Course syllabus

Course-PM

EEN040 Development of medical devices lp2 HT19 (7.5 hp)

Course is offered by the department of Electrical Engineering

Contact details

Faculty

• Max Ortiz Catalan, Examiner and Lecturer, maxo@chalmers.se
• Sabine Reinfeldt, Lecturer, sabine.reinfeldt@chalmers.se
• Hana Dobsicek Trefna, Lecturer, hanatre@chalmers.se
• Torbjörn Lundh, Lecturer, torbjorn.lundh@chalmers.se

Teacher assistants (TAs)

• Eva Lendaro, lendaro@chalmers.se
• Autumn Naber, naber@chalmers.se
• Massimiliano Zanoli, zanoli@chalmers.se

2019 Student representatives:

MPBME   bakidou@student.chalmers.se       Anna Bakidou
MPBME   makris@student.chalmers.se          Melina Makris
UTBYTE  maitaneolaizola@gmail.com            Maitane Olaizola
MPBME   davidsandersongull@gmail.com   David Sanderson Gull

Course purpose

This course aims to provide specific knowledge in the ideation, creation, and certification of medical devices including product development procedures.

Schedule

TimeEdit

Preliminary Schedule:

Dates	W-crs	W-yr	Mond	Tuesd	Wednesd	Thursd	Frid
4-8 nov	1	45	x	10-12:L1	8-10:L2	x	10-12:P-CS
11-15 nov	2	46	x	10-12:L3	8-10:L4	x	10-12:P1
18-22 nov	3	47	x	10-12:L5	8-10:L6	x	10-12:P2
25-29 nov	4	48	x	10-12:L7	8-10:L8	x	10-12:P3
2-6 dec	5	49	x	10-12:L9	8-10:L10	x	10-12:P4
9-13 dec	6	50	x	10-12:L11	8-10:L12	x	10-12:P5
16-20 dec	7	51	x	10-12:PF1	8-10:PF2	x	10-12:PF3
6-10 jan	8	52	x	x	x	x	x

 

Lectures	Topic				Lecturer
L1	Intro + needs and market				Max
L2	Ethics + Ideation				Torbjörn / QRTech
L3	Regulatory affairs - EU				Ajrula Zuta
L4	Regulatory USA and world				Ajrula Z. / Marcus Holmberg
L5	Testing - Bench				Lennart Hasselgren
L6	Testing - Animals				Cecilia Bull
L7	Testing - Humans				Sandra Olsson
L8	Intellectual property (IP)				Fredrik Ö. (KW)
L9	Product development				Erik Holgersson
L10	Product development				Mikael Duvander
L11	Business matters
L12	1. Hy5 / 2.Innv. Ecosys CTH				Ola Kyrkjebø/ Tomas Faxheden

Presentations:

P-CS: Nils Löfgren, Alten

P1-P5: Students' weekly presentations

PF1-3: Students' final presentations

Guest lectures
Name	Ajrula Zuta
Education	MSc in Chemistry, European Regulatory Affairs Certified
Position	Regulatory Affairs consultant.
Mail	ajrula@meddev.se
Bio	Having worked for several medical device companies for more than 21 years, Ajrula developed knowledge and understanding of the global regulatory environment. Ajrula have strong regulatory expertise, with knowledge of the global medical device regulatory environment, and proven record of providing valuable strategic and regulatory input throughout the product lifecycle for the US, EU, Japanese, Australian and Canadian medical device markets. Ajrula core competencies include regulatory compliance and strategy, regulatory submissions and liaison with regulatory bodies, design control, post market surveillance, quality assurance and quality auditing
Topics	Regulatory Affairs
Name	Mikael Duvander
Education	M.Sc. EE, Chalmers University
Position	Business Unit Manager Electronics, i3tex AB
Mail	Mikael.Duvander@i3tex.com
Bio
Lecture	A walk through of a medtech project. Includes examples concerning Product structure, block schematics, EMC, IP, Risk management, Usability, Handling of documents, external testing, Traceability, Biocomp, etc.
Name	Charlotta Aguirre Nilsson
Education	M.Sc. Biomedical Engineering (CTH)
Position	Software Responsible (Mjukvaruansvarig, SWKA)
Mail	charlotta.aguirre.nilsson@qrtech.se
Bio	Has been working with machine learning and image analysis within the automotive industry as well as medtech. Additionally she has good knowledge from simulations and product testing. Today, she’s working as Software Responsible on the Component side and is responsible for that the software is delivered as expected.
Lecture	Ethics
Name	Medina Velic
Education	M.Sc. Biomedical Engineering (CTH)
Position	Software Engineer
Mail	medina.velic@qrtech.se
Bio	Has been working with machine learning and image analysis in different fields, including the medtech industry. Additionally she has been working within the automotive field, focusing on software development.
Lecture	Ethics
Name	Erik Holgersson
Education	M.Sc. Material/Medical (M, CTH)
Position	Group Manager R&D Oticon Medical
Mail	eiho@oticonmedical.com
Bio	Erik is working as group manager of Oticon Medical´s R&D function in Gothenburg. He has previously held various positions at Cochlear as Developer, Project Manager and leading the System Engineering Function. He later held positions at Mölnlycke as Project Manager, Technical category manager for their electro-mechanical devices.  He holds a MSc in Mechanics but has worked throughout his career with multidisciplinary technical disciplines. He overall have a good awareness of the requirements developing devices within Medtech field.
Topics	Product development
Name	Marcus Holmberg
Education	MSc Electrical engineering, Chalmers; PhD (Dr.-Ing.) in hearing research, Darmstadt University of technology
Position	Senior Director, Clinical Affairs BAHS, Oticon Medical AB
Mail	mhol@oticonmedical.com
Bio	Marcus Holmberg is Senior Director, Clinical Affairs at Oticon Medical and is responsible for the clinical documentation, research and training for bone anchored hearing systems. Holmberg has an  engineering background and carried out his doctoral research on models of speech encoding in the inner ear and auditory brainstem. Prior to joining Oticon Medical, Holmberg worked with audiology of high-end hearing aids at Oticon in Copenhagen as well as a stint as head of audiology at the world’s first “hearables” company Bragi.
Topics	Regulatory
Name	Nils Löfgren
Education	PhD in Electrical Engineering, Chalmers - "The EEG of the Newborn Brain - Detection of Hypoxia and Prediction of Outcome, MSc in Electrical Engineering, Chalmers
Position	Vice Managing Director at Larix, an Alten Group company
Mail	nil@larixcro.com
Bio	My passion is within Life Science and I have been active both in medical devices and pharmaceuticals. With background in biomedical engineering companies, the multinational consultance business, and academia, I have a broad understanding of various perspectives of management, product development, business development, sales strategies, and recruitment. My background is technical, and always with a drive to connect with people from different fields and an enthusiasm for taking on challenging tasks.
Topics	P-CS: Medical device development exemplified
Name	Tomas Faxheden
Education	Master's of Law, Intellectual Capital Management
Position	Innovation Adviser/Management Support to the Vice President for Utilisation
Mail	tomas.faxheden@chalmers.se
Bio	Before joining the Innovation Office I worked as School Manager at Chalmers School of Entrepreneurship and Project Manager at the Department for Technology Management and Economics
Topics	The lecture is an overview of the entrepreneurial ecosystem at Chalmers, and in particular support for students

 

 

Course literature

Durfee and Laizzo, Medical Device Innovation Handbook, University of Minnesota, 2017. Available at https://sites.google.com/a/umn.edu/mdih/

Course design

This is a project-based course. Students will take an idea for a medical devices through the process of developing it into a potential product. Students are encourage to explore their own ideas for a medical device. If the students do not have their own idea, case studies/projects will be provided.  

Students must form groups of 3 people (2 people in special circumstances). Registration of the groups is done in Canvas.

There are three lectures per week. New concepts will be introduced in first two lectures (Tuesdays and Wednesdays), and students will present the application of such concepts to their project in the third lecture (Fridays). Observe the following requirements for student presentations:

• All students should present equally (distributed over all presentations)
• A student can only miss two presentation sessions to pass this course
• All students must participate in the final presentation of their project (Dec, 16-20) 

 

Learning objectives and syllabus

Learning objectives:

• explore the implementation of technologies within the field of medicine;
• classify a medical device according to European and USA regulations;
• implement a verification and validation plan for a medical device;
• judge which type of tests that are needed for verification and validation of a medical device;
• perform risk assessments of medical devices;
• implement projects which meet the technical and safety requirements of medical devices;
• confront criteria in the decision-making process, and make judgements from information which may be incomplete or limited within the field of biomedical engineering;
• apply previously developed knowledge and skills to work with engineering solutions in medicine;
• identify value creation for external stakeholders;
• seek and acquire information from relevant scientific publications when working in a project team;
• in oral presentations and written report in English, describe a medical device development process; and
• reflect on own and other's abilities and roles in relation to project work.

Link to the syllabus on Studieportalen.

Examination form

The grading of this course is divided as follow:

• Project - 6.0 p
• Laboratories - 1.5 p

To approve this course students must:

• Complete the project report
• Complete all laboratories
• Participate in the final presentation of their project (16-20 - Dec - 2019)
• Be present in their project presentations. A maximum of two sessions can be missed under special circumstances.

Changes made since the last occasion

This is the first time this course is taught.