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.
CPD Hours: 12
Course Content
- Day 1
- Overview of the regulations and market routes
- The design and development process
- Day 2
- Design control
- Risk management - what is required?
- Clinical evaluation, human factors and usability - how to comply
Speakers
David Howlett
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.
