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An Introduction to the Design and Development of Medical Devices Training Course

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

12-13 Oct 2020

& 14-15 Oct 2020 , 24-25 May 2021 , 26-27 May 2021 , 11-12 Oct 2021 , 13-14 Oct 2021

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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.

Book now

Book now

12-13 Oct 2020
Face-to-face, Rembrandt Hotel London
12-13 Oct 2020
Face-to-face
Rembrandt Hotel London
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 31 Aug*
Enrol now
to attend
Face-to-face
Rembrandt Hotel London
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
14-15 Oct 2020
Live webinar
14-15 Oct 2020
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 2 Sep*
Enrol now
to attend
Live webinar
24-25 May 2021
Live webinar
24-25 May 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 12 Apr 21*
Enrol now
to attend
Live webinar
26-27 May 2021
Face-to-face, (venue not yet confirmed)
26-27 May 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 14 Apr 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
11-12 Oct 2021
Face-to-face, (venue not yet confirmed)
11-12 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 30 Aug 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
13-14 Oct 2021
Live webinar
13-14 Oct 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 1 Sep 21*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Aerpio Therapeutics Inc
  • Biogen Idec
  • DSTL
  • Elekta
  • Komax Systems LCF SA
  • Leica Biosystems
  • NNE Pharmaplan A/S
  • Nypro Healthcare
  • Ovelle Ltd
  • P&G
  • Pfizer Ltd
  • Sanofi-Aventis Deutschland GmbH
  • Topdental
  • Zimmer GmbH

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