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Medical Device Product Development & Sewing

From Research and Product Development To The Final Solution

Our world-class medical device product development and sewing team works with the latest technology create the exact product you need. Our extensive experience and knowledge of prototype development, materials, and construction allows us to transform the most challenging ideas into a custom-sewn and sealed product that meets the fit, form, and function of your application’s specifications.

To meet your expectations, we provide the following services for medical device product development and sewing:

  • Design for manufacturability
  • Engineering to meet customer performance testing (drop testing, water ingress etc.)
  • 3D CAD renderings
  • Bill of Materials (BOM) management
  • Prototype development
  • Prototype & Document control
  • Product cost estimates

Our prototype development and sewing creation process is simple: we meet with you, review the product realization document and recommend materials, create the patterns and prototype the solution. We will make immediate adjustments to the pattern as necessary and update the sewn solution. For all sewn products, we can work from simple sketches or DXF files to come up with the perfect solution for your project. From the product realization document, we are able to efficiently determine the appropriate materials and test criteria for the project.

We employ the most appropriate fabrication techniques and advanced manufacturing methods throughout the medical device product development and engineering process. We also streamline production by engaging supply chain partners early in our process to make full use of their expertise.

At TPI Custom Solutions, we always aim to work closely with our customers in producing the best possible solution. Our expertise in medical device product development and sewing allows us to develop the most challenging custom concepts. Examples of our medical device projects include a respirator bag to carry a portable ventilator, CPAP headgear, and a military medic bag with a stretcher.

For more information, call us today at (612) 588-8230 so we can help you meet your specific medical device product development requirements!

Contact Us

Looking for prototype sewing services?

We work with medical device and OEM manufacturers as your single source for custom cutting, sewing and sealing.  Contact us to get started on your project today!

FAQ's for Prototype Development

      1. On average, how long does it take to complete a prototype development project?  

              The amount of time it takes to complete a prototype development project varies depending on the requirements and the method of construction chosen. For a product that requires sewing the pattern development and completion of the product can be accomplished within 4 weeks. It is important to note that material selections and availability can alter the amount of time it takes. When it comes to welding solution, they usually require a temporary tool to be designed; It can range from 6 to 10 weeks to complete a prototype.  

      2. How are TPI’s prototype development services unique? 

            – We use a product realization process to determine material requirements. 

            – We assess risk based on the intended use and address this with the customer. 

            – We stock a wide range of materials used in both sewing and fabric welding solutions. 

            –  We staff our development team with the latest CAD software systems specific to sewing and welding.   

            – We offer 3D software modeling of prototypes during the early stages of development. 

            – We offer solid works CAD services to deliver tooling designs and bills of materials when needed. 

            – 3D printing of plastic components for rapid prototyping. This provides a one stop option when customized plastic components are needed. 

            – We assign a program manager to each project so there is a point of contact to keep the communication flowing. 

      3. How do I know that TPI’s prototype development services are high quality? 

             Before starting prototype development projects, we identify important criteria with our customers to ensure that the customers expectations are exceeded. We also often recommend solutions to minimize risk to the end users to enhance durability. 

      4. What is the average lifetime of a product created by TPI?   

             The average lifetime of a prototype development project varies depending on each product as they are customized to our customers specifications.   

      5. Are there any recommendations that TPI that pertain to prototype development projects? 

             Where possible, we recommend specific construction methods to enhance durability or automation of specific items to achieve the aesthetics to meet requirements.   

      6. What types of materials are used when creating a prototype development project? 

              A wide variety of fabrics such as Nylon, Polyesters, Laminates, Vinyl, Leather, TPU films, various coated materials and single use options are commonly used. We also create materials specific to the requirements or specifications of the project.