This course introduces those who are new to medical device design and development to the critical elements of the process. It aims to provide delegates with an introductory insight into the tools and techniques required to design and develop a medical device. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the course will also address device constituent parts of combination products.
Attending this training will provide delegates with a comprehensive appraisal of the critical elements and processes, and provide an opportunity to discuss the complexities involved with an experienced industry expert.
Overview to the regulations and market routes
The design and development process
The design and development process (continued)
Risk management – what is required?
Clinical evaluation, human factors and usability – how to comply
Discussion session and Q & A
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.