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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

4-5 Oct 2022

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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

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
4-5 Oct 2022
Live webinar
09:00-16:30
UK (London)
4-5 Oct 2022
Live webinar
09:00-16:30
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 30 Aug*
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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

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

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
  • Astrazeneca
  • Bespak
  • Biogen Idec
  • Cambridge Design Partnership
  • Cambridge Design Partnership Limited
  • Capretto
  • ConvaTec
  • ConvaTec Ltd
  • DSTL
  • Elekta
  • Elekta Limited
  • Elekta Ltd
  • Galderma UK Ltd
  • Idorsia Pharmaceuticals Ltd
  • Komax Systems LCF SA
  • Leica Biosystems
  • NNE Pharmaplan A/S
  • Nouvag AG
  • Nypro Healthcare
  • Occuity Limited
  • Ovelle Ltd
  • P&G
  • Pfizer Ltd
  • Renfrew
  • Sanofi-Aventis Deutschland GmbH
  • Sever Pharma Solutions
  • TISSIUM
  • Topdental
  • Zimmer GmbH

I would recommend it to anyone with no experience of design controlled medical device development. A good overview with a good amount of detail.

Hugh Clark, Mechanical Engineer, Cambridge Design Partnership, Apr 22

Good pace. Mixture of text and graphics... David did a good job and was engaging considering that the course was online, which is always difficult.

Danny Kendall, Senior Physicist, Elekta Ltd, Apr 22

Mr. Howlett was very forthcoming, open to questions, and he really poured his expertise in the training, which made all the difference... I liked a lot the first day about design and development, of which I did not know anything.

Christian Micheletti, RA Manager, Nouvag AG, Apr 22

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

Christopher Thorpe, Junior Engineer, Osler Diagnostics, Oct 21

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