A true early-stage development partner for med device founders.
Product development and low-volume manufacturing under one roof, organized around wherever you are in development.
Incubation Services
Office and lab space on the Northland campus, the Egret Ventures network, funding facilitation and a regulatory/clinical brain trust on call. Given our own experience and success in startup development, we offer founders that same hands-on, back-office support, including company formation, lab and office space, funding network introductions, and clinical advisory relationships, all the things needed to stand up and initiate the hard work it takes to bring a technology to market.
Concept & Feasibility
We establish a product development plan with detailed cost estimates and timelines, including regulatory assessment and pathway to market.
- Idea Generation and Market Fit
- Rapid Product Protoyping
- Proposals Catered to Start-up Resource Constraints
Product Development
Flexible iterative approach to product development, including intended use and design specifications, material selection.
- Testing & Validation
- Mechanical / Electrical / Software Engineering
- Final Design Specifications
Quality & Regulatory
Develop regulatory and clinical strategy, to ensure adherence into a safe FDA-compliant device.
- Determine FDA Device Classification
- Regulatory Pathway: 510(k) / De Novo / PMA
- Identify Applicable Standards and Testing Requirements
Low-Volume Manufacturing
ISO 13485 quality system and a Class 10K clean room for pilot builds.
- ISO 13485
- Class 10K Clean Room
- Sterile Packaging and Labeling
Advisory Services
Beyond device development, our team brings direct operating, reimbursement, health economic and commercialization expertise to providers and founders alike.
Direct operating experience running efficient, high-performing hospitals and ASCs.
- Revenue Cycle Management
- Hospital and ASC Operations
- Strategic Planning
- Capacity Management and Throughput
- Physician Contracting
Market and reimbursement strategy for device companies at any stage, from early concept through launch.
- Market Assessment
- Medical Device Reimbursement Strategy
- Evidence Generation Planning
- C-Suite Strategy
Built for flexibility, because early-stage moves fast.
The Rookery works across a broad range of medical service lines.