An Introduction to the Design and Development of Medical Devices

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

28-29 Nov 2019

& 27-28 May 2020 , 14-15 Oct 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

This course introduces those who are new to medical device design and development to the critical elements of the process. It aims to provide delegates with an introductory insight into the tools and techniques required to design and develop a medical device. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the course will also address device constituent parts of combination products.

Attending this training will provide delegates with a comprehensive appraisal of the critical elements and processes, and provide an opportunity to discuss the complexities involved with an experienced industry expert.

Who should attend?

  • Design and development personnel
  • Development engineers
  • Quality personnel
  • Regulatory personnel
  • Design control professionals
  • Documentation managers
  • Programme managers
  • Anyone who needs an overview of the medical device design and development process

Programme day one

Overview to the regulations and market routes

  • Regulatory pathways
  • Medical Device Directive (MDD) vs Medical Device Regulation (MDR) – key differences
  • EU vs US (FDA) – markets to consider 11.00 uRefreshments
  • Medical device vs combination product (drug/device and device/drug) – which regulation applies?
  • Device classification and the implications for your product
  • Resources and sources

The design and development process

  • The stages of design and development
  • Key considerations
  • Terminology
  • Intended use
  • Project complexity
  • Mandatory requirements
  • Design and development tools

Workshop one

The design and development process (continued)

  • Inspiration, innovation and determination
  • Materials and biocompatibility
  • DFx, Design for…………?
  • Manufacturing – key considerations

Programme day two

Design control

  • Appropriate design and development planning
  • Translation of marketing requirements
  • SMART design inputs
  • Is a trace matrix appropriate?
  • Meaningful design outputs
  • Verification and validation
  • Design reviews
  • Design transfer
  • Design history file vs technical file
  • Change control
  • Notified Bodies (NB)

Risk management – what is required?

  • What is risk management and when should it be applied?
  • What does the guidance say?
  • Help or hindrance?
  • How to implement a practical risk management plan
  • Tools and techniques to help you succeed

Workshop two

Clinical evaluation, human factors and usability – how to comply

  • Planning your clinical evaluation
  • How to incorporate human factors and usability studies into your design and development process – MDR and FDA requirements
  • User instructions
  • Training considerations – when and who do you need to train?
  • Formative studies
  • Validation/summative studies

Discussion session and Q & A

Presenter

David Howlett

In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.

David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.

PharmaDelivery Solutions Ltd has provided input ranging from GAP analysis and comment to complete remedial implementation in areas including

• Design Control
• Risk Management
• Materials strategies
• Regulatory documentation
• Technical reviews and opinion

In addition to activities supporting commercial organizations, David has been involved in the following roles;

Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms.

A UK national expert representing the British Standards Institute on ISO TC84 developing new international standards for pulmonary and nasal delivery devices syringes and catheters.

David has also worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol in emerging markets around the world.

Book now

28-29 Nov 2019
28-29 Nov 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
Limited places
27-28 May 2020
27-28 May 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
14-15 Oct 2020
14-15 Oct 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • Aerpio Therapeutics Inc
  • Biogen Idec
  • DSTL
  • Komax Systems LCF SA
  • NNE Pharmaplan A/S
  • Nypro Healthcare
  • Pfizer Ltd
  • Sanofi-Aventis Deutschland GmbH