When you begin thinking about creating medical devices, foam can play an important role in your plan. It’s lightweight yet durable and adds comfort and safety to devices. Custom manufacturers usually begin with an inquiry form or a simple call. They can work with you to help you produce a quality medical device for the patients.
Understanding and communicating the critical end-use characteristics will help determine the foam properties that can aid you in achieving market differentiation from the competition. The foam may already exist, or a vertically integrated foam manufacturer can help you develop a specific technical foam. A valuable advantage of a single manufacturer that develops, pours, tests, and then converts and fabricates PU Foam that it is traceable and high quality from start to finish. FDA-approved manufacturers guarantee components meet strict standards to help you adhere to regulatory requirements and avoid costly issues.
What are your secondary goals in seeking out a better part for the device? Will the part make the product more marketable, thus increasing the money you can make? Will the foam component save you money compared to other materials? Are you looking for a part that can reduce risk? Risk can be defined in terms of reduced risk of device failure, reduced risk of getting to market, or even reduced risk to your reputation. Developing a medical device can be a very personal endeavor. You likely have goals in addition to just the part you need. Sometimes, you can’t assign a number to the value of a manufacturer you can work well with. Knowing someone has a vested interest in your success can be immeasurable.
Working with a Technical Sales Representative is a good place to begin describing the function of the foam in the device. Every component, large or small, is important when it comes to performance and FDA approval. Lean on medical device manufacturers to find the value they can offer in understanding your end-user and the market you are entering. When you clearly communicate what you are trying to achieve and what issues and challenges you are facing, you will ultimately find more value than just a company that can make a part.
Your Technical Sales Representative should understand the product they are representing and where you are in the development process. Do you have something you like but it needs to be taken to the next level? Or do you dislike something and haven’t found a solution yet? Either way, when they have your priorities in mind, it becomes a winning team that follows a process based on solutions and results.
From there, how do you describe foam? Some descriptions can be subjective, so ask your Technical Sales Representative for samples to help better communicate. Is it soft or rough? Course or fine? Others are less subjective. Does it need to repel water (hydrophobic) or retain water (hydrophilic)? Will it filter fluids or absorb them? Does foam weight and density play a factor? Are there other foam properties that will benefit the device, such as treating the foam with an antimicrobial? Is maintaining temperature important? Your Technical Sales Representative can help you find the answers to these questions and more.
From foam to finish means you not only have a team of R&D, chemists, laboratory, and testing personnel, but you also have a specific person, your Technical Sales Representative, with whom you can build a trusting relationship to walk you through the steps.
With foam specifications available, polyurethane foam is then fabricated to the shape, thickness, and size of your device specifications, followed by prototyping and first article inspection before mass producing your foam parts. Each step relies on excellent communication and constant attention to detail.
The road to market for medical devices can be a long journey. There are many decisions to be made, and you may not know what direction to go sometimes. A good team can help the process go more smoothly.
Foamtec International provides an experienced R&D team and materials testing laboratories. We are the only vertically integrated foam manufacturing and fabrication company globally. Our expertise is incorporating the production of medical-grade polyurethane foam Medical Devices in an ISO 13485, FDA-registered cGMP manufacturing facility. Contact us today for more information.