We treat every element of our design and engineering work as critical components of an established plan to bring your market to market – in compliance, and as quickly as possible.

Think smart

Boulder iQ’s specialists go beyond the traditional phase-gate approach for medical devices. With our “think smart” approach, we focus on the end users at the beginning of the design and development process. We learn how they will test and use the product, and what their goals are – all before expending substantial time in development.

• Deep market research
• Clear value messaging
• Evidence generation 

Regulatory compliance

Our design and development specialists continually interface with our in-house regulatory affairs and quality assurance teams.

Decades of experience working with early-stage developers have honed our expertise in regulatory strategy development. We know how and when to handle FDA submissions, how to prepare for and work through audits, how to develop Clinical Evaluation Reports and more. Moreover, we develop smart design choice recommendations that will get your product on the market, and producing revenue, as quickly as possible.

 

Design for manufacturing flexibility

At Boulder iQ, we’re always thinking ahead. Product ideation may start with innovation, but we take a broader view of how design will affect manufacturing quality, speed and cost. We know how to incorporate flexibility into design to allow for the inevitable changes to come – even those that occur once a product is on the market.

 

Rapid prototyping

Smart design and engineering strategies include rapid prototyping (3D printing). Here at Boulder iQ, we know when to use it and when not to use it, based on product design, eventual manufacturing strategy and investor considerations.