Medical Device Development Service

STEMart offers state of the art comprehensive services for your medical device developments through all phases: from the initial ideation stage, through product design, development and validation up to manufacturing and launch. Our medical device development services cover across diverse product categories, including medical imaging devices, surgical equipment, therapeutic devices, patient monitoring, drug delivery systems, emergency care systems, oral appliances, automated lab equipment, food safety products and more.

Today’s medical and life sciences companies face intense cost pressures to develop new innovative products in shorter time frames. Medical device companies have to overcome many significant challenges when bringing a new product to market. Along with the exorbitant costs throughout the product design and development process and into manufacturing, a medical device product development often involves cutting-edge technology and strict regulation requirements, which gives it an extra level of complexity.

To meet these challenges, STEMart brings full-service covering all development phases to accelerate your medical device project. In our medical device development service, you have an expert, multidisciplinary, technical partner that can support your project in every way, and you can access these resources at any stage of medical device product development. The medical device development team helps you make clear definitions and smart choices that protect you from costly mistakes, ensure the desired quality and increase your speed to market.

We Deliver

STEMart delivers services in each of the following medical device product development areas to accelerate your project reach the next milestone. We are also able to act as a dedicated project partner capable of adding increasing value through every stage of the journey to market.

• Concept & Requirements Definition and Development

  Our teams capture all input required to create a well-defined medical device design that ensures reliable performance and regulatory compliance. We leverage human-centered industrial design, digital product design, and human factors expertise to translate insights from research into product solutions.

• Detailed Design & Engineering Development

  We help you to translate completely new medical device or early concepts into focused, detailed, engineered solutions. Our engineers will help you solve complex mechanical, electronics and software challenges to deliver capable and robust medical devices.

• Product Prototyping and Testing

  Our product prototyping and testing services are quite valuable in confirming an idea’s feasibility or appeal, comparing different concept functionalities, and eliminating costly mistakes early on. This phase also encompasses risk management activities, engineering verification prototyping, functional testing, human factors/usability evaluations.

• Pilot Production

  In this phase, we brings together project, manufacturing, and quality engineers to oversee production tooling development and configuring manufacturing lines, conduct process validation and complete risk management activities, including the Process FMEA. Your pilot production is supported with our dedicated clean rooms and production resources.

• Testing and Verification

  Our testing and verification services ensure the product meets requirements for functionality, reliability, usability and safety through rigorous verification and validation testing. We provide thorough Medical test & verification services that enable you to prove your medical device design meets the safety standards that regulatory bodies, such as the FDA, CSA, CE, and UL, recognize.

• Manufacturing

  We have the talent and the resources to take your medical device manufacturing project from pilot to full-scale manufacturing with comprehensive and stringent project management oversight every step of the way.

Whether you're developing a new device or looking to improve an existing one, STEMart has the experience to guide you through the design, engineering, manufacturing, and regulatory challenges unique to medical device development. Our engineers, physicists, industrial designers, regulatory and manufacturing experts will work together with your team to ensure an optimal outcome.

If you have additional questions about Medical Device Development or would like to find out more about our services, please feel free to contact us.