New Product Development for Medical Devices and Other Innovations

Pathway Medtech believes no design is complete until it can be manufactured efficiently, repeatedly, and to meet top quality standards and regulations. We excel at the design and development of medical devices and other new products without ever compromising quality.

Navigating the complex development process for a medical device requires comprehensive quality management. This journey, led by our team of experienced engineers, begins with creative conceptualization and design stages. Following these early stages of medical device development, the Pathway Medtech team seamlessly guides clients through the regulatory and manufacturing phases.

The conceptual prototype phase is often fraught with stress; many of our clients come through our doors with more questions than answers. The Pathway Medtech team has the experience to help companies of all sizes navigate the intricacies of initial ideation and risk analysis, in order to develop a viable proof of concept that checks off every box – without breaking the bank. We do this by working side-by-side with clients to educate them on the nuances of medical device design.

For Pathway Medtech, helping clients overcome technical challenges is a crucial focus in all we do. More than that, we are a reliable, empathetic partner that can support the entire journey to market. Our extensive experience and resources allow us to tailor our services to meet the unique needs of our clients.

This, in many ways, is the getting-to-know-you phase of our work with clients. What are you looking for? What counts as critical criteria for your design? Does the patent landscape require some review before moving forward? These discovery stages precede design to ensure we tick off every possible box. We work to ensure full usability and a top-notch user experience.

A feedback loop connects conceptualization to original expectations/requirements for all of our projects. With the proper direction, hurdles can be navigated with efficiency and innovative devices can be brought to market faster. Your work walks a fine tightrope between innovation and risk; it is our job to ensure concept design encompasses technical awareness, the current regulatory climate, and the creation of sustainable products.

Pathway Medtech’s facilities enable rapid iteration across the digital and physical spectrum for product renderings, which range from digital files to 3D-printed models. From laser cutters to additive manufacturing solutions, we are fully equipped to execute product designs that:

Testing cycles are critical to developing a new medical device, and ignoring proper verification and validation requirements can hamstring your team. Current FDA regulations inform our prototype testing recommendations. Clients reduce their risk by working with our experienced and highly qualified designers, who understand the ramifications of incomplete or substandard testing.

One of Pathway Medtech’s chief goals is to help clients decrease the cost and complexity of manufacturing their products, a process known as Design for Manufacturability (DFM). Even in the earliest design stages, it is important to consider assembly, production, and many other details that will impact the overall cost and timeline to make medical devices market-ready. Each design element must contribute to the whole in order for products to be viable and economical to manufacture.

We often see some mistakes during conceptualization stages – they might pay too much for tooling, or create needless additional complexity, among other issues. Our experts know how to avoid costly redesigns while following the FDA’s stringent guidelines for quality control.