phd in medical device design

MEMP PhD Program

Hst’s memp phd program, is this program a good fit for me.

HST’s Medical Engineering and Medical Physics (MEMP) PhD program offers a unique curriculum for engineers and scientists who want to impact patient care by developing innovations to prevent, diagnose, and treat disease. We're committed to welcoming applicants from a wide range of communities, backgrounds, and experiences.

How is HST’s MEMP PhD program different from other PhD programs?

As a MEMP student, you’ll choose one of 11 technical concentrations and design an individualized curriculum to ground yourself in the foundations of that discipline. You’ll study medical sciences alongside MD students and become fluent in the language and culture of medicine through structured clinical experiences. You’ll select a research project from among laboratories at MIT, Harvard, affiliated hospitals and research institutes , then tackle important questions through the multiple lenses of your technical discipline and your medical training. As a result, you will learn how to ask better questions, identify promising research areas, and translate research findings into real-world medical practice.

What degree will I earn?

You’ll earn a PhD awarded by MIT or by the Harvard Faculty of Arts and Sciences.

What can I do with this degree?

Lead pioneering efforts that translate technical work into innovations that improve human health and shape the future of medicine.

How long will it take me to earn a PhD in HST’s MEMP program?

Similar to other PhD programs in MIT's School of Engineering, the average time-to-degree for MEMP PhD students is less than six years.

What are the degree requirements?

Science / engineering.

Choose one of the established concentration areas and select four courses from the approved list for the chosen area. Current MEMP concentration areas are:

• Aeronautics & Astronautics
• Biological Engineering
• Brain & Cognitive Sciences
• Chemical Engineering
• Computer Science
• Electrical Engineering
• Materials Science & Engineering
• Mechanical Engineering
• Nuclear Engineering

Harvard MEMPs fulfill Basic Science/Engineering Concentration and Qualifying Exam through their collaborating department (SEAS or Biophysics).

Biomedical Sciences and Clinical Requirements

Biomedical sciences core.

• HST030 or HST034: Human Pathology
• HST160: Genetics in Modern Medicine
• HST090: Cardiovascular Pathophysiology

Restricted Electives - two full courses required*

• HST010: Human Anatomy
• HST020: Musculoskeletal Pathophysiology*
• HST100: Respiratory Pathophysiology**
• HST110: Renal Pathophysiology**
• HST130: Introduction to Neuroscience
• HST162: Molecular Diagnostics and Bioinformatics*
•  HST164: Principles of Biomedical Imaging*
• HST175: Cellular & Molecular Immunology

*  May combine two half-courses to count as one full course **Must choose at least one of HST100, HST110

Clinical Core

• HST201: Intro. to Clinical Medicine I and HST202: Intro. to Clinical Medicine II
• HST207: Intro. to Clinical Medicine

PhD Thesis Guide

Letter of intent #1:.

Research advisor and topic. Due by April 30 of 2nd year.

Letter of Intent #2:

Tentative thesis committee. Due by April 30 of 3rd year.

Thesis proposal:

Defended before thesis committee. Due by April 30 of 4th year.

Final Thesis:

Public defense and submission of final thesis document.

Harvard MEMPs must an electronic copy of the final thesis including the signed cover sheet. Harvard MEMPs should not register for HST.ThG.

Qualifying Exam

TQE: Technical qualification based on performance in four concentration area courses and Pathology

OQE: Oral examination to evaluate ability to integrate information from diverse sources into a coherent research proposal and to defend that proposal

Professional Skills

Hst500: frontiers in (bio)medical engineering and physics.

Required spring of first year

HST590: Biomedical Engineering Seminar

Required fall semester of first year. Minimum of four semesters required; one on responsible conduct of research and three electives. Topics rotate.

Required for all MEMP students. (Biophysics students may substitute MedSci 300 for HST590 term on responsible conduct of research.)

Professional Perspectives 

Required once during PhD enrollment 

What can I expect?

You’ll begin by choosing a concentration in a classical discipline of engineering or physical science. During your first two years in HST, you’ll complete a series of courses to learn the fundamentals of your chosen area.

In parallel, you’ll become conversant in the biomedical sciences through preclinical coursework in pathology and pathophysiology, learning side-by-side with HST MD students.

With that foundation, you’ll engage in truly immersive clinical experiences, gaining a hands-on understanding of clinical care, medical decision-making, and the role of technology in medical practice. These experiences will help you become fluent in the language and culture of medicine and gain a first-hand understanding of the opportunities for — and constraints on — applying scientific and technological innovations in health care.

You’ll also take part in two seminar classes that help you to integrate science and engineering with medicine, while developing your professional skills. Then you’ll design an individualized professional perspectives experience that allows you to explore career paths in an area of your choice:  academia, medicine, industry, entrepreneurship, or the public sector.

A two-stage qualifying examination tests your proficiency in your concentration area, your skill at integrating information from diverse sources into a coherent research proposal, and your ability to defend that research proposal in an oral presentation.

Finally, as the culmination of your training, you’ll investigate an important problem at the intersection of science, technology, and medicine through an individualized thesis research project, with opportunities to be mentored by faculty in laboratories at MIT, Harvard, and affiliated teaching hospitals.

Interested in applying? Learn about the application process here.

HST MEMP grad Grissel Cervantes-Jaramillo’s road to a PhD began in Cuba and wound through Florida

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Medical Technology Design (MedTech): Master's Degree and Certificate

Discover. Design. Deploy.

The global markets for medical devices is growing fast — by $7 billion a year in the United States alone, by one estimate.

Few universities are as equipped as Duke to deliver best-in-class graduate education in medical technology design. Learn why Duke is the leader

Duke BME offers two options in this exciting and high-impact field:

• Master of Engineering degree
• Graduate certificate

Contact admissions »

" Duke's advanced medical technology design courses reminded me of the impact engineering can make." ALEJANDRO PINO , MD | Pulmonologist and ELECTRICAL ENGINEER

3 Reasons Why Duke leads in MedTech design

1. Innovation is in our DNA

• First accredited BME major in the United States
• First real-time 3-D ultrasonic scanner
• First patented bioabsorbable vascular stent

2. Our faculty has decades of real-world experience

• Best practices in design, from needs-finding to prototyping to development
• Obtaining regulatory approval and licensing
• Creating curricula and courses aligned to industry needs

3. Our students work on real-world design challenges

• MedTech master's students team with Duke Health clinicians
• Student teams have the real possibility of making real impacts
• At job interviews, our graduates have those all-important, real-life stories to tell

Hear just one of those stories—

Master of Engineering Degree

Become a designer through intensive, hands-on experiences

The core of Duke's MedTech Design Master of Engineering is a carefully curated program of lockstep courses.

As they progress through a diverse series of projects, our master's students build strong, practical design skills.

In addition to design courses, you'll complete:

• Core courses on management fundamentals for high-tech and MedTech design industries
• A required course in advanced mathematics and another in a life science topic
• A required internship

How to Get Started

Apply to this Duke Master of Engineering program. How to apply »

Sample Course Schedule

  Browse course descriptions »

Graduate Certificate

The Duke graduate certificate in medical device design exposes students in other Duke BME master's programs to a four-course design skills sequence. Completion of the certificate is noted on your Duke transcript.

This certificate program is open to students in Duke BME master's degree programs in biomedical engineering:

• Master of Science (MS)
• Master of Engineering (MEng)

The four (4) MedTech Design courses that fulfill this graduate certificate provide 12 of the 30 course credits required to complete a master's degree in BME at Duke:

• Advanced Design and Manufacturing, or Medical Electrical Equipment
• Design in Health Care 1, or Design in Health Care 3
• Design in Health Care 2
• Quality Management Systems

Browse course descriptions »

How to Start the Certificate

Apply to the certificate program during your first semester at Duke BME. The certificate is completed during your second and third semesters.

But first , apply to a Duke master's program in biomedical engineering. More about our master's degrees »

Paul J. Fearis

Associate Professor of the Practice of Biomedical Engineering

An engineer and industrial designer with decades of experience as a product development consultant to the medical device industry and lecturer at Johns Hopkins University. More »

Kristy Fearis

A biomedical engineer who has managed R&D teams at Medtronic and Edwards Lifesciences who is a specialist in quality management systems and product commercialization. Certified ASQ Quality Manager and Auditor. More »

Joseph A. Knight

Adjunct Professor

He is president & CEO of InnAVasc Medical Inc., a biomedical engineer, and an MBA graduate of Duke's Fuqua School of Business.  More »

Eric S. Richardson

A biomedical engineer who has managed R&D teams at Medtronic and the founder of two innovation programs at Rice University.  More »

Course Descriptions

This course is designed to bring the practical application of academic engineering to medical design while developing design skills that can be immediately transferred to industry projects—making students attractive prospects to industry recruiters.

The skills course establishes a mindset and set of practical skills that form a foundation for the Design Health sequences. Students also start to build a portfolio of design projects to showcase their design thinking.

Through a series of modules, the skills course introduces Design for Manufacture and important concepts around production cost and the interplay between design choices, manufacturing processes and cost. Medical image reconstruction and the design of an implanted device take students inside the body, designing for specific anatomy and bio-compatibility.

The Duke skills course is supported by industry leader Protolabs, and the program is hugely grateful for their input and assistance in readying students for careers in design and development.

This course will make students aware of the design process and considerations associated with electronics and software functionality in medical devices. Electronic hardware topics will include microcontrollers, data communication protocols (e.g., SPI, I2C, Bluetooth, WiFi, Zigbee), power supplies, analog and digital signal management, UI/UX for input/output, electronic signal transduction, heat management, PCB layout and fabrication, and cabling and connectors.

This course concentrates upon the identification of medical device innovation opportunities through the detailed identification and analysis of unmet, underserved and unarticulated stakeholder needs. Students work closely with clinical staff from Duke Health and other clinical experts to identify needs through primary qualitative research including first-hand observation, stakeholder interviews and other secondary processes.

Utilizing industry best-practice techniques captured in the Insight Informed Innovation process students take a broad area of focus and work with clinicians, engineering and business faculty to focus, identify and specify impactful opportunities that will become the basis of design projects take forward in the Design in Healthcare 2– Design course.

Students define their projects, considering clinical impact, regulatory and reimbursement strategy, technical feasibility and interest with an eye to the generation of intellectual property, licensing and/or startup opportunities.

In this course, teams take a validated problem from Design in Healthcare 1— Discovery , and then generate broad ranges of solutions, iterate, and mature toward proof of principle and proof of (market) concept prototypes.

Students work in multidisciplinary teams, representative of industry team make-up, including clinical, engineering and business functions to develop engineering solutions, business plans and supporting regulatory documentation as would be required in industry.

Design in Healthcare 2 draws heavily upon the Skills and Quality courses, training students to consider product development as a holistic process where decisions are complex and interrelated.

The course is taught by industry veterans who maintain active industry roles and projects in order to stay current and relevant.

This course progresses a group of active projects from Design in Health Care 2— Design , and other sources, to a level of maturity appropriate for the consideration of licensing and/or startup opportunities.

Largely self-guided, student teams apply risk management and other practices to eliminate unknowns, and generate supporting performance and usability data and investor pitches.

Interaction with Duke Engineering Entrepreneurship (EngEn) and Duke's licensing and venture functions brings a sharp focus to projects—exposing students to the realities of the medical device business today.

Quality Management Systems (QMS) form the backbone of medical device companies, from specification through development to regulatory submission and commercial launch, medical device designers must be comfortable working with and producing a broad spectrum of supporting documentation.

Using projects from the Design in Health Care courses as the active vehicle, this course introduces students to the workings of industry quality management systems and standards adherence.

Students generate QMS documentation to support development, risk management, design controls and regulatory submissions.

The course is taught by an American Society of Quality-certified Quality Manager and Quality Auditor and equips students with up-to-date practices designed to make the transition into a regulated industry seamless.

After an introduction to the broader landscape of healthcare innovation (including BioTech, MedTech, and Pharma), the course provides a high-level introduction to the key non-technical areas to consider when bringing forward a medical device—including regulatory, reimbursement, business model, funding, sales, and marketing.

The focus is not only on a basic understanding of each area but also on the interplay between and among each. The course concludes with an exploration of finance-related topics where students learn the importance and application of financial statements to medical device innovation, as well as various methods of how a MedTech company is ultimately valued at acquisition.

This course addresses critical qualities of leadership, management skills, and decision-making in complex environments.

Essential topics include:

• Leadership and communication principles
• Strategic decision-making where outcomes depend on high technology
• Management of project-based and team-based organizational structures
• Role of the manager in expertise-driven organizations

Medical Device Innovation

Medical Device Innovation is a one-quarter, project-based course that invites freshmen and sophomores to invent and build medical devices, to learn how medical innovations are brought from concept to clinical adoption, and to apply design thinking to the broader healthcare system.

Through two design projects, students gain early exposure to clinical need identification, stakeholder interviews, ideation, and prototyping. Experts on intellectual property, FDA regulation, reimbursement, and startup financing introduce non-technical factors that help shape an innovation’s path to impact. Healthcare entrepreneurs and innovators illustrate course themes by sharing their own stories of failure and success.

Enrollment is managed through the Stanford Introductory Seminars website. Visit exploreintrosems.stanford.edu for more information, including application instructions and deadlines. Question? Contact Ryan Pierce .

• Introduce students to the process of medical device design, to the non-technical factors that impact a medical technology’s clinical and market success, and to emerging themes that are shaping healthcare innovation.
• Challenge students to apply design thinking to the broader healthcare system.
• Accelerate exposure to the medical device industry to the early undergraduate years, when students are choosing majors, internships, and extracurricular activities.
• Build students’ capability and confidence as problem solvers and communicators, transferable to any career path they choose.

What the Students Are Saying…

“BIOE 70Q gave me the privilege to learn and try out the design thinking process, which was an invaluable experience for me. In addition, having the chance to be under the tutelage of such seasoned entrepreneurs and investors was truly a once in a lifetime experience that I will carry with me post-undergrad.”

“Would 100% recommend this class. You learn so much that has real-life applications…. This course is great for anyone interested in medical device innovation. This has been one of my favorite classes at Stanford.”

“This was a great course. I learned many useful things, including need finding, medical device design, and prototyping. The speakers were all fantastic.”

“If you are thinking at all about health tech or medical device entrepreneurship as a career – TAKE THIS COURSE! Really great way to build connections and understand the field better.”

Course Leaders

2.75/2.750: Medical Device Design

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Class Information

Fall | Undergraduate/Graduate | 12 Units | Prereq:  2.008 ,  6.101 ,  6.111 ,  6.115 ,  22.071 , or permission of instructor

Provides an intense project-based learning experience around the design of medical devices with foci ranging from mechanical to electro mechanical to electronics. Projects motivated by real-world clinical challenges provided by sponsors and clinicians who also help mentor teams. Covers the design process, project management, and fundamentals of mechanical and electrical circuit and sensor design. Students work in small teams to execute a substantial term project, with emphasis placed upon developing creative designs - via a deterministic design process - that are developed and optimized using analytical techniques. Instruction and practice in written and oral communication provided. Students taking graduate version complete additional assignments. In person not required. Enrollment limited.

Class Website

Instructor Information

Alexander Slocum (Fall,Spring)

Walter M. May (1939) and A. Hazel May Chair in Emerging Technologies

Interest Areas

• Precision machine design
• Medical device design
• Machines for the energy industry

Nevan Hanumara (Fall,Spring)

Research Scientist 3

• Medical devices
• Human-centered design
• Technology translation

Giovanni Traverso (Spring)

Karl Van Tassel (1925) Career Development Professor

• Biomedical device development
• Ingestible and implantable robotics
• Drug delivery for optimal drug adherence

Anthony Pennes (Spring)

Technical Instructor

• Engineering education
• Electronic design
• Electro-mechanical systems

Engineering Medical Devices

Mechanical engineering students from MIT work with clinicians from Boston-area hospitals to design cheaper, safer, and more efficient medical devices.

• © 2021

Humanizing Healthcare – Human Factors for Medical Device Design

• Russell J. Branaghan 0 ,
• Joseph S. O’Brian 1 ,
• Emily A. Hildebrand 2 ,
• L. Bryant Foster 3

Research Collective, Tempe, USA

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• Teaches readers to design medical devices that are safer, more effective, and less error prone
• Explains the role and responsibilities of regulatory agencies in medical device design
• Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing

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• Table of contents

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Table of contents (15 chapters)

Front matter, introduction.

Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Qualitative Human Factors Research Methods

Quantitative human factors research, usability evaluation, visual perception, human factors regulations for medical devices, controls: designing physical and digital controls, human–computer interaction, designing instructions for use(rs), reusable medical devices, reprocessing, and design for maintenance, home healthcare, back matter.

This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs.

• Teaches readers to design medical devices that are safer, more effective, and less error prone;
• Explains the role and responsibilities of regulatory agencies in medical device design;
• Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.
• Human Factors
• Biomedical engineering
• Medical device
• Usability testing
• User Experience
• Patient Safety
• Industrial design
• Quality assurance
• Regulatory affairs
• quality control, reliability, safety and risk

Book Title : Humanizing Healthcare – Human Factors for Medical Device Design

Authors : Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

DOI : https://doi.org/10.1007/978-3-030-64433-8

Publisher : Springer Cham

eBook Packages : Engineering , Engineering (R0)

Copyright Information : Springer Nature Switzerland AG 2021

Hardcover ISBN : 978-3-030-64432-1 Published: 22 February 2021

Softcover ISBN : 978-3-030-64435-2 Published: 23 February 2022

eBook ISBN : 978-3-030-64433-8 Published: 21 February 2021

Edition Number : 1

Number of Pages : XXVIII, 395

Number of Illustrations : 21 b/w illustrations, 162 illustrations in colour

Topics : Biomedical Engineering and Bioengineering , Biomedical Engineering/Biotechnology , Quality Control, Reliability, Safety and Risk , Industrial Design , User Interfaces and Human Computer Interaction

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• Postgraduate taught

Medical Device Design and Entrepreneurship

Develop research and analytical skills towards a career in bioengineering or for further PHD study.

Develop research and analytical skills towards a career in bioengineering or for further PHD study

Get industry recognition with an accredited degree

Receive dedicated training in medical device entrepreneurship

Course key facts

Qualification, september 2024, £17,600 home, £40,900 overseas, delivered by, department of bioengineering, south kensington, minimum entry standard, 2:1 in an engineering, physical sciences, mathematical, life sciences or biomedical sciences subject, course overview.

Build your appreciation of biomedical engineering and enhance your entrepreneurial skills on this Master's course.

You'll develop research and analytical skills related to bioengineering before specialising in the area of medical device development.

You'll then examine the processes required to get a device to market, from concept to business planning and market emergence.

Much of the training is based around a year-long project aimed at developing a start-up business plan around a medical device concept.

This work will prepare you for further PhD study, or an innovative research career in bioengineering or business.

This page is updated regularly to reflect the latest version of the curriculum. However, this information is subject to change.

Find out more about potential course changes .

Please note:  it may not always be possible to take specific combinations of modules due to timetabling conflicts. For confirmation, please check with the relevant department.

Core modules

Optional modules.

• Major Individual Project

You’ll take all of these core modules.

Medical Device Entrepreneurship

Explore various aspects of medical device entrepreneurship, looking at case studies from start-ups, industry and investment firms to gain a sense of the process and challenges in developing your own business idea.

Computational and Statistical Methods for Research

Discover the basics of python programming and statistical methods and understand the underlying concepts of statistics.

Topics in Biomedical Engineering and Business

Choose from a wide range of modules examining key aspects of biomedical engineering and business.

Planning for Medical Device Entrepreneurship

Begin the background research and planning for your project.

For the Topics in Biomedical Engineering and Business module, you'll choose two or four optional modules.

Example modules are shown here, but are subject to availability.

Advanced Biomaterials and Tissue Engineering

Discover, describe, and differentiate diverse ranges of biomaterials and their synthesis and functional characterisation.

Advanced Chemical Sensors

Analyse the different methods of (bio)chemical sensors and understand basic chemical sensing principles and their application.

Advanced Imaging Technologies for Systems Biology

Examine advanced imaging technologies and critically evaluate and design imaging experiments to analyse dynamic processes in complex biological systems.

Advanced Physiological Monitoring and Data Analysis

Explore the core aspects of biological and clinical measurement such as data handling, sampling and measurement.

Bioengineering Approaches to Cancer

Understand the fundamental biological and biophysical processes involved in cancer and the application of bioengineering to better understand and manage the disease.

Biomaterials for Bioengineers

Become familiar with the major classes of biomedical implant materials including metals, ceramics and polymers.

Biomechanics

Explore the principles of mechanics, such as solid mechanics and fluid mechanics, and their application to living systems.

Biomimetics

Cover the scope of biomimetics and investigate the principles that help engineers solve technical problems using inspiration from nature.

Brain Machine Interfaces

Discover technology used in clinical settings for interfacing of the human brain to electronic circuitry.

Cellular and Molecular Mechanotransduction

Study biomechanics on a cellular scale and investigate methods of sensing and cell manipulation.

Computational Neuroscience

Appreciate the role of computational and theoretical approaches to understanding the nervous system.

Engineering in Cancer Therapy

Understand the basic physics of ionising radiation as safely implemented in radiotherapy, and review the range of applications used in the treatment of patients.

Hearing and Speech Processing

Learn about the neurobiology of hearing and the characteristics of speech and the principles of its processing.

Human Neuromechanical Control and Learning

Assess the control of human movement from the perspective of both adaptation of the neural control system and adaptation of properties of the mechanical plant.

Image Processing

Examine digital image processing relevant to image analysis and appreciate aspects of computation involved in interpreting images.

Industrial Applications of Cellular Engineering

Assess the different industrial applications of cellular engineering and synthetic biology and learn about engineering cell behaviours in a variety of fields.

Ionising Tissue and Flow imaging

Appreciate the basic physics of nuclear medicine and discover the range of applications used in the diagnosis and treatment of patients.

Mathematical Methods for Bioengineers

Analyse a range of appropriate mathematical models to model biological systems and analyse complex biological data.

Medical Device Certification

Deepen your understanding of the key skills needed by professional engineers in the development of medical systems and devices, specifically in the preparation of regulatory approval.

Molecular Cellular and Tissue Biomechanics

Analyse engineering principles and approaches towards the study of biomechanical behaviour from a cellular to tissue scale.

Nanotechnologies for Cancer Diagnosis and Cancer Therapy

Explore the latest nanotechnological advances in the field of cancer diagnostics and cancer therapies.

Neuroscience

Gain a grounding in core neuroscience concepts and understand the ‘state of the art’ with regard to research methodology.

Non-ionising Functional and Tissue Imaging

Become familiar with the latest advanced features of medical imaging (CT, X-ray, MR and US) and their use in modern hospital practice.

Orthopaedic Biomechanics

Discover the mechanics of the musculoskeletal system, including the structure and function of the musculoskeletal tissues.

Principles of Biomedical Imaging

Examine how images of the body can be obtained using different forms of penetrating radiation and how different forms of imaging work.

Reinforcement Learning

Understand reinforcement learning and its mathematical foundations.

Systems Physiology

Learn how to describe organ systems and their functions, covering everything from the cardiovascular system to brain function and the musculoskeletal and respiratory systems.

Tissue Engineering and Regenerative Medicine

Examine fundamental concepts in normal tissue development and discuss their imitation within a lab setting.

Build on the knowledge and skills from the course and apply them to current engineering, design and research problems that interest you. 

The project  helps you to develop important project management, team working and communication skills that are highly valued by employers and

international research groups.

The  majority of work is undertaken in the summer term, when you will be expected to work on the project full time

The project may involve collaboration with groups in other Imperial departments or with Industry.

Wed 6 March 2024, 14.00 – 16.00 GMT

Bioengineering Masters Courses Open afternoon

If you’re interested in studying a Masters course with the Department of Bioengineering at Imperial, come along to our in-person afternoon to find out more about our courses. Please note: this event is an in-person event only.

Royal School Of Mines, South Kensington Campus

Professional accreditation

This degree is accredited by the  Institution of Engineering and Technology  (IET), the  Institution of Mechanical Engineers  (IMechE), the  Institute of Materials, Minerals and Mining  (IOM3) and  Institution of Engineering Designers  (IED), on behalf of the Engineering Council as meeting the requirements for Further Learning for registration as a Chartered Engineer.

Our accreditation agreements are renewed every five years and the current agreement runs until 2023.

Teaching and assessment

Balance of teaching and learning.

• Lectures and tutorials
• Independent study
• Research project
• 4% Lectures and tutorials
• 18% Independent study
• 78% Research project

Teaching and learning methods

Balance of assessment.

• 45% Coursework
• 50% Practical

Assessment methods

Entry requirements.

We consider all applicants on an individual basis, welcoming students from all over the world.

• Minimum academic requirement
• English language requirement
• International qualifications

2:1 in an engineering, physical sciences, mathematical, life sciences or biomedical sciences subject.

All candidates must demonstrate a minimum level of English language proficiency for admission to the university.

For admission to this course, you must achieve the  standard university requirement  in the appropriate English language qualification. For details of the minimum grades required to achieve this requirement, please see the  English language requirements .

We also accept a wide variety of international qualifications.

The academic requirement above is for applicants who hold or who are working towards a UK qualification.

For guidance see our accepted qualifications  though please note that the standards listed are the  minimum for entry to the College , and  not specifically this Department .

If you have any questions about admissions and the standard required for the qualification you hold or are currently studying then please contact the relevant admissions team .

How to apply

You can submit one application form per year of entry. You can choose up to two courses.

Application deadlines – Round 3 closes on Friday 5 July 2024

Application rounds

Applications will be considered in three rounds. When you apply will determine which round you are considered in and when you can expect a decision on your application.

• Apply by Friday 15 December 2023
• Decision can be expected by Friday 26 January 2024
• Apply by Friday 1 March 2024
• Decision can be expected by Friday 26 April 2024
• Apply by Friday 5 July 2024
• Decision can be expected by Friday 2 August 2024

We recommend that you apply as early as possible to give you the best chance of being considered for your preferred project.

Application fee

There is no application fee for MRes courses, Postgraduate Certificates, Postgraduate Diplomas, or courses such as PhDs and EngDs.

If you are applying for a taught Master’s course, you will need to pay an application fee before submitting your application.

The fee applies per application and not per course.

• £80 for all taught Master's applications, excluding those to the Imperial College Business School.
• £100 for all MSc applications to the Imperial College Business School.
• £150 for all MBA applications to the Imperial College Business School.

If you are facing financial hardship and are unable to pay the application fee, we encourage you to apply for our application fee waiver.

Read full details about the application fee and waiver

Application process

Find out more about  how to apply for a Master's course , including references and personal statements.

ATAS certificate (overseas candidates)

Unless you are from an exempt nationality, you will need an ATAS certificate to obtain your visa and study this course.

Nationals from the following countries are exempt: Switzerland, Australia, Canada, Japan, New Zealand, Singapore, South Korea, USA and EEA members.

Use this information when applying for an ATAS certificate to study this course:

• CAH code :  CAH10-01-06
• Descriptor : bioengineering, medical and biomedical engineering
• Supervisor name : Professor Anthony Bull

Get guidance and  support for obtaining an ATAS certificate .

Tuition fees

Overseas fee, inflationary increases.

You should expect and budget for your fees to increase each year.

Your fee is based on the year you enter the College, not your year of study. This means that if you repeat a year or resume your studies after an interruption, your fees will only increase by the amount linked to inflation.

Find out more about our  tuition fees payment terms , including how inflationary increases are applied to your tuition fees in subsequent years of study.

Which fee you pay

Whether you pay the Home or Overseas fee depends on your fee status. This is assessed based on UK Government legislation and includes things like where you live and your nationality or residency status. Find out  how we assess your fee status .

Postgraduate Master's Loan

If you're a UK national, or EU national with settled or pre-settled status under the EU Settlement Scheme, you may be able to apply for a  Postgraduate Master’s Loan  from the UK government, if you meet certain criteria.

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How will studying at Imperial help my career?

The first of its kind in the UK, this MRes aims to enhance medical device development.

The extensive research project will prepare you for further study and research at PhD level.

Gain transferable skills relevant to a career in biomedical engineering or similar fields.

With specialised knowledge, you'll be highly sought after in a range of sectors.

Medicine, healthcare and the medical device industry are just some of your options.

Other potential career paths could include research, teaching, start-ups, consultancy and finance.

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Level-up your career opportunities with an accelerated master’s degree. Learn to develop medical devices and work with industry sponsors to solve real-world problems.

What if you could save someone’s life by inventing a groundbreaking medical device? Do you want to know how technology is harnessed to meet healthcare needs? During our accelerated Master of Science in Medical Device Engineering (MSMDE) program, students:

• Approach design problems by understanding the clinical setting and user needs.
• Apply industry practices to develop and manufacture viable medical devices.
• Work in teams with industry sponsors to solve real-world problems.

The program expands the career opportunities of our graduates, preparing them for engineering and related roles in research, development, and production of medical devices in specialties such as in-vitro diagnostics, assistive technology, or drug delivery.

If you would like to have a conversation about the MSMDE program, contact the program director, Anna Hickerson, [email protected] , to set up a meeting.

Interested in the MSMDE program?

Complete this form to receive more information, program quick facts, msmde program details.

At KGI, we focus on developing students’ skills in areas identified by industry partners. This helps students quickly expand their career opportunities. The MSMDE program is intentionally designed using information gained through research and interviews with alumni and employers. The program has an exceptional record for completion of the program and job placement in the medical device industry.

The curriculum  covers the essential areas of expertise to apply engineering skills to the specialized field of medical devices and provides authentic experiences with the industry. 

In support of their courses, students have access to the Medical and Assistive Device (MAD) Lab. Students use the room to work on class projects, team master’s projects, research activities, and as a place to study. The lab is equipped with modern prototyping equipment for electronics and mechanical work, such as a laser cutter, vacuum former, electronic testing equipment, and 3D printers. Students use this space for collaborating, designing, prototyping, and showcasing their work.

Industry Experience

The MSMDE program leverages the strong industry relationships of the Henry E. Riggs School of Applied Life Sciences to provide authentic experiences and networking opportunities for our students. These include:

• Visiting speakers
• Case-based coursework
• Industry sponsored projects
• Alumni network
• Advisory Board connections 

Culminating in a capstone experience— the Team Master’s Project —students work in teams with an industry sponsor and faculty support on a medical device project that integrates the curricular elements into a single experience.

MedTech is a vast and steadily growing industry with a need for qualified engineers. The MSMDE program helps develop the most requested skills, including:

• Product development
• Project management
• Quality management

Students will also develop sought-after professional skills through practice and mentorship, including:

• Communication
• Teamwork/collaboration
• Problem solving
• Organizational skills

Graduates of the program have started their post-graduate careers in positions including:

• Research and Development Engineer
• Product Development Engineer
• Process Engineer
• Manufacturing Engineer
• Field Application Scientist
• Medical Student

The knowledge from the degree combined with the experience in these positions opens opportunities to quickly advance.

The MSMDE program is designed for those with a passion for medical devices and diagnostics who want to:

• Apply engineering to healthcare problems
• Design devices to diagnose and treat medical needs
• Lead the development of the next generation of transformative medical devices
• Plan and manage the production of medical devices to improve worldwide healthcare

KGI’s Medical Device Engineering Program Now a One-Year Accelerated Master’s 

What if you could save someone’s life by inventing a groundbreaking medical device? Keck Graduate Institute (KGI)’s Master of Science in Medical Device Engineering (MSMDE) program, which started in 2019 […]

#155—Dr. Anna Hickerson on Medical Device Engineering

In this episode of the KGI podcast, Dr. Anna Hickerson, associate professor and program director for KGI’s Master of Science in Medical Device Engineering program, talks about her background, the […]

What Are Different Types of Engineering Master’s Degrees?

Do you have an insatiable curiosity? Do you enjoy learning by doing? Are you a creative problem-solver who loves working with others to find innovative solutions to complex challenges? Consider […]

KGI Celebrates 2021-2022 Accomplishments During Awards and Recognition Ceremonies

In celebration of KGI’s accomplishments during the 2021-2022 academic year, the Henry E. Riggs School of Applied Life Sciences (Riggs School) and School of Pharmacy and Health Sciences (SPHS) hosted […]

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Anna iwaniec hickerson, phd, angelika niemz, phd, ed arnheiter, phd, kiana aran, phd, james sterling, phd, day in the life of an msmde student.

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The MAS in Medical Device Engineering (MDE) degree program was sunset in 2019 after graduating its seventh cohort with 100 graduate alumni. A key feature of the program was a 3-quarter capstone that required a combination of in-class, laboratory, and off-campus work. The capstone provided an opportunity for students to integrate knowledge acquired over previous quarters in a written report and oral presentation.

The MDE was a specialized degree that offered a focused cross-disciplinary technical education program catering to the needs of engineering professionals. The program provided:

• specialized courses in clinical needs assessment
• the option of designing and prototyping a medical device or instrument
• technical education in mechanics and transport, anatomy and physiology, biomaterials
• instruction in life science technologies, embedded controls, computer-aided design
• introduction to business issues including product launching, regulatory and payment issues, and standards and compliance

Fall Quarter

Medical Devices: Clinical Perspectives This course is a seminar series with invited clinician speakers intended to address needs and opportunities for meaningful application of engineering principles in clinical practice, with emphasis on next generation medical devices.

Winter Quarter

Fundamentals of Physiology and Anatomy A basic introduction to human physiology and anatomy form and function as it relates to clinical perspectives on patient needs. An emphasize will be on case studies of integrative physiology to understand how this information is useful in designing combination medical devices and instruments for diagnosis or research.

Mechanics and Transport Processes for Biomedical Device Design This course provides an advance overview of diffusion, heat and mass transfer, and transport processes in biological systems applicable to the design of biomedical devices. Application covers biosensor, heart-lung machines, dialysis machines, and microfluidic systems for analysis and drug delivery systems.

Spring Quarter

Computer Aided Design of Medical Devices Computer-Aided Analysis and Design with applications to medical devices. Solid model representation, finite element analysis for strength and deformation, material selection, kinematics, statistical analysis, and visualization of analytical results. Software packages used will include 3D CAD, FEA solvers, and student generated code. Analytical methods will be applied to case studies of medical devices.

Life Sciences and Technologies A general survey of modern high throughput instruments used for imaging and analyzing structure-function relationships at the molecular and cellular levels. An overview of potential human genomic and systems approaches for designing and validating medical device safety and performance.

Fall Quarter - Year Two

Design and Implementation of Medical Device Technology I Introduction of project-based course in medical device engineering, medical product regulation, quality systems and standards, engineering project management, and business development.

Biomaterials for Medical Device Design This class will cover biomaterials and biomimetic materials. Metal, ceramic, and polymer biomaterials will be discussed. Emphasis will be on the structure-property relationships, biocompatibility/degradation issues and tissue/material interactions. Synthesis and mechanical testing of biomimetic materials will also be discussed.

Winter Quarter - Year Two

Design and Implementation of Medical Device Technology II Second of a 3-quarter sequence, project-based course in medical device engineering, medical product regulation, quality systems and standards, engineering project management, and business development. Students will begin to design a medical device and an engineering strategy.

Embedded System Design This course gives an introduction to Digital Signal Processing (DSP) techniques and Data-Based Parameter Estimation (DBPE) techniques for the measurement, filtering and analysis of experimental data obtained with embedded systems in medical devices.

Spring Quarter - Year Two

Design and Implementation of Medical Device Technology III Third of a 3-quarter sequence, project-based course in medical device engineering, medical product regulation, quality systems and standards, engineering project management, and business development. Students will complete and implement their medical device design and engineering strategy.

Biobusiness: Small to Large Biotech is a special breed of business, especially in the start-up and early phases. Whether you are considering joining a biotech start-up or want to be successful in a life science organization, it pays to understand this unique business model. In this course, you will study and analyze (1) start-up proposals (2) the genesis of the biotech industry (3) biotech categories and growth strategies (4) the process of spinning out viable product concepts from academia (5) financing techniques (6) business development (7) acquisition/IPO valuation methods and (8) potentially disruptive technologies. The format is highly interactive and learning is enhanced by means of exercises, team presentations, and case studies.

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Systems thinking and designerly tools for medical device design in engineering curricula

Max schoepen.

a Department of Industrial Systems Engineering and Product Design, Ghent University, Ghent, Belgium

b Department of Human Structure and Repair, Ghent University, Ghent, Belgium

Ewout Vansteenkiste

c Department of Physics and Astronomy, Ghent University, Ghent, Belgium

Werner De Gersem

In this paper we focus on medical device development (MDD) in Industrial Design Engineering (IDE) academia. We want to find which methods our MDD-students currently use, where our guidance has shortcomings and where it brings added value.

We have analysed 19 master and 3 doctoral MDD-theses in our IDE curriculum. The evaluation focusses around four main themes: 1) regulatory 2) testing 3) patient-centricity and 4) systemic design.

Regulatory aspects and medical testing procedures seem to be disregarded frequently. We assume this is because of a lack of MDD experience and the small thesis timeframe. Furthermore, many students applied medical-oriented systemic tools, which enhances multiperspectivism. However, we found an important lack in the translation to the List of Specifications and to business models of these medical devices. Finally, students introduced various participatory techniques, but seem to struggle with implementing this in the setting of evidence-based medicine.

1. Introduction

Traditional new product development (NPD) approaches inherently apply to a broad set of industries. This general nature may turn them insensitive to the specificities of demanding contexts. For healthcare, with its high level of regulations, complex economics and a very diverse set of stakeholders, the need for detailed additions to general NPD approaches has been recognised in literature (Medina et al., 2012 ; Ocampo & Kaminski, 2019 ). Accordingly, different NPD models specifically for medical device design (MDD) have been proposed, often elaborating on the complex regulatory context (Kaplan et al., 2004 ; Ogrodnik, 2019 ; Pietzsch et al., 2009 ). These MDD models mostly apply to industrial companies, whose products are heavily influenced by economic and regulatory conditions. For academia, specific MDD models and programmes have been proposed, such as Stanford’s BioDesign Process (Yock et al., 2011 ) and TU Delft’s Medisign programme (Goossens et al., 2004 ). These models usually show the development process, but do not specifically cover the practical tools and methods to apply in MDD.

In the Industrial Design Engineering (IDE) curriculum at our university, we noticed an increasing popularity of MSc theses in MDD in recent years. Here, students develop a medical device for (and together with) a hospital, care institution or medical device company. The end result mostly is a proof-of-concept prototype and a written report. Our MSc students are coached by their university promotor and the external institution. Furthermore, they can fall back on general design and engineering courses from earlier in the curriculum. Our IDE programme offers a broad polytechnical education with a specialisation in industrial design engineering; specifics can be found in the Addendum. However, we currently do not offer specific courses on MDD in our IDE curriculum, nor is there a specialisation track. We wish to improve the thesis guidance of our MDD students and wish to be more efficient as promotors. Therefore, we have analysed the MDD theses from the past 8 years in this study. By investigating which tools our MDD students currently use, we may find where our guidance and curriculum show shortcomings and where they bring added value.

Our teaching curriculum, research and thesis supervision are influenced by the fields of Industrial Design Engineering and Systems Thinking. Both fields have a strong implementation in the healthcare sector. Nevertheless, their individual approaches cannot fully serve every problem. We hypothesise that a synergy arises when combining them. In this study, we quantified the implementations of these fields and their tools in MDD-related theses to get a better understanding of their added values.

1.1. Systems thinking in healthcare

Healthcare is a classic example of a complex sociotechnical system, as a whole of interactions between interdependent parts (Jones, 2013 ). Systems thinking approaches are widespread in healthcare and medical device management. In risk and quality management particularly, different models have been introduced that investigate the different levels of a system and the relationships between its components. Frameworks such as Systems Engineering Initiative for Patient Safety (SEIPS) have contributed in enhancing patient safety in a holistic manner (Carayon et al., 2006 ). Many of these models stem from systems and Human Factors Engineering (HFE), such as the Cognitive Work Analysis (Naikar, 2017 ). Here, the human factor is not analysed standalone but in its systemic context.

1.2. Industrial design engineering in healthcare

In IDE, user-centred approaches (e.g., Human Centred Design) often take a central role in the development process, making sure the user desires the product and is able to use it properly. In most MDD, user research is also structurally embedded via HFE, but this mostly is for a different reason. Here, usability tends to be investigated for patient safety and risk mitigation reasons, pushed by the high level of regulations (Benker, 2015 ). Although these are valid motives, the user acceptance aspect may be overlooked this way (Karsh, 2004 ). This is unfortunate, as it is crucial to detect and mitigate use errors and user rejection as early as possible, in order to reduce development costs. On the other hand, user-centred design often lacks a systemic perspective (Santos & Wauben, 2014 ; Sevaldson, 2010 ).

It is therefore suggested that the user-centred, empathic and pragmatic approaches of IDE may overcome the shortcomings of HFE in MDD (Barbero & Pallaro, 2017 ; Privitera, 2017 ; Privitera et al., 2015 ). Similarly, the HFE methods may tackle the lack of a systemic approach of user-centred approaches. Therefore, we believe it is useful to investigate how students implement these various approaches in MDD.

2. Materials and methods

We have collected and analysed all MDD-related theses from the Industrial Design Engineering specialisation, submitted between 2014 and 2021 at our local university. These 19 MSc and 3 PhD theses are listed in Table 1 and are available throughout the institutional repository. Projects were identified as dealing with MDD if they met the EU Medical Device Regulations’ ( REGULATION (EU) 2017/745 , 2017) definition of a medical device. In brief, a medical purpose such as prevention, diagnosis, monitoring or treatment was required for the device. Projects that fell into the broader healthcare spectrum without medical purpose (e.g., commercial health wearables) were withdrawn from this selection.

List of the analysed theses. In the second column, a short description of the thesis is given. The third column describes whether this was a MSc or a PhD thesis. In the fourth column, the type of client is given. We divided these into 3 main categories: medical device manufacturers, universities or university hospitals, and care institutions. The fifth column shows the academic year in which the thesis was submitted. In the sixth column, the anonymised code of the promotor is given. In the seventh column, the reference to the university website is given to find more details on the thesis.

For this qualitative study we followed the QUAGOL guideline, derived from Grounded Theory Approach (Dierckx de Casterle et al., 2012 ) In the first part of QUAGOL, documents are analysed iteratively and rich information is clustered into concepts. In this case, a list of MDD-related theses was composed. The four researchers then individually scanned the theses for tools, methods and guidelines where medical specificities were indispensable. The full methodological list was shared and discussed amongst the investigators. To structure the coding into concepts, the researchers together came up with 4 common themes after the first iteration: 1) regulatory aspects, 2) testing methods, 3) patient-centricity and 4) systemic design. In the second part of QUAGOL, the concepts are critically analysed by the group of reviewers. With the final concepts structured, documents are analysed again for conclusions. In this case, the MDD-related theses were divided amongst the investigators and read thoroughly. The investigators coded the information and finally discussed the outcomes for conclusions.

Table 2 shows three general methodologies that we teach to students. Although they are general, this combination of methodologies is not taught in every IDE curriculum and is thus typical to our institution. We embedded them in Table 2 as they presumably influence the work of our students, and as they are used to further structure the tools and methods in the Results section.

Overview of general methodology in our IDE programme. Our curriculum and research combine three typical methodologies: research-through-design, co-design and systems thinking. In the third column, we linked each of these general methodologies to the main themes that were identified in this analysis: 1) regulatory aspects, 2) testing methods, 3) patient-centricity and 4) systemic design. This can also be found in Figure 1 .

The quantitative results can be found in Table 4 , supported by qualitative information in Figure 1 and Table 3 . Figure 1 provides a schematic overview of the methodologies, tools and guidelines that were discussed in this analysis. This figure serves as a guide to see the relationships between the examined methods and tools. Table 3 provides a structured summary of the different methods and tools that appeared (at least once) in the analysis. Table 4 shows the frequency of the different methods and tools. The data of Table 4 is analysed below.

Overview of methodologies and tools used in MDD at the Industrial Design Engineering specialisation at our university. The first row shows a simplified version of Pahl and Beitz’ Systematic Approach. This is our design workflow of choice at Ghent University, but as shown by Ocampo (Ocampo & Kaminski, 2019 ) different general design workflows are applicable in MDD. The second row shows the general approaches we actively teach that also may show added value to MDD. The 3rd row shows the 4 main aspects we focused on. Next to these aspects, the initials of the general approaches from the 2nd row are placed, showing which approach is typically used in the given aspect. In the 4th row, we placed the different tools and guidelines that were found in the analysis, sorted underneath the proper main aspect.

Summary of the methods and tools. Each of these appeared at least once in the analysed theses. Column 1 shows the main theme to which the tool or method can be linked. This allocation was discussed amongst the researchers and is not exhaustive. Column 2 shows the specific tool, method (or guideline) that was analysed. A structured overview of the themes and their tools can be found in Figure 1. Column 3 offers a short description. Column 4 refers to related methods and tools, that were not found in the student theses but are also relevant to MDD. This non-exhaustive list was composed by researchers with experience in MDD.

Count of the different methods and tools. We divided both the MSc and the PhD theses in 3 subgroups, differentiated by the client type. For the methodologies, tools and guidelines, we used the same structure as found in Figure 1.

3.1. Analysis

Medical regulatory aspects (device classification, MDR, FMEA, …) are often disregarded in the analysed MSc-theses. If the project gets picked up further (e.g., PhD-thesis or industrialisation), this may result in important and costly problems later on, as explained in the design paradox. Similar tendencies were found for medical testing. Little medical testing protocols were applied in the analysed cases.

Both Patient Journey Maps, Treatment Journey Maps and Stakeholder Maps were commonly used in the theses. We consider this as systemic MDD tools that support multiperspectivism. Nonetheless, we noticed that the wishes and demands of stakeholders, uncovered in these tools, were regularly overlooked in the List of Specifications.

Rather classic systemic tools such as causal loops and function-structure diagrams were used in a minority of theses. As for business models, we found a large frequency in theses for medical device companies whilst business models were underexposed in theses for universities, hospitals and care institutions.

3.2. Examples

Figure 4 shows a selection of valid examples of different tools that were used in the analysed theses. Table 5 gives further details on these examples and explains their added value.

Thesis examples of different methods and tools for MDD. In this table, we highlighted some good examples of tools used in the analysed MDD theses. In the 4 th column we explain the added value of this method or tool for the end result of this specific thesis, addressed by the student (in the thesis) or the reviewers. In the 5 th column we explain the potential pitfalls of these tools, addressed by the reviewers. The examples are visualised in Figure 4 .

Visual examples of tools used in the examined theses. The letters (A-F) 406 correspond with the detailed explanation given in Table 3 .

4. Discussion

By quantifying the tools and methods that our students use in MDD-related theses, we wanted to find trends and opportunities that could enhance the guidance of thesis students. With the results listed, we can now explain the observed trends and make recommendations for MDD-related theses.

In many theses (n° 1–13, 15, 18–19), we encountered an important lack in anticipating regulatory requirements. We assume that the short timeframe (10 months at 40% of their total workload) and limited experience of students may evoke other priorities. A big regulatory lack was found in theses for hospitals, presumably as they’re not primarily focussed on marketable products. Students often referred to the slow nature of clinical trials, their large administrative workload and the difference in priorities between the student and the medical researchers. In theses with medical device manufacturers however, the regulatory side wasn’t highlighted that often either. We presume that this is because these companies have in-house knowledge to further tackle regulatory issues. Altogether, we would suggest a short introduction of the most important regulatory aspects to thesis students and a structural integration in their List of Specifications. This is important, as projects may suffer from regulatory flaws in further development stages.

As for the use of systemic design, we noticed that some medical-oriented systemic tools (e.g., Stakeholder Mapping) were popular (n° 1, 3–5, 8–15, 17, 19, 21–22), but that general systems thinking tools (e.g., function-structure diagrams) were not widely applied (n° 1–2, 8, 13, 21–22). Systemic tools may be useful in complex settings for different applications such as problem finding, problem reframing, future forecasting and value communication (Peters, 2014 ). However, understanding and interacting with systems can take a lot of time and effort. For our master theses, the timeline may be too limited to elaborate on systemic interactions. We should therefore aim for time-efficient systemic tools in MDD, like Treatment Journey Mapping.

Furthermore, we found that participatory design methods were applied often (n° 1–2, 4–6, 9–10, 12–13, 16–22), but classic medical testing procedures were applied less (n° 2, 10–12, 14, 18, 20–22) . For industrial design engineers, these different research approaches may be difficult to cope with (Groeneveld et al., 2018 ). Whilst medical testing relies on strict protocols and quantitative data, participatory techniques are less defined and open to the researcher. It may be difficult to apply these two opposed ways of thinking, and also to convince medical staff of their added value as they’re not used to these rather subjective methods. Nevertheless, both research methods are of important value in MDD. Participatory techniques support in obtaining end user acceptance, while traditional medical testing (“evidence-based medicine”) is vital to obtain an effective, safe end product that also surpasses the regulatory requirements. For the students, it can be useful to anticipate on further medical testing in the future work section of the thesis. Figure 2 is an adapted model of the Verification and Validation model, that originates from the FDA’s Design Control. Here, it is shown how this regulatory framework can serve as a template for designerly tools, bridging both approaches. Figure 3 shows a list of MDD testing methods, adapted from Stanford’s Biodesign process (Yock et al., 2015 ). This summary may help IDE students to efficiently overcome differences in both approaches.

Validation & Verification (Design Control) as a template for designerly tools in MDD (adapted from (Privitera et al., 2015 ).The work of professor Privitera shows the possibility of using the classical Design Control figure as a template to map different design techniques upon. It is noteworthy that next to the clinical and technical requirements, participatory techniques can play a useful role in uncovering user needs. This may lead to a usable and desirable product, as checked by the Validation process. Furthermore, the active testing of prototypes is an important step to valorise the overall functioning of the product, as checked by the Verification process. For this process, we have described the benefits of using a Research through Design approach in a co-design trajectory.

Testing methods in MDD (adapted from (Yock et al., 2015 )). The first row shows the simplified “Levels of evidence in healthcare design”, which give students notice of the ways healthcare professionals determine evidence. The second row shows the “Testing continuum”, a schematic overview of the different testing procedures in MDD and their respective order. The “Testing continuum” is not limited to medical devices, whereas the “Key R&D” milestones (3rd row) provides a chronological order of important testing milestones that relate to medical devices.

By implementing co-design and participatory design methods, we believe students facilitate multiperspectivism in a medical context with different types of stakeholders. This may support the user acceptance and usability. However, we also found that the requirements of these various stakeholders are not all translated into the List of Specifications. This is a point of attention, as not only the patient and other main stakeholders have a large influence on the medical product and its underlying processes. Furthermore, we found that only students at medical device companies paid attention to the business model behind the product. This seems evident, as these companies focus on marketable products whereas hospitals and care institutions do not. Also, it can be difficult to envision the financial mechanisms as a lot depends on the reimbursement of the device, which is not yet clear in the development phase. Nevertheless, we think it’s unfortunate that students take the effort of portraying all stakeholders, but do not put them together in a business model. This not only involves the financial aspects but also other forms of value exchange: who handles and owns the medical data, can used products be remanufactured, …

We could not distinguish any clear trends over time, except for the Patient Journey Map that became more widespread, whilst the Stakeholder Map was the overall most frequent tool. Furthermore we also examined the influence of the promotor on the use of tools. We did not find any clear differences, but we found that some promotors guided increasingly more MDD-related theses over time. This experience presumably adds to the efficiency of the guidance. A last comparison can be made between MSc and PhD theses, although the sample size of the PhD theses is too low for generalisations. We found that the PhD theses used a larger variety of tools, which is presumably facilitated by the larger timeframe (>4 years versus 1 year). The impact of design implementations could also be better evaluated as there is a larger timespan. PhD students are also expected to spend more time on scientific work, which is noticeable in the theses. Here, the experiments were better performed, based with less subjective and more scientific outcomes. The creative R&D-process was more pronounced in the MSc-theses.

Finally, we want to discuss the shortcomings of this analysis. The sample size (n = 22) was rather small, and the analysis may be prone to bias as our curriculum logically influences the theses results and ourselves as researchers. As for the future, it would be useful to incorporate the findings of this manuscript in guiding new thesis students. Furthermore, we would like to continue this evaluation to obtain bigger sample sizes, and to compare it to analyses of other (design) engineering curricula. Also, we would like to include interviews with students, to uncover why certain tools were (not) applied.

5. Conclusions

In this case-study based analysis, we screened 22 MDD-related theses of industrial design engineers for the methods and techniques that were applied. In the end, we wanted to find the added value and pitfalls of different methods that demand extra attention from our part as promotors.

Regulatory aspects and medical testing procedures seem to be disregarded frequently in theses, although these are of great importance to a sound MDD. We assume the small thesis timeframe plays an important role, next to limited experience with MDD. Furthermore, many students applied medical-oriented systemic tools such as treatment journey mapping, which enhance multiperspectivism. However, we found an important lack in the translation of these multidisciplinary insights to the list of specifications and business models for medical devices. Finally, students introduced various participatory techniques, which enhances the usability aspect of different stakeholders. However, it seems that students working for hospitals struggled to fully implement these participatory techniques in settings of evidence-based medicine. The insights of this paper may be of interest to other academic curricula, including but not limited to: mechanical engineering, biomedical engineering and medicine curricula.

Disclosure statement

No potential conflict of interest was reported by the author(s).

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Course info.

• Dr. Hongshen Ma

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• Mechanical Engineering
• Electrical Engineering and Computer Science

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Biomedical devices design laboratory, course description.

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Master of Science in Medical Device and Diagnostic Engineering

The Master of Science in Medical Device and Diagnostic Engineering program (available both on-campus and online via DEN@Viterbi) is designed to provide the knowledge and skills needed for the development of medical devices and diagnostic techniques, including aspects of medical product regulation and of product development.

The course of study requires successful completion of 28 units of coursework and has been designed to be completed in three semesters of full-time study.

Students in the program will complete a 19-unit core and must select a six-unit specialization (or “track”) and one elective from a list provided by the department.

Students in the MS in Medical Device and Diagnostic Engineering degree program must choose a six-unit specialization (or “track”) from the following:

• Medical Technology and Device Science Track
• Product Development Track
• Regulation Track

Related Programs

The Department of Biomedical Engineering also offers the following program concentrations:

• MS in Biomedical Engineering (BME)
• MS in BME-Biomedical Data Analytics (On-campus only)
• MS in BME-Medical Imaging and Imaging Informatics

For a complete list of graduate programs offered online in the USC Viterbi School of Engineering, please visit the  DEN@Viterbi Program Offerings .

Career Opportunities

A variety of career opportunities exist, but primarily in the areas of:

• Cellular, Tissue, Genetic, Clinical and Rehabilitation Engineering
• Bioinstrumentation
• Biomaterials
• Biomechanics
• Drug Design and Delivery
• Medical Imaging
• Orthopedic Surgery
• Pharmaceuticals
• Systems Physiology

Earn your Master of Science in Medical Device and Diagnostic Engineering online via DEN@Viterbi. Request information today.

Same Faculty. Same Program. Same Degree.

DEN@Viterbi  strives to meet the needs of engineering professionals, providing the opportunity to advance your education while maintaining your career and other commitments. By breaking down geographical and scheduling barriers, DEN@Viterbi allows you to take your classes anytime and anywhere.

DEN@Viterbi students undergo the same academic requirements, curriculum, and must adhere to the same academic standards as on-campus students; therefore, your diploma is ultimately issued by the University of Southern California. There is no difference between remote students and on-campus students.

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MIT MEDICAL DEVICE DESIGN

Engineering Solutions to Clinical Challenges

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Course Numbers: 2.75, 2.750, 6.4861, 6.4860, HST.552 – all meet jointly Term : Spring Term Time : Monday & Wednesday 1:00 – 2:30 PM Location : 3-270 Units : 3 – 3 – 6 Prerequisites : one of the following  2.007 , 2.008 ,  2.009 , 6.101 ,  6.111 ,  6.115 ,  22.071 or instructor permission. Note: These pre-requisites are guidelines and we recognize that students at MIT have a diversity of experiences, so please see “Who can take this course?” below. Undergraduates : 2.750 fulfills both the Institute CI-M requirement and the MechE capstone requ irement and is an alternative 2.009.

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Why should I take this course?

This course is designed to offer an industry-modelled, hands-on discover-design-demonstrate experience, while learning about the healthcare industry in general and medical devices in specific. This course is a good option if you want to:

• Work on a real medical / health / wellness challenge
• Learn the deterministic design process
• Apply mechanical & electrical engineering principals
• Prototype and test a solution to a clinical challenge
• Learn about the healthcare industry from professionals
• Develop your communication & presentation skills
• Potentially publish your work

Who can take this course?

Officially, this course is listed for Seniors and Graduate Students in Mechanical Engineering, Electrical Engineering and HST, however, other majors are welcome and, in the past, have brought valuable talents to the projects. Juniors are accepted with advisor and instructor permission. LGOs, SDMs and Course 20 students have found interesting projects. Our goal is to make sure that you are prepared to succeed, and we ask students to have a prior hardware / manufacturing / design / analysis background, from either a course or industry, and are ready for a capstone experience. Bring your (figurative or physical) toolbox and we will solve a clinical problem together!

If you are interested but unsure whether this course is a good fit, please do not hesitate to contact the instructors . We are happy (and it is our job!) to discuss your background and aspirations and, together, help you assess whether this course will be a good fit.

What is the course format and content?

In the first half of the semester lectures cover fundamental topics in mechanical and electrical engineering and the design process. In the second half they transition to focus on industry-specific topics and case studies. Brief in-class quizzes and short at-home assignments serve primarily as a feedback mechanism for both students and instructors. There are no tests.

Labs involve building mechanical and electrical hardware, specifically, a kinetical coupling, an EKG, and a mechatronic medical device, a syringe pump. The goal of these labs is to demonstrate fundamental principles, ensure that everyone develops hands-on skills and intuition and build team skills. We provide special help sessions for the first two labs, while the third is conducted in-class. All labs are completed by midsemester, so that you can focus on your projects.

Project challenges are sourced competitively from clinical and industry professionals who will present these projects to you the second and third classes. You will have the opportunity to ask questions, discuss with your peers and then indicate your project preferences. We ask that you select projects based on both your skills, interests and backgrounds. We will form teams of 3 – 5 students each. For the next 12 weeks we will work on these projects together, following a Deterministic Design process. Each project proposer commits to supporting and meeting with their team. Additionally, each team will be supported by one or more mentors from the course staff who will meet with you every week. We will work with you to brainstorm solutions, keep on track and locate the resources that your specific project needs. The goal is to arrive at the end of the semester with a proof-of-concept prototype medical device and appropriate analysis, documentation, testing and an honest (positive or negative) assessment of the results.

This is a communications intensive class and each team will present their progress three times during in-class design reviews. These provide the opportunity for feedback from the entire class. End of semester deliverables include: a final presentation, a conference/journal format paper and a one-page poster/summary. Frequently, final papers are submitted for publication.

Can I continue my project post class?

Select projects, where students and clinicians remain engaged, may be invited to continue to evolve from a proof-of-concept to beta prototype, conduct testing submit a journal paper and develop a path forward for the project.

For students continuing at MIT, we may be able to arrange credit as an Independent Study for substantial continued contribution. This must be arranged with the instructors, your department and the project proposer post completion of the course.

COVID & Health Concerns

As per MIT Spring 2023 guidance, all instruction will be in person .

In case of a change in the situation, we may make a Zoom feed available on an as-needed basis. While we can’t anticipate every scenario this Spring, we can promise to be flexible and work with individuals and teams to succeed together. The key is to communicate any concerns in advance.

Departments

• MIT Alum & Portal Instruments CTO Visits
• 2.75 Designed Torniquets Commercialized
• 2021 Projects published by ASME and IEEE
• 2020 Syllabus Posted
• IEEE EMBC 2020 Papers

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Graduate Certificate: Medical Device Design and Entrepreneurship

The graduate certificate in medical device design and entrepreneurship includes nine credits of coursework and three credits of project work. Anyone who is interested in a graduate certificate is eligible to apply. 

Required courses

• BIOE 5054 Regulatory Affairs (3 credits)
• BIOE 5420 Biomedical Device Design and Entrepreneurship (3 credits)
• One bioengineering elective (3 credits)
• Entrepreneurship project (3 credits)

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Past projects

Past projects include Substantial Equivalence Analysis to Support Regulatory Approval for a Medical Device; Freedom to Operate Analysis of New Orthopedic Instrument; Design and Development of a Novel Heart Valve Fixation Device; Optimization of a Gel to Close Abdominal Aortic Aneurysm Endoleaks; In vitro evaluation of a Novel Biomarker for Reflux Disease; Characterization of Bone Analogs to Study Orthopedic Device Fixation; A Novel Shape Memory Polymer Hernia Patch: In Vitro and In Vivo Studies; and others.

Ongoing/new projects

Ongoing / new projects are available on: New Device for Microbiome Sampling; New Surgical Instruments for Hip Arthroscopy; Development of a Business Plan around a Novel Method for Evaluating Reflux Disease; New Devices for Vascular Embolization; Biochemical Sensors for More Sensitive Cancer Detection; Minimally Invasive Techniques to Characterize GI Inflammation in COVID-19; Simulation Tools to Optimize Battlefield Triage; and many others.  You are welcome to propose your own project as well.

Are entrepreneurs born or made? However you feel about this question, there is a common set of skills and knowledge that successful entrepreneurs possess. In this program, we explore the key ingredients needed to develop value in medical devices. Students will work directly with experienced mentors to learn the practical skills for success in this space.

Robin Shandas

Western Regional Graduate Program

All College of Engineering, Design and Computing graduate programs are eligible for the WRGP. 

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Persistent In-Line Sensor for Real-World Loading Characterization of Osseointegrated Implants and Prosthetic Devices

CERSI Collaborators: Jonathan Thornhill (JHUAPL), Courtney Moran C.P. MS (JHUAPL); Luke Osborn, PhD (JHUAPL); Jared Wormley (JHUAPL) Jill Curran (JHU)

FDA Collaborators:  Kimberly Kontson, PhD (CDRH); Snehal Shetye, PhD (CDRH);

CERSI Subcontractors:  Weill Cornell Medicine Art Sedrakyan, MD, PhD; Jim C. Hu, MD, MPH; Jialin Mao, MD, MS; Miko Yu, MA; Sendong Zhao, PHD, Vahan Simonyan, PhD

CERSI “In Kind” Collaborators:  Michelle Nordstom, MS, OTR/L (USUHS)

Project Start Date: September 1, 2022

Project End Date: August 31, 2023

Regulatory Science Challenge

Osseoanchored prosthetics use a permanent bone anchored osseointegrated (OI) implant that penetrates and locks into the long bone inside the body and passes permanently through the skin to the outside to facilitate direct skeletal attachment of external arm and leg prosthetic devices. Such OI implants provide an alternative to traditional socket-based attachment systems and can eliminate issues with skin irritation, ease of applying and removing prosthetics, and improve range of motion. Although certain OI devices have been used internationally for the last decade, the emergence of OI use in the US market is more recent but steadily increasing. While there have been studies that have explored the loads placed on the implant abutment, or support, and consequently the bone and soft tissue to which it is implanted, few of these studies have quantified the loads and forces created during real world use. To date, most measurements of forces between the attached prosthetic and the implant have been interpreted from externally measured forces between the ground and prosthetic foot. Others have used sensing technology in a controlled laboratory and clinical setting whose size and bulk can impact the accuracy of some prosthetic limb movement. This means that the loads experienced by wearers during daily use have yet to be directly determined. Early adopters of OI devices report activities of daily living and recreational activities that are likely creating loads well above what has been measurable to date. Smaller, lighter sensors which can be integrated as part of arm and leg prosthetic systems, attached to the implant, and worn daily can provide critical information to understand the actual implant loads being experienced.

Project Description and Goals

The goal of this project was to design and test a prototype sensor for amputees implanted with OI implants which is small, light, accurate and safe enough to be used day-to-day as part of the total OI prosthetic limb system. The results informed whether a small light load sensor could accurately measure the range of loads placed on an OI implant by a prosthetic limb during real world use and demonstrate a sensor with form and function that can be included as part of the daily prosthetic system. To achieve this, investigators 1) Designed a low profile multi-axial load sensing prototype compatible with real world use; 2) Quantified load sensing ranges relative to overall device size and 3) Validated load sensing responsiveness, accuracy and repeatability in bench top model.

Research Outcomes/Results

JHU CERSI will continue research, development, test and evaluation of the prototype sensor for persistent OI sensor. To date, JHU CERSI has achieved significant progress toward specific aims.

• Design and fabrication of a low-profile load sensing prototype that measures4.5 cm diameter X 2.5 cm high and weighs 3 grams (not including boards and sensors) which is 1.5 and .5 cm smaller than our target and 161 grams lighter.
• Through bench testing, demonstrated the ability to measure multidirectional bending loads up to the maximum load of 70 Nm measured during take home tests with an experimental arm. Please note that experimental features included integrated load sensing capability.
• Validated the persistent load sensor prototype ability to sense loads in two axes: bending loads and torsional(rotational) loads. Sensor prototype accuracy has also been maintained over repeat loading and does so for bending loads up to 35 Nm of torque and 32 Nm of bending load. Both values exceed the max loads expected to be seen in real world upper limb use based on our past research experience.

Overall, investigators, to date, have demonstrated proof-of-concept for a compact lightweight dual axial load sensor prototype capable of measuring loads consistently at load limits higher than expected during real world use ensuring the full range of loads both expected and unexpected are measurable.

Research Impacts

Demonstration of a prototype sensor small and light enough to be integrated as a persistent prosthetic component for amputees with OI implants is the first step in realizing FDA’s regulatory science priority of understanding real world use in general, and specifically to the use of OI implants. This is especially true of upper limb OI implant users. Our prototype demonstrates that the load limits up to those expected in real world upper limb OI users can be captured accurately in a bench top model and in a light, small enough package to be used with upper limb amputees.

The bench top demonstration is the ‘catalyst for future research’ as the foundation required to realize the next steps which include real time communication of measured loads in a closed loop information delivery application. The delivery of load information directly to the patient/wearer of the prosthetic device and capturing information from the patient about the activities being performed. Investigators expect ongoing development to lead to a final design that can inform the goal of establishing targeted rehabilitation protocols, development of methods to encourage rehabilitation exercise compliance, and empowerment of the end user to understand the impact of their activities on device loading.

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Fall 2024 CSCI Special Topics Courses

Cloud computing.

Meeting Time: 09:45 AM‑11:00 AM TTh  Instructor: Ali Anwar Course Description: Cloud computing serves many large-scale applications ranging from search engines like Google to social networking websites like Facebook to online stores like Amazon. More recently, cloud computing has emerged as an essential technology to enable emerging fields such as Artificial Intelligence (AI), the Internet of Things (IoT), and Machine Learning. The exponential growth of data availability and demands for security and speed has made the cloud computing paradigm necessary for reliable, financially economical, and scalable computation. The dynamicity and flexibility of Cloud computing have opened up many new forms of deploying applications on infrastructure that cloud service providers offer, such as renting of computation resources and serverless computing.    This course will cover the fundamentals of cloud services management and cloud software development, including but not limited to design patterns, application programming interfaces, and underlying middleware technologies. More specifically, we will cover the topics of cloud computing service models, data centers resource management, task scheduling, resource virtualization, SLAs, cloud security, software defined networks and storage, cloud storage, and programming models. We will also discuss data center design and management strategies, which enable the economic and technological benefits of cloud computing. Lastly, we will study cloud storage concepts like data distribution, durability, consistency, and redundancy. Registration Prerequisites: CS upper div, CompE upper div., EE upper div., EE grad, ITI upper div., Univ. honors student, or dept. permission; no cr for grads in CSci. Complete the following Google form to request a permission number from the instructor ( https://forms.gle/6BvbUwEkBK41tPJ17 ).

CSCI 5980/8980 

Machine learning for healthcare: concepts and applications.

Meeting Time: 11:15 AM‑12:30 PM TTh  Instructor: Yogatheesan Varatharajah Course Description: Machine Learning is transforming healthcare. This course will introduce students to a range of healthcare problems that can be tackled using machine learning, different health data modalities, relevant machine learning paradigms, and the unique challenges presented by healthcare applications. Applications we will cover include risk stratification, disease progression modeling, precision medicine, diagnosis, prognosis, subtype discovery, and improving clinical workflows. We will also cover research topics such as explainability, causality, trust, robustness, and fairness.

Registration Prerequisites: CSCI 5521 or equivalent. Complete the following Google form to request a permission number from the instructor ( https://forms.gle/z8X9pVZfCWMpQQ6o6  ).

Visualization with AI

Meeting Time: 04:00 PM‑05:15 PM TTh  Instructor: Qianwen Wang Course Description: This course aims to investigate how visualization techniques and AI technologies work together to enhance understanding, insights, or outcomes.

This is a seminar style course consisting of lectures, paper presentation, and interactive discussion of the selected papers. Students will also work on a group project where they propose a research idea, survey related studies, and present initial results.

This course will cover the application of visualization to better understand AI models and data, and the use of AI to improve visualization processes. Readings for the course cover papers from the top venues of AI, Visualization, and HCI, topics including AI explainability, reliability, and Human-AI collaboration.    This course is designed for PhD students, Masters students, and advanced undergraduates who want to dig into research.

Registration Prerequisites: Complete the following Google form to request a permission number from the instructor ( https://forms.gle/YTF5EZFUbQRJhHBYA  ). Although the class is primarily intended for PhD students, motivated juniors/seniors and MS students who are interested in this topic are welcome to apply, ensuring they detail their qualifications for the course.

Visualizations for Intelligent AR Systems

Meeting Time: 04:00 PM‑05:15 PM MW  Instructor: Zhu-Tian Chen Course Description: This course aims to explore the role of Data Visualization as a pivotal interface for enhancing human-data and human-AI interactions within Augmented Reality (AR) systems, thereby transforming a broad spectrum of activities in both professional and daily contexts. Structured as a seminar, the course consists of two main components: the theoretical and conceptual foundations delivered through lectures, paper readings, and discussions; and the hands-on experience gained through small assignments and group projects. This class is designed to be highly interactive, and AR devices will be provided to facilitate hands-on learning.    Participants will have the opportunity to experience AR systems, develop cutting-edge AR interfaces, explore AI integration, and apply human-centric design principles. The course is designed to advance students' technical skills in AR and AI, as well as their understanding of how these technologies can be leveraged to enrich human experiences across various domains. Students will be encouraged to create innovative projects with the potential for submission to research conferences.

Registration Prerequisites: Complete the following Google form to request a permission number from the instructor ( https://forms.gle/Y81FGaJivoqMQYtq5 ). Students are expected to have a solid foundation in either data visualization, computer graphics, computer vision, or HCI. Having expertise in all would be perfect! However, a robust interest and eagerness to delve into these subjects can be equally valuable, even though it means you need to learn some basic concepts independently.

Sustainable Computing: A Systems View

Meeting Time: 09:45 AM‑11:00 AM  Instructor: Abhishek Chandra Course Description: In recent years, there has been a dramatic increase in the pervasiveness, scale, and distribution of computing infrastructure: ranging from cloud, HPC systems, and data centers to edge computing and pervasive computing in the form of micro-data centers, mobile phones, sensors, and IoT devices embedded in the environment around us. The growing amount of computing, storage, and networking demand leads to increased energy usage, carbon emissions, and natural resource consumption. To reduce their environmental impact, there is a growing need to make computing systems sustainable. In this course, we will examine sustainable computing from a systems perspective. We will examine a number of questions:   • How can we design and build sustainable computing systems?   • How can we manage resources efficiently?   • What system software and algorithms can reduce computational needs?    Topics of interest would include:   • Sustainable system design and architectures   • Sustainability-aware systems software and management   • Sustainability in large-scale distributed computing (clouds, data centers, HPC)   • Sustainability in dispersed computing (edge, mobile computing, sensors/IoT)

Registration Prerequisites: This course is targeted towards students with a strong interest in computer systems (Operating Systems, Distributed Systems, Networking, Databases, etc.). Background in Operating Systems (Equivalent of CSCI 5103) and basic understanding of Computer Networking (Equivalent of CSCI 4211) is required.

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