Hybrid systems are electronic devices where traditional silicon integrated circuits are embedded within functional smart substrates comprising flexible batteries, sensors, interconnects, antennae and displays and represent the only viable solution to integrate sophisticated functionalities in miniaturized systems in a cost-effective way. Such systems are the natural endpoint of the rush to ubiquitous computing and while still in their early days, are ultimately aimed to be deployed in a number of industries from logistics to medical devices, from consumer electronics to industrial sensing in mass volumes (hundreds of millions to billions per year) and usually have ultra-low target prices (few tens of cents).
The design and development of these tiny but complex devices poses tight constraints from system design to process development, and from materials selection to assembly equipment design.
In this work we present the unique challenges presented in the development of a new generation of flexible hybrid electronic devices and the critical role of such systems to unlock new applications for disposable.
• From the perspective of a polymer based component and device manufacturer
• On the examples of silicone based micro and 2-component parts for smart, wearable combination products to implantable
drug eluting devices
• Shoulder-to-shoulder development between drug, device and components
• From concept to serial production via scalable process development
• Design for Manufacture (DFM) and process integrated quality
In partnership with Voisin Consulting Life Sciences.
• Drug delivery technologies: smart devices, selective, targeted delivery…
• Regulatory background: MDR (EU) 2017/745 new requirements for drug delivery devices and drug-devices combination medicinal products and directive 2001/83/EC amendment (scrutiny and clinical evaluation, article 117)
• Discussion on implementation issues, impact on device’s technical file and medicines MAA dossier and new challenges and business perspectives for manufacturers
Drug delivery devices are becoming increasingly complex and integrated, combining various advanced technologies (digital, coated, nanoparticles…) allowing to deliver the right dose at the right time and right location. They can be ruled as medical devices on their own, as well as device’s part of drug-device combination products regulated as medicinal products. We will explain in practical terms the regulatory requirements of the Medical Device Regulation (EU) 2017/745 (MDR) for these products (including for their digital components), with a focus on the clinical evaluation scrutiny by an expert panel prior to the placing on the market and on the article 117 which clarifies that the medical device constituent part of a medicinal product shall comply with MDR general safety and performance requirements. Finally, we will discuss the new business challenges and operational model implied by this regulation for pharma and medtech industries.
• China FDA regulatory update on drug packaging & drug delivery devices and the impacts for new drug registration
• Expectations and suppliers management from Chinese pharma companies perspective
• Business opportunities and advices for China market entry