Medical Device industry, the logical step after academia
Event details
| Date | 23.11.2017 |
| Hour | 17:30 › 19:30 |
| Speaker | Dr Szymon Kostrzewski, CTO of KB Medical Kim Rochat, Senior Partner and Cofounder of Medidee Services SA Dr Wojciech Bobela , Project Associate at Medidee Services SA |
| Location | |
| Category | Internal trainings |
SV PhD Student Association (ADSV) and Medidee Services SA have a great pleasure to invite you to the seminar “Medical Devices industry, the logical next step after your studies”. You will have a chance to learn about medical device development and compliance, as well as opportunities of non-academic career paths within regulatory affairs field.
When: 23rd November, 17h30
Where: SV1717
The talks will be followed by an apero where you can discuss informally with the speakers.
Speakers and Topics:
17h Registration
17h30 Welcome and Introduction
17h35 Talks and Q&A
18h35 Apero
Talks and BIOs:
The challenge of compliance for medical devices
1) The regulatory journey of a Surgical Robotic system
As a Spin-off of the EPFL, KB Medical has developed the AQrate System, a minimally invasive, surgical robotic assistance system for a wide range of spinal procedures, requiring high level of precision and rigidity. KB Medical went through the complete design and validation journey and got cleared for marketing in Europe and started the process in the US. Activities included clinical investigations, technical validation, audits and review by Notified Bodies as well as interaction with competent authorities. In 2017, KB Medical has been acquired by Globus Medical, a global, US-based manufacturer. You want to develop a medical device? This is what you should be prepared for.
Before founding KB Medical, Dr Szymon Kostrzewski conducted research at renowned institutions including the Stanford University, EPFL in Switzerland and the German Aerospace Center DLR. As the CTO of KB Medical, Dr Kostrzewski led KB Medical R&D team into the technical and regulatory journey of developing a complex medical device.
2) The challenge of compliance for medical devices
Before being able to place a medical device on European Market the manufacturer has to comply to numerous legal requirements organized in complex regulations and standards. With the current change in regulation, increased scrutiny on all stakeholders the market seems more like a battlefield rather than an organized economy. Prepared for a true challenge? This is how you can contribute to a growing economy.
Kim Rochat is Senior Partner and Cofounder of Medidee Services SA. His mission is to support medical devices manufacturer in the constant and most efficient compliance to legal requirements. His activities range from implementation of quality management systems, regulatory affairs and clinical investigations and evaluations.
3) The life of a scientist outside of academia
Every young scientist during the course of their PhD, sooner or later will ask themselves at least one of the following questions… “should I continue my career in academia?”; “if I choose to quit, what options do I have?”; “is my skill set valuable to a potential employer?”. The world of medical devices offers an exciting, and challenging professional opportunity for scientist who want to be at the front line of technological innovation in the world of medicine. Interested in the regulatory aspects? This is how your competences make the difference.
Dr Wojciech Bobela obtained his degree from EPFL, in the field of Neuroscience. As a Project Associate at Medidee Services SA, he provides quality management and clinical support to the medical device manufacturers. His activities range from performing clinical evaluations, designing protocols and analyzing results of clinical investigations, as well as implementation of quality management systems.
When: 23rd November, 17h30
Where: SV1717
The talks will be followed by an apero where you can discuss informally with the speakers.
Speakers and Topics:
- Dr Szymon Kostrzewski, CTO of KB Medical, “The regulatory journey of a Surgical Robotic system”
- Kim Rochat, Senior Partner and Cofounder of Medidee Services SA, “The challenge of compliance for medical devices"
- Dr Wojciech Bobela , Project Associate at Medidee Services SA , “The life of a scientist outside of academia"
17h Registration
17h30 Welcome and Introduction
17h35 Talks and Q&A
18h35 Apero
Talks and BIOs:
The challenge of compliance for medical devices
1) The regulatory journey of a Surgical Robotic system
As a Spin-off of the EPFL, KB Medical has developed the AQrate System, a minimally invasive, surgical robotic assistance system for a wide range of spinal procedures, requiring high level of precision and rigidity. KB Medical went through the complete design and validation journey and got cleared for marketing in Europe and started the process in the US. Activities included clinical investigations, technical validation, audits and review by Notified Bodies as well as interaction with competent authorities. In 2017, KB Medical has been acquired by Globus Medical, a global, US-based manufacturer. You want to develop a medical device? This is what you should be prepared for.
Before founding KB Medical, Dr Szymon Kostrzewski conducted research at renowned institutions including the Stanford University, EPFL in Switzerland and the German Aerospace Center DLR. As the CTO of KB Medical, Dr Kostrzewski led KB Medical R&D team into the technical and regulatory journey of developing a complex medical device.
2) The challenge of compliance for medical devices
Before being able to place a medical device on European Market the manufacturer has to comply to numerous legal requirements organized in complex regulations and standards. With the current change in regulation, increased scrutiny on all stakeholders the market seems more like a battlefield rather than an organized economy. Prepared for a true challenge? This is how you can contribute to a growing economy.
Kim Rochat is Senior Partner and Cofounder of Medidee Services SA. His mission is to support medical devices manufacturer in the constant and most efficient compliance to legal requirements. His activities range from implementation of quality management systems, regulatory affairs and clinical investigations and evaluations.
3) The life of a scientist outside of academia
Every young scientist during the course of their PhD, sooner or later will ask themselves at least one of the following questions… “should I continue my career in academia?”; “if I choose to quit, what options do I have?”; “is my skill set valuable to a potential employer?”. The world of medical devices offers an exciting, and challenging professional opportunity for scientist who want to be at the front line of technological innovation in the world of medicine. Interested in the regulatory aspects? This is how your competences make the difference.
Dr Wojciech Bobela obtained his degree from EPFL, in the field of Neuroscience. As a Project Associate at Medidee Services SA, he provides quality management and clinical support to the medical device manufacturers. His activities range from performing clinical evaluations, designing protocols and analyzing results of clinical investigations, as well as implementation of quality management systems.
Links
Practical information
- General public
- Free
Organizer
- ADSV