Digital Health Works Inc.
Digital Health Works is a commercialization agency for digital health, MedTech, and medical device ventures. Their mission is to connect medical innovations to the people who need them most by helping companies navigate market access, regulatory, and product development to bring innovative medical technologies and devices to the US and European markets. They aim to make the regulatory and commercialization process accessible for all, ensuring that innovations can generate revenue and have a positive impact on lives.
Industries
Nr. of Employees
small (1-50)
Digital Health Works Inc.
Digital Health Works Inc.
Products
Medical Commercialization
Assists digital health and med tech ventures in bringing their products to market, including market access planning and strategy development.
Medical Regulatory Services
Provides guidance on obtaining necessary certifications and regulatory approvals for digital health and med tech products.
Medical Product Development
Supports the development of medical products from concept to market readiness, including design, testing, and validation.
Radiology AI
Offers support for startups and research institutions in the radiology AI sector, including regulatory guidance, market access planning, and partnership cultivation.
Medical Commercialization
Assists digital health and med tech ventures in bringing their products to market, including market access planning and strategy development.
Medical Regulatory Services
Provides guidance on obtaining necessary certifications and regulatory approvals for digital health and med tech products.
Medical Product Development
Supports the development of medical products from concept to market readiness, including design, testing, and validation.
Radiology AI
Offers support for startups and research institutions in the radiology AI sector, including regulatory guidance, market access planning, and partnership cultivation.
Services
Consulting to create business and financial plans, validate markets, identify points of entry, and develop partnership strategies for US and European markets.
Regulatory strategy and support across the lifecycle including classification, submissions, post-market activities, audit readiness, implementation of QMS and SOPs, and training to build internal regulatory capability for US and European markets.
Services to align product vision to market realities, focusing on user needs, clinical and economic outcomes, and stakeholder requirements during development.
Consulting to create business and financial plans, validate markets, identify points of entry, and develop partnership strategies for US and European markets.
Regulatory strategy and support across the lifecycle including classification, submissions, post-market activities, audit readiness, implementation of QMS and SOPs, and training to build internal regulatory capability for US and European markets.
Services to align product vision to market realities, focusing on user needs, clinical and economic outcomes, and stakeholder requirements during development.
Expertise Areas
- Commercialization strategy for digital health and MedTech
- Regulatory lifecycle management and submissions (US/EU/UK)
- Regulatory infrastructure and quality management system implementation
- Product development and market-aligned design
Key Technologies
- AI for medical imaging
- Telemedicine and remote care platforms
- Digital therapeutics (DTx) applications
- Clinical decision support systems