All products should delight. We meld the design thinking of consumer products with the rigour of medical device development. We consider all stakeholders when designing a product, balancing requirements of go-to-market cost, reimbursement, product architecture, and regulatory strategy/requirements. Our depth of in-house product development experience is supported by a trusted network of advisors who help clarify go-to-market challenges of medical devices.
NextBringing a new medical device to market is the opposite of user-centered design. We questioned the status quo and built a proprietary ISO 13485 Quality Management System that accelerates medical device time to market. Conceptual design drives requirements in early project stages, then requirements drive engineering, prototyping and testing as the product is fully commercialized. This flexibility allows us to uncover novel solutions in early product phases and brings formality to build all design control documentation required for market submission.
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A new medical device is more than just a new product, it’s also testing & documentation that proves to regulatory bodies that the device has been verified and validated, meets user needs and provides safe and effective treatment. As we develop your device, we build the required Design History File, or DHF, that is critical to your product’s successful market authorization.
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