Proception Medical develops product development plans, conducts market research, secures intellectual property, identifies development partners, identifies resource requirements and create budgets, timelines and exit strategies.
Finally, Proception Medical facilitates a sale of the products and any associated rights to a strategic exit partner, or “Strategic.” Typically, a Strategic is an established medical device company with broad marketing and sales capabilities in the product’s intended indication. Throughout the development process, Proception Medical identifies and engages potential Strategics and maintains an ongoing dialogue to ensure that the product offering is well aligned with their marketing and growth strategies, and therefore, are attractive potential addition to their product lines.
Once funding is secured, the product candidates enter development. Proception Medical employs proven, world-class engineering and manufacturing partners for the development and regulatory submission phases. The internal Proception Medical team provides leadership, project management, regulatory and quality assurance oversight. In addition, Proception Medical creates all regulatory, quality control and manufacturing documentation, and obtains marketing clearance from the appropriate regulatory agency.
Following marketing clearance, Proception Medical will conduct beta testing through a limited number of clinical procedures (either through controlled trials or early sales) utilizing the device in its intended setting. These initial trial procedures provide critical “real world use” data that increases product value and assists in the exit process.
Proception Medical utilizes a unique business model focused on identifying innovative, clinically relevant medical device solutions, securing development financing, and obtaining marketing clearance from the appropriate regulatory body. Proception then works to facilitate a sale of the product to a strategic partner, or “Strategic,” typically an established medical device company with broad marketing and sales capabilities.
Proception Medical then secures investors through a newly formed, single purpose limited liability company (LLC) which is financially responsible for completing product development, and later, selling rights to the finished product. Proception Medical co-invests in the LLC through contribution of both its product rights and any product development completed to date.
Proception Medical finds, evaluates and in-licenses products, product concepts or intellectual properties that address established clinical needs, target high growth markets, and can provide a differentiated advantage compared to an existing products or technology. Our team utilizes a robust due diligence process, thoroughly vetting a product or product concept both clinically and technically through a team of experienced executives, clinicians, advisors and technologists. We seek products that fit an identified clinical need, utilizing already available materials and technologies and which may be able to utilize a simplified regulatory clearance process, usually the 510(k) route.