PAVmed’s Unique Proven Business Model.
Our proven business model is intensely focused on capital efficiency and speed to market. Through careful project selections and well honed business processes, we are able to advance products from concept to commercialization faster and with far less capital than typical medical device companies. Our multi-product strategy, specialty call point, enhances value creation through risk mitigation, economies of scale and more versatile utilization of capital.
Rapid and Cost-Effective Path to Regulatory Clearance
We believe medical devices have the potential to move from concept to commercialization much more rapidly and with significantly less capital investment, however, most medical device companies are not structurally or operationally equipped to fulfill this potential. Our business model has allowed us to significantly surpass these industry benchmarks.
*Typical Company data from Markower, et al. FDA Impact on US Medical Technology Innovation 2010
A critical component to our success has been our regulatory strategy, which focuses on identifying the narrowest and most efficient path to initial clearance.
KEY BUSINESS PROCESSES DRIVE CAPITAL AND TIME EFFICIENCY
Our model incorporates key business processes which leverages external resources allowing us to operate as a larger organization while maintaining a smaller and more efficient corporate footprint.
Commercially-Driven Project Selection
Heavy emphasis on products with high margins and high impact in attractive markets without regard to target speciality or clinical area.
Unmet Critical Need
Reduce invasiveness, shift care to lower cost venues, decrease complications, accelerate recovery, increase cost effectiveness through improvements to existing or new platform technologies.
Primarily single use interventional products not requiring significant capital equipment with strong intellectual property, low-to-moderate technological complexity and manufacturing costs.
Favor products eligible for FDA 510(k) pathway, with or without clinical safety studies, to achieve quickest path to initial regulatory clearance. Expand indications and clinical applications based on real-world clinical use.
Favor products with existing reimbursement codes or the opportunity to seek reimbursement under existing codes for higher-value surgical procedures.
FLEXIBLE COMMERCIALIZATION STRATEGY ACCELERATES VALUE CREATION
Flexibility to self-commercialize or partner with larger strategic entities. Tailor a commercialization pathway for each product which maximizes value creation while avoiding or deferring fixed costs associated with the premature establishment of a broad and expensive direct salesforce.
- Based on product’s unique market profile.
- Rapid, iterative product development based on market feedback.
Accelerate Revenue Growth
- Expand marketing and professional education.
- Leverage sales and marketing power of larger corporate partner, if available.
Remain Opportunistic to Maximize Value Creation
- Acquisition/licensing of product by corporate partner
- Build direct sales force