Medical Device Regulations – Overview and Guiding Principles

Dr. Bert Roossien; Jan van der Kuil 

The medical technology industry is subject to rapidly evolving regulations that are often complicated by legal technicalities and regional differences. Obtaining marketing approval for  a new medical device is therefore a precarious route which a R&D team needs to pass. As a medical engineer you need to consider regulatory requirements for safety and effectiveness when designing a new device and its associated manufacturing process. Guiding principles for regulatory affairs and quality management attempt to make the subject easier to grasp and help you to reduce time to market. 

In a two day workshop Bert Roossien and Jan van der Kuil will introduce you to these guiding principles. Practical examples will make you understand the different phase in the development of a medical device; how authorities regulate the medical device market (Medical Device Directives and Quality System Regulations), which routes you must take to enter the market, how product safety and performance risks can be managed and what the critical elements of a medical device quality management system (ISO 13485) are. This workshop will make you a more effective designer and valuable collaborator in the design control process.

Biomedical Instrumentation

Ass.Prof. İ. Cengiz Koçum

Complete medical care involves three distinct but related activities: diagnosis, therapy, and monitoring. Diagnostic devices are designed to determine physical signs of disease and/or injury without alteration of the structure and function of the biological system. Some of these devices are based on collecting electrophysiological signals, and some of them are based on spectrophotometric measurements, microscopic evaluation and counting techniques which can only be carried out at medical laboratory as well.

There are several surgical equipments, some of them are simple hand tools, and some of them are advanced devices. On the other hand, because of affectivity of therapy and patient comfort, endoscopic techniques are widely used in surgery. For this reason one of the most important tools for endoscopic surgery is electrosurgical devices because of its small size, it is being make possible bloodless surgery.

The goal of this course is to provide a representative overview of basic electronic circuits to acquire physiological signals, fundamentals of some medical laboratory devices like spectrophotometer, blood gas analyzers, blood cell counters, and basic principles of electro surgery devices 

Course Outline:
Basic electronic circuits to acquire physiological signals: Operational amplifiers and their applications, filters and some special amplifiers. Medical Laboratory devices: microscopic techniques, photometric techniques, ELISA test principles, some blood measurement techniques. Electrosurgery fundamentals, basic electronic circuits.

DATE COURSE SYLLABUS
28.08.Operational amplifiers and their applications, filters, etc.                                            
Lab: Basic Opamp Circuits
29.08.Some blood measurement techniques
Microscopic techniques
Lab: Basic Opamp Circuits
30.08.Photometric techniques
ELISA test principles
Electro surgery fundamentals, basic electronic circuits
31.08.Lab: Photo detector

Biomedical Applications of Microcontrollers

Mehmet YÜksekkaya

Today microcontrollers have been used in many electronic machines; as well they became an integral part of biomedical devices. This course discusses the programming model and basic features of a microcontroller and the application of microcontrollers to biomedical instrumentation. Lectures and laboratory experiments cover the basic principles of hardware and software design for a microcontroller based system and interfacing biomedical sensors to microcontrollers are emphasized. 

Course Outline:
Overview of PIC microcontroller, Basic MikroC programming for PIC microcontroller, Interface of sensors and I/O devices to microcontroller chips, Design of microcontroller systems for medical use such as design of a heart beat monitor and/or a digital thermometer. 

DATE COURSE SYLLABUS
28.08.Introduction to microcontrollers and embedded design.
29.08.PIC microcontrollers and MikroC programming language.
30.08.Programming PIC microcontrollers and designing simple microcontroller applications.
31.08.Analog to digital conversion using microcontrollers and digital thermometer application.

Biomedical Applications of Microcontrollers

Mehmet YÜksekkaya

Today microcontrollers have been used in many electronic machines; as well they became an integral part of biomedical devices. This course discusses the programming model and basic features of a microcontroller and the application of microcontrollers to biomedical instrumentation. Lectures and laboratory experiments cover the basic principles of hardware and software design for a microcontroller based system and interfacing biomedical sensors to microcontrollers are emphasized. 

Course Outline:
Overview of PIC microcontroller, Basic MikroC programming for PIC microcontroller, Interface of sensors and I/O devices to microcontroller chips, Design of microcontroller systems for medical use such as design of a heart beat monitor and/or a digital thermometer. 

DATE COURSE SYLLABUS
03.09.Introduction to microcontrollers and embedded design.
04.09.PIC microcontrollers and MikroC programming language.
05.09.Programming PIC microcontrollers and designing simple microcontroller applications.
06.09.Analog to digital conversion using microcontrollers and digital thermometer application.

Biomaterial Science: 
Fundamentals & Nanotechnological Applications

Ass.Prof. Dilek ÇökeliLer

During the last century, interest in biomaterials has grown from mere curiosity to routine clinical use, saving lives and improving the quality of life for millions of people. Today, biomaterials and medical devices are a $100 billion industry. This course will cover many fundamental areas such as: 

  • An overview of the biomaterials field (definitions, etc.),
  • The current status of the biomaterials field, 
  • The properties of biomaterials that make them useful in medical (and clinical) applications, 
  • Introduction to the major classes of biomedical materials: ceramics, metals, and polymers. Their structure, properties, and fabrication connected to biological applications, from implants to tissue engineered devices. 
  • New trends and future prospects. 

Course Outline:
Material science and relation between medicine. Properties of polymeric, metallic and ceramic biomaterials. Natural biological materials. Artificial biologic materials. Applications of material sciences in biomedical engineering. Mechanics, corrosive and surface properties, tissue reactions of biomaterials. Medical applications of researches in material sciences. Synthesis of nanomaterials, nanoparticles and biomedical applications. Nanostructured coatings. 

DATECOURSE SYLLABUS
28.08.   Introduction to the Material Science & Engineering Biomaterial Science
Bulk properties - chemical bonds - surface energy 
Classifications & advanced biomaterials
29.08.Polymeric, metallic & ceramic biomaterials
30.08.Composite biomaterials performance of biomaterials; Mechanical and biological tests
31.08.Introduction to the nanotechnology 
Fundamentals of synthesis and characterization of nanomaterials 
Nanostructured coatings; Plasma polymerisation technique nanosensors; NEMS and MEMS 
Carbon nanotubes

Cognitive Ergonomics / User Centred Design

Richard Vos, M.Sc.

During this course we will go into the user’s side of development, we will explore who and what the engineers are working for. 

Now, we realize that anything can be made by now, and if not technologically doable today, it will be tomorrow. This makes that the ‘consumer’ industry in refocusing from technology driven design towards user-centered design. Yes, sustainability is also a buzzword these days, but think about it, does sustainable only mean degradable or reusable? No, of course not! If things need to be sustainable it means also that these products are used well and to the satisfaction of the customer / user.

The two days programme course Cognitive Ergonomics / User Centred Design (UCD) will focus on product development from an interaction design perspective in which insights from psychology and the domain of user interfaces will be applied. You will work in a project team towards a solution to a real world problem. A theoretic framework will be offered and several user-centred methods and techniques from the field of interaction design will be applied. In the end each team will present their solution.

The course will contain these topics: 

  • Beyond usability; what the user really wants, but has not even thought of yet – lecture and workshops in which you will be introduced to the field of Human Technology interaction. You will have to try thinking the thoughts of your targeted user, understand the context of use, the human-product interaction, requirement specification, and more.
     
  • Lectures will focus on cognitive ergonomics, user interfaces, principles of design, and, yes… bloopers. 

In addition, the second day we will start with cultural background presentations (for this part each nationality has to prepare a really smashing presentation). Afterwards we’ll be discussing intercultural differences and how we - and international product development - relate to these differences. 

User Centered Design

Richard Vos

During this course we will go into the user’s side of design, we will explore who and what the ‘bleep’ we, designers, are working for. 

 Now, we realize that anything can be made by now, and if not technologically doable today, it will be tomorrow. This makes that the ‘consumer’ industry in refocusing from technology driven design towards user-centered design. Yes, sustainability is also a buzzword these days, but think about it, does sustainable only mean degradable or reusable? No, of course not! If things need to be sustainable it means also that these products are used well and to the satisfaction of the customer / user. 

 The course will contain these four topics: 

  • Usage scenario / LCA writing – a workshop in which the use and usage of these simple yet powerful tools will be explored through different stages of the design process. 

  • Beyond usability; what the user really wants, but has not even thought of yet – lecture and workshop in which you will try to think the thoughts of your targeted user.

  • Criteria specification with anthropometric data – an interactive lecture that aims to show how the scenario serves to complete the list of criteria and how anthropometric data can be used to make certain criteria operational / of use to designers.

  • Collages and mood boards – lecture on the use and the do’s and don’ts, plus a workshop for the practice and to show you that an image can say more than many words. (In case making Collages is known to most of the group, we will alter plan and go for an inspiring session of Creative Problem Solving)

Holistic View on Design

ir. Marten Wiersma

To design a new product there are a lot of possible methods and activities. 

In this course we will show you the different aspects of the design process. In general the design process is: think and find a best solution for a need. The thinking can be done in different ways. This difference is related to the complexity of the design process. A designer has to fulfil a lot of different requirements, for example: 

  • financial cost 
  • the function 
  • material requirements 
  • production methods 
  • environment 
  • ethics 
  • culture 
  • etc.  

In this course "Cultural Design Aspects" we will introduce you to a method for design related to these aspects.

The design process depends on the designing person. The designing person has his own background, based on culture and personality. Therefore we will also look at the differences between cultures and we will find out what the basic behaviour is of each person. It is important to recognise the differences between people and to their solutions for a given problem. 

It is important to know what is acceptable during design. To show you what is acceptable or not, you will be introduced in ethics. The introduction consists of 3 basic principles. Each principle will be discussed. Part of it is the theory of argumentation. 

After a design has been chosen, you have to check the design for its safety aspects. In this course we will introduce you a method of checking the safety of the design by "Failure Mode and Effect Analysis" (FMEA) 

Of course it is important to have the best solution for a product. Therefore it is possible to check the functions in relation to the costs of that function. We will introduce you the system of Value Analysis / Value Engineering (VA/VE). 

The testing of equipment is very important. When is a test valid? We will see what is important to check during the performance of a test. 

Besides lectures, we will work in projects as companies in real life work in projects. So feedback is important, because it is the basic of good communication. An introduction in feedback is scheduled. 

Introduction to Project Management

Dr. Miklós Daróczi, Associate Professor  

The main objective of the course is to deliver some theoretical and practical knowledge related mainly to the project planning, scheduling and budgeting. The module starts by defining the project and differentiating project management from general management. The project manager’s role, the project life cycle and the elements of project plan are also briefly discussed. The common formats of schedule the Gantt-charts and PERT/CPM networks, some methods of budgeting and cost estimating are also covered. Based on these techniques students will be able to participate in project planning and implementation.

Student teams will prepare a report and give a presentation on a special project. The purpose of this assignment is to deepen your knowledge on planning projects and to share that knowledge with the rest of the group. The topic of the project will be selected by the students.

Product Development of Biomedical Applications

PEKKA Salonen

Themes of the course: 

  • Introduction to product development process / methodology

  • Introduction to efficient product development tools

  • Case studies of biomechanical applications

    • Prostheses and Orthoses
    • Technical aids for disabled persons
    • Trauma implants
    • Spinal implants 
  • Product and design requirements for biomechanical applications

  • Learning by doing -> product development work in teams.

Goal of the course is to introduce students to product development of biomechanical applications by showing participants several real-life product case-studies and letting the students perform product development tasks in teams. Teachers of the course are professionals in product development and development of biomechanical applications. 

Medical Electronics

Drs. Jan Zijlstra

Assignment:
A non-invasive blood pressure monitor will be built during this course and signal analysis is done on the computer.

In this one-week course the students will have an introduction on how to measure non-invasive signals from the body and how to use measuring devices like oscilloscopes and multimeters. Signals tend to be weak and disturbed by noise, so they have to be filtered and amplified. How this can be done by using operational amplifiers and filtering techniques will be part of the course. Necessary medical background about blood pressure measurement and the used electronic components is presented. Existing software will be used to analyze and interpret the recorded signals.

The course consists of theoretical sessions in the morning and practical (group) workshops in the afternoon. Theory and practice seamlessly coming together in this course. The test is to show an operating blood pressure monitor with correct signal analysis.

Modelling of Biomechanical Systems

Prof. Dr. Mirela Toth-Tascau, Dr. LUCIAN RUSU

Generally, Biomedical Engineering deals with human body modelling and biomechanics, static/dynamic structural analysis, biomaterials, modelling of biological systems, tissues engineering, biosensors, medical informatics, medical electronics, medical imaging investigations, design and manufacturing of medical devices.

Biomechanics combines the field of mechanical engineering with the fields of biology, physiology, and medicine. In biomechanics, the principles of mechanics are applied to the modelling, conception, design, development, and analysis of medical devices and systems in biology and medicine. The modelling of biomechanical systems contributes to the development of medical diagnosis and treatment procedures.

The main purpose of the Modelling of Biomechanical Systems course is to develop the theoretical basics of the biomechanical studies in front of the engineers and researches who work in the Biomedical Engineering field.

Kinematic modelling of biomechanical systems deals with bones, joints, and their motions. One of the most used conventions for geometric and kinematic modelling is Denavit-Hartenberg convention. Based on this convention, human limbs are modelled.

Static modeling of biomechanical systems deals with equilibrium of biomechanical systems (bones, muscles, ligaments and connecting joints). Based on the principles of mechanics, human limbs equilibrium is studied.

Dynamic modelling deals with the laws of motion of material bodies subjected to the action of a force system. The fundamental characteristics and general theorems are presented and applied in order to study the human locomotion.

The implants can be used as replacement of damaged or diseased part of the anatomy (e.g. total joint replacement), to aid in healing of tissue (e.g. fracture plate) or to correct deformity (e.g. a plate used after osteotomy). Several implants for long bones and head skeleton are presented. Also, basic knowledge of biomaterials used for implants manufacturing is essential.

Finite Element Method is considered as the dominating and leading numerical technique in research and engineering practice in the mechanics of solids and structures. Also, FEM represents one of the most important and interesting approach in Tissue Engineering. Thus, the FEM part of the course consists of basics of FEM theory, general ANSYS specific capabilities and steps to solving any problem in order to predict the strain and stress fields within a solid body (a certain tissue) subjected to external forces, and several examples using ANSYS program.

Medical Imaging E-Processing

Dr. Szabolcs Sergyán

 Topics of the course are image processing fundamentals and object recognition: 

  • Image representation
  • Spatial filtering
  • Greyscale and colour images
  • Morphological image processing
  • Image segmentation
  • Colour object recognition

 
The course has theoretical as well as practical parts.

Biomechanics and Anatomical Models

Elza Fonseca

This module will be organized in two sessions during two days. Each session will have theoretical and practical sessions.

Topics to be covered during module:

  • biomechanics applications and 3D models construction,
  • non-invasive high resolution CT data,
  • rapid prototyping applied to 3D models construction,
  • computational anatomical modelling,
  • constitutive and mathematical equations,
  • stress and strain definition,
  • tensile and compressive stress,
  • bending and torsion,
  • material properties of cortical and trabecular bone,
  • loads and boundary conditions,
  • exercises using stress-strain equations for biomechanics applications,
  • quizzes to measure growth in knowledge in covered topics.

 
Theoretical sessions will be in classroom with multimedia facilities and powerpoint slides. In practical sessions, exercises and different quizzes will be produced by students.

Biomaterial Science: 
Fundamentals & Nanotechnological Applications

Ass.Prof. Dilek Çökeliler

During the last century, interest in biomaterials has grown from mere curiosity to routine clinical use, saving lives and improving the quality of life for millions of people. Today, biomaterials and medical devices are a $100 billion industry. This course will cover many fundamental areas such as: 

  • An overview of the biomaterials field (definitions, etc.),
  • The current status of the biomaterials field, 
  • The properties of biomaterials that make them useful in medical (and clinical) applications, 
  • Introduction to the major classes of biomedical materials: ceramics, metals, and polymers. Their structure, properties, and fabrication connected to biological applications, from implants to tissue engineered devices. 
  • New trends and future prospects. 


Course Outline
:
Material science and relation between medicine. Properties of polymeric, metallic and ceramic biomaterials. Natural biological materials. Artificial biologic materials. Applications of material sciences in biomedical engineering. Mechanics, corrosive and surface properties, tissue reactions of biomaterials. Medical applications of researches in material sciences. Synthesis of nanomaterials, nanoparticles and biomedical applications. Nanostructured coatings. 

DateCOURSE SYLLABUS
30.08.   Introduction to the Material Science & Engineering Biomaterial Science
Bulk properties - chemical bonds - surface energy 
Classifications & advanced biomaterials
31.08.Polymeric, metallic & ceramic biomaterials
01.09.Composite biomaterials performance of biomaterials; Mechanical and biological tests
02.09.Introduction to the nanotechnology 
Fundamentals of synthesis and characterization of nanomaterials 
Nanostructured coatings; Plasma polymerisation technique nanosensors; NEMS and MEMS 
Carbon nanotubes

Microfluidic Devices

Prof. Dr. Michael Schlüter, Prof. Dr. Heidi Lenz-Strauch

The application of microtechnology to chemistry and biology – summarized in the name "lab-on-a-chip" – is a rapidly increasing field of activity with many applications in biomedical engineering. In this course the following topics are covered: 

  • Micro fluidics
  • Polymer micromachining 
  • Glass micromachining
  • Characterization of microstructures.

In the practical part of the course the students design simple micro fluidic structures, build them by different manufacturing methods, characterize the structures and test them. 

Biomedical Applications of Transducers, Microcontrollers and Related Electronics

Ass.Prof. Dr. I. Cengiz Koçum, Mehmet Yüksekkaya

Sensors and transducers are the eyes and ears of modern measurement instrumentation and control systems. Many types of machines and also medical instruments depend on transducers and sensors to provide input data about the environment. Widely used in both analog and digital instrumentation systems, sensors provide the interface between electronic circuits and “real world” where things happen.

Nevertheless, all the data have to be processed. The most common technology consists in the use of microcontrollers. So this course also discusses the programming model and basic features of microcontrollers and their application to biomedical instrumentation.

The goal of this course is to provide a representative overview of sensors, how they work, how they are applied and what basic electronic circuits are needed to support them. Further lectures and laboratory experiments cover the basic principles of hardware and software design for a microcontroller based system and interfacing biomedical sensors to microcontrollers are emphasized.

Course Outline:
Sensor and transducer principles. Common transducers for biomedical applications. Overview of PIC microcontroller, Basic MikroC programming for PIC microcontroller. Interface and related electronics of sensors and I/O devices for microcontrollers. Design of microcontroller systems for medical use such as design of a heart beat monitor and a digital thermometer.

Date COURSE SYLLABUS
30.08.    Transducer, sensor and related circuits with some applications.
31.08.Introduction to microcontrollers and embedded Design. PIC microcontrollers and MikroC programming language. Designing simple microcontroller applications.
01.09.Amplifier basics. Transducer to microcontroller interface and related electronics. Analog to Digital conversion using microcontroller.
02.09.A heart beat monitor and digital thermometer will be built using microcontroller.

Sensor Instrumentation

Friedrich Mayr

Sensor Instrumentation is a widely underestimated challenge in the construction of medical devices. It covers the operation of the sensor (for example power supply) and the proper conditioning of the analog signal for a subsequent A/D conversion.

In this 4 days course we will work on a pulse oxymeter, a device that calculates the oxygen saturation of the human blood by illuminating the skin and measuring the light absorption. It is therefore a non-invasive sensor, consisting of a light source, usually two LED's with different wavelength, and a photosensor. We will design the instrumentation of this sensor step by step.

In the morning sessions we will learn how this sensor as well as the required electronic circuits work and we will discuss different ways to obtain a proper signal for digitalization. In the afternoon sessions we will put our conclusions to a practical test by simulating and prototyping the respective electronic circuits.

Devices for Medical Imaging

Prof. Dr. Thomas Anna

Topics of the course are different medical devices for image acquisition:

  • X-ray
  • Ultrasound
  • Computer tomography
  • Magnetic resonance
  • Nuclear / radioactive imaging

Cardiac Pacemakers

Prof. Dr. Thomas Anna

The course gives information about the function of the circulatory system, its major malfunctions and the concept of stimulating the heart electrically. Various pacemaker types are presented. The technology of pacemakers, the programming and safety are addressed. The implantable defibrillator and future concepts are discussed at the end.