Efficiently linking innovation with execution to deliver impactful medical devices and services to market
We deliver essential strategic guidance and hands-on support for de-risking, engineering, and developing emerging medical innovations. Partnering with healthcare leaders, we bring cutting-edge innovations to life.
Ways to work together
Opportunity assessment
The assessment is a written analysis and strategic roadmap that outlines essential steps for positioning and advancing an innovation. This includes an evaluation of the market opportunity, a review of clinical, regulatory, and reimbursement considerations, and results in an initial operating plan. The report covers items critical for diligence with internal stakeholders and investors.
Concept de-risking
We focus on cost-effective prototyping and hands-on evaluation, using a deep understanding of anatomy and physiology, mechanisms of action, user experience, and engineering. We have extensive experience leading concept de-risking of new therapies spanning from initial phantom testing to conducting first-in-human studies. We know how to manage and progress through the entire spectrum of concept evaluation.
New product introduction
We have expertise in developing a range of medical devices, including active hardware and software, wearables, invasive products, and services. Our team is well-versed in the standards and regulations necessary for bringing products to market, such as ISO 14971, IEC 60601, and ISO 13485. We excel in managing design history files to ensure compliance throughout the development process and enable regulatory approvals.
Selected projects
Let’s work together
We invite you to discuss your project with us and explore how we can help bring it to life. Our process begins with a complimentary initial consultation. Whether you are an individual physician innovator or managing an innovation portfolio within a department or investment focus area, we have the expertise to support your specific needs and drive successful outcomes.