HL2034 Clinical Innovation and Design 9.0 credits

Klinisk innovation och design

  • Education cycle

    Second cycle
  • Main field of study

    Medical Engineering
  • Grading scale

    A, B, C, D, E, FX, F

Course offerings

Autumn 19 for single courses students - To application

  • Periods

    Autumn 19 P1 (4.5 credits), P2 (4.5 credits)

  • Application code


  • Start date


  • End date


  • Language of instruction


  • Campus

    KTH Flemingsberg

  • Tutoring time


  • Form of study


  • Number of places *

    Max. 20

    *) If there are more applicants than number of places selection will be made.

  • Application

    Apply for this course at antagning.se through this application link.
    Please note that you need to log in at antagning.se to finalize your application.

Autumn 18 for programme students

Autumn 18 for single courses students

  • Periods

    Autumn 18 P1 (4.5 credits), P2 (4.5 credits)

  • Application code


  • Start date


  • End date


  • Language of instruction


  • Campus

    Campus Flemingsberg

  • Tutoring time


  • Form of study


  • Number of places *

    Max. 20

    *) If there are more applicants than number of places selection will be made.

  • Course responsible

    Bertil Gonzalez Guve <guve@kth.se>

  • Teacher

    Bertil Gonzalez Guve <guve@kth.se>

  • Target group

    All master programs

Intended learning outcomes

The students will gain knowledge and practical experience on how to use thr BioDesign process frpm Stanford to create innovation in healthcare.

After taking the course the student should be able to:

1. describe the different steps in th e BioDesign process

2. describe how to execute the steps in Sweden and Europe

3. discuss why the steps are performed and in which order they should be conducted

4. apply the BioDesign method: Start with a need (provided from observations in healthacre)

5. choose suitable criteria to conduct need validation, concept generation, and concept validation

6. generate a buisiness plan

Course main content

The course consists of:

Twelve evening seminars, following the steps of the Biodesign process:


- Sem. 1-2: Needs Finding: Strategic Focus, Observation and Problem Identification, Need Statement Development

- Sem. 3-4: Need validation: Disease State Fundamentals, Treatment Options, Stakeholder Analysis, Market Analysis, Needs Filtering


- Sem. 5-6: Concept Generation: Ideation and Brainstorming, Concept Screening

- Sem. 7-8: Concept Selection: Intellectual Property Basics, Regulatory Basics, Reimbursement Basics, Business Models, Prototyping, Concept Selection


- Sem. 9-10: Development Strategy for: IP, R&D, Clinical, Regulatory, Sales

- Sem 11-12: Integration: Operating Plan and Financial Model, Business Plan Development, Funding Sources, Licensing

Feedback meetings:

After the seminars 4, 6, 8, and 10, each group gets an hour of feedback meeting with an expert.

Individual work:

- Preparations for seminars

- Making and presenting a poster after seminar 4

Group project:

- Generation of business plan and presentation


Eligible students should have completed a minimum of 180 credits. The course is interdisciplinary and we welcome a mix of students from different fields: technology, medicin, management, economy, design or other subjects viewed as relevant by the course organizer.

Proficiency in English corresponding to English A/English 6 is required.


Zenios, Makower and Yock, “Biodesign. The Process of Innovating Medical Technologies” ISBN 0521517427


  • PRO1 - Group project and presentation, 4.0, grading scale: A, B, C, D, E, FX, F
  • RED1 - Presentation, 2.5, grading scale: A, B, C, D, E, FX, F
  • SEM1 - Seminars, 2.5, grading scale: P, F

Part 1:

- Active participation in seminars, 2,5 credits

- Poster presentation, 2,5 credits. The poster presentation needs to be passed to be able to participate in part 2 of the course.

Part 2:

- Group project with oral presentation, 4 credits

Offered by

CBH/Biomedical Engineering and Health Systems


Bertil Gonzalez Guve (bertil.guve@sth.kth.se)


Bertil Gonzalez Guve <guve@kth.se>


Course syllabus valid from: Spring 2019.
Examination information valid from: Spring 2019.