Scott Youmans Email & Phone Number

London, England, GB

Seattle, Washington, US

Consulting services for Class II and III Device and combination product development. Supply chain development and management, commercial launch, and technical operations related to medical device, combination product and pharmaceutical products.

Seattle, Washington, US

• Leads Technical Operations for Impel’s lead asset, Trudhesa, establishing and scaling the global combination product manufacturing and supply chain, administering a $15 million operating budget, aligning business.
• Directs complex supply chain operations and manufacturing across 13 international and domestic suppliers, overseeing the product’s co-packaging, DSCSA compliant serialization, drug fill and finish, device assembly.
• Precision management of supply for the Trudhesa combination product, which has a 12-month shelf-life, with minimal expiry and no product shortages to date.
• Led the delivery of commercial product in channel within nine days of the assigned PDUFA date.
• Partners with suppliers to ensure an overall A (>95%) score across the global supply chain with respect to on time delivery, in full delivery, and component quality.

Seattle, Washington, US

• Led the company’s novel POD product development that delivered first-pass NDA approval 4 days ahead of the assigned PDUFA date, during COVID.
• Guided development and clinical manufacture and distribution providing business critical pivotal clinical results ahead of schedule, completing a 17-month timeline in just 13 months—resulting in the successful.
• Led the execution of stock recovery during a Phase III pivotal study, ensuring adequate supplies to all enrolled patients further enabling completion of the clinical study without timeline impacting shortages.
• Worked directly with device and drug suppliers to resolve key manufacturing issues during development ensuring robust post PDUFA supply with zero commercial rejected lots to date.
• Authored and guided significant sections of the NDA submission relating to design controls, product functionality, statistical justification, change management, sample size, and the pharmaceutical development report.
• Presented technology specifics of the novel drug delivery system to FDA.

Seattle, WA, US

• Led thirty-two employees across sales, marketing, engineering, project management, R&D, operations, and quality—providing strategic direction and vision, communicating corporate priorities, and ensuring a productive.
• Established the global supply chain and guided the development and distribution of class II medical devices, combination products, and drug products with commercial and clinical manufacturing in both the US and China.
• Rapidly implemented a new product (including injection mold tooling) based on an existing, company owned 510k approved design leveraging the virtual supply chain to achieve product to market within 120 days of program.
• Implemented process improvements and solved quality issues through design and instilling proper functional test methods. Dramatically reduced device defect rate by 50% resulting in the design demonstrating a 99.7%.

• Led multiple development projects, design verification, and validation activities that resulted in the clearance of sixteen 510k special FDA clearances within 5 years, significantly expanding the company's product.
• Developed the system definition, engineering, and integration of the electro-mechanical Jetstream™ peripheral vascular atherectomy system—establishing operational guidelines, performance specifications, and.
• Established and managed core supply chain for clinical stage product and responsible for in-house clinical stage manufacture of disposable product and consoles for 150 patient definitive EU clinical trial.
• Collaborated with cross-functional leaders throughout the organization to establish long-term strategic roadmaps, facilitate the flow of clinical feedback to R&D teams, and drive exceptional success in securing FDA.
• Led the platform expansion and the iterative development and improvement of the Jetstream™ atherectomy technology from a complaint rate of 11.3% (MDR rate 4.2%) in 2008 to a 2.3% (MDR rate 0.04%) complaint rate in.
• Led a team of 30 across R&D, engineering, manufacturing, manufacturing engineering, quality assurance, quality control, documentation, and regulatory affairs.

A-Med was founded to improve beating heart surgery through innovative medical devices. The Paraflow™ system was commercialized in 2000.Engaged in multiple roles simultaneously to develop new products and support in-house injection molding and tooling of commercial products for cost effective manufacture.

Marlborough, MA, US

Heart Technology, the creator of the Rotablator™ rotational angioplasty system, acquired by Boston Scientific in 1995.Managed the injection molding operation and provided injection molding tooling and tooling expertise for highly technical precision injection molded parts. Led the development of the T-REX biopsy forceps product to fruition, a mission.

Oxford, CT, US

PTA, privately owned, specialized in rapidly developed injection molded parts to very tight timelines using QC7 aluminum tooling for fortune 500 companies.Provided a business service to all three PTA locations by performed all Moldflow filling simulations for designated tooling. Provided technical expertise to manufacturing toward the goal of cost.

Spokane Valley, WA, US

KeyTronic at the time, was the largest vertically integrated keyboard manufacturer in the United States. KeyTronic molded over 275M component parts annually at this time frame and produced ~1.5M keyboards for the largest PC manufacturers of the time.Performed all Moldflow filling simulations for the 125 machine injection molding environment ranging from.

Bachelor Of Science - Bs, Manufacturing Technology, Design, Plastics Part Manufacture And Design

Credential Of Readiness, Market Analysis, Economics For Managers, Financial Accouting