Adrian Healy

Collaborated with a contract manufacturer on the design, develop, manufacture, inspect, and test a multi-sheath catheter assembly for implant delivery. • Guided the project from concept to validation using catheter manufacturing expertise. • Critically assessed manufacturer proposals and generated specifications, manufacturing, inspection, and risk documentation. • Provided on-line support and problem-solving for design verification and clinical trial builds. Led and executed a process improvement project for catheter sub-assembly, achieving a 30% increase in yield and a 50% reduction in cycle time. • Conducted and documented bench-top testing to evaluate potential improvements. • Presented project results to an internal cross-functional team for review.

Successfully transferred project from engineering environment to operations. Created and released Part numbers, Routers, Bill of Material, Material specifications, Manufacturing and Inspection procedures, Visual standards, Purchase orders, Deviations, Equipment calibration, Machine maintenance. Undertook training personnel in sister site on Enterprise Quality Management Software. Allowing Router, Bill of material and Documentation updates to be outsourced freeing up engineering hours. Completed validation activities such as, OP/PQ reports, Equipment Installation and Operation Qualifications, Validation checklists, Validation assessments. Generated project yield trackers and pareto analysis charts through router reviews to identify reject sources and targeted areas for process improvement. Generated a process development plan from yield trackers and pareto analysis charts to outline process development tasks and timelines to complete tasks. Key failure causing processes and parameters were identified and resolved on braiding, reflowing and welding processes through A3 problem solving, DOE and characterisation studies. Designed fixturing for cutting, welding and gluing processes improvements to reduce reject numbers improve process ergonomics

Designed patented process for incorporation of temperature sensors into hot ablation balloon system. Designed flexible hypotube cut patterns for high load bearing steerable introducer sheaths, pushable kink resistant braided catheter inners for compliant balloon shape conformance, steerable braided multiple durometer catheters from navigating tortuous anatomy. Developed tipping process to prevent delamination of the liner at the tip of the device. Worked on all components of device design from conception to design verification of minimally invasive devices and access devices systems including: Steerable delivery catheters, Ablation Catheter with temperature sensors and Neurovascular catheters. Developed knowledge in catheter manufacturing processes such as, braiding, braid termination, skiving, reflow, coiling, laser welding, laser cutting, electronics and handle integration. Created documentation for Design Failure Mode and Effects Analysis, Design verification test methods, Gage R&R protocols & reports, Device verification, Real Time and Accelerated Aging protocols. Completed test method Gage R&R, Design Verification, Real Time & Accelerated Aging testing. Successfully completed design inputs and outputs reviews with customers. Liaising with customers to provide accurate quotations for work as well as optimising product design through each build.

Work experience included the development of frictional test methodology to accurately predict product frictional performance in comparison to existing materials. Standardising of material test methods, including test method validation to ensure confidence in results. Training of new personnel on the documented test method. Skills developed included communication, scheduling, analysing and problem-solving test set-up variation. Also developed an understanding for the need for, and the requirement to conform to, quality standards.

Work experience included collaborating on the development of new catheters for R&D and PD, including various quality standard tests to assess the catheters viability and performance. Installing & commissioning a new tube stretcher for balloon catheter moulding involving IQ, OQ and PQ validation to ensure the tube stretcher could meet production requirements. Calibrating equipment and performing preventative maintenance. Performing a Lean Assessment of a production line. Skills developed included problem solving, teamwork, and the use of solid works. Also achieved an understanding of establishing equipment parameters to optimize capability for commercial production and how to assess new equipment from a quality perspective for faults and performance. Understand the usefulness of lean as a tool to increase product outputs and reduce cycle times.

Work experience included analysing line production data from previous years for various different lines and plotting data on excel for comparison purposes. This helped develop Excel skills and the importance of making data easy to interpret and understand. Using 5S methodologies to standardise the production environment, updating charts and carrying out inventory checks of cells. Also supported the development of a new clean room during free time. Skills developed included problem solving skills to resolve issue regarding the potential contamination of shipping mandrels, which helped eliminate waste and improved yields. Mapping out floor area for equipment placement in the clean room to optimise process flow to reduce cycle times.

Work experience included operating a sand-blaster to remove coating on mandrels before new coating could be applied. Preparing mandrels for coating by cleaning, drying and preparing coating mixture. Removing excess coating material from machinery before next batch and preforming performance checks on machinery. Skills developed included understanding the importance of following procedures to standardise actions to reduce the number of product defects.

Won the Aerogen sponsored ‘Best Thesis’ 2017 The area selected was transportation of neonates who suffered from birth asphyxia as most of these patients require treatment at specialised centres Identified an opportunity in the market for the use of Therapeutic Hypothermia as a treatment option. This included investigation of the current use of the treatment (cardiac arrest patients and neonates who suffered birth asphyxia) and brainstorming to identify new market areas. This opportunity was then developed into a product that could be released to the market using brainstorming tools and filtering matrices. The project plan establishing the product development and commercialisation requirements, including a full patent and regulatory pathway, was then developed. The project was reviewed by a process of weekly presentations.