CDIO Methodologies for Medical Devices
Speaker: A. Diaz Lantada
This lesson introduces the engineering design process, a methodical series of steps (or methodology) that engineers use in creating functional products, processes and systems for secure and straight-forward developments. This methodology is presented in a form adapted to the special challenges of the biomedical industry and with advices for better tackling medical needs. The conceive-design-implement-operate phases are detailed covering aspects including: medical needs, market analyses, product specifications, global functions, conceptual designs, basic engineering & prototyping issues, detailed engineering topics, production planning and supply chain questions and overall sustainable development concerns. The steps are illustrated by means of a real case of study for providing participants with an overview of the process to live along the design school with their biomedical projects.
Standards and regulations on Medical Devices
Speaker: Alice Ravizza
This presentation will describe the regulatory requirements for the design, manufacturing and use of medical devices. It will allow the participants to identify the correct test methods to ensure the device safety according to international standards. The presentation will also describe the essential requirements for safety according to the European approach and will identify the main safety standards to be used in each stage of the device life cycle. Lastly, the presentation will identify the risk-based approach and the risk subjects for each step of the device lifecycle.
Mass personalization of medical devices
This lesson introduces production techniques for medical devices, analyzing varied tools and processes for the promotion of personalized production with a practical approach. Common processes linking medical imaging with manufacturing tools are detailed and illustrated by means of real cases of study, with the contribution of the R&D team of EOS.
- Mass personalization of medical devices – Part I
- Mass personalization of medical devices – Part II
- Example of files used in Additive manufacturing (knob.FCStd, knob.stl, knob_ASCII.stl and knob_for_SLA.stl)
Usability of medical devices
Speaker: Alice Ravizza
The presentation will describe methods to identify use error- related risks in the use of medical devices, methods for designing medical devices according to Human factors engineering principles and for identification of mitigation measures to use error- related risk, methods for testing the normal and abnormal use of medical devices.
Creativity promotion in medical devices
This workshop aims to “deconstruct” creativity and presents creativity promotion as a methodic process, which can be understood and systematically trained. A set of creativity promotion techniques, linked to the main stages of the creative process, namely generation, association and evaluation, are presented and actively employed during the workshop by teams of participants. Connections with common engineering design methodologies and with the CDIO approach are presented, which will serve teams of students during their design tasks along with their biomedical project implementation. Cases of study in relation with innovative medical devices developments are discussed to illustrate these methods and techniques.
Promotion of personal skills for project and team management
Speaker: Luis Ignacio Ballesteros Sanchez
This workshop focuses on project and team management skills needed for developing complex engineering projects, especially focusing on the challenges linked to the engineering design of biomedical devices. Successfully leading these projects, which requires working in multidisciplinary teams, depends not only on necessary knowledge and technical skills, but also on a wide set of personal skills including: communication skills, honesty, work ethics, flexibility, ability to work in harmony, loyalty, among others. This workshop will help participants to rapidly detect and solve problems when working in multidisciplinary and multicultural teams. It will also provide the teams from UBORA with resources for identifying key roles and for enhancing overall team performance, by taking advantage from individual skills and from mutual support. The participation of UBORA mentors is also highly recommended to create a debate for good practices in collaborative biomedical engineering projects and education.
Electronic Simulation of the Signal Acquisition Process
Speaker: Philippa Makobore
The workshop will focus on signal acquisition, specifically filtering and amplification of a signal. We have chosen this topic because signal acquisition is a key component in the design of biomedical devices. Physiological signals almost always need to be filtered and amplified before any meaningful information can be derived from them.
- Proteus software
- Workshop manifesto
- Electronic Simulation of the Signal Acquisition Process
- Example file
3D scanning and 3D printing
This workshop, in connection with the lesson on “Mass production and mass personalization of medical devices”, will present common tools for digitalizing human geometries and for designing and prototyping biomedical devices personally adapted to the patients. Optical imaging digitalization and related software reconstruction tools will be used during the workshop and teams will have the opportunity of scanning their components, in case some of the biodevices to be developed during the UBORA School may benefit from personalized approaches. Some cases of study linked to ergonomic supports and splints for articular pathologies will be presented.
Speaker: June Madete
This workshop uses Biomechanics (body as a machine) principles to analyse motion. It will focus on calculating the orientation of a body in a three-dimensional space using a maker based system and show how 3 coordinates, x,y,z, can be transformed to motion of the Knee. In addition, compare the marker data to CT scans and Fluoroscopy and show how engineering principles can be applied to clinical data to.
Speaker: Chiara Magliaro
Large amounts of biomedical and clinical data rely on images, and their processing and analysis are crucial for research as well as for diagnostic and therapeutic purposes. This workshop introduces the main concepts of image processing and analysis and their implementation using the Matlab Image Processing Toolbox.
After a quick theoretical lesson on image fundamentals, contrast enhancement and image segmentation, during the hands-on training you will use Matlab to implement a simple “Mood detector” from an image of a person. Workshop highlights:
- Understanding of the concepts of Image Processing;
- Practical sessions on Image processing, applied to face detection;
- Implementation of an algorithm for detecting people mood from an image of a person.
Physiological signal acquisition using open source tools
Speaker: Ashwin K Whitchurch
This workshop will focus on using open source hardware to measure human physiological signals and derive not only basic vital signs such as heart-rate, respiration and SpO2, but also more advanced analyses such as heart-rate variability, stress, cardiac function and so on. Participants will have a chance to get hands-on on some open source hardware for this purpose and would leave with an idea about how to work with these devices to develop new applications.
Open source tools for usability analysis of medical devices
This workshop aims at presenting PVSio-web, an open source toolkit for design and analysis of user interfaces for medical devices. Using the toolkit, one can transform a static picture of a device into an interactive simulation that closely resembles the behaviour and visual appearance of a real system. A formal (i.e., mathematical) model defines the behaviour of the device. The model can be analysed systematically to check use-related safety properties of the user interface design, such as visibility of operating modes, ability to recover from use errors, and predictability of automated user interface functions. The students will learn how to use the toolkit to design the data entry system of medical device, which is typically used by clinicians to setup the therapy in the device. A set of already developed simulations based on real devices will be used as running examples.
A brief (practical) story of the pacemaker
Speaker: Mannan Mridha
To study the pacemaker signal with the help of Oscilloscope and calculate the energy it delivers, and design a pulse generator to deliver variable energy to stimulate heart with different needs and conditions.
Pacemakers are implantable medical devices that are prescribed for people whose hearts are beating too slowly or irregularly. A pacemaker stimulates the heart muscle with precisely-timed discharges of electricity that cause the heart to beat in a manner quite similar to a naturally occurring heart rhythm. A pacemaker consists of:
- A pulse generator with battery and circuitry providing electrical energy and timing;
- A pacing lead – an insulated wire that carries electrical impulses to the heart and information about the heart’s natural activity back to the pulse generator; one or two leads are used depending on the type of pacemaker prescribed. The idea is to demonstrate how the above is achieved by connecting a pacemaker pulse generator to an oscilloscope.
- The signal delivered is presented on the Oscilloscope, and the amplitudes and the pulse width is measured.
- Measurement of the Pulse width and Pulse duration should be done again, and this time by connecting a 50 Ohm resistor parallel to the oscilloscope and study the signal again, measuring the signal and the draw the pulse form. It is required to Draw the pulse form and Measure Pulse width, Pulse Amplitude and Calculate Time constant, RC.
- Calculate the voltage drop on Rin, and current through Rin to find the value of Rin. Now, knowing the time constant, and Rin total, Calculate the value of Cin.
- Calculate the total energy delivered by the pacemaker to 50 Ohm load.
The students can use the circuit above to deliver variable energy required to stimulate a heart, depending on the needs and conditions. The students can learn to:
- Vary the pulse amplitude by changing R1 and R2
- Change the pulse width by varying R3 and R4 to achieve the desired pulse width to get different energy for pacing.
- Calculate the time constant T from oscilloscope by studying the signal from op pin 2 and comparing the result from the respective R C values.
- Finally, calculate the energy it delivers in a certain time.
Open source innovation and entrepreneurship
Speaker: Ashwin K Whitchurch
Open source software has been a long-time contributor to the needs of businesses both large and small. Now it’s open source hardware’s turn to take the world by storm. The combination of advances in technology and innovation has allowed us to explore new applications, especially in the medical and healthcare field. This talk will focus on the newest advances in open source medical devices and the barriers this has broken to explore new avenues of entrepreneurship.
- Presentation: Open Source HW & Entrepreneurship
Bioprinting human organs, the next frontier of bioengineering
Speaker: Prof. Giovanni Vozzi
Bioprinting promises to create three-dimensional in vitro models to study pathological states and possible new therapies, and in the future, to produce complex tissue and organ replacements. The keynote will describe the recent advances in bioprinting technologies to engineer artificial tissues and organs by controlling spatial heterogeneity of chemical and physical properties of scaffolds and, at the same time, the cellular composition and spatial arrangement.
Technology and surgery current challenges and future perspectives
Speaker: MD, PhD Paolo De Simone
Technology and dexterity are the basic components of surgery. The recent technological advancements are even more demanding, in that they require novel skills and integration of physical, visual, and cognitive capacities on the part of surgeons. Experience and human factors also contribute to quality of surgical practice, even though their role is often neglected in scientific debates. From an elastic point of view, surgery requires integration of all of these dimensions and consistently with type of disease, patients, and curricular course.
Advances in medical imaging
Speaker: Prof.Luigi Landini
Medical imaging has dramatically improved the ability to accurately diagnose and recognize disease and allow understanding of the molecular mechanisms of diseases and their respective responses to therapy. Technological improvements, as well as deeper knowledge in physical phenomena coupled with new information technology and image fusion/integration capabilities, will be presented, delineating a possible scenario to translate scientific research into improved patient care.
Nanomaterials for breakthrough innovations
Speaker: Prof. Gianluca Fiori
In this talk, I will provide the perspective of new nanomaterials (like two-dimensional materials 2DMs) for electronics, which have already demonstrated huge potentials for a wide range of applications, spanning from Radio Frequency, to Biomedical, and Flexible and Wearable applications. In particular, I will show the latest results on printable electronics based on 2DMs, which could pave the way towards on-demand and just-in-time circuits.
- Presentation: Nanomaterials for breakthrough innovations