Development team working infront of a large screen in a lab

Continuing Education

Product development of biomedical devices

Tampere University

Extent

5 ECTS

Course dates

1.8.2022-31.12.2022

Application period

1.5.2021-19.8.2022

Fees

1400,00 + VAT 24 % (Price incl. VAT 1 736 €)

Faculty or school

Language of instruction

English

Study fields

Management, Administration and Economics

Technology and Natural Sciences

Health and Welfare

Data Processing and Information Technology

Organising unit

Tree – Continuing Education

Study level

Other studies

Product development of medical devices could be thought as a multi dimensional project. How to be able to apply funding, quarantee the patient safetyness according to regulatory requirements and still please the customer and make profitable business?

In the course, a product development project for a biomedical product is planned from idea to finished product. The NABC model, teamwork and pitching will become familiar.

In addition to various studies and plans, a schedule and budget are made for the project and the cost structure of the product is determined. At the end of the course, the product and project are presented to a jury which evaluates them.

Target group

This course is targeted for those who are working or willing to work in R&D and/or quality and regulatory roles in health technology companies.

This course is part of Health technology solutions – product development and commercialization (programme). Get acquainted with the programme and other courses included in it.

The programme offers a formal additional education for a “Person responsible for regulatory compliance” required by the new EU regulations in Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR).

Completion of studies

The course covers the following topics:

Process and design stages of a biomedical product from an idea to a final product
Literature review: patent survey, marketing survey, setting up the requirements of the application, properties of the components of the product studied
Influence of regulatory aspects to medical device R&D chain
Risk analysis
Setting up the schedule, workflow and budget for the project
Written and oral presentations of the work stages

After completing this course, you:

have collected, combined and explained the planning process stages of a health technology product from an idea to a final product including regulatory aspects and risk analysis
have collected data and compiled review reports in groups which include patent and market surveys and survey requirements for the application and the health technology product
have critically overviewed scientific articles and different databases for the information retrieval
As a part of a group you have planned and prepared schedule, budget, and workflow for the project
have presented group work as written document and as an oral presentation in seminar
have also assessed the work of other groups and received criticism

Teaching

The course includes regular joint meetings throughout the course. Three of the meetings are seminars where groups present their projects. The course also includes project group meetings, presentations and written final report. The course can be completed entirely online.

The teacher of the course is Eija Pirhonen.
She has worked with biodegradable materials, medical devices and quality systems in several companies. The focus areas have been in materials research, product development, regulatory compliance, quality, IPR and clinical trials.

In addition, professionals from health tech companies and organizations are involved.

Cancellation terms

Application for the training becomes binding after the last application date.

For cancellation made after the end of the application period, 50% of the participation fee will be charged.
If the cancellation takes place 1-14 days before the start of the training, the entire price of the training will be charged.

In the event of an obstacle, the place of training can be handed over to a colleague. In trainings with separate selection criteria, a place cannot be handed over to another.