Biomerics has a strong portfolio of manufacturing capabilities that supports prototyping and getting a customer’s design or concept into their hands in a quick, efficient and meaningful time frame. Getting to a finished prototype can help save hundreds even thousands of dollars’ in development time, while at the same time, create a product that has all the relevant specifications, details and requirements embedded in it to support the end result. All of these, can help the product development timeline and proper filing process with the necessary regulatory bodies, thereby, enabling a product to compete with other devices already in the market and readily get into the hands of the physicians, nurses, and practitioners to provide the needed health care treatments for their patients.

We recently sat down with 2 of our R&D engineers to get their perspective on the benefits of Prototyping and the value it brings to the medical device development process. Below is a collaboration of their thoughts and feedback.

Why is prototyping important?

The most important reason for prototyping and rapid-prototyping is because it’s a process that gets a customer’s concepts and designs off of the napkin or paper, and into a real, working example of the device. Through prototyping, an engineer can understand the unique elements of the product, how the device will function and its manufacturability before going through subsequent development stages. Prototyping can save valuable time and resources which are typically limited or constrained. It is through rapid prototyping that testing and refinement of different concepts can be completed to ensure the final design is sent to design verification. It is also a crucial step when it comes to determining a budget that would support a full-scale manufacturing process.

What tools does Biomerics have at their disposable to make prototyping possible?

Our engineering teams have exclusive access to many resources they can draw upon to prototype any design whether it be a component or a full-scale device. Before any design hits the actual printing stage, our engineering teams work to design a printable model using Solidworks. After the initial design phase, it is then transferred to a 3D printer, to make a replica of the item.

Biomerics has many 3D printing technologies on-hand, including FDM (Fused Deposition Modeling) and SLA (Stereolithography). We use these machines on a regular basis to assist in the prototyping process. This equipment allows us to print with a variety of resin types from pure, clear resin/polymers to other higher caliber resins that provide more durability, and can be used with higher temperatures of heat. Using this technology, we can have an example back to the customer to review, adjust and change as necessary which can help speed up the process, and improve overall lead times.

What is also great about our capabilities here at Biomerics is we can also consult with other departments and engineers to determine if additional components/resources need to be sourced during the design and development process. It may include additional tubing/extrusions, bonding of parts/pieces or machining needs. All of our engineering teams have a great deal of knowledge and experience they can draw upon both within the Biomerics family of companies and from our business relationships with other vendors and suppliers who are experts in their respective areas because they can provide valuable feedback, or assistance in the overall process.

What are your estimated timelines for prototyping?

In many cases, the timing for prototypes depends on the type of component or full-scale model our customers has invited us to develop. If it is strictly 3D printing that is needed, we can have a working prototype back to the customer in as little as 1-2 weeks, and sometime earlier. On the other hand, if the device is more complex, and requires the use of our external partners, one could expect a 3-5 week lead time. We make it a priority to try and work collaboratively with the customer to design a prototype that reflects the design as it was initially intended.

What challenges in Prototyping could customers encounter during the process?

The most challenging part of prototyping, is ensuring that the product can be manufactured in the long run. Part of the engineering process, involves asking if the prototype can be replicated, both in low and high volumes? And can it maintain the level of quality and durability for which it was intended? In many cases, we have to work with our molding teams, to ensure that the right molds have been correctly designed, the right materials are in place, and the proper quality standards are established. It is an opportunity for us to work collaboratively with our customers, to be a guide and support throughout the entire process and provide information and recommendations on how the design and manufacturing of the product can be improved to be both cost-effective and beneficial to the end product. That is why we always look at our business relationship and make sure that the products we work with are a good fit, and comply with the resources and capabilities we have in our different facilities. We want the whole process to be a team effort and in the end, successful for our customers.

What is your favorite part of the prototyping process?

We love the ability to work directly with the inventors, entrepreneurs, and engineers to understand the purpose of each device. It is always an exciting experience to get into the innovators head, to see how they intend to use the tool, how they would hold it, handle it, and ultimately how it would benefit the end-user. We see hundreds of designs come in, and some of those designs are concepts we have never seen before. It’s an excellent opportunity to go deep with the customers to know and understand what the end product will do and how it will help solve some of the most challenging healthcare needs.

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