Will Clifton, Md Email and Phone Number

Polyvascular is developing a polymeric, percutaneous heart valve to reduce surgeries for kids with congenital heart disease. During my time at PolyVascular, I served as Principal Investigator for a $2.5M Phase II NIH SBIR grant, designing a biomimetic, manufacturable valve, building a team of exceptional engineers, establishing manufacturing and clean room facilities, leading clinical and regulatory strategy, and directing operations and board meetings.Since 2014, Polyvascular has led the effort to improve children's lives with non-surgical heart valves. Our valves are affordable to manufacture in pediatric and adult sizes, expand to accommodate growth of children, and reduce the need for repeat open-heart surgeries.

Clinical Trial Design, Strategic Marketing, Market Surveillance, Regulatory Strategy, QMS Implementation, Pre-clinical testing strategy

Enventure is a Houston-based nonprofit with programs designed to support life science innovators at every stage of the process, from needs finding, to business model development, to clinical strategy, and beyond. In doing so, we also provide our pool of advanced degree candidates with hands-on experience and opportunities to build professional networks in life science industries.

Develop and teach TMC Biodesign program. Advise Biodesign teams through weekly meetings. Serve on TMC Biodesign Steering Committee.

At Rice, I grew the Medical Innovation program through collaborations at Rice (Bioengineering, Jones Graduate School of Business), throughout Houston (Baylor College of Medicine and the TMC), and globally. Our unique focus was on the global future of medical innovation, where the city of Houston, with its prolific medical research community and diverse culture, is a natural home.Responsibilities:• Oversee the Medical Innovation professional master's program. http://innovation.rice.edu/ • Oversee a summer internship experience for the med innovation students in Costa Rica, involving collaboration with local universities and clinicians to develop design projects as well as an industry internship at a global medical device company• Serve as an industry liaison for undergraduate and graduate students to promote internship and career opportunities• Build on renowned medical innovation offerings, providing education and resources to promote graduate's success in medical innovation fields

Procyrion is developing Aortix, a tiny heart pump for the treatment of heart failure. More than 1M patients are hospitalized for heart failure each year in the US. For these patients, drugs are no longer working, and it's too early for something as risky and invasive as a transplant. Aortix is designed to be a safe, simple solution to unload the heart and improve kidney function.• Clinical Trial Design- Design multi-continent clinical pilot study for class III medical device• Clinical Strategy- Develop and maintain relationships with 15+ key opinion leaders and clinical investigators, serve as medical expert to internal and external inquiries, communicate strategy to BOD and potential investors• Strategic Marketing- Explore potential patient populations for the Aortix device based on Aortix data and disease pathophysiology, identify treatment gaps and patient needs, develop cost-effectiveness model, evaluate market size of indications and geographies• Market Surveillance- Monitor heart failure technologies, conference presentations, clinical trial results, regulatory approvals, and gather physician feedback• Project Management- Develop and track to $4M budget and timeline for clinical operations

• Designed and executed a First-In-Human Clinical Study including site selection and setup, writing investigational plan, brochure, consent, and protocol, ensuring compliance with regulatory requirements and Procyrion procedures• Developed Clinical and Regulatory strategy and communicated to BOD and potential investors• Performed clinical data analysis, presentation, and authored manuscript• Communicated and presented clinical results internally, to BOD, potential investors, and at conferences• Developed clinical training protocols and proctored clinical cases• Performed market surveillance activities to inform company and BOD of heart failure landscape

• Developed and executed product development and clinical strategies• Built product development timeline and budget• Managed over 30 large animal studies including GLP studies• Managed relationships with all contractors / vendors• Comprehensive review of FDA and international regulatory standards and guidance to develop product specifications, implement design controls, and perform risk analysis within an ISO 14971 and ISO 13485 quality and risk management system

• Design and build early Aortix pump designs, delivery systems, and electronics prototypes• Developed clinical strategy case for cardiorenal syndrome that is now the go to market indication• Wrote and submitted SBIR grants• Coordinated senior design and internship programs

Received grant funding from HHMI to study the mechanisms of noise induced hearing loss and develop the next generation of cochlear implants to treat hearing loss.

Research and development of Sencil, a fiberoptic, percutaneous, minimally invasive, glucose sensing device.