Device Development
From Start To
Finish.
Get In Touch
Lean approach
Start To Finish.
Over 35 years of contract manufacturing and drug delivery system launches. End-to-end services from research and regulatory filings to final assembly.
Step 1
Define Scope
Identify clinical needs, regulatory constraints, and market demands. Align with drug formulation, infusion parameters, and patient adherence challenges.
Step 2
Feasibility
Assess material compatibility, infusion precision, and user ergonomics. Computational modeling and HFE inform initial concept validation.
Step 3
Design
Mechanical, electrical, and firmware engineering to optimize performance, biocompatibility, and regulatory compliance (ISO 13485, FDA 21 CFR Part 820).
Step 4
Prototyping
Rapid prototyping and iterative refinement ensure real-world reliability. Adherence monitoring and auto-calibration enhance usability for specialty pharmacies and HCPs.
Step 5
Validation
Preclinical testing, simulated-use studies, and risk management files (ISO 14971, DHF) support FDA 510(k), De Novo, PMA, and CE Mark submissions.
Step 6
Regulatory
Clinical validation, usability studies, and real-world evidence generation. Post-market surveillance ensures ongoing performance and regulatory compliance.
.jpg)
Step 7
Manufacturing
Process validation (IQ, OQ, PQ), supply chain optimization, and quality control. Real-world evidence drives continuous innovation and regulatory alignment.
Step 8
Commercialization
Full-suite services bridging device development to market entry. Regulatory alignment, reimbursement planning, and sales enablement from FDA clearance to commercial traction.
How can we
support you?
Select your role to find the information, solutions, and support tailored to you.
Start here
Optimized
outcomes.
This structured development approach ensures compliance, enhances patient adherence, and streamlines market adoption for pharmaceutical companies, specialty pharmacies, and healthcare providers.
Get In Touch