Commercialization of medical devices and software

This module prepares the student for the commercialisation of health technology products including fulfilling the regulatory requirements.

In commercialisation process, the standards and regulations in different markets such as USA, EU, China and Japan need to be taken into account – from the research phase to marketing and after sales services. Thus, anyone who is interested to be part of any kind of company in biomedical productisation will benefit from this module.

Moreover, a new EU regulation requires all companies to have a “Person responsible for regulatory compliance”. This module offers a formal education for this profession. After this, the person has to do work based training to get the approval to work as a regulatory compliance person.

Required minimum amount of ECTS for making this module a minor is 20 ECTS.

In this module, there are two mandatory courses:

  • BMT-62237 Introduction to quality and regulation for medical product development
  • BMT-62356 Product development of biomedical devices

You must choose 1 or 2 from the optional compulsory courses:

  • BMT-62107 Regulatory requirements for design and manufacture of medical devices
  • BMT-57408 Standards, interoperability and regulations in health informatics

Additionally, you can choose from these complementary courses up to 20 credits:

  • BMT-86006 Health technology and life science R&D
  • BMT-86106 Health technology and life science business

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Lääkintälaitteiden ja ohjelmistojen kaupallistaminen

Lääkintälaitteiden ja ohjelmistojen kaupallistamisen prosessi on monesta muusta tuotteesta poiketen erittäin tarkasti viranomaisten regularisoima.

Laitteiden, ohjelmistojen ja kudosteknologisten hoitojen turvallisuus ja tehokkuus on todistettava perustuen erilaisiin standardeihin ja säädöksiin. EU:n, USA:n, Kiinan tai muiden maiden standardit ja määräykset on otettava huomioon tuotteen suunnittelussa perustutkimuksessa, tuotteen kliinisissä kokeissa ja koko tuotteistamisen elinkaaren aikana. Jokainen lääkintälaitteiden ja ohjelmistojen kanssa jossain muodossa työskentelevä henkilö joutuu toimimaan näiden asioiden kanssa, on kyse sitten tutkimuksesta, suunnittelusta, myynnistä, huollosta tai käytöstä esimerkiksi sairaalaympäristöissä.

Uusi EU:n lääkintälaiteasetus lisää osaamisen tarvetta huomattavasti. Asetus edellyttää, että jokainen yritys nimeää henkilön, jonka vastuuna on valvoa säännösten noudattamista. Tämä 20 opintopisteen laajuinen kokonaisuus tarjoaa osaamistarpeen täyttävän kokonaisuuden sen opiskelevalle henkilölle, mitä voi työkokemuksella täydentää säädösten vaatimuksia vastaavaksi.

Jos haluat moduulin sivuaineeksi, sinun on suoritettava vähintään 20 opintopistettä.

Tässä moduulissa on kaksi kaikille pakollista kurssia:

  • BMT-62237 Introduction to quality and regulation for medical product development
  • BMT-62356 Product development of biomedical devices

Lisäksi on kaksi valinnaista pakollista kurssia, joista valitset joko yhden tai molemmat:

  • BMT-62107 Regulatory requirements for design and manufacture of medical devices
  • BMT-57408 Standards, interoperability and regulations in health informatics

Seuraavista valinnaisista kursseista voit täydentää opintojasi 20 opintopisteeseen saakka:

  • BMT-86006 Health technology and life science R&D
  • BMT-86106 Health technology and life science business

Courses included in the programme:

= Contact learning
= Online learning
= Blended learning (online & contact learning)
Health technology and life science business (BMT-86106), 5 ECTS. 26.8.–22.12.2019.

After completing the course, the student:

  • has basic understanding of the Health Tech and Life Science business environment
  • has gained knowledge on what an inventors needs to understand about business and finance when targeting on to exploit the commercial value of their solutions
  • will gain solid basis for business expertise in their later career either as entrepreneurs, in industry or in academia

During the course, the students will apply the theories into practice by doing course work. In the course work, they will participate in actual innovation projects in SPARK Finland and create a business plan, go-to-market plan as well as financing and market analysis for the projects. Students present the group work as written document and as an oral presentation in a seminar. Student also assess the work of other groups and receive feedback.

More information on the course page.

Standards, interoperability and regulations in health informatics (BMT-57408), 5 ECTS. 7.1.–1.3.2020.

Prerequisites: Knowledge on basics of health information systems. See other prerequisites and advisable courses on the course page.

This course introduces student with key principles related to standards and regulations which are essential to know while working in the health informatics domain. Health information systems interoperability and key standards will also be studied.

After having passed this course, the student:

  • Can define what data security, privacy and safety
  • Knows the central regulations related to health information systems and privacy and security of health data and knows how they need to be taken into account in health information system development
  • Knows general health informatics standards and interoperability approaches and can describe how they are applied in practice
  • Can apply the most important standards which are widely used in Finland in health information systems in software development
  • Can assess whether a health information system is implemented according to regulations and interoperability principles

More information on the course page.

Introduction to quality and regulation for medical product development (BMT-62237), 5 ECTS. 2.3.–31.5.2020.

After completing the course, the student:

  • can explain the definitions introduced in the course and the main steps of a biomedical device product research and development process
  • can explain the main standards and regulations concerning medical devices in EU and USA and the main parts of the most common quality systems for the medical devices
  • can explain the most typical tests for electrical and biological safety as well as mechanical and biomechanical testing
Regulatory requirements for design and manufacture of medical devices (BMT-62107), 5 ECTS. 2.3.–31.5.2020.

After completing this course, the student:

  • is able to describe the regulatory pathway of a medical device from description of the intended purpose to placing into market and putting into service
  • is able to recognise the general safety and performance requirements for a medical device including the principles of risk management and clinical evaluation
  • can explain the main elements of a quality system covering design and manufacture and choose a conformity assessment procedure based on classification rules
  • is able to understand the main principles and challenges of vigilance system and post-market surveillance

 

Health technology and life science R&D (BMT-86006), 5 ECTS. 2.3.–31.5.2020.

After completing the course, the student:

  • has basic understanding of the Health Tech and Life Science R&D process
  • has gained knowledge on how the e.g. customer needs, value proposition, product market fit, regulatory issues, IPR as well as project and process management are related to biomedical R&D
  • has gained solid basis for R&D expertise in their later career either as entrepreneurs, in industry or in academia

During the course, the students will apply the theories into practice by doing course work. In the course work, they will participate in actual innovation projects in SPARK Finland and make surveys such as IP, regulator, competitor and market analysis for the projects. Students present the group work as written document and as an oral presentation in a seminar. Student also assess the work of other groups and receive feedback.

Product development of biomedical devices (BMT-62356), 5 ECTS. Periods I–II in fall 2020.

Prerequisites: All other courses of this module (i.e. 15 credits) have to be done before this course. Students should have finished their BSc degree studies AND have obtained 50 credit units of MSc studies. Students must show that they have 30 credits from the field of biomaterials, biotechnology, biomedical engineering, medicine or related subjects. The course is intended for the students in their last study year for MSc degree (or for PhD students).

If you are unsure, contact responsible teacher for your qualifications.

After completing this course, the student:

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

More information on the course page.

Further information

Professors in charge:

Timo Allinniemi (timo.allinniemi@tuni.fi)
Minna Kellomäki (minna.kellomaki@tuni.fi)
Jari Hyttinen (jari.hyttinen@tuni.fi)
Alpo Värri (alpo.varri@tuni.fi)

Contact person in practical matters: Sanna Kivimäki (sanna.kivimaki@tuni.fi)

Type of study unit

Minor

Credits

5–30 ECTS

Teaching semester

2019–2020

Host university

Tampere University

Open for degree student

Yes

Open for non-student

Yes

Level of studies

Master

Teaching methods

Blended learning

Location

Tampere

Programme suitable for

For MSc or PhD students who want to get background for biomedical device or software commercialisation and regulation

Language

English

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