Product Pact Program
We partner with entrepreneurs, clinicians, nurses, and hospitals to design and commercialize innovative medical supplies, implants, and instrumentation solutions. We don’t spread ourselves thin with projects that are outside of our expertise. We focus on IP/Tech Transfer and novel product ideas that have the ability to impact the healthcare ecosystem.
Our specialists offer expert assistance at every stage of the product commercialization cycle.
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Product Concept Analysis
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Mission and Vision
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Founder Mentoring
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Capacity Building
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Quality Management System
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FDA Submission
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NIH, SBIR, STTR, and NSF Proposal Writing and Submission
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Non-Conformance and CAPA Management
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Regulatory Compliance
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Regulatory Affairs
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Operational Management
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Manufacturing and Engineering
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Commercialization Plan
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Traditional and Lean Business Plan Development
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Business Strategy
Our Plan
Unmet Critical Need
Increase cost-effectiveness through improvements to existing or new platform technologies.
Regulatory Pathway
Favor products eligible for FDA 510(k) pathway, with or without clinical safety studies, to achieve the quickest path to initial regulatory clearance.
Technology Profile
Focus primarily on single-use products not requiring significant capital equipment with strong intellectual property, low-to-moderate technological complexity and manufacturing costs.
Our Strategy
Initial Commercialization
- Based on product’s unique market profile.
- Rapid, iterative product development based on market feedback.
Accelerate Revenue Growth
- Expand marketing, professional education, and clinical training.
- Leverage sales and marketing power of larger corporate partner, if applicable.
Remain Opportunistic to Maximize Value Creation
- Acquisition/licensing of product by corporate partner
- Utilize independent distribution network to establish traction
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222 E. Witherspoon St
Ste 105 Louisville, KY 40202 -
8007413995