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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

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

Course overview

This intensive two-day course will introduce those who are new to medical device design and development to the critical elements of the process. It has been designed to provide delegates with an insight into the tools and techniques required to design and develop a medical device and offer an essential overview of the current regulatory landscape. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the programme will also address device constituent parts of combination products.

Attending this event will provide delegates with a comprehensive appraisal of key aspects of this process and an opportunity to discuss the complexities involved with an experienced industry expert.

Benefits of attending:
  • Gain a comprehensive overview of the design and development process
  • Comply with the regulatory requirements and standards
  • Learn about design controls
  • Review materials and biocompatibility
  • Access key information on documentation management and systems
  • Understand how risk should be managed
  • Consider human factors and usability studies

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

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

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

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

Presenter

David Howlett (More...)

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.

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 5-6 Apr 2022
  • 4-5 Jul 2022
  • 4-5 Oct 2022

Book now

Previous customers include...

  • Aerpio Therapeutics Inc
  • Astrazeneca
  • Bespak
  • Biogen Idec
  • Cambridge Design Partnership
  • Cambridge Design Partnership Limited
  • ConvaTec
  • ConvaTec Ltd
  • DSTL
  • Elekta
  • Galderma UK Ltd
  • Idorsia Pharmaceuticals Ltd
  • Komax Systems LCF SA
  • Leica Biosystems
  • NNE Pharmaplan A/S
  • Nypro Healthcare
  • Occuity Limited
  • Opiant Pharmaceuticals
  • Osler Diagnostics
  • Ovelle Ltd
  • P&G
  • Pfizer Ltd
  • Renfrew
  • Sanofi-Aventis Deutschland GmbH
  • TISSIUM
  • Topdental
  • Zimmer GmbH

All round excellent score. David was very clear with his diction and could not be faulted. He clearly has vast knowledge and experience in this field.

Christopher Thorpe, Junior Engineer, Osler Diagnostics, Oct 21

David was very knowledgeable about the course content, and was able to answer all questions put to him throughout the course. David did well to deliver the training via the webinar.

Richard Arthur, Quality Engineer, Occuity, Oct 21

Very informative

Shaun Phillips, Eng manager, Renfrew group, May 21

Very good. A lot of information delivered clearly.

Michael Phillips, Design Development Director, Renfrew Group, May 21

Good level of detail.

Miguel Lopes, Head of New Concepts (S&A), TISSIUM, Oct 20

I learned a lot and got some great insights into the process of design and development. It is an intense course with a lot of ground covered.

Damien Tackney, Reg Affairs, Ovelle Ltd, Nov 19

Great overall. All topics of design control were covered well and I think everyone left with a better understanding than when they arrived. I have definitely applied some of the lessons we learned to my current role.

Emma Fairhall, R&D Manager, Leica Biosystems, Nov 19