Key insights for the development of a successful electronic device, ensuring full compliance to regulations - Ophthalmic case study
Using electronics today is a part of our daily lives. It is almost impossible to imagine how the world would be without electronics. The healthcare industry is not an exception to this. The drive towards having connected healthcare has become a well-established facet of current drug delivery device development, the overwhelming potential benefits has led to an explosion of development projects aiming to create connected devices.
By offering significant improvements into compliance and right usage of drug delivery devices, electronics is a major disruption in the healthcare market. For example, an electronic add-on built around an ophthalmic eye dropper can offer important improvements in the way patients use their devices thanks to advance sensors and tracking systems. However, electronic devices must comply with many different norms & guidances. Developers must ensure the right functioning and the right usage of these types of products, to avoid/limit any potential risks as a result of the electronics.
In this webinar, after summarizing the main trends converging towards electronics, speakers will address the Regulatory Landscape leading the development process of electronic drug delivery devices. This overview will be illustrated through a case study example based on our smart ophthalmic device e-Novelia®, an add-on for preservative-free eye droppers.
We will introduce the approach on how we propose to fullfil regulatory expectations during development of such a device:
- requirements linked with the electronic itself,
- requirements linked with usability and the way patients will interact with the device,
- requirements linked with cybersecurity.
Recognized as a world leader in design development and manufacturing, Nemera will provide useful advice for the successful development of electronic drug delivery devices, with respect to regulatory requirements.
Sign-up today to learn what developing an electronic drug delivery device means in term of regulation and what are the key topics that must be taken into account during development!
Presented by
Hadrien Gremillet,
Senior Strategic Marketing Analyst
Hadrien works in the strategic department of Nemera. He is responsible of Nemera’s electronic strategic project.
Prior to Nemera Hadrien spent 3 years as an entrepreneur in the mobile internet sector and 3 years as a consultant at McKinsey.
He graduated from Ecole des Mines de Saint Etienne and ESSEC business school.
Fanny Sellier,
Ophthalmic Category Manager
Fanny is responsible for ophthalmic products at Nemera, including the preservative-free technology, Novelia®. She joined the company in 2011.
A graduate from the ISEG business school in Strasbourg and the IUT de Chimie (chemical sciences) in Besançon, France, Ms Sellier worked for seven years for Rhodia (now Solvay) in the US in marketing, Lean enterprise and business development. She was then with BASF in a marketing position managing products for the healthcare industry.
Ahmed Mallek,
Regulatory and Compliance Project Manager
Ahmed works in Regulatory department of Nemera. He is responsible with the quality department to guarantee conformity and compliance of Nemera’s electronic projects. Prior to Nemera, Ahmed worked as a Regulatory Specialist in medical device industry and Biomedical Technician in a hospital.
After he graduated from “Institut supérieur d'ingénieurs de Franche-Comtéâ€, he worked as Quality and Regulatory Engineer for electro medical device companies including X-Ray tables, Infusion Pump Systems, Cry
