Combination Products End to End Integrated Device Solution

At the heart of our services lies the “Combination Products End to End Integrated Device Solution,” an offering tailored for clients navigating the complexities of combination product development. Our role transcends traditional boundaries, positioning us as the Technical Project Manager for the device aspects of your combination product development project.

We seamlessly integrate with your team, ensuring a cohesive and unified approach throughout the development lifecycle. By taking the helm on the device side, we provide an end to end solution that meticulously manages every phase from concept to commercialization, ensuring a streamlined and efficient pathway to market.

Our approach is built on a foundation of deep industry knowledge and regulatory acumen, allowing us to navigate the intricate landscape of combination product development with precision. From design inputs to the regulatory submission, our team is adept at addressing the unique challenges that arise at the intersection of pharmaceuticals and medical devices. Our commitment is to not only meet but exceed regulatory standards, eliminating “grey areas” and minimizing unnecessary work that could delay your project.

Our expertise extends beyond initial development; we’re equipped to support you through commercialization and regulatory filings, ensuring a comprehensive support system throughout your product’s lifecycle. With our End to End Integrated Device Solution, we’re not just consultants; we’re your partners in innovation, dedicated to transforming your visionary ideas into tangible solutions that advance healthcare. We can manage all the deliverables and tasks below for your combination product project:

Technical Project Management

  • Integration Between the Device and Pharma Teams
  • Project Management of Device Suppliers and Manufactures
  • Overall Project Management of the Device Deliverables

Drug Delivery Platform

  • Trade off Analysis and Studies
  • Systems Analysis
  • Drug Delivery System Decision Analysis

Design Controls

  • Design and Development Plan
  • User Needs and Stakeholder Needs
  • Design Inputs
  • Design Outputs
  • Design Verification & Design Validation
  • Test Method Validation
  • Trace Matrix

Risk Management

  • Risk Management Plan and Report
  • Design Failure Mode Error Analysis (DFMEA)
  • Process Failure Mode Error Analysis (PFMEA)
  • Use Related Risk Analysis (URRA)
  • Product Hazard Analysis (HA)
  • Risk Analysis Matrix
  • Clinical Risk Benefit Analysis (CRBA)

Human Factors

  • Human Factors (HF) Plan and Report
  • Creation of the Use Related Risk Analysis (URRA)
  • Human Factors Execution
  • Integration of Usability into Product Design
  • HF Formative and Summative Plan, Protocols and Reports

Quality & Regulatory

  • Creation of Quality Systems in Compliance with ISO 13485
  • Quality Assurance Review and Approval
  • Regulatory Strategy
  • Regulatory Submissions

Design Transfer

  • Contract manufacturing organization selection (CMO)
  • Creation of Device Master Record (DMR)
  • IQ/OQ/PQ
  • Process Validation
  • Mold Approvals
Our Clients
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What Our Clients have to say

“Ventura Solutions has been our strategic R&D consulting vendor since July 2017 and has been instrumental in the updating of our risk management quality system as well as authoring risk deliverables for our top projects. His consultants truly became an extended part of our organization as they quickly embraced our company culture, people, and processes to seamlessly integrate onto project teams. They share the same sense of passion to improve physician efficiency and patient satisfaction worldwide. and deliver on commitments with a high level of professionalism and quality. Ventura Solutions is an outstanding resource extension vendor that truly partners with you to exceed your business objectives.”

- Patrick Lee VP R&D Laborie Medical Technologies Corp.

“Ventura Solutions offers consultants with a rare blend of technical expertise + super communication skills. During combination product risk management and design control projects, A Ventura Solutions consultant was assigned as an SME to communicate to clients on very deep technical info as well as put together strategic insights. I would highly recommend Ventura Solutions consulting services for any engineering, quality or similar work.”

- David Amor CEO, Medgineering