Design Practices Track
Moderator: Avner Gal, Co-Founder & CEO, Iridium Consultancy & Technologies
11:20 - 11:40
AI Solution For the Next Generation Healthcare Devices
Latest advances in medical science demonstrate, that general-purpose medical diagnosis and treatment are gradually evolving toward precision medicine and personalized medical services. By incorporating the latest AI and imaging technology we help MED manufacturer to achieve their time to market targets.
AI, in addition to multitasking and accelerated computing, will play an important role in the next generation of medical applications. AI will be particularly important in medical imaging diagnosis, genetic sequencing, and specialty applications, like surgery robots and precision medical solutions. AI will help smart medicine equipment make the step to the next level. In this presentation we will introduce how we could assist in developing next-generation medical and provide overview of Advantech latest solutions for medical equipment manufacturers.
B.Sc.EE with more than 20 years in Embedded R&D for consumer and industrial applications. Implementing embedded solutions for defense and medical projects, specializes in AI & IoT applications
Senior Application Eng.
11:40 - 12:00
Packaging Guidelines – Helping You Design a Creative and Customized Packaging Solution
Herewith some of the topics we will discuss in my lecture:
Innovative packaging solutions
How to choose the proper packaging
Review of raw materials which are being used for rigid and flexible packaging
Packaging design – process steps
My name is Michal Beeri and over the last 3 years I am in charge of the medical device packaging solution at Yail Noa Group
I have B.Sc degree in Chemistry and I have the knowledge and experience at leading start-up & mature companies throughout the process of developing and manufacturing the proper packaging solution.
Medical Device Account Manager
VP Sales & Marketing
12:00 - 12:20
Novel Miniature Batteries for Active Implanted Medical Devices
Designers of next generation medical implants are miniaturising their disruptive technologies to enable implantation nearer to targeted organs, in more pockets in the body and by less risky procedures. Miniaturisation is opening an increasing number of applications in the area of neurostimulation, cardiac sensing, smart orthopaedics etc… Ilika is developing a novel battery type using solid state technology which can create mm-scale energy sources, enabling further miniaturisation and long term operations for new implanted medical devices.
John Tinson joined ilika in 2019 as VP Sales, supporting ilika’s sales directors in the US, China , Japan and Europe. John has a degree in Physics from Birmingham University and has since focussed his career on early stage UK technology companies in sectors such as opto-electronics, cabling solutions , industrial lasers and semiconductor design.
The Qt Company
12:20 - 12:40
Next Level User Experience for Medical Devices with Qt
When creating a working user interface, there is often a disconnect between the Designer’s UI design, and what Developers can do to bring the design to fruition. This is typically due to the design and development teams using different sets of tools, with different capabilities. Qt Design Studio bridges the gap by allowing the designer’s vision to be compatible with the development tools, creating an easy way for both teams to interact with the end product.
With Qt you can create a modern interface that not only impresses your end-users but gives them a natural and self-guided user experience, in all environments, be it home or hospital. Join our experts Emmanuel Penzes and Arnaud Armengaud, who will guide you through building modern & reusable, multiplatform graphic applications through our designer-developer workflow and break the cycle of painstaking feedback loops between designers and developers.
Emmanuel Penzes BIO:
As a Pre-Sales Engineer at Qt, Emmanuel's focus is on demonstrating the Qt framework capabilities and how Qt customers can create cross-platform UIs quickly. Before joining Qt, Emmanuel architected and developed set-top box customer solutions. Emmanuel is a Computer Science Engineer from Universite de Technologie de Belfort-Montbéliard, France.
Arnaud Armengaud BIO:
Arnaud Armengaud works as a Technical Artist at Qt, supporting the development of design tools and helping wide range of industries to build their next generation products based on Qt Framework. Before joining Qt, Arnaud has worked in various roles from UI/UX Designer to Head of Design for several different media companies. He comes from France, where he studied at Art School in Paris.
The Qt Company
Engineering and Validation Project Manager
12:40 - 13:00
Process Validation in Medical Device
Process validation is an essential part of medical device manufacturing. The regulations defines process validation as establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. The goal of a quality system is to consistently produce products that are fit for their intended use. Process validation is a key element in assuring that these principles and goals are met.
The aim of the presentation is to provide an overview on the regulatory and practical aspects, benefits and implementation of Process Validation in the medical devices industry, including real life case studies.
Haim is a talented quality and validation engineer, holds an M.Sc. in Genetics and molecular Biology in plants, and B.Sc. in Life Science, from Tel Aviv University.
He has a vast knowledge and experience in equipment qualification, process validation and computerized system validation in medical devices and Pharma regulated companies
Quality engineering expertise aligned with biopharmaceutical and Medical device highest level regulation standards
Haim held key positions in leading Process validation projects in the medical devices industry.
13:00 - 14:00 : Lunch, Exhibit Viewing
Quality Assurance and Regulatory Affairs Manager
14:00 - 14:20
Adoption of New or Modified Products into an Existing Validated Ethylene Oxide Sterilization Process
Medical device manufacturers are constantly developing new products and improving the design, packaging and/or load configurations of their current products.
AAMI TIR 28:2016 may be used as a guidance for introduction of new or modified product or establishing process equivalence to an existing ethylene oxide sterilization cycle, reducing the need for an extensive full validation of these changes.
Extensive experience in multiple disciplines of the Medical Device industry: R&D, Manufacturing, Quality System Management as well as Regulatory submissions and registration with International Authorities. (US FDA, European Notified Bodies and Japanese Ministry of Health.) Manages a team of Quality and Validation engineers who design, guide and monitor the Validation and Routine sterilization processes of medical devices at Mediplast.
14:20 - 14:40
Working with a Contract Development Partner
Working with a CDMO to bring your product to market can be fraught with challenges. Selecting the right partner is a critical first step. My colleague Jim Kelley presented some of the key elements to consider when selecting a CDMO partner at MDI 2020. Building on this theme, we will look at how best to engage with and manage your project with your chosen CDMO partner to have a successful relationship
Medical Device Professional with 25yrs experience in Catheter manufacturing, including 20+ yrs working in the contract design and manufacturing environment. Leadership roles in Operations including Plant Management, Product Management and Business Development as well as extensive experience in Engineering and Project Management roles including Tech transfers (customer and intercompany), NPI, Process Development, Validation, LEAN and Operational Excellence
14:40 - 15:00
Power Design for Your Medical Device — Getting it RightAdvanced Energy
Challenges in designing the power stage of a medical device are numerous. Power output, size, weight, efficiency, noise levels, patient safety and certification are but a few of the design verticals that challenge the designer.
These design considerations should be addressed and agreed upon in the early stages of the design, as they will have great effect on the final product in both the application and the commercial aspects.
The aim of this presentation is to present a few best-known practices in choosing the correct power stage for a given product.
Liran Katzir joined Advanced Energy in 2019 and currently serves as the company’s R&D Manager in Israel. He is responsible for new product development, R&D and the engineering efforts in Israel. Prior to assuming his current role, he held senior product development and technical leadership positions at Volex Power, Betterplace and Applied Materials.
Dr. Katzir brings over 20 years of experience in power systems research and design, delivering advanced power solutions for the semiconductor, industrial and medical verticals. He started his career at Saifun semiconductor, designing the power and analog parts in the MLC family of chips.
Dr. Katzir Holds a PhD in electrical engineering from Tel Aviv University and has over 25 published papers and patents.
Dr. Liran Katzir
Israel R&D Manager
Vinod Kumar Ramu
Product Manager MEMS Sensors
15:00 - 15:20
Human Fall Detection Systems Using MEMS 3-axis Acceleration Sensor
Accidental falls represent one of the major problems faced by elderly people. The evident possibility of initial injury may lead to severe consequences, if the person is not treated immediately. There are different approaches used in developing the human fall detection systems for elderly people. These approaches are classified as wearable and non-wearable based fall detection systems. The proposed approach in this case study uses a wearable-based system using MEMS 3-axis acceleration sensor to detect human fall. The case study on fall detection system with 3-axis MEMS acceleration sensor without continuous communication between controller and sensor is presented. Sensor interrupts based approach reduced the communication time between controller and sensor by more than 50%. The approach seems to be effective for low battery power fall detection systems.
Vinod Kumar Ramu received his Master of Science in Optics and Photonics from Karlsruhe Institute of Technology in Germany. He has Bachelor of Engineering degree in Electronics and Communication from Anna University in India. From 2014 to 2016, he was working with MEMS sensor development projects in thin film material characterization, MEMS packaging and integration in Singapore and Germany. In 2018, he joined Würth Elektronik eiSos GmbH as a product manager responsible for MEMS inertial and Environmental sensor.
After successfully introduction of MEMS 3-axis acceleration sensor and humidity sensor at Würth Elektronik eiSos GmbH in 2019. He is actively working to expand the MEMS sensor product portfolio for Industrial and IoT (Internet of things) application.
15:20 - 15:40
Why You Should Consider Regulatory Requirements Already During Early Stages of the Design
Regulatory requirements play a major role in medical devices development, and take a meaningful portion of the project’s budget.
A wise planning of the necessary activities, including clinical trials, while taking into account the timing, embedment in the development stages, and proper synchronization with the progression of the development activities are essential to ensure effective and efficient progress.
On the other hand, “stand-alone” development, and consideration of regulatory requirements only in later stages may lead to excess expenses, longer time to market and even need for medical device recall, followed by significant impact on the company.
With over 45 years in the electronics field, Avner brings reach experience in project management and system engineering, of which, over 20 years in the medical devices arena.
Mr. Gal holds BSc and MSc degrees in Electrical Engineering from the Technion and Naval Postgraduate School, CA, USA, accordingly, and MBA from University of Derby, UK.
During the past 25 years (and currently) he founded and managed private and public companies, involving innovation and complexed challenges.
Avner published about 40 medical devices professional papers, has a few patents and is a guest speaker in the Technion and other institutes about project management and innovation.
Co-Founder & CEOIridium Consultancy & Technologies