Our consistent and targeted approach enables an immersive experience between users and devices. From first prototype to finished product, we take full responsibility for managing the entire project. Employing our vertically integrated approach to design enables more efficient product development, regulatory approval, and transfer to manufacturing.
Our first step is typically-a-face to face meeting where we identify your objectives and decipher exactly how we can help. Think of this as a fact finding exercise spanning all verticals of product strategy, design, intellectual property, development, regulatory, distribution and support.
The next step involves a deeper dive into your concept, your product’s intended uses, patient population, predicate devices (if any), and regulatory compliance issues. We then provide a comprehensive project proposal based on our deep experience in product development and experience with similar projects. Our flexible business model allows payment through development fees (typically at-cost or reduced rate), equity, or a combination of the two. This allows our clients to hit value-creating milestones with far fewer dollars than otherwise possible, while aligning our interests toward reaching commercialization and future manufacturing agreements.
Upon project approval a development agreement is executed, which allows us to put your product through our proprietary product development engine, which we’ve painstakingly developed and refined over the last two decades. This ensures smooth passage through the development process and future regulatory hurdles. Our engineers employ an agile method of product development involving rapid prototyping, close client collaboration, continued iteration and refinement until both parties agree that near-perfection has been achieved.
We know that creating engaging products and user experiences takes a well-rounded, seasoned, and multi-disciplinary team working side-by-side. Our open office development environment enables high levels of communication and interaction, achieving seamless and efficient product development.
Our process, which is in compliance with FDA’s Design Controls, ISO 13485:2016 and ISO 14971, allows us to create and manage Design History Files, while helping our clients create their own quality management systems.
Our product development services culminate in fully developed and validated medical devices. We provide clients full documentation, including design document control, risk management files, design history files, device master records, and quality system guidance documents.
After development, we have in-house regulatory expertise to navigate both FDA and CE mark filings. We work directly with regulatory agencies to get our clients products approved for marketing. Alternatively, we also provide technical support and documentation for client-managed regulatory submission packages.
We can help take your products from small-scale manufacturing to large-scale commercialization to successful exit with major medical device companies. By employing our large network of contacts, we initiate business development activities toward strategic investments, license agreements, or acquisition deals.