Design Practices Track

Moderator: Avner Gal, Co-Founder & CEO, Iridium Consultancy & Technologies

11:20 - 11:40

Solvay High Performance Polymer Solutions For Biopharma and Surgical Robots
 

Technical requirements in Biopharma and Surgical Robots, two of the fastest growing markets in the healthcare industry, are extremely challenging for most materials. Compatibility with multiple sterilization methods, resistance to aggressive disinfectants and high mechanical properties are in fact all needed to guarantee the proper functionality of the components used in these demanding applications.

Solvay’s wide range of high performance polymers offers key properties to meet all these challenges, allowing design engineers to exploit the advantages of plastics without ever compromising on performances.

The aim of this talk is to introduce the audience to Solvay's materials portfolio, with specific focus on solutions for Biopharma and Surgical Robots applications.
 

BIO:

Federico is a Technical Development Engineer at Solvay Materials based in Bollate, Italy. Federico holds a Masters degree in Mechanical Engineering from Politecnico di Milano,  Italy. He was then awarded a PhD in Manufacturing Engineering by the Technical University of Denmark, where he specialised in micro injection molding for medical devices. He joined Solvay in 2019 and, since then, he supports application development and provides technical support for customers in the Consumer, Healthcare and Construction markets in EMEA.

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Federico Baruffi, Ph.D

Customer Technical Development Engineer

Solvay

11:40 - 12:00

Computerized Software Validation in MD Industry

The presentation focus on the following subjects:

  • CSV purpose and Concurrent Regulations

  • Software Categories (GAMP5) and 'V' Shape models

  • EU GMP Annex 11: What's needed?

  • CSV Regulation Warning letters- where the main current focus is?

  • CSV: From where should I start?

  • Risk assessment

  • FDA Flip paradigm- which evidence should we document during testing?

  • CSA-The GAMP Computerized Software Assurance latest methodology and Critical Thinking

  • Which Supporting SOPs before CSV Takes place?

  • What are the main 21 CFR Part 11 requirements?

  • Software change- what shall we verify?


BIO:

M.Sc. in Genetics and molecular Biology in plants, Tel Aviv University  

B.Sc. in Life Science, Tel Aviv University

Deep knowledge in Regulation, Standards and Guidance Requirements:

GAMP5 |(FDA)   21 CFR PART 11, Part 820, | EudraLex-Annex 11| GHTF| ISO 13485 2016GPSV (FDA) |

Haim has Experience in implementation of entire lifecycle CSV of complicated ( GAMP5 Category 5 and 4) and simple computerized system validations: SAP, Priority, customized applications  and OTS software's (GAMP5 Category 3) , Process Validation In MD and Risk Analysis (pFMEA).  Haim is Certified as Internal Auditor ISO 13485.
 

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Haim Eliyahu

Validation & Engineering Team Leader

Gsap

 

Aviad Yedgar

Director of R&D

Integer Israel site

12:00 - 12:20

Factors to Consider when Developing a Medical Device

Factors to Consider when Developing a Medical Device - how to identify and define user needs, translate them into proper achievable and affordable design requirements - through effective bench and pre-clinical studies to reach a successful design freeze.

BIO:
Aviad holds BSc. In Biomedical engineering and MSc. In mechanical engineering – has been working in the industry for the past 12 years in different engineering position both in the Pharma and Medical device fields. Currently leading Integer Israeli R&D team.

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Gaby Lindenberg

CEO

Lindenberg Industrial Design

12:20 - 12:40

Integrating Industrial Design into Product Development
 

The development of medical devices requires the consideration of many technical parameters. However, there is often little talk about the relationship between the product and its user. It is the role of the industrial designer to challenge the engineering aspects and focus their development process on the end user.
 

BIO:

Gaby established Lindenberg Industrial Design in 2005, five years after completing his studies in Industrial Design at the Hadassah College in Jerusalem.
Over the past 17 years he has been responsible for many products in the medical, military, communications, and consumer industries. His exceptional ability to identify the key points in the development process and to provide solutions that are amazingly accurate, have made Lindenberg Industrial Design one of the leading companies in its field in Israel.
Gaby says that for him, responsibility is of primary importance. He is totally committed to the company's clients, a person who provides professional service and lovely treatment. France, where he studied at Art School in Paris.

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Daniel Gurevich

Senior Application Engineer

Advantech IL

12:40 - 13:00

Advanced Storage Solutions For Medical Devices

The development of medical devices implies various technical challenges, often with a gap about the liaison between the product and the end user. It is the role of the designer to challenge the engineering aspects and focus their development process on a favor of the end user.

In this presentation, we will introduce Advantech's SQFlash and SQRAM industrial medical-grade products that includes highly durable and reliable storage and memory solutions, with excellent compatibility, performance and security.


BIO:

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.

13:00 - 14:00 : Lunch, Exhibit Viewing

14:00 - 14:20

How NEXA3D’s Ultrafast Resin 3D Printers are Accelerating the Design and Manufacturing of Devices

We will present the leading ultrafast 3d printing solution which will enable medical device companies to decrease time to market, improve productivity, improve functionality and reduce total cost.

BIO:

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Izhar Medalsy

Chief Technology Officer

Nexa3D

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Henrik Bjoerk

Director / Co-owner

IPC – Innovative Polymer Compounds

14:20 - 14:40

Additive Manufacturing For Human Tissue Engineering

IPC’s objective is to develop a new range of up to 120 polymer compounds (a mix between plastic/polymers and additives that we supply in the form of pellets, that can be used for 3D printing (or Additive Manufacturing). The method of 3D printing is called “bio-inkjet”.

During the 3D printing, human cells will be injected into the medical device.

The difficulty IPC has to overcome is finding a suitable compound that will work together with the human cells added during the 3D printing.

BIO:
BA in International Business Administration and Marketing

Founder and Director of IPC – Innovative Polymer Compounds since 2008
 

14:40 - 15:00

Re-Startup!

How to completely turn around a company from BOD to management to strategy and even location to create a leader in women’s health thru impact recognized by the World Economic Forum.  Keren will take you thru the journey of creating a platform company, thru challenges in commercialization, R&D, clinical development, Board trust and management resetting. 
 

BIO:

Mrs. Leshem is a seasoned executive with specific background in marketing, sales and Business Development. She has over 20 years' experience in the medical device and pharmaceutical industries specializing in the management of innovative start-ups, disruptive technologies, licensing and financing. Keren recently joined OCON after spending a few years in the EU working for a leading Pan-European Pharmaceutical company in the Ophthalmic field, which marketed and distributed innovative ophthalmic pharmaceuticals across the EU, EMEA & Asia & Australia.

Ms. Leshem currently sit on FemTech Lab’s admissions and advisory Board as well as LSX’s Advisory Board and is a Mentor in the 8400 Healthtech Network and was recently admitted to the World Economic Forum’s tech pioneers.
 

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Keren Leshem

CEO
OCON Healthcare

15:00 - 15:20

SCUDO - Increases Confidence in Our Ability to Function Continuously During Virus Outbreaks

SCUDO is an Active Antiviral Shield and sensor wearable technology, and Smart Digital Platform, which aim to give people back the freedom to work, travel, connect, and still be protected from existing and future viruses and airborne risks.

Trust, especially trust in government policy, is a key factor in effectively responding to a virus outbreak. Epidemics are not just contagious conditions; they are human conditions. The social context and the health context are important. SCUDO uses digital technology to transfer this responsibility from governments to organizations and  to increase confidence in the public, organizations and their people in their ability to function continuously during an epidemic.

SCUDO provide trust in all parts of the process:

  • The active antiviral shield protection is effective and efficient.

  • The software applications do not compromise users' privacy.

  • The use of technology is friendly, simple, and accessible to everyone.

  • Decisions made by the smart digital platform will be data-driven, objective, and not arbitrary or influenced by foreign considerations.

  • People may feel that regulation, government entities, organizations and their people have mutual interest in maintaining functional continuity during epidemics.

 

BIO:

Yair is a technologist, inventor and “people first” leader. He is the Co-founder and CEO of SCUDO. He holds a Ph.D. in Nanotechnology from the Technion. Over the past 10 years, he has built, managed, and led startups and R&D and engineering teams in hands-on development of multidisciplinary and advanced technologies and products.

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Yair Paska, Ph.D.

CEO
SCUDO