NOVEMBER - 20229The MedTech innovation service provider landscape is fragmented comprised of a vast number of small firms operating within a single vertical. This has several implications for MedTech clients seeking outsourced services. Substantial time is wasted getting each new service provider up to speed on a particular device's design, mechanism of action, and clinical and regulatory history. There is, unfortunately, limited or poor coordination between service providers serving the same company from different institutions. MedTech clients frequently encounter poor customer service and missed deadlines from under-resourced, sub-scale providers seemingly continuously back-filling resources only after confirming engagements. Alongside Summit Partners and AccelMed, Lauxera Capital Partners invested inVeranex, a MedTech concept-to-commercialization outsourced services partner. Our shared vision is to build the market leading end-to-end solution-provider for our industry. Veranex offers its clients the capabilities needed for the entire product development journey including Product Design & Engineering, Regulatory Affairs, Medical Device Evaluation, Data Management & Analytics, Commercial Strategy& Market Access. Remote work, software-intensive MedTech development efforts, and increased regulatory scrutiny have put substantial pressure on MedTech quality management systems (QMS) and their functional leaders. In a world where traceability, consistency, and one truth across up-to-date documents are paramount, electronic quality management systems are rapidly replacing paper-based systems and non-MedTech QMS-specific cloud and electronic signature solutions. Earlier this year, Lauxera acquired a majority stake in Matrix Requirements, a German software company focused on MedTech QMS software solutions for complex and software-intensive devices. The company's flagship offering is an Application Lifecycle Management tool (ALM) enabling clear visualization and traceability of technical specifications, risks, tests, and test results. The company also provisions a highly flexible and customer-centric Quality Management System that reduces audit risk and accelerates time to market. Medtech innovation is hard and getting harder. Critical to success is getting the expertise you need relevant to your specific circumstance now. Increasingly, that requires an organization like Veranex with global scale. Increasingly, successful audits (and ultimately, regulatory clearances) require optimizing processes and coordinating the work output of geographically diffuse teams. Software is eating the Medtech quality function led by world-class tools like Matrix Requirements. Translating an idea for a Medtech innovation into a product with clinical evidence and regulatory approval is an odyssey. It's an odyssey that will increasingly be supported by technology-enabled MedTech innovation service providers. Electronic Quality Management Software: Matrix RequirementsSamuel LevyTranslating an idea for a Medtech innovation into a product with clinical evidence and regulatory approval is an odyssey. It's an odyssey that will increasingly be supported by technology-enabled MedTech innovation service providers
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