From concept to clearance…

We lead, support, or supplement your product development effort at all stages of the product lifecycle— we integrate seamlessly with your team to help make your products come to life.

Strategy + Feasibility

Medical device development is complex, and it can be daunting to know how and where to begin. Our strategy and feasibility services provide a clear roadmap for your project, identifying challenges and opportunities early on to streamline the development process.

Setting A Clear Trajectory for Success in Device Development

  • Regulatory strategy & product classification assessment

  • Product Development roadmap and budgeting

  • proof-of-concept prototyping

  • Technical feasibility assessments

  • Risk management and mitigation strategies

  • SBIR submission support

  • Ad-hoc advising

FREQUENTLY ASKED QUESTIONS

  • Great! We are the experts in the process of navigating medical device development from the earliest stages— even if it is only an idea. We can provide direction and advice on funding, patents, prototyping, and development, and can give realistic expectations on the time and cost to bring a device to commercial launch.

  • We consider all aspects of development, including design, prototyping, testing, regulatory submissions, and market launch, alongside timelines and cost estimates to provide a comprehensive roadmap and budget.

  • Proof-of-concept prototyping is crucial for validating the fundamental functionality and feasibility of your device concept, allowing for early identification of potential issues and opportunities for innovation. Proof-of-concept testing can also establish the clinical merit and potential patient benefit of your device.

  • We provide startups with comprehensive support, from ideation and prototyping to navigating regulatory pathways, tailored to accelerate their journey to market.