HOW IT WORKS
Let Us Help You Propel Your Medical Device to Market Success
What sets us apart is our commitment to expertise, acceleration, and flexibility. We collaborate within almost any budget, delivering comprehensive solutions in a singular engagement without compromising expertise, compliance and financial viability.
Our services are tailored to address your unique needs, and we work within almost any budget.
Step 1 is a Free Discovery Call
Needs Assessment
- A thorough review of clients current state and where they would like to accomplish
- Client receives an overview that lays out the high level strategy (scope, time, budget) to make a definite decision on path forward
- Takes 1-2 weeks (end of project)
Strategy Development
- Step 1 is our free discovery call
- Project initiation
- Research & Analysis: collect necessary documents, stakeholder interviews, analyze client current state and refine the scope and path forward
- Strategic Planning: Develop a customized strategy for market access and market adoption, considering clinical and regulatory pathways and market entry strategies.
- Deliverable Meeting: Comprehensive roadmap and project execution plan inclusive of budget, time, resources. Strategy Plans are ready for implementation (end of project)
Implementation
- Program/project Management
- FDA submission and negotiations
- Clinical study development and trial management
Frequently Asked Questions
Yes, we welcome speaking to potential clients! Contact us to schedule a free discovery call or fill out the contact form to schedule a chat.
Our medical device specialty families are implantables, robotics, IVDs, catheters, and enabling technologies.
Our biopharma specialties are small molecules, injections, and NSAIDs.
Every company is different, so we prefer to discuss your goals and tailor a proposal (fee) that fits you.
Absolutely! Our clinical consultants hold ACRP-CP® certifications. Our project managers hold PMP® certifications. We also have strong leadership and industry acumen powered by business and scientific degrees.
We work with startups, emerging and large companies.
We work closely with biotech entrepreneurs on strategic planning, road mapping, SME advisory, and building out functional departments.
We have over a decade of experience working with top Fortune 500 biotech companies.
We respond within 48 hours.
