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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
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
Day 2
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
Speakers
Mr David Howlett,
Director ,
PharmaDelivery Solutions LtdDavid Howlett is the Director of PharmaDelivery Solutions Ltd. In 2003 he established the company as a highly specialised consultancy service in the field of drug delivery 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, establishing design control systems and design verification, planning and execution, materials strategies and type III device Drug Master Files (DMFs).
PharmaDelivery Solutions Ltd has provided key programme inputs in various forms including due diligence, regulatory GAP Analysis, strategic and detailed planning, implementation, mentoring and training.
In addition to activities supporting commercial organizations, 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 developing international standard ISO 20072:2009 for pulmonary and nasal delivery, and a committee member on other standards committees
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
An invited speaker at a number of international meetings and symposia on device development related subjects, including regulatory expectation, DPI development, extractables and leachables control and emerging markets
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
