April Bright

orthopaedics orthopedic omtec 2016 omtec 2019 fda orthopaedic supply chain management medical devices additive manufacturing oem quality control design 3d printed implants manufacturing product management regulatory research process validation purchasing development quality joint replacement trauma orthopaedic surgeons risk management coatings joint reconstruction contract manufacturer regulations orthopaedic supply chain orthopaedic sector iso 13485:2016 iso 13485 costs regulatory and clinical affairs udi regulatory affairs zimmer biomet operations notified bodies spine surgery ce mark data society of manufacturing engineers fracture healthcare iso audits orthopaedic manufacturers verification orthopaedic device companies computational modeling orthopaedic implant device design arthroplasty supply chain 21 cfr europe surgeon perspective consigned inventory leading healthcare delivery models manufacturing processes implants and instruments mechanical testing design controls quality management systems mdsap buyer/planner udi data quality udi adoption regulatory/clinical affairs materials/commodity management clinical affairs mymobility digital health wearables augmented reality robotics patient specific innovation antimicrobial communication lead times risk simulation logisitics single-use ambulatory surgical center project management engineering iso fracture fixation orthobiologics employee engagement postmarket study nestcc real world evidence spine osma automation factory physics operations science medical device regulation mdr eu european union capa mis minimally invasive surgery process control testing adsurgo statistics qms production biovera strategy standards cdrh depuy synthes sme astm surface modification surface dynamics eurocoating osseointegration musculoskeletal bone extremities titanium peek polyetheretherketone qs regulation gagliardi compliance value-based medicine hospital froimson value volume balance goals strengthsfinder gallup personal development financial management time management life hacks bryan cornwall althausen asc value based implant orthopaedic leaders biomedical powder metals rapid prototyping consumer trends mobile health global regulatory changes product launch technology assessments mergers and aquisitions supply chain consolidation commercialization device reimbursement surgeons implant innovation data-driven design industry shifts proactive reimbursement custom implants custom market regulatory affiars device makers r&d quality coordinating committee device labeling process supply chain models suppliers and service providers regulatory scrutiny orthopaedic device industry models pvd hydroxyapatite titanium plasma coating trends supplier relationship additive manufacturer design for manufacturability dfm machined manufacturing life cycle design engineers molded manufacturers instrument performance disposable instruments clinical reprocessing packaging solutions research/development/design management materials/commodity employee training catastrophic event recovery control processes material quality material identity material consistency quality systems material integrity surgerytrack cost reduction tracking patient information mobile medical apps medical device consumerization am medical devices 3d-printed tissue developement rfq gap analysis supplier partner executive management risk-based decision making systemically-driven problems asia pacific markets timelines global payer requirements resourcing demands patient attrition enrollment delays long-term follow up & staff turnover implementation and clearance research & development lean manufacturing principles juran trilogy built-in-quality product lifecycle maintenance product development vs. product management cross-functional product team effective leader productivity tenured vs. millennial employees performance-based organization outpatient setting less invasive procedures orthopaedic care shifts orthopaedic urgent care centers