Jose Fernandez Email & Phone Number

Raleigh, North Carolina, Us

Raleigh, North Carolina, Us

Foxborough, Massachusetts, Us

Banyan Biomedical exists to advice and support medical device companies in the following areas:-All Stages of Product Development and Commercialization-Medical Device Product Conceptualization and Design-Quality Remediation and Regulatory Compliance-Due Diligence, M&A, and Integration-Technology TransfersBanyan Biomedical brings over 25 years of experience with medical devices across all classes and spanning a diverse range of indications.

Milano, Italia, It

DESCRIPTION: Recruited to lead the development of a novel delivery system for the Saturn Mitral Valve. Company is a pre-commercial stage firm specializing in the structural heart / interventional cardiology space primarily focused in the replacement of the mitral valve through a trans-catheter approach.—Recruited and hired engineering team to support trans-septal catheter delivery system development—Established infrastructure to conduct pilot manufacturing and evaluation of system components—Terminated poor-performing vendors and re-created entire supply chain to improve performance—Directing activities from concept through commercialization—Reduced kit costs by 60%—Conceptualized and developed tools for work within the structural heart space—Completed a full redesign of the system, achieved feasibility, and reached all milestones within commitments made to the business

Nashville, Tn, Us

DESCRIPTION: Promoted into this challenging role, I lead R&D while overseeing worldwide quality and regulatory compliance after the divestiture from Symmetry Medical and spinoff as a separate public company. I was tasked with applying broad technical and engineering expertise to build a Research and Development Group while correcting internal compliance, customer, and integration issues involving 30,000 products.Scope: Global Oversight | Reported to CEO--> ESTABLISHED A NEW R&D ORGANIZATION COMPLETE WITH NEW DESIGN CONTROL SYSTEMS AND PROCEDURES WHILE TRANSFORMING / IMPROVING QUALITY AND REGULATORY COMPLIANCE.DELIVERED RESULTS:► Led acquisition-related due diligence in R&D, regulatory compliance, and quality assurance.► Delivered 75% of new products within 2 weeks of their original commitment or earlier, increasing availability of existing product portfolio in new countries, resulting in CE markings on 8,000 products.► Promoted a disciplined environment for product commercialization within budgets while maintaining flat costs YOY.► Eliminated ~$1M annual costs to offset inflation and vendor price increases.► Reduced complaints from a backlog of open complaints >1.5 years to all complaints closed within average of 60 days.

Warsaw, In, Us

DESCRIPTION: I was recruited due to my astute expertise in developing devices for various clinical specialties to expand growth beyond orthopedic roots with commercialization. I piloted conceptualization, development, and commercialization of medical instrumentation and devices.Scope: Global Oversight | Reported to CEO--> CREATED A NEW PRODUCT DEVELOPMENT DEPARTMENT TO CREATE PROPRIETARY PRODUCTS SOLD TO OEM CUSTOMERS AND HOSPITALS. --> DOUBLED REVENUE FROM PROPRIETARY PRODUCTS.--> ESTABLISHED FOUR PRODUCT DEVELOPMENT FACILITIES IN THE US, ENGLAND, AND MALAYSIA.DELIVERED RESULTS:► Launched 5 times more products at Year 2’s end than in previous 5 years combined.► Accelerated average number of patents filed annually to 4 times the average number filed in each of previous 3 years.► Integrated quality staff to professional-level R&D Group to monitor compliance. Established centers of excellence for sports medicine and joint reconstruction.► Established Project Management systems and Design Control procedures in order to conduct New Product Development.

DESCRIPTION: As a result of my extensive mechanical / orthopedic device design experience, I was recruited to manage complex projects and execute commitments. Initially hired as Director of R&D, reporting to the VP of R&D, I was then promoted to Senior VP to oversee product commercialization after only 2 months. As a technical leader, I was able to turn-around a non-performing organization and restructured most of the operational company functions that allowed the company to begin clinical work 9 months later.Scope: ~7 Direct Reports | $2M Engineering Budget | Reported to CEO--> PIONEERED POSTERIORLY IMPLANTABLE LUMBAR DISC. --> FURTHERED TESTING AND PRODUCT IMPLANTATION WHILE DECREASING MANUFACTURING COSTS BY OVER 50%.DELIVERED RESULTS:► Spearheaded clinical use of the World’s First Posteriorly Implantable Lumbar Disc in 8 months.► Enabled physicians to perform several types of procedures using a single set of instruments and surgical approach by coordinating surgical instrumentation design and development. ► Reduced cost of goods sold (COGS) by over 50%.► Sustained a track record of no surgical complications or adverse events reported in any of clinical cases completed.► Turned around non-performing R&D organization and created the operational infrastructure in the company that allowed us to receive CE mark and distribute our products to support clinical cases in Europe within 9 months.

Irvine, California, Us

DESCRIPTION: In this role, I was recruited to commercialize the product and resolve gaps in product development and team performance. I conducted extensive physician and commercial team training globally and provided marketing and multi-project support. As part of the launch, I accommodated 100+ clinical cases.Scope: ~25 Direct Reports | $15M Direct Budget | Reported to Director, New Product Development--> COMMERCIALIZED THE WORLD’S FIRST RECAPTURABLE, SELF-EXPANDING INTRACRANIAL STENT WITHIN 18 MONTHS. DELIVERED RESULTS:► Helped treat 80,000 patients worldwide who could not be treated with existing methods.► Conducted training around the globe for the sales force and physician on the device benefits and technical performance.► Created a disciplined approach to product development that focused on achieving commitments and focusing on regulatory compliance. This allowed the teams to host and pass 6 different audits by JNJ's Corporate Regulatory Compliance in the span of one year that yielded no observations.► Earned Team Excellence Award due to facilitating stellar group performance after turning around what had previously been a poor performing team.

DESCRIPTION: I was recruited to manage development of novel coronary and peripheral stent platforms. This role involved establishing virtual companies including outside vendors, consultants, and contract testing facilities in US, Latin America, and Europe as well as deploying solid testing and regulatory strategies.Scope: $1M Budget | Reported to Vice President, R&D--> PILOTED AND EXECUTED PROJECTS, CREATING EXTERNAL INFRASTRUCTURE TO HELP DEVELOP AND COMMERCIALIZE PRODUCTS, WHILE SUPPORTING DUE DILIGENCE ACTIVITIES BY SEVERAL LARGE GLOBAL HEALTHCARE COMPANIES. DELIVERED RESULTS:► Improved consistency and manufacturability by 60% – from ~25% to 90%+ yield improvements – fueling an overall reduction in cost of goods sold by 80%.► Salvaged 1 year’s product development time.► Facilitated due diligence activities by numerous large global healthcare companies seeking to acquire technology while garnering technology licensing to a third party that acquired technology at early stages.

Miami Lakes, Fl, Us

DESCRIPTION: I was recruited to commercialize a stent for treatment of carotid artery disease, undergoing clinical trials and global commercialization.Scope: ~8 Direct Reports | $6M Budget | Reported to Director, New Product Development --> AWARDED JOHNSON & JOHNSON STANDARDS OF LEADERSHIP AWARD FOR DRIVING EXCEPTIONAL BUSINESS RESULTS.DELIVERED RESULTS:► Project Manager for teams that conducted the development and commercialized the PRECISE OTW and PRECISE RX Stent Delivery System.► Conceptualized and developed a deployment system that delivered stent more accurately with lower deployment forces and greatly simplified device assembly. ► Decreased costs by up to 20% over pre-existing technologies.

Gainesville, Fl, Us

DESCRIPTION: As Project Manager, I led a multi-functional team in product development and launch of innovative revision Hip Replacement System, providing physicians with 53,000 different combination options. DELIVERED RESULTS:► Led product development teams that successfully launched 6 new joint replacement implant systems that included the ability for a physician to implant four different types of femoral hip implants using the same instrumentation. The increased simplicity, provided the surgeons more flexibility, and reduced surgical instrument capital expenditures by 50%.► Inventor in patent on modular tapered connections (US Patent 6,319,286). Technology resulted in significant tapered connection resistance to torsion and a magnitude decrease in metallic debris wear over competitive systems.► Developed proprietary titanium material, increasing implant fatigue endurance limit by 20%.► Designed and implemented the company's CRM and Document control system which facilitated company-wide access to product, vendor, sales representatives, and customer information.

Washington, Dc, Us

► Finished in the top 2% of my class at both Naval Nuclear Power School and Nuclear Prototype Training Unit.► Selected for the Navy's Broadened Opportunity for Officer Selection and Training program and earned an ROTC Scholarship to the University of Florida.► Stationed in Orlando FL, Windsor CT, and San Diego CA.► Served as a Midshipman on the USS Helena (SSN 725), a nuclear-powered Los Angeles Class fast-attack submarine based in Pearl Harbor Hawaii.

Bsme, Mechanical Engineer

Education record