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HL2034 Clinical Innovation and Design 9.0 credits

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Headings with content from the Course syllabus HL2034 (Spring 2019–) are denoted with an asterisk ( )

Content and learning outcomes

Course contents

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

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 disposition

No information inserted

Literature and preparations

Specific prerequisites

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.

Recommended prerequisites

No information inserted


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

Examination and completion

If the course is discontinued, students may request to be examined during the following two academic years.

Grading scale

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


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

Based on recommendation from KTH’s coordinator for disabilities, the examiner will decide how to adapt an examination for students with documented disability.

The examiner may apply another examination format when re-examining individual students.

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

Opportunity to complete the requirements via supplementary examination

No information inserted

Opportunity to raise an approved grade via renewed examination

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Ethical approach

  • All members of a group are responsible for the group's work.
  • In any assessment, every student shall honestly disclose any help received and sources used.
  • In an oral assessment, every student shall be able to present and answer questions about the entire assignment and solution.

Further information

Course web

Further information about the course can be found on the Course web at the link below. Information on the Course web will later be moved to this site.

Course web HL2034

Offered by

Main field of study

Medical Engineering

Education cycle

Second cycle

Add-on studies

No information inserted


Bertil Gonzalez Guve (