Medical device companies must overcome many significant challenges when bringing new products to market. In addition to the high costs throughout the product design and development process and manufacturing, manufacturers must ensure compliance with specific regulations for the markets in which they plan to sell medical devices. 
If you have an idea for developing a new medical device with the aim of improving the quality of life, it is your responsibility as a device manufacturer to develop the highest quality product possible. This means that the resources that contribute to the process should be qualified and able to achieve this result. There are many design and development companies that specialize in these services to help companies turn their great ideas into functional, compliant and commercially viable products.

For most medical device innovators, rapid prototyping is one of the most exciting times in product development. It was very satisfying and fun to see early design images and specs physically come to life. But if the team is financially constrained and interested in capital efficiency processes, that excitement breeds the temptation to bypass multiple elements that must precede prototyping.
Clinicians follow very specific processes when preparing for surgery; imaging, preoperative planning, team and operating room scheduling, cleanup, etc. Likewise, engineers should not build without a plan, strategy, and flowchart. In order to maintain a capital efficient and flexible process, the innovator has the best chance of reaching the desired goal in the shortest time.

Create prototypes for your medical device ideas

Because prototyping is an important part of the medical device design and development process, you must work with a development team that has prototype production capabilities. This includes having in-house manufacturing and tooling capabilities to ensure consistent quality and efficiency and to protect your intellectual property.
We prototype for learning and for communicating ideas and concepts. While 3D printing is undoubtedly a very useful tool, there are many low-fidelity prototyping methods that can help launch successful products.
As a medical device developer, you are often faced with making design decisions on a tight budget. Prototype medical devices should not be skipped due to cost. The look, feel, and perception of a product are not only critical to its success, but also have a major impact on a project even before it hits the market. 
Attractive design affects investment in equipment. Industrial design is not just about how it looks, it’s about how a device functions, how it’s used, and how it’s made. Sketching is a great first step. It’s fast and can bring concepts to life, but design decisions are often made with what’s at hand.
We can create virtual models (CAD), but it’s not quite the same as touching and manipulating tangible things. When you first pick up a prototype, things that are nearly impossible to see in CAD become immediately apparent.

Why prototyping is integral to medical device performance

When you outsource the production of medical devices, you need to know that the contract medical device manufacturer you choose has expertise in all areas of the production process. The ability to produce working prototypes or pre-production samples is especially important.

Prototyping techniques range widely: from the ability to make simulated versions of equipment using custom parts to the ability to use low-cost prototype injection mold tools. At elimold, our expertise covers this range of services.
This prototyping expertise gives you a degree of flexibility in how you test, improve and develop your device, giving you a better product and faster time to market

our way

We start with the big picture and take an honest look at the goals and potential of the product. As we dig deeper into device strategy, we use our process to break the big picture down into smaller pieces.
In the early stages, our goal is to use evidence-based decision making for product development that steers the product towards the most efficient and effective path. Our input comes from extensive analysis, including clinical markets, regulatory pathways and competing products. Integrating these inputs, we can generate design concepts and functional prototypes to support design decisions and intellectual property strategies.

Initial Conception and Patent Obtained

The first stage of the medical device development process is a broader in-depth study of the new invention that defines you. The best way to do this is to answer questions about the main pillars of trying to sell a brand new product in the healthcare industry.
Market Assessment: What Problems in the Medical Industry Does Your Device Solve? How is it different from other devices trying to solve this problem?
Business Model: What is the cost of production? How are you going to sell it and who are your investors?
Engineering: Did you use existing technology to develop this product? Are these components available to you, or do you need to make new components to help you create inventions?

Does your device already have a patent?

Along the way, you know exactly what steps you need to take to bring your dream device to life. Before you get your hopes up, an important step is getting a patent.
No patents are issued after the prototype is made. Patents are used to exclude others from creating your product. So, in theory, people have already obtained patents that are not yet on the market. They are essentially patent squatting.

must be novel

Societal needs require skills in this field of inventionResearch, Discovery and Prototyping,The digital age has made it easier for inventors and manufacturers to work in sync with each other when creating designs for new parts. While hard paper blueprints may still exist, 3D CAD files allow product development and research to evolve at a faster rate.
You can purchase software to build and check CAD files, or work with a prototyping company that gives you access to this handy technology.
These CAD files allow you to focus on the functionality of the design, not necessarily the design and its appearance. Once the capabilities of the device have been determined, you need to utilize the most practical method to prototype a new medical device.

What kind of prototyping do you need for your medical device?

After researching and discovering the best way to create a part, you need to take it off your computer screen and turn it into something tangible. This is called prototyping, and there are multiple approaches.
3D printing: powerful and already working wonders in the medical world
Injection moulding: used to ensure that all parts fit together in your new equipment without wasting resources on the materials you will be using
CNC Milling: Manufactures extremely accurate parts for designs with specific angles and provides fully functional parts that can be tested
Casting: Makes your part flexible so it can replicate the bends and twists you will require the final part to perform
Creating your first prototype will be an exciting experience as you see your invention come to life. But making life-size models can also highlight flaws in your design. This means a redesign and proof of concept will be required.

Proof of Concept and Redesign

During medical device development, the functionality of a part needs to be demonstrated before it can be sent anywhere for approval. These tests are usually performed by engineers on the test bench. Here, they verified the correctness of the device design by simulating usage.

Iterative redesign process

When a prototype fails professional engineering tests, an iterative redesign process is initiated. Iterative redesigns account for prototype failures and identify data points to better understand medical devices and the complexity they can have. It’s also cheaper to initiate a redesign at the prototype level rather than making changes after the part has been built.
By understanding the characteristics of the device through an iterative redesign process, the inventors can determine the viability of the device for commercialization.

Market approval steps

The steps to market approval are established by a quality management system (QMS), which provides a framework to ensure that your medical device is legal through policy and development procedures.
QMS is regulated by Good Manufacturing Practice to guide the device development process and create a Design History File (DHF). DHF records test times for parts and provides background information on the design and manufacturing process. The DHF was created so the FDA could audit the process to ensure it is safe and effective for users of new medical devices.
After completing the DHF and meeting the FDA testing requirements, you will need to submit your device for regulatory clearance. DHF will certify to the FDA that your medical device is safe, and then you can start marketing and selling your product.
For a more comprehensive assessment of the FDA certification process, you can find their medical device development process on their website.
If you’re ready to take the first step towards realizing your dreams, consider partnering with elimold. We provide the capabilities and industry knowledge to get your medical invention out of your head and into the hands of patients who need it most.

Prototyping services your contract manufacturer should provide

To help you make the right decision for your product, request for contract manufacturer medical device prototyping services. Your partner medical device manufacturer should have the following capabilities:
Possess advanced design capabilities – this means having the in-house expertise to review and understand 2D sketches or ideas and, if needed, create the 3D CAD data needed for the next stage of the prototyping process. They should also be able to generate 3D CAD models suitable for the intended manufacturing technology.
Use advanced techniques – such as Fusion Definition Modeling (FDM) techniques. FDM technology produces strong, durable and dimensionally stable parts with extreme precision and repeatability.
Understand the device and its end application – this can significantly reduce the amount of prototype modifications and material changes required during the device life cycle. This experience and understanding of the manufacturing process can save you time and money.
Having dedicated machines for R&D and prototyping – Using smaller machines that are not often used for production purposes gives engineers time to improve prototype devices and quickly create mock-up devices without waiting for production slots.
Ability to create different types of prototype devices – The contract medical device manufacturer of your choice should be able to quickly and cost-effectively create a wide range of device prototypes to near production-ready levels. Such equipment includes IV bags, pump sets, injection molded parts, RF welded components, and products for R&D testing.

Prototype modeling expertise is critical to the medical device manufacturing process and product quality. For this reason, you should only use medical device contract manufacturers that offer this proprietary technology as part of their end-to-end development and production services.
Elimold is an established and experienced contract medical device manufacturer specializing in a broad range of medical device design, development and supply services.
To learn more about how elimold can help you design and manufacture medical products, fill out our online form today, or email us.

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