Why SCIE Solutions?
Empowering Medical Innovators. Accelerating Commercial Success.
SCIE Solutions was founded in 2007 with a clear mission:
Help people build companies that improve the lives of patients.
Too many innovative MedTech startups fail before they can bring life-changing products to market. Often, founders are experts in their field—brilliant engineers, scientists, or clinicians—but lack the business, regulatory, and operational expertise required to navigate the complexities of the medical device and biologics industries.
At SCIE Solutions, we bridge this gap.
We provide end-to-end support across Quality & Regulatory Compliance, Supply Chain Management, Operations, Business Development, and Commercialization Strategy, ensuring startups and established companies move swiftly, remain compliant, and scale efficiently—all while maintaining investor confidence and securing regulatory approvals.
From product ideation to full-scale commercialization, SCIE Solutions partners with you every step of the way, executing strategies that drive business success.
We are more than consultants—we are execution partners.
Why SCIE Solutions? Deep Industry Expertise Across the Entire Product Life Cycle
SCIE Solutions doesn’t just provide generic business advice. We offer specialized expertise in:
- Medical Devices (Class I, II, III) – Including cardiovascular, orthopedic, trauma, and wound care
- Biologics & Regenerative Medicine – Including PRP, allografts, and biomaterial-based therapies
- Pharmaceutical & Digital Health – From traditional drug delivery to AI-driven diagnostics
- Veterinary & Specialty Healthcare – Bridging innovations across human and animal health
Business Development and Commercialization Expertise
Through our expertise in business development, financial planning, and commercialization strategy, we help organizations position their innovations for success, secure market access, and drive sustainable growth. Whether launching a new product, expanding market reach, or preparing for an acquisition, SCIE Solutions is the trusted partner for achieving business milestones efficiently and compliantly.
Comprehensive Support for Business Development
Strategic Planning and Development
Product Commercialization and Marketing
Business Automation and Optimization
Financial Planning and M&A
Global Compliance & Regulatory Mastery
SCIE Solutions specializes in guiding medical device and healthcare technology companies through the world’s most stringent regulatory landscapes, ensuring a seamless path from concept to commercialization. Our deep industry expertise enables startups and established businesses to navigate the complexities of product development, regulatory compliance, and market entry with confidence.
FDA – 21 CFR 820/821 Compliance for U.S. market entry
ISO 13485:2016 – Medical Device Quality Management System for global markets
EU MDR & MDSAP – Ensuring European and international compliance for scalability
Electronic QMS Integration – Implementing Greenlight Guru, Qualio, and Cognidox
Hands-On Execution, Not Just Strategy
With a comprehensive suite of services—including business strategy, quality management, supply chain optimization, and go-to-market execution—SCIE Solutions provides end-to-end support that accelerates commercialization, mitigates risk, and enhances operational efficiency. We tailor our approach to each client’s needs, offering strategic planning, regulatory readiness, and scalable business solutions that empower companies to thrive in competitive and highly regulated markets.
Many consulting firms provide advice—we provide execution. We don’t just tell you what to do; we work side-by-side with your team to implement solutions and drive measurable results.
Business Development & Fundraising Guidance – increasing investor confidence
Full-service business operations support – from order-to-cash to ERP integration
Supply Chain Optimization – reducing costs while improving efficiency
