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Prototype Development for IVDs
Situation
AmplifiDx faced an aggressive 90-day deadline to develop a molecular point-of-care instrument using isothermal detection and LAMP amplification technology. The challenge was creating a functioning proof-of-concept device from scratch to meet critical NIH grant deliverables within an extremely compressed timeline.
Successes
Veranex successfully delivered a functioning prototype within the critical 90-day deadline, enabling AmplifiDx to meet their Phase 1 grant requirements on time and budget while establishing a clear FDA EUA pathway. The rapid development expanded to include five fully functional prototype units that were validated to requirements and deployed for clinical trials, creating a solid foundation for continued partnership and development of broader testing capabilities with new instrument iterations.
Services by Veranex
Veranex leveraged proprietary pre-built technology infrastructure to achieve rapid development within the compressed timeline. Our team provided:- Rapid prototyping and proof-of-concept development: From-scratch instrument design using existing technology platforms
- Complete multidisciplinary design: Industrial design, mechanics, electronics, software, firmware, and optical systems
- Regulatory pathway development: FDA design control process guidance and EUA submission strategy
- Product requirements and architecture: Technical specifications and system design optimization
- Verification and validation testing: Comprehensive system testing and performance validation
- Bridge-to-manufacturing services: Pre-production unit development and manufacturing readiness support
Regulatory Transition for IVDs
Situation
A client faced the complex task of transitioning a diverse portfolio of 30 blood grouping devices from the In Vitro Diagnostic Directive (IVDD) to the stricter In Vitro Diagnostic Regulation (IVDR). The sheer number of devices presented a significant hurdle for achieving timely and efficient CE-marking.
Successes
Through our strategic intervention, the client successfully achieved CE-marking under IVDR for their entire device portfolio. The grouping strategy resulted in a reduction in the number of required conformity assessments from 30 to 5, saving time, resources, and accelerating market access.
Services by Veranex
Veranex developed a strategic approach focused on optimizing the conformity assessment process. Our team:- Devised a sophisticated strategy that grouped 30 individual devices into just 5 product families. This was subsequently approved by the Notified Body, reducing the number of required conformity assessments.
- Provided comprehensive Technical Documentation (TD) support, including mitigating existing technical documentation gaps, ensuring all files met IVDR requirements.
- Led performance evaluation activities, including expert writing of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER).
- Oversaw the design and execution of crucial analytical performance studies to gather necessary data.
- Leveraged and optimized all available clinical data, including information from batch-to-batch release, to support the IVDR transition.
Commercial Strategy and Market Access for IVDs
Situation
A leading diagnostic manufacturer needed to develop a comprehensive value communication strategy for their innovative biomarker tests designed to monitor hypertensive pregnant women at risk of preeclampsia. The challenge was creating a global communication tool that would effectively demonstrate the clinical and economic value to healthcare providers and payers while enabling commercial teams to raise market awareness.
Successes
Veranex successfully developed an evidence-based value communication platform that articulated unmet medical needs and established compelling value drivers across patients, clinicians, and laboratories. The modular tool provided the commercial team with adaptable materials for multiple audiences and identified viable reimbursement pathways with targeted provider messaging, creating a complete go-to-market communication foundation.
Services by Veranex
Veranex delivered a comprehensive commercial strategy and market access solution focused on value demonstration and stakeholder communication. Our team provided:- Literature review and evidence synthesis: Comprehensive analysis of current clinical evidence and burden of illness studies
- Value proposition development: Definition of unmet medical needs and identification of key value drivers for patients, clinicians, and laboratories
- Modular communication platform creation: Provided references that the commercial team could use to develop external facing materials for payers and providers and to support internal training initiatives
- Reimbursement pathway analysis: Assessment of current payment mechanisms for similar diagnostic tests and identification of viable reimbursement strategies
