Presented by
Management Forum
An Introduction to the Design and Development of Medical Devices In-house Training
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
★★★★★ "Good speaker, clearly very knowledgeable in the area. He was happy to have conversations about any s... more (18)"
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
- An Introduction to the Design and Development of Medical Devices
- Human Factors and Usability Engineering in the Development of Drug Delivery Products
- Cyber Security for Medical Devices
- Sustainable Design and Manufacture for Medical Devices
- Metered Dose Inhaler (MDI) Technology
- Pre-Filled Syringes: End-to-End Processing
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
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
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
This 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
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.
Reviews of IPI's An Introduction to the Design and Development of Medical Devices training course
Good speaker, clearly very knowledgeable in the area. He was happy to have conversations about any specific scenarios/examples/questions we had.
Very friendly and i applaud his speaking almost continuously on this topic for two days
Jul 24 2024
Michaela Hume 
Engineer, 42 Technology
Jul 24 2024
Very good, lots of relevant material and clearly outlined.
Kurt Blinston
R&D Manager, Medtrade Products Ltd
Jul 24 2024
Good content, covered all aspects that I required.
Anna Short
Design Manager, DM Orthotics
Jul 24 2024
David was a very good presenter in going through the content in detail and made it easy to follow. Great with regards to answering questions people had. Very good webinar for all aspects, would recommend to others
Simran Sandhu
R&D Scientist, Medtrade Products Limited
Apr 24 2023
overall I was very happy with the content, speaker and presentation however it was lots of information to take.
Ewa Radziwon
Product Development Manager, Calla Lily Clinical Care Ltd.
Apr 24 2023
David is a very good and eloquent speaker.
Dror Sever 
Senior Device Information Scientist, Novo Nordisk
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.
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
- 42 Technology
- Astrazeneca
- Bespak
- Calla Lily Clinical Care Ltd
- Calla Lily Clinical Care Ltd.
- Cambridge Design Partnership
- ConvaTec
- ConvaTec Ltd
- Dermal Laboratories
- DM Orthotics
- DSTL
- Elekta
- Elekta Limited
- Elekta Ltd
- Galderma UK Ltd
- iLoF
- Insight Regulatory Consultancy
- Leica Biosystems
- Medigen Regulatory Limited
- Medtrade Products Limited
- Medtrade Products Ltd
- Mundipharma Research Ltd
- Northumbria Pharma Ltd
- Occuity
- Opiant Pharmaceuticals
- Osler Diagnostics
- P&G
- Pfizer Ltd
- Ramsay MD-Regs Ltd
- Renfrew
- Renfrew group
- RUA Life Sciences
- Topdental
Switzerland
- Accuray International
- Biogen Idec
- Idorsia Pharmaceuticals Ltd
- Komax Systems LCF SA
- Nouvag AG
- Sonova AG
- Zimmer GmbH
Germany
- Beiersdorf AG
- bitop AG
- Sanofi-Aventis Deutschland GmbH
- Semigator GmbH
Denmark
- NNE Pharmaplan A/S
- Novo Nordisk
- Novo Nordisk A/S
United States of America
- Aerpio Therapeutics Inc
- Cambridge Design Partnership
- Vertex Pharmaceuticals Incorporated
Ireland
- Nypro Healthcare
- Ovelle Ltd
Netherlands
- DSM Biomedical
- Sever Pharma Solutions
Belgium
- Cabezon Consulting BV
Canada
- Globalmed
France
- TISSIUM
Iceland
- Capretto
Run An Introduction to the Design and Development of Medical Devices Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- 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:
