Whether you are developing a medical device, a drug delivery device or a user interface THAY Medical can help.
- Medical Device Development
- Drug Delivery Device Development
- Risk Management
- Project Management
THAY Medical’s expertise is in developing usable products. We apply the human factors elements, focused on the user(s) of the medical product for the development of safe, effective devices.
How do we develop? By working alongside medical device developers in project teams.
What expertise do we offer? We are able to project manage and perform the human factors elements.
What medical devices do we develop? We are able to assist in all medical device developments.
Why use THAY Medical? To have an independent, added-value partner in your medical device development.
THAY Medical develop medical devices for customers.
We work alongside all members of project teams to develop the product, and then alongside regulators, marketing, commercial and sales teams to enable the launch of the devices globally. We do this seamlessly as if we are “one of the team” and can promote the value of a user focused development within that team if required. We are the extra resource, the extra team members, the extra added value to the product development.
Tasks and supporting documentation that THAY Medical specialise in are:
- Device design Documents (Specifications, Design Input Documents, Requirements Documents)
- User Research (Ethnographic Research, Heuristic Evaluations, Task Analyses)
- User Documents (User Manuals, Instructions for Use, Patient Information Leaflets)
- Product Training & Training Materials (Training Plans, Scripts, Brochures, Training Manuals)
- Product Labelling & Graphics (Labels, Packaging, Artwork, Graphics)
- Verification or Validation Test Protocols & Reports
- Human Factors & Usability Engineering Documents (Specifications, Analyses, Research)
- Human Factors Studies (Exploratory, Comparative, Formative, Validation)
- Market Research (Focus Groups, Individual Interviews, Product Gap Analyses)
- Clinical Evaluation Reports (Clinical Research, Product Research, Equivalence Reports)
- Verification or Validation Test Plans
and many more items not listed here. In fact no aspect of medical device design is outside of our scope apart from the actual design and registration of the medical product.
Developing drug delivery devices.
We have a wealth of experience particularly in pen injection devices and infusion pump systems. It is the link between developing a drug delivery device and ensuring it will be usable that is key in ensuring future business success – compliance is beneficial to both patient and medicine provider, with the most compliant medicines housed in usable drug delivery devices.
If a patient cannot use the drug delivery device then the medicine may not be accessible. Usability and medicinal compliance are linked and getting a drug delivery device usable by its intended users is what THAY Medical can help you achieve.
Risk Management for device developments.
THAY Medical regard the process of risk management as the crux of medical device development. When developing medical devices, it is imperative to ensure there is a focused risk management plan which can be implemented – so that a safe, usable medical device can be the result of the development.
We are able to work with you to develop, manage and implement risk management into the medical device development. We really specialise on usability risk management, since this is part of our core expertise – human factors and usability engineering, and is key in performing these activities.
We are able to assist with –
- Risk Management Planning
- Clinical Risk Assessment
- Usability Risk Assessment
- Design Risk Assessment
- Production Risk Assessment & Optimisation
- Risk Management Reporting
All risk management is performed to the latest global regulatory standards such as ISO 14971.
Meeting milestones and budgets.
THAY Medical is able to project manage device developments to the latest global regulations and to your business needs. We are able to work within product development teams or work externally, delivering the projects to agreed schedules and costs. We understand the need for timely and cost effective project delivery, and to ensure this happens, we use our highly motivated staff and the latest industry project management methods. We want your project to be a success, and THAY Medical can help you achieve this.