Medical Device Development – Every Challenge is a Tough Challenge

Medical Device Development – Every Challenge is a Tough Challenge

Working in medical technology product development, we understand the need to work towards making things better. The universal goal of our team, our clients, and the end users of our products is improvement. Whether it’s relieving pain, making treatment adherence easier to remember, or to comply with, or driving simple logistics like walking or breathing, our end goal is always about the patient. Key Tech is in this industry because we love compelling challenges, and we love contributing to helping to improving health, quality of life, and ease of use.

ISO 13485 certified with a full scope team of 50+ members across Computer Engineers, Mechanical Engineers, Electrical Engineers, and Industrial Designers, Key Tech’s robust capabilities and passion to solve the toughest technology problems gives us an unmatched advantage in MedTech development. It’s common that the products we develop require multiple disciplines to tackle the problems at hand.

Our de-risking philosophy throughout the product development cycle is core to our success. Our clients choose to work with us for specific expertise that we can bring to the table. Or because they need the additional bandwidth. When companies are looking for fresh ideas or an independent perspective, they turn to Key Tech. We design for manufacturability and reliability and partner with world-class contract manufacturers to make the products we develop.

We think differently, resulting in elegant solutions to difficult problems. Our customers need concepts fast to demonstrate feasibility. Key Tech offers short and intense rapid innovation engagements to brainstorm and prototype solutions to technical and user-centric design challenges. We bring expertise to bear from other markets, and an experienced team, which results in clever solutions to new product challenges.

Some customers ask “Can this be done?” Some customers license or acquire new technology for integration into their products.  Key Tech designs a series of de-risking experiments and custom test fixtures to study the technology.  We’ll collect the data, run statistical analyses, and iterate on test designs until the technology, and its impact on the overall system architecture, is understood.

Other customers are looking to outsource complete system or subsystem development to our team.  We have a compliant quality system, and an ISO 13485 compliant process to develop the complete product, starting with input product requirements and ending with a design that is ready to be transferred to a contract manufacturing partner.  We’ll make sure to assess risk early and report status throughout development.

We’re fortunate enough to have recently celebrated our 20th anniversary, and with that, bringing in steady growth and new energies for the coming decade as technology integrations and development shoot off the horizon. It is truly an exciting time to be working in technology, especially MedTech, and contributing to solutions to the world’s challenges both big, and small.

Contact us to learn more about our process and to discuss your tough challenges: or 410-385-0200.

Every challenge is different – Tell us about yours.