ROI MedTech Advisory is not a standard fee-for-service regulatory advisory. Our experience enables us to operate as comprehensive commercialization partners that understand the science, technology, market & regulatory landscape, and clinical realities of your product in order to move it further and faster than standard consultancies. We ensure that medical device innovators, from start-ups to established firms, work directly with our partners.
We partner with you to deliver significant ROI.
Comprehensive Commercialization
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Comprehensive commercialization planning cannot be done in isolation Our integrated approach enables clients to understand how product positioning reshapes clinical trial design, how trial design moves the timeline to revenue, and how the competitive landscape should inform claims, indications, and evidence priorities. Our product strategies are built for speed-to-market and durable commercial success well beyond regulatory clearance.
Regulatory Strategy & Execution
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Our experts develop and drive your FDA strategy, including Q-Submission packages and leading FDA interactions. We develop, submit, and own 510(k), De Novo, Breakthrough Designation, IDE, HDE, and PMA applications for all device types, including paediatric, implantables, cardiovascular, wearables, SaMD, AI, and medical software. We focus on time-to-market, competitors, and adoption drivers to ensure your US market entry is sustainable and positioned for growth.
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Our expertise includes EU MDR Technical Documentation and Clinical Evaluation development and submission management for Class IIa, IIb, and III devices and IVDs. We routinely unstick submissions from EU Notified Body review (e.g., BSI, Intertek, TUV, SGS, DQS, etc) through interaction and response management.
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We develop regulatory & go-to market strategies for devices of all risk classes in other major global markets including Canada, Australia, UK, etc.
Domain Expertise
Clinical Study Design, Management, & Evaluation
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We develop "minimally viable" trial strategies and lead early regulatory engagements to de-risk clinical studies that drive your commercialization plans through market entry, clinical utility, and for FDA, EU, and beyond.
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We author efficient and compliant clinical protocols to gather the data needed to fulfil your specific market entry strategy.
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Our team works in tandem with Clinical Research Organizations to successfully execute pre-clinical, first-in-human, pilot, and pivotal studies at all scales.
Product Development & Pre-Clinical Evidence
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Our experts lead your team through product development in compliance with key international standards and regulations, from product planning through design inputs & traceability, verification & validation planning, testing, and reporting, and design transfer to production either in-house or with manufacturing partners. We ensure every step works in tandem with the overarching commericialization strategy to avoid unnecessary work and resource commitments.
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We develop critical design inputs including Risk Management Files per ISO 14971, Human Factors/Usability Engineering Files per IEC 62366-1 and FDA Guidances, Biological Evaluation Plans and Reports per ISO 10993-1, Software Development & Maintenance Plans, Verification & Validation Plans, etc.
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We manage critical external testing processes performed by qualified third-party labs on your behalf, including but not limited to electrical safety & EMC, battery certification, laser safety, biocompatibility, sterilization validation, packaging, stability & shelf life, etc. to save time and cost.
Quality Management & GMP
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We establish and support lean ISO 13485:2016, FDA QMSR, EU MDR, and MDSAP-compliant QMS for companies of all sizes, from <4 to over 70 employees, scoped to what is needed.
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We conduct internal & supplier audits and support and defend certification & surveillance audits, and provide ongoing Quality Operations support for processes like CAPA, NC, and ECO management.
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We handle Contract Manufacturer qualification and management, including written manufacturing and quality agreements, and manage Design Transfer to Production between manufacturers and CMOs.
15+ year relationships with Clients, Private & Public Investors, Regulators, Testing Houses, Innovation Hubs, IRB/REBs, Clinics & Hospitals, Distributors, and Sales Teams.
We pull the right levers at the right time to propel you forward.
Partners
Abhiram Pushparaj, PhD
With over 15 years in the medical device industry as a start-up founder and VP Clinical & Regulatory, Abhi brings a deep background in regulatory affairs and R&D. He has extensive experience engaging and negotiating with FDA, EU, and Health Canada Reviewers across a range of devices to secure efficient and timely approvals, including Class III implants, combination products, and paediatrics.
Aparajit Sahai, MASc
Aparajit has over 10 years of experience in engineering, quality, and regulatory leadership as Quality Manager and Regulatory Consultant. He has worked on a range of devices, from digital health and SaMD (Software as a Medical Device) to surgical instruments and robotic systems. He brings an extensive background in strategic regulatory affairs and product development, as well as quality management leadership and auditing.
Martin Musiol, RAC, CMDA
Martin has over 10 years of experience serving in Senior Consultant, Director, and Fractional roles, leading cross-functional teams at start-ups and mid-sized medtech companies to achieve critical milestones and scale. He specializes in developing efficient and compliant regulatory and product development strategies that bridge the gap between technical vision and commercial reality across North America, Europe, and APAC.
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