以商业为重点的QARA解决方案在全球医疗技术中的价值

The Value of CommerciallyFocused QARA Solutions inGlobal MedTech How MedTech leaders go to market, grow in market, andstay in market Table of contents Executive summary1Market context and imperatives3The three structural challenges4Why commercially focused QARA wins7A Target operating model for digitized QARA8Pragmatic AI: Where it works now9Regulatory and governance considerations for AI12Change management and risk mitigation13Conclusion14About the author14 Executive summary There has never been a time when the innovation and commercialization ofglobal MedTech solutions have been more dynamic, more demanding and morecomplex. Accelerated innovation from new materials and technologies, theadvance and divergence of global regulations and standards, and commercialpressures to deliver shareholder value collide with heightened public awarenessof what constitutes a high quality, safe and effective device. A key differentiatorfor companies that successfully navigate this environment of complex drivers isthe maturity and agility of their Quality Assurance and Regulatory Affairs (QARA)professional function. Their ability to achieve right-first-time execution acrossdesign and development, product submission and registration, manufacturingand supplier quality, and post-market surveillance positions QARA as a truemarket access enabler. This paper, created from a live presentation duringIQVIA’s October 2025 Fusion Conference in Florida,presents a pragmatic, commercially focused blueprintwith key points for consideration when digitizing andharmonizing QARA solutions to accelerate patientaccess, improve commercial performance, and enhanceproduct quality. It outlines the primary challenges in theexisting environment (i.e. country regulatory divergence,product-specific standards, and elongated globalregistration timelines), shows how to convert QARAexcellence into a value driver for top-line growth, anddetails roadmap principles for AI-enabled workflows thatcan be deployed in a range of QMS and RIM processes. The approach aligns commercial, quality, regulatory,clinical, and supply chain around a shared set ofoutcomes and KPIs, ensuring organizations not only goto market with improved speed and predictability butalso maintain market access through ensuring continuedcompliance to an ever evolving global landscape.Ultimately this pulls through into how QARA solutionsenable an organization to deliver a dual focus on patientsafety and commercial performance. Driving harmonized, digitized QARA processes and systems Unlock potential through optimisation of professional activities, while driving global compliance THE PROBLEM STATEMENT: MedTech, including IVD, strives for global market access frameworks t hat are: 1. Aligned to commercial and strategic objectives2.Efficient, timely, and repeatable3.Effective in adapting to global compliance process variations Market context and imperatives Global Medtech markets are progressively challenging Optimizing innovation pipeline, commercial activities and operational efficiencies are critical Operationalefficiencies innovation can play a critical role, not only in productregistration activities, but in customs and importationand reimbursement activities that are necessary in arange of countries The global environment that QARA teams need tonavigate to provide MedTech solutions to global marketscontinues to evolve across a four key fronts: • Innovation velocity: Adoption of software as aMedical Device (SaMD), Software-in-a-Medical Device(SiMD), new Artificial Intelligence (AI) and MachineLearning (ML) capabilities, and the advancements ofmaterial science are accelerating product innovation.Commercialization of such solutions must keep pacewithout compromising safety or compliance and QARAplay a key role in ensuring the development of suchsolutions is both safe and effective • Regulatory complexity: Divergence in regulationsand standards continues to evolve. Requirements inhealthcare ‘vertical’ regulations need to interplay withbroader ‘horizontal’ regulations For example, in Europealone the requirements of the EU MDR and IVDRverticals can interplay with the horizontals of the EUAI Act, EU GDPR and environmental regulations suchas the EU WEEE, REACH, RoHS and Waste Packagingacts are some of many. Globally, requirements arebroader than those in the U.S. and EU with countriessuch as China and Russia in many cases requiringlocal technical, toxicological and clinical studies, • Global market access and commercial performance:Evidence-led HCP adoption is critical to acceleratepatient access and sustain growth. Data generatedduring the design and development phase of MedTech additional technological infrastructure and divergentinternal processes executing the same client facingoutputs. Companies are now looking to harmonize,with a focus on optimizing data capture andmaintenance, process execution and technologicalecosystems. QARA are under the same pressures asthey review the