ANTHONY ESPLIN
Add: Pocatello, Idah, USA || Phone: (208) 221-5662 || Mail: toniesplin11@gmail.com || LinkedIn
SUMMARY
Transformational healthcare executive and biomedical engineer with a proven record of building and scaling FDA-regulated medical technology organizations from innovation through commercial success. Combines expertise in corporate leadership, enterprise strategy, product innovation, operational execution, and capital formation to accelerate business performance and create long-term enterprise value. Successfully secured more than $1 million in investment funding while leading cross-functional initiatives spanning regulatory affairs, clinical development, manufacturing, quality systems, and market expansion. Trusted advisor to executive leadership teams on organizational strategy, commercialization, fundraising, and business transformation within highly regulated healthcare environments. Recognized for aligning technical innovation with strategic execution, fostering high-performing partnerships, and delivering sustainable competitive advantage across the medical technology sector.
CORE COMPETENCIES
Corporate Strategy || Executive Leadership || Enterprise Strategy || Business Transformation || Commercial Strategy || Enterprise Growth || Capital Formation || Investor Relations || Board Governance || Product Commercialization || Manufacturing Operations || Regulatory Affairs || Clinical Development || Cross-Functional Leadership || Strategic Partnerships || Organizational Development || Operational Excellence || Risk Management
SKILLS
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Medical Device Commercialization
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Product Development
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FDA Regulatory Affairs
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Clinical Development
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Design Controls
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Quality Management Systems (QMS)
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Manufacturing Operations
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Commercial Strategy
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Go-to-Market Strategy
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Financial Modeling
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Investor Relations
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SolidWorks
EXPERIENCE
SLEEP EASY TECHNOLOGY, INC.
South Bend, United States
Founder & Chief Executive Officer Feb 2021 to Current
Founded and lead a venture-backed, FDA-regulated medical technology company, providing executive leadership across corporate strategy, product innovation, commercialization, regulatory affairs, manufacturing, finance, and organizational development. Drive enterprise-wide initiatives that accelerate commercialization, strengthen operational performance, and position the organization for sustainable growth. Partner with investors, Board stakeholders, and cross-functional leadership to align strategic priorities, optimize capital deployment, and advance long-term business objectives.
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Orchestrated enterprise strategy across engineering, regulatory affairs, manufacturing, commercialization, quality systems, and finance, establishing the operational framework required to transform an innovative concept into a scalable medical technology business.
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Secured more than $1 million in institutional and angel investment by leading valuation strategy, financial modeling, investor engagement, due diligence, financing negotiations, and Board communications, providing the capital necessary to advance product development and commercialization.
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Implemented a phased commercialization strategy that generated early revenue through adjacent product offerings, validated market demand, strengthened brand recognition, and created a sustainable pathway for flagship and next generation medical device commercialization.
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Optimized manufacturing operations by establishing a contract manufacturing network supporting 30+ commercial SKUs across six suppliers, enhancing production readiness through design transfer, inventory planning, quality documentation, first article inspections, and supply chain coordination.
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Cultivated strategic partnerships with healthcare providers, patient advocacy organizations, manufacturers, affiliate networks, and international distributors, expanding market access, strengthening commercialization capabilities, and creating scalable revenue opportunities.
CREATIVE SEWING DESIGNS
Elkhart, United States
Fractional VP – Business Strategy & Commercial Growth Oct 2025 to May 2026
Recruited to accelerate commercial growth and strengthen market competitiveness for a manufacturing organization facing declining customer acquisition and limited revenue expansion. Partnered with executive leadership to develop strategic growth initiatives, expand into new OEM markets, optimize supplier performance, and establish scalable business development processes that improved profitability and positioned the company for long-term growth.
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Spearheaded a targeted OEM growth strategy focused on high-value, recurring manufacturing accounts, repositioning the business for sustainable revenue growth and improved long-term profitability.
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Architected the company's first structured business development framework by implementing strategic account planning, executive relationship management, opportunity prioritization, and proactive customer engagement to strengthen the sales pipeline.
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Expanded the organization's presence into adjacent OEM markets, including marine, hot tubs, and specialty manufacturing, aligning customer acquisition initiatives with existing production capabilities to increase higher-margin business opportunities.
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Cultivated executive relationships with nine manufacturing plants, generating a qualified sales pipeline that exceeded the company's previous annual revenue while doubling B2B revenue within six months.
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Enhanced gross margins by approximately 15% through strategic international sourcing initiatives, supplier optimization, and procurement improvements that increased operational efficiency and supported long-term financial performance.
CYTIVA
Logan, Utah, United States
Scientist, R&D Apr 2019 to Apr 2020
Contributed to research and development initiatives supporting the commercialization of bioprocessing technologies within a regulated life sciences environment. Partnered with cross-functional teams to strengthen material qualification, supplier strategy, and product development while improving supply chain resilience and supporting business continuity during critical sourcing challenges.
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Championed a strategic material characterization initiative during a global amino acid supply shortage by developing analytical methodologies and supplier qualification processes that diversified sourcing options and strengthened supply chain continuity.
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Designed comprehensive supplier characterization databases that enabled data-driven sourcing decisions, streamlined supplier qualification activities, and enhanced long-term management of critical bioprocess materials.
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Collaborated with multidisciplinary research, engineering, and quality teams to support material evaluation, technical analysis, and product development initiatives, contributing to operational efficiency and informed decision-making across R&D programs.
BECTON DICKINSON – BARD ACCESS SYSTEMS
Salt Lake City, Utah, United States
R&D Engineering Intern Mar 2018 to Apr 2019
Supported research and development initiatives for implantable vascular access devices within a global medical technology organization. Contributed to product innovation, biomaterials evaluation, and engineering validation efforts while collaborating with cross-functional teams to advance next-generation medical device development and strengthen customer-focused product design.
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Generated six invention disclosures within the first six months, contributing innovative concepts that expanded the organization's medical device intellectual property portfolio and strengthened the product innovation pipeline.
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Assessed next-generation biomaterials for implantable vascular access ports, providing technical insights that supported device miniaturization, product performance, and future research and development initiatives.
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Engineered clinician simulation procedures that enhanced engineering teams' understanding of real-world clinical workflows, enabling more user-centered product development and informed design decisions.
MEDICAL TECHNOLOGY VENTURES
United States
Strategic Advisor
Advise founders and executive leadership teams across early-stage medical technology ventures, providing strategic guidance on commercialization, regulatory strategy, clinical development, fundraising, manufacturing, and market expansion. Partner with organizations to strengthen operational execution, accelerate product commercialization, and align business strategy with long-term growth objectives within highly regulated healthcare environments.
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Guided founders and executive teams through corporate strategy, FDA regulatory pathways, commercialization planning, clinical evidence generation, manufacturing strategy, fundraising initiatives, and market entry, strengthening organizational readiness for growth and investment.
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Applied proven regulatory, clinical, and commercialization frameworks to streamline execution, reduce development risk, enhance cross-functional decision-making, and improve the efficiency of product development and commercialization efforts.
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Influenced the advancement of four medical technology companies by providing strategic counsel that supported fundraising, clinical study execution, regulatory planning, strategic partnership development, and key commercialization milestones.
EDUCATION AND TRAINING
MASTER OF SCIENCE: ENGINEERING, SCIENCE, TECHNOLOGY, ENTREPRENEURSHIP May 2021
University of Notre Dame, Notre Dame, Indiana, United States
BACHELOR OF SCIENCE: BIOMEDICAL ENGINEERING (MINOR: CHEMISTRY) May 2019
University of Utah, Salt Lake City, Utah, United States
LEADERSHIP & COMMUNITY ENGAGEMENT
Religious Mission | Manila, Philippines
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Provided leadership, mentorship, and coaching to volunteers while coordinating operations across multiple geographic regions.
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Directed the activities of 40+ volunteers, fostering collaboration, accountability, and leadership development within a multicultural environment.
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Strengthened communication, relationship-building, and organizational effectiveness by mentoring individuals from diverse backgrounds and supporting team performance in a mission-driven setting.