Medical Device Development

We help physician inventors and virtual start-up companies design medical devices in the early stages of development for a fraction of the cost of larger engineering companies. Using industry standard CAD (computer aided design) tools, we provide the same high quality design and mechanical engineering services offered at larger firms at much lower costs. Our years of experience designing medical devices has given us the skills necessary to efficiently design your device in a way that is optimized for both manufacturability and functionality.

Developing medical devices can be a costly ordeal. However, Pipeline Design & Engineering is structured to reduce these costs in the early stages of development without sacrificing quality by implementing the following strategies:

  • Very low overhead
  • Elimination of costly practices unnecessary during the early stages of medical device design

Medical device design is held to significantly higher standards in regards to quality control and regulatory requirements. FDA-compliant manufacturers and engineering firms must implement sophisticated quality systems and document control measures to ensure devices are developed within a safe and controlled environment. These environments ultimately protect patients against design flaws and manufacturing errors and are necessary tools in mitigating the intrinsic risk involved in developing and marketing medical devices.

However, such systems are not necessary during the “uncontrolled” phase of product development (i.e. early stage concept generation and exploration, 3D modeling design, and functional prototyping before an appropriate concept is identified). In fact, these systems can be counterproductive during the uncontrolled phase of development since so many changes are being made to the early concepts and prototypes. Most companies do not have reduced rates for the uncontrolled phase of medical device development. As a result, the customer ends up paying a premium rate for time which does not require the overhead associated with said premium rates.

Pipeline Design & Engineering holds a unique market position in that it focuses solely on the early stages of medical device development. Our intention is not to compete with the FDA-compliant environments offered by other companies. It is, rather, to provide individuals, groups, and organizations with an extremely affordable avenue for developing their ideas up to the point at which it becomes necessary to introduce a controlled environment. We are thus able to deliver the same amount of design work at 65% or less of the cost of a traditional.

Our team will:

  • Work with you to identify a mechanically sound concept
  • Create 3D CAD models and engineering drawings
  • Procure prototype components
  • Iterate on your design until a reliable solution has been achieved
  • Help you transfer the project into a controlled system with one of our trusted partners

Contact us now to get started on your product.