Systems Engineering

Bringing successful products to market in the volumes needed to meet demand is a time-consuming, high-risk proposition. Our team’s goal is to strengthen yours. We’re a nimble “right hand” with the technical knowhow and perspective to commercially scale your regulated medical devices, drug delivery devices and other products in the life sciences industry. Our engineers and technical experts work with you to develop and execute a structured process that’s scalable, robust and well controlled.

Process Development and Demonstration

Process Development and Demonstration

We design, prototype and oversee the technical processes necessary to scale your devices.

Commercialization

Commercialization

We help you take products all the way to market, launching full-scale production and ensuring sustainable performance over the product lifecycle.

Risk Management

Risk Management

We identify, quantify and monitor potential risks so your team can make well-informed, timely decisions.

Validation

Validation

We partner with you to navigate the complex processes of validation, qualification and commissioning to achieve compliant solutions.

Life Cycle Planning

Life Cycle Planning

We make plans, projections and decisions to ensure that operating costs can be effectively managed throughout the product’s life cycle.