Problems We Solve

This is the question for entrepreneurs. The right product will fully address the unmet need, deliver real-world clinical value, have clear stakeholder alignment, and have a viable path to market. Getting an outside viewpoint can highlight gaps in the product profile or possible risks during development. We can assist with product strategy to boost your confidence that you’re building the right product.

Great medical device design hinges on a clear understanding of the unmet clinical need. We assist our clients by analyzing clinical problem areas, conducting clinical observation, and uncovering unmet needs. By translating these insights into clear product requirements and validating early prototypes with users in realistic workflows, we can help clients avoid common development challenges and ensure their product meets the needs of clinical users.

Health technology innovations made in academia don’t always cross the chasm to clinical practice, to the detriment of patients. In the past, university tech transfer offices have been the sole partner in helping labs translate their ideas to startups. We can augment these services to provide guidance, fundraising strategies, and development plans to help transform your idea into a viable startup.

Cross-functional innovation is the magic behind some of the most impactful health technologies. As organizations grow, this can be hard to continue to foster. We can help by facilitating cross-functional brainstorming, guiding early-stage prototyping, and supporting a culture of creative confidence.

A holistic understanding of medical device risks and opportunities is required to thoroughly vet the innovation for strategic investment. A sound recommendation includes evaluation of the clinical need, technology, market, intellectual property, regulatory strategy, reimbursement, and commercialization approach. We have experience collaborating with entrepreneurship programs, incubators, and accelerators to evaluate such opportunities. We offer support in due diligence, risk assessment, and strategy advice.

Combining ideas from different fields can lead to promising innovations (think: digital health!). However, moving beyond the concept stage can be difficult, especially for entrepreneurs new to the regulated healthcare sector. Questions arise like how does verification and validation work, why is recording early usability feedback important, and when is it time to freeze requirements. Our experience with many Silicon Valley medtech startups allows us to share best practices with our clients. We can help you to build a product development roadmap, navigate industry requirements, and create a strategic plan.