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An Introduction to the Design and Development of Medical Devices and Device-Drug Combination (DDC) Products Training Course

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

★★★★★ "I think the course was extremely informative. The connection between real-world examples to the text... more (19)"

29-30 June 2026
+ 9-10 December 2026 »
from £1299

Need help? Enrol/reserve

Course overview

Step into the world of medical device and DDC innovation with this intensive two-day course designed specifically for those new to the field of medical device design and development. Whether you're transitioning into MedTech or starting your journey in the industry, this course offers a comprehensive introduction to the essential elements of the development process.

Over two focused days, you'll gain valuable insight into the tools and techniques required to bring a medical device from concept to reality. The course also provides a clear and up-to-date overview of the current regulatory landscape, helping you understand how compliance and standards impact each stage of development.

Key topics include the importance of ensuring safety and efficacy through design controls, effective risk management strategies, and the critical documentation needed throughout the lifecycle of a device. With combination products representing a significant and growing segment of the market, the programme also explores the device constituent parts of these innovative therapies.

By attending, you'll walk away with a solid understanding of the core aspects of medical device development and have the opportunity to engage directly with an experienced industry expert to discuss the challenges and complexities involved.

This course is part of our range of Medical Devices training courses

Benefits of attending

Gain a comprehensive overview of the design and development process, equipping you with the knowledge to confidently approach each stage
Comply with the international regulatory requirements and standards by understanding the current expectations and how to meet them effectively
Learn about design controls and their essential role in ensuring quality and consistency throughout product development
Review materials and biocompatibility to ensure safety, performance, and compliance in real-world applications
Access key information on documentation management and systems to support efficient, audit-ready development processes
Understand how risk should be managed throughout the product lifecycle to enhance safety and reduce potential issues
Consider human factors and usability studies to design user-friendly, effective devices that meet both clinical and patient needs

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

Popular with...

This course has proven particularly popular among our customers in these roles:

Engineer
International Medical Director
International Medical Manager
MD, PhD
Project Manager
Quality Engineer
R&D Lead
Senior International Medical Manager

Enrol/reserve

This course will cover:

Day 1
Day 2

Overview of the regulations and market routes

Do I have a medical device or a DDC?
Regulatory pathways
Roles and responsibilities
Medical Device Directive (MDD) vs Medical Device Regulation (MDR) - key differences
EU vs US (FDA) - and other 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

Risk management - what is required?

What is risk management and when should it be applied?
What does the guidance say?
Accountability Vs Responsibility
What is reasonably forseeable
Help or hindrance?
How to implement a practical risk management plan
Tools and techniques to help you succeed
Reporting and post-market surveillance

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
Approaches to Task Analysis
Training considerations - when and who do you need to train?
Leveraging literature reviews
Formative studies
Validation/summative studies - are they always necessary

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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

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

29-30 June 2026

Live online

09:30-16:45 UK (London) (UTC+01)
10:30-17:45 Paris (UTC+02)
04:30-11:45 New York (UTC-04)
Timings may be different for each day
Course code 16288

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 25 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

9-10 December 2026

Live online

09:30-16:45 UK (London) (UTC+00)
10:30-17:45 Paris (UTC+01)
04:30-11:45 New York (UTC-05)
Timings may be different for each day
Course code 16612

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 04 Nov

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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; and apply only when booking multiple delegates on the same date.

Reviews of IPI's An Introduction to the Design and Development of Medical Devices and Device-Drug Combination (DDC) Products training course

I think the course was extremely informative. The connection between real-world examples to the texts was helpful.

Dec 3 2025

Joshua Parker United Kingdom
NPI Engineer, PolarSeal

Jul 24 2024

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

Michaela Hume United Kingdom
Engineer, 42 Technology

Jul 24 2024

Very good, lots of relevant material and clearly outlined.

Kurt Blinston United Kingdom
R&D Manager, Medtrade Products Ltd

Jul 24 2024

Good content, covered all aspects that I required.

Anna Short United Kingdom
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 United Kingdom
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 United Kingdom
Product Development Manager, Calla Lily Clinical Care Ltd.

Apr 24 2023

David is a very good and eloquent speaker.

Dror Sever Denmark
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 Switzerland
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 Switzerland
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 United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
Junior Engineer, Osler Diagnostics

May 24 2021

Very good. A lot of information delivered clearly.

Michael Phillips United Kingdom
Design Development Director, Renfrew Group

May 24 2021

Very informative

Shaun Phillips United Kingdom
Eng manager, Renfrew group

Oct 14 2020

Good level of detail.

Miguel Lopes France
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 Ireland
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 United Kingdom
R&D Manager, Leica Biosystems

United Kingdom