Medical Devices
Confidently Navigate the Challenges of Medical Device Development from Concept to Commercialization
The medical device industry continues to grow rapidly, even in the wake of temporary sales declines and supply chain issues brought on during the COVID-19 pandemic. This growth has given rise to numerous challenges that medical device inventors and companies must overcome to successfully market their products in the US and abroad. Among these challenges are the growing cost and complexity of analytics to drive innovation; the volume and complexity of guidances from the FDA, EMA, and other global health authorities; and increasingly complex regulatory and quality compliance standards—all of which can be overwhelming for new and established medical device companies alike.
Medical device companies also face unique challenges in clinical development: device trials tend to be smaller than drug trials, endpoints are highly diverse, and many require complex study designs to perform successfully.
Pearl Pathways helps medical device developers answer questions such as:
- Are there already products on the market that fill the same need or serve a similar function? Would any of these products serve as a predicate for the product I plan to launch?
- Does my product fall under Class I, Class II, or Class III regulatory controls?
- How and to whom will I sell/distribute my device?
- What is the best path to market based on the least burdensome approach?
- What manufacturing, non-clinical, and clinical studies may be required for my device to be approved/cleared/granted?
- Which standard operating procedures (SOPs) are critical in early-stage development to ensure proper documentation and quality controls?
No matter the product classification or stage of development, we can guide you through the many regulatory, quality compliance, clinical, and post-market hurdles – helping you balance risk, speed to market, and cost to develop and commercialize your medical device.
Specialized Expertise Across a Wide Range of Medical Devices
Pearl Pathways advisors are well-equipped to guide startup and large medical device companies through the complexities of developing and commercializing all types of medical devices, from simple Class I medical supplies, to high-risk, complex Class III implantable devices. We routinely support the development of the following types of devices:
- Implantable devices
- Imaging technology
- In vitro diagnostic devices (IVD)
- Single use products and disposables
- Over-the-counter (OTC) devices
- Mobile health apps
- Software as a medical device (SaMD)
- Wearables
- Drug delivery devices
- Wound care products
- Laboratory instrumentation
- Analyzers
- Capital equipment
[We] were discussing how refreshing it is to watch well experienced regulatory professionals collaborate with one another, and… proactively apply creative approaches to our entire program. I know we have a long way to go, but we can’t thank you enough!
Comprehensive End-to-End Solutions to Support Every Stage of the Medical Device Development Lifecycle
Pearl Pathways designs custom regulatory, quality compliance, and clinical solutions to support the design, development, validation, regulatory filing, and post-market support of medical devices. Our flexible, nimble team provides decades of clinical, scientific, quality, and global regulatory expertise to help companies achieve their product development and commercialization goals.
We can partner with your company in whatever capacity best fits your specific needs—whether providing short-term project-based support; acting as head of your regulatory, quality, or clinical organizations; and/or serving as an extension of your team throughout design, development, and beyond.
Regulatory
- Initial and ongoing regulatory strategy
- Full-service submission support for regulatory applications (510(k), De Novo, PMA, IDE Application) and ongoing maintenance filings
- Communication support with FDA and other Global Health Authorities
- Clinical and non-clinical development
- Due diligence of new product platforms/technologies
Quality Compliance
- GxP Quality System development, implementation, and management
- GxP audits of facilities, labs, suppliers/vendors, quality systems, etc.
- Verification, validation, and remediation support
- Supplier management and oversight of CMOs, CROs, etc.
- Design control support
Clinical Services
- Initial and ongoing clinical development strategy
- Full-service CRO services for device and diagnostic studies, including human factors and useability research
- Medical writing support for regulatory applications, clinical study protocols, research documentation, etc.
- Good Clinical Practice (GCP) and research site support services
- Biostatistics and data management
- Pharmacovigilance, post-market surveillance, medical device reporting, clinical evaluation reports
Independent Review Board (IRB)
- Central or single IRB services for multi-site trials
- Flexible working model for local institutional review boards
- IRB review services for all research involving human subjects