Design Practices Track
Sponsored by:
Moderator: Matan Tofach, Manager, R&D Catheter Line, Integer
11:20 - 11:40
Best Practice & Experiences from Start-up Acquisition to Successful Integration and Scale Up
John will share his experiences and best practices he has seen with multiple acquisitions and how best innovative start-ups companies should develop their products and position them to return maximum value for all stakeholders.
BIO:
John has extensive experience in the medical device business, specifically with Boston Scientific where he was the R&D/Process Development lead for the Integration of multiple acquisitions, the majority of which were scaled up in to very successful commercial franchises. He was the process development leader for the CRM business unit driving projects and next gen platforms which drastically reduced costs in manufacturing and also increased quality on multiple product platforms. He was the site leader for their Electrophysiology design centre in San Jose, CA (in the heart of Silicon Valley) and also held the same role in Cambridge MA after the acquisition of Rhythmia Medical (an EP mapping system), where the site was scaled up post acquisition to become a strategic design centre for Boston Scientific EP mapping systems.
John Cooney
VP R&D,
Integer
11:40 - 12:00
How to Succeed in Process Validation in 5 Steps at the Medical Device Industry
What are those 5 steps that will lead you to success in Process Validation?
You will be exposed to those day-to-day challenges that make so many organizations get trapped in the Process Validation activities.
Hours and hard work are often spent without a justified reason. Things can actually be easier if methodically done.
These 5 steps will not only save time-to-market but reduce the burden of long waged hours, paper work, while providing compliance and a higher professionalism inside the company.
Apply these steps in in-house assembly lines, New Product Introduction and also introduce them to your sub-contractors and component suppliers, national-wide or abroad.
BIO:
Expert in Process Validation and Quantitative Methods for the Medical Device Industry. Working as a SME Senior Project Manager in GSAP, holding a M.Sc. Industrial Engineer degree, Six-Sigma and B.Sc Mechanical Engineer. Extensive Engineering, Managing and Validation practice at the Medical Device and Pharmaceutical industries
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Jose (Yossi) Chvaicer
Senior Process Validation Engineer and Quantitative Methods Expert
Gsap
Erez Lampert
CEO
PathKeeper
12:00 - 12:20
AI & 3D Optical Active Navigation in Robotic Surgery
Robotic surgery and AI have penetrated the medical world in a storm during the last decade and although some the buzz is strong the actual adoption and proof of value is limited.
In this presentation we will explore Spine robotic surgery as a specific use case and through it look at the future of surgery.
BIO:
BsC and MsC in Electrical Engineering, specialising in Artificial Intelligence
BA in Mathematics, and MBA
20+ years in R&D for medical industries and aerospace
3D medical imaging expert
Led the development of the itero element, Intraoral 3D dental scanner for Align Technology (Invisalign’s Israeli branch)
Aylvin Dias, Ph.D., M.Sc.
Principal Scientist
DSM Biomedical
12:20 - 12:40
How to Approach Biomaterial Selection in Medical Devices and Components
From DSM Biomedical, unrivaled experts in biomaterials science, on considerations for selecting and therefore benefitting from combining highly advanced technologies and innovations to create sustainable solutions to meet and exceed your device design and clinical objectives. On partnerships path from concept to commercialization, biomaterials portfolio, custom solutions, material selection per Form-Fit-Function approach, evaluation, and finally manufacturing.
BIO:
Aylvin A. Dias Ph.D., M.Sc. is the Principal Scientist for material – biology interactions at DSM Biomedical. He obtained his B.Sc. (Biological Chemistry), M.Sc. (Organic Superconductors) and Ph.D. ( Polymer photochemistry) at University of Kent at Canterbury. In 1994 after his Ph.D. he worked at Total Chemie on materials for food packaging. In 1996 he joined DSM in the Netherlands. In the first 5 years he worked on optical fiber and 3D printing. Since 1999 he established the biomedical research program and thereby was one of the founders of DSM Biomedical. While at DSM he has lead the developments in 3D printable resins WaterShed & Bioclear, medical coatings platform ComfortCoat. He then went to establish a drug delivery group and managed technology transfer of drug delivery platform the polyesteramide polymer into DSM. Aylvin Dias has 40+ patents and 30+ peer reviewed publications. He has served as chairman of the supervisory board of Xilloc Medical bv in 2013 and on advisory panel at the University Medical Centre Utrecht, The Netherlands, Biointerfaces International, Switzerland, POLY division of the American Chemical Society and was President of the Surfaces in Biomaterials Foundation (USA) in 2015. His current research is primarily focused on understanding biointerfaces of medical biomaterials.
Liat Diamant Porat
CEO
LDP consulting
12:40 - 13:00
Human Factor and Usability Requirements
The application of usability engineering is in principle reducing medical device’s unacceptable risks and improving patient care by reducing the potential for harmful use error through enlightened user interface design. The usability engineering includes 3 major steps: carful and detailed identification of the user, use environment, user interfaces and agreement on critical tasks followed by formative usability process and validation usability testing (also known as summative study). User related risk analysis (URRA) is now becoming a significant tool for product developers mitigating the associated hazards with the task analysis. In this short session, we will try to provide you with insights on the requirements and assist in promoting good usability engineering rather than turning the usability engineering process into a paperwork generation exercise.
BIO:
Liat holds LL.B, and B.sc in Life Science Biochemistry and Molecular Biology.
Liat has more than 20 years of experience in regulatory affairs, clinical management, and quality assurance for medical devices. Prior to founding LDP and Duet Medical, two consultancy agencies, she served many years as the regulatory and clinical manager in start-up companies, mostly in the field of Class III cardiovascular devices, like BBalloon and ByPass Maakafim.
Her part in start-up companies allowed her to acquire a deep understanding of design and manufacturing constraints and limitations, risk management, and usability processes.
13:00 - 14:00 : Lunch, Exhibit Viewing
14:00 - 14:20
Hybrid Endoscopy
Hybrid Endoscopy brings the benefit of both worlds into the medical field.
With High image quality, avoiding contamination risks, with low cost, higher accessibility, and higher availability.
BIO:
Dr. Shahmoon established Zsquare after years of intense research and academic work in the field of photonics at the Friedrich–Alexander University (FAU), in Nuremberg Germany where he completed his post-doctorate in photonic devices related to the clinical field. Asaf was awarded the photonics 21st, a European award for student innovation.
Dr. Shahmoon has always strived for excellence, achieving multiple awards for outstanding accomplishments throughout his academic career; he was awarded the Rector’s prestigious award for excellence in teaching, as well as the Rector’s award for student excellence in doctoral programs at Bar Ilan University in Israel and has gained an excellency scholarship from the Bar-Ilan nanotechnology center. Dr. Shahmoon has published more than 25 papers in peer-reviewed journals, written two book chapters, and submitted 10 patents related to medical device optics. Before launching Zsquare Dr. Shahmoon was involved in multiple business initiatives, R&D, and Business Development projects.
Dr. Asaf Shahmoon Ph.D
CEO and Co-founder
Zsquare
Aharon (Arik) Cohen
Founder and CEO
Taryag group
14:20 - 14:40
Holistic Design For the Sterile Product: Package, Cleaning, Shelf life, Sterilization and Laboratory Tests
The manufacturing process of a sterile device ends by shipping the packed device from the manufacturer site to a sterilization site and shortly after to the market.
As designers and manufacturers, we might think sterilization is a generic process with simple output outside our responsibility and control. Still, it is not: The sterilization process, which will always remain part of the manufacturing chain of the device, is a process related to many design factors.
A holistic and broad approach to selecting materials and technologies, the cleaning and assembly process, and packaging design will allow us to run a routine of simple and fast sterilization after the first version of the devices is released to the market.
BIO:
An entrepreneur at heart, the founder and owner of Taryag, Aharon Cohen, holds more than 20 years of experience in medical device management, design, manufacturing, and regulation. In 2015, following stints in several medical startups, Aharon established Taryag believing that a new, integrated services approach is needed to provide medical innovators with the optimal infrastructure for making a rapid, meaningful impact on patient care. Eternally curious and always seeking a new, better way of doing things, Aharon's proactive mindset drives Taryag to continuously innovate and improve its offerings.
14:40 - 15:00
CORA – Coronary Artery Assessment, a Novel Device For the Early Detection of Coronary Artery Disease
In this lecture we would cover the technological aspects of the R&D process of developing CORA - a novel device for the early detection of coronary artery disease. The CORA operates by a few minutes’ measurement of the patient’s electric activity of the heart, oxygen saturation and respiratory phase.
Our technology is based on two new bio signals, enhanced waveform display and ML-powered signal processing algorithms. CORA has the potential to save the lives of millions of people worldwide, while lowering related healthcare costs.
BIO:
Benny is a veteran R&D leader with almost 40 years of experience in executive roles within numerous hi-tech organizations, in various fields. Benny started his career at the Israel Military Industries in the rocket division’s computer center. Following that Benny joined Tecnomatix as product manager, where he developed 3D computer aided process planning later implemented by several large car manufacturers as well as aerospace, energy, and industrial companies. After that, Benny served as VP of Technologies at PixelMultimedia. Following that, Benny was the co-founder and VP of R&D at New Media Communications, which was acquired by Harmonic Data Systems, where Benny was appointed as CTO.
Benny has a BSc (cum laude) and an MSc in mechanical engineering, both from the Technion, the Israeli Institute of Technology, and he holds 4 patents under his name.
Benny Shani
CTO
AccuLine
15:00 - 15:20
Creating a New Surgical AI Reality
Ron Schneider
CEO
Beyeonics
Artificial Intelligence (AI) is advancing rapidly within health care industry and making its steps into the surgical environment. Many of the AI implementation challenges into the operating room lies on the ability to create near to prefect artificial decision-making. Other significant challenges are related to the accessibility of AI outcomes to the surgeon in a trusty and efficient way. Beyeonics has designed an advanced imaging system for Ophthalmic surgeries coupled with augmented reality headset. Using strong processing and deep learning methods, the system can guide the surgeon through complicated procedures. Using the augmented reality makes the work flow natural and easy.
BIO:
Mr. Ron Schneider is a co-founder of Beyeonics and serves as its chief executive officer for the last 5 years. During his role he managed to build the company from R&D to commercialization for advanced medical device systems for Ophthalmic and Orthopedics surgeries. Before Beyeonics Ron was serving as the medical devices development senior director for Elbit systems where he led the technology, clinical, marketing and business developments in the ophthalmic and Neurosurgery fields. Prior to that Ron was leading the development of cutting edge electro-optic systems at Elbit aerospace division specializing in the development of head mounted displays, imaging systems, multi-spectral cameras and laser gated imaging. Ron holds a masters degree in electrical engineering from the Technion Israel institute of technology.