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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

★★★★★ "Mr. Howlett was very forthcoming, open to questions, and he really poured his expertise in the train... more"

24-25 Apr 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

Enrol or reserve

The An Introduction to the Design and Development of Medical Devices course will cover:

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

Enrol or reserve

David Howlett
Pharma Delivery Solutions

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.

More details

Book An Introduction to the Design and Development of Medical Devices Live online/Classroom training

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

24-25 Apr 2023

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 12848

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 20 Mar

Limited places remaining

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Not ready to book yet?

for 7 days, no obligation

3-4 Jul 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12246

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 29 May

  • 2 days 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

5-6 Oct 2023

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12355

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 31 Aug

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's An Introduction to the Design and Development of Medical Devices training course


Mr. Howlett was very forthcoming, open to questions, and he really poured his expertise in the training, which made all the difference.

Apr 5 2022

Christian Micheletti
RA Manager, Nouvag AG

Apr 5 2022

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 5 2022

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 5 2022

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

Oct 11 2021

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 11 2021

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 11 2021

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

May 24 2021

Very good. A lot of information delivered clearly.

Michael Phillips
Design Development Director, Renfrew Group

May 24 2021

Very informative

Shaun Phillips
Eng manager, Renfrew group

Oct 14 2020

Good level of detail.

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

Nov 28 2019

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 28 2019

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

United Kingdom

  • Astrazeneca
  • Bespak
  • Cambridge Design Partnership
  • ConvaTec Ltd
  • DSTL
  • Elekta
  • Elekta Limited
  • Elekta Ltd
  • Galderma UK Ltd
  • Insight Regulatory Consultancy
  • Leica Biosystems
  • Mundipharma Research Ltd
  • Occuity
  • Opiant Pharmaceuticals
  • Osler Diagnostics
  • P&G
  • Pfizer Ltd
  • Renfrew
  • Renfrew group
  • Topdental

Switzerland

  • Biogen Idec
  • Idorsia Pharmaceuticals Ltd
  • Komax Systems LCF SA
  • Nouvag AG
  • Zimmer GmbH

Denmark

  • NNE Pharmaplan A/S
  • Novo Nordisk
  • Novo Nordisk A/S

Germany

  • Beiersdorf AG
  • Sanofi-Aventis Deutschland GmbH
  • Semigator GmbH

Ireland

  • Nypro Healthcare
  • Ovelle Ltd

United States of America

  • Aerpio Therapeutics Inc
  • Cambridge Design Partnership

France

  • TISSIUM

Iceland

  • Capretto

Netherlands

  • Sever Pharma Solutions

Enrol or reserve

Run An Introduction to the Design and Development of Medical Devices Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy