Design Control for Drug - Device Combination Products
Im Auftrag der ECA Academy

Design Control for Drug - Device Combination Products Im Auftrag der ECA Academy

Copenhagen, Denmark

Seminar Nr. 16944


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Mark A. Chipperfield, Corvus Device Limited, UK

Dr Jochen Heinz, Transcoject, Germany

Paolo Mazzoni, PTM Consulting, Italy

Lee Wood, medHF Switzerland


This Education Course provides a comprehensive overview of the regulatory requirements for the combination of medical devices with drug products (EU & US). Participants will learn and understand

  • the basics – distinctions between drugs, devices and ‘combination products’,
  • the current applicable regulations, standards and guidelines
  • the key elements of the Design Control, Risk Management and Human Factors Engineering processes,
  • many of the relevant process interfaces (change management, vendor management, data handling),
  • specific presentations in quality systems, vendor management, design verification and human factors design validation.
Case Studies are an integral part of the course programme.


“Combination Product” is a term defined by the FDA to cover various combinations of drugs, biologics and medical devices. Since 2002, there has been an Office of Combination Products (OCP) at the FDA. Alongside several historical guidances and regulations, the FDA has issued the 21 CFR Part 4 regulation on the current Good Manufacturing Practice (cGMP) requirements applicable to Combination Products, effective on July 22, 2013. In January 2015 FDA published the draft-guidance “Current Good Manufacturing Practice Requirements for Combination Products” which also brings more clarification to this topic.

In the EU, there is currently no equivalent term to “Combination Product”, a product is either considered a Medical Device or a Medicinal Product. Classification of the product is based upon the Primary Mode of Action (PMOA) and the intended use. Regulation is based upon the Medical Device Directive or the Medicinal Product Directive - however there are some recent and ongoing initiatives for change; the Medical Device Regulation, ISO 13485:2016, ISO14971, IEC 62366, ISO 9001, PS 9000 which impact the development activities within the pharmaceutical industry in future.

As a consequence, drug manufacturers who extend their development and/or manufacturing operations into delivery (Medical) devices; or vice-versa; may not only need to follow traditional cGMP approaches, but may also have to fulfil additional requirements of Regulation, Directives, Normative Standards and guidances. They will likely have to develop or enhance their quality system to satisfy these additional requirements.

The existing 21CFR820 Quality Systems Requirements (1996) defines several requirements including the Design Control development model which needs to be applied both pre- and post-production to the device constituent part of the Drug-Device Combination Products.

Additionally, the recent increase in attention to Human Factors Engineering; or Usability Engineering; has led many manufacturers into difficulties as they aim to prove high levels of intuitive use, use safety and efficacy of the drug delivery system as a whole - for a Combination Product it is no longer just about the drug. Again, regulation, directives, guidance, standards and review expectations continue to evolve in this area.

For the established pharmaceutical industry it can be a challenge to adopt new vocabulary and approaches (e.g. Design Control, Design Input, Design Output, Design Verification, Design Review, Design Validation, Design Transfer, etc.) into their existing and traditional development processes.


This Course is designed for all scientists, engineers, managers and executives from Pharmaceutical and Biotech Development Units, including Device Development, Packaging Development, Quality Assurance, Regulatory Affairs, Marketing, and Project Management, who are involved in the development, industrialisation and control of drug-device combination products.


Regulatory Background

  • Requirements for Medical Devices and Drug Delivery Products (Single Integral Product, EU)
  • Requirements for Drug – Device Combination Products, USA
  • Design control requirements
Device Development - Challenges and Considerations
  • Integration of Medical Device development activities within Pharma
  • Significant Challenges & Experiences
  • Combination product stability & shelf-life
  • Control Strategy
  • Product Remediation
  • Recommendations to facilitate proficient Combination Product development
Further Quality System Elements for Medical Device Development and Design Control Interfaces
  • Document Management
  • Change Management
  • Deviation Management
  • Risk Management
  • What is a “Risk”
  • Regulatory background (Drugs, Medical Devices)
  • Risk Management as a design control element
  • Integration of Risk Management into the company
  • Tools (FMEA, FTA, HACCP)
  • Design Verification
    • Design verification as a design control element
    • Regulatory background
    • PRS and URS
    • Verification levels
    • Test methods
    • Protocols, reports and documentation
    Case Study I: Pre-Filled Syringes

    Introduction to Human Factors Engineering
    • Introduction to discipline of Human Factors
    • Engineering
    • The current state of the regulatory environment
    • The requirements of Human Factors Engineering as an activity under design controls, IEC62366 and ANSI-HE75
    Case Study II: Human Factors Validation
    Introduction and example of Human Factors
    • Validation
    • Pre-requisites as part of design controls: Planning, Health Authority Submission, Ethics Approval, Key considerations for study design, GMP Quality considerations, Key trends in regulatory feedback
    External Development
    • Vendor qualification and audits
    • Quality Agreements
    Case Study III: Inhaler Development
    Some considerations when developing inhalation combination products

    Case Study IV: Autoinjector Development
    Some considerations when utilising syringes in autoinjector combination products

    Case Study V: Integrating Design Controls, Risk Management and Human Factors
    Ensuring integrated key concepts during development and post-market activities


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