Dean H. Stanton · Selected Work
Large-Scale Medical Product Development & Launch Program
Cross-functional medical-device product realization spanning opportunity identification, design, testing, risk, reimbursement and regulatory considerations, product data, sourcing, manufacturing transfer, training, labeling, and commercialization.
Results
Results and contributions.
01
Situation
Operating context
A growing orthopedic medical-device business needed a repeatable way to turn clinician, customer, sales, partner, complaint, reimbursement, regulatory, material, and portfolio inputs into products that could be manufactured and commercialized reliably.
02
Challenge
What made the work difficult
Product development had to connect design work to quality, supply chain, product data, manufacturing transfer, training, labeling, and commercial launch across a large portfolio.
03
Dean's role
Responsibility and authority
Dean led the cross-functional product-development and commercialization system across evolving engineering, operations, and executive roles. He connected opportunity identification and design to testing, validation, risk, product data, sourcing, manufacturing transfer, training, labeling, and launch.
04
Actions
How the work moved forward
- Established and governed an end-to-end product-realization workflow from opportunity identification through manufacturing and commercial launch.
- Integrated design, prototype, testing, validation, risk, reimbursement and regulatory considerations with product-data and manufacturing requirements.
- Coordinated PDM, BOMs, routings, materials, sourcing, obsolete-inventory review, production cut-in, work instructions, training, labeling, catalog, website, and commercial communications.
- Managed product realization as a cross-functional operating process rather than an isolated engineering activity.