IPAC-RS has launched a Roundtable webinar series on digital devices for 2021. Presented by subject matter experts in the pharmaceutical sciences, this is a unique opportunity to learn about the latest research and regulatory trends focused on digital devices.
The third webinar in the series, Digital Devices: Manufacturing and Design Considerations is scheduled for Wednesday, September 29, 2021 from 8:30 – 10:00 AM US ET.
S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.
Daniela Gramaglia, Ph.D., Design Control and Documentation Specialist, Chiesi Group
Andreas Meliniotis, Director, Device Development, Vectura
Phil Swanbury, Director, Device Development, Vectura
Stathis Louridas, Ph.D., Head of Electronics and Software, Team Consulting
Brennan Miles, Managing Consultant – Drug Delivery, Team Consulting
Webinar Program and Abstracts:
I. Welcome and Overview of Webinar
Moderators: Prasad Peri and Daniela Gramaglia
II. Design of Low Environmental Impact Connected Devices with High Functionality and Ease of Use
Phil Swanbury and Andreas Meliniotis, Vectura
This presentation covers how to meet the needs of the patients and the wider users, whilst achieving a connected device which has a high functionality and thus provides high confidence of the user adherence and compliance metrics. Consideration is given to the top level objectives when designing sustainable connected devices, and how to apply different R&D manufacturing approaches to achieve the desired device whether this is an add-on or integral solution.
It is possible to add functionality to an integrated device, by adding sensors or mechanisms in order to gain use data, however the higher functionality ultimately leads to higher costs, more complicated manufacturing and a higher environmental burden. Thought should be given to the overall goal, including those related to cost, manufacturing and sustainability, in order to achieve a solution which meets the patients and wider users.
In order to design an add-on device that can take signals from the base device, there can be advantages to considering both the design of the connectivity module and the base device. This can come with regulatory implications, but if considered early enough in the design cycle, the benefits can be large.
Throughout the device development process there can be different needs at different times, for instance the needs of a clinical system compared to the needs of a commercial system. The level of data required may be different, and the benefits for a user interface system such as an App may be greater for a large clinical trial or for a commercial system. Tailored systems, based on the current needs can ensure that the patients and the wider users can receive the right level of information or perhaps that the data is available to fulfil the needs for reimbursement. It may be most efficient to build in all functionality from the start, and activate or validate the functions as needed.
III. Practical Considerations for Developing Software in Connected Health Solutions and the Assessment of Sustainability in Respiratory Devices
Stathis Louridas and Brennan Miles, Team Consulting
The integration of electronics and connected health solutions in respiratory products are becoming more prevalent in both clinical trial and real-use settings. The flow of investment into this area is driven principally by the need to gather better quality use-data and the acute pressure for improvements in both medication adherence and device competence. There are numerous benefits to this technology, but the cost of entry into the connected world is high. There is a trade-off to be found between increasingly complex device technology and the global trends towards reducing cost, reducing waste, and improving the environmental impact of device manufacture. Consequently, the question of whether to launch a connected device (and what features to include) is one that many pharma companies are currently facing.
As recognised experts in the field of drug delivery technology, Team Consulting works closely with clients across the world’s leading respiratory companies. We have a privileged insight into the direction of travel of the industry and of the common challenges that companies are facing when developing connected/digital solutions for respiratory devices.
In this session we will discuss these challenges and highlight the practical considerations for developing electronics and software for respiratory devices. We will also focus on the use of Life Cycle Assessment tools and how they can be used to inform and drive more environmentally sustainable decision making for future products.
IV. Moderated Q&A Session with the speakers
Click to view Speaker Bios. Feel free to share the registration information with interested colleagues.