Medical Device Trials: A Virtual Experience

We welcome Faouzi Kallel to provide the opening address.

• High level review of the medical device regulation and its timeline
• Current status of the notified body designation process
• Summary of the new clinical data requirements
• Details regarding the planned transparency with the new legislative framework

Covid-19 has forced a reckoning in how we conduct all aspects of our lives, and clinical trials are no exception. Patient safety is the foundational principle of any trial, and suddenly we have a situation where having patients come into clinical sites for their scheduled visits poses a significant risk to their health and well being.

Trials are having to rapidly adjust how they are structured and how data is being captured, sometimes in the middle of ongoing studies. This is accelerating conversations that have been ongoing in the industry for years, with the power of shifting study tasks into the safety of the patient’s own home becoming starkly evident.

This talk will share Medidata’s perspective on how clinical trials will be affected in the short term, as the industry rapidly attempts to manage the crisis caused by Covid-19, but also the long term view of how the landscape will be changed by the increased use of technology in trials and the move to trial virtualization.

The talk will cover:

• Considerations for adjusting data collection strategies in the middle of ongoing studies
• Trial virtualization and how the move to decentralization will only accelerate in a post-Covid-19 world

Surveys are one of the activities medical device companies can use to collect data for Post-Market Clinical Follow-Up. But a PMCF survey under the MDR is not like a traditional marketing survey. As a sponsor, you need to ensure that the methods and data will pass the scrutiny of the Notified Bodies. This session will present advice and guidance on how to conduct a PMCF Survey, based on success stories from the MedTech industry, which includes:

• How to determine the appropriate sample size and population
• How to decide what data to collect, and how
• How to design your survey questionnaires to maximize the response ratio
• Ways to approach distributors, clinicians, or patients, without infringing data privacy or confidentiality

• Introducing the challenges and opportunities with biologics formulations with medical devices
• Covering how to achieve added value of enhanced stability for biologics in clinical trials
• Evaluating how artificial intelligence can be used in stability improvements projects

Be sure to tune into this session where a member of the Arena Team will discuss the details of our prize draw competition – not something you will want to miss out on!

By your friendly Arena Conference Team

Oliver Healthcare Packaging introduces their brand new Technical Center in Galway, Ireland. In this center we want to collaborate and ideate with you. It is a hands-on learning environment, where our customers are invited to work with healthcare packaging experts to design their packaging and produce & test prototypes. In this talk we will discuss our technical capabilities and possibilities this Technical Center can bring you. So join this presentation to learn more about our European Technical Center.

In this session, Ian Morgan from Sharp Clinical will be covering:

• ISO Certification
• Qualification of Supply Chain
• Timelines
• Training
• Validation
• Commercial Integration

Take a break and visit the exhibition or just make yourself a cup of tea.

• Looking at the impact the new regulations have on the process of gaining
  certification of medical devices
• Has implementation of MDR led to accelerated approvals by manufacturers?
• How has COVID-19 impacted IVDR Roll out?

• New technologies can make it easier to recruit and retain patients
• Examining how you can make your trials more efficient through the use of wearable technologies. Can something as simple as an automated reminder for patients keep your trial costs down?
• Exploring how technology could be helping you to better engage with patients and the implication this could have on patient retention throughout a trial period
• The potential use of wearable technologies, ‘smart home’ devices and mobile apps and whether they are the least burdensome methods for capturing data

• Providing insight based on real-life examples of good and bad clinical trial design from the FDA perspective that will help you adjust your operational strategy
• Explaining why prioritizing patient-centricity and safety is a crucial component of receiving FDA approval
• Summarizing key updates to 510(k) clearance guidance to understand the changes
• Looking at the relationship between the FDA’s Quality System Regulations and ISO 9001 and best practices for meeting both sets of guidelines
• Examining the two De Novo classification pathways to determine which option is best for your low-to-moderate-risk device review

Head to the engagement zone for a chat with your colleagues or take a coffee break

• Providing an overview of the landscape of women’s health in the medical device industry
• Outlining the history of basic research that created the FemTech landscape
• Presenting case studies of the impact of diversity on clinical trials
• Breaking down the key design principles for companies working in FemTech
• FemTech – closing thoughts & predictions for 2030

Be sure to tune into this session where a member of the Arena Team will discuss the details of our prize draw competition – not something you will want to miss out on!

By your friendly Arena Conference Team

In this session we welcome John Hsu, CEO of iPill Dispenser, to discuss the advantages of using a combined digital health/medical device solution to securely store, safely dispose of contained drugs, and collect patient data on the time of ingestion and side effects.

This will be a case study on how a medical device (the iPill Dispenser) can be successfully used in the prevention of opioid diversion and in the collection of accurate and meaningful data, leading to better patient care.

The session will touch upon:

• What does having a Unified eClinical Platform really mean?
• The benefits of having all eClinical Services under one platform
• Centralizing the way we look at clinical trial data
• Introduction to Fusion – Axiom’s Unified eClinical Suite

Covid-19 has forced a reckoning in how we conduct all aspects of our lives, and clinical trials are no exception. Patient safety is the foundational principle of any trial, and suddenly we have a situation where having patients come into clinical sites for their scheduled visits poses a significant risk to their health and well being.

Trials are having to rapidly adjust how they are structured and how data is being captured, sometimes in the middle of ongoing studies. This is accelerating conversations that have been ongoing in the industry for years, with the power of shifting study tasks into the safety of the patient’s own home becoming starkly evident.

This talk will share Medidata’s perspective on how clinical trials will be affected in the short term, as the industry rapidly attempts to manage the crisis caused by Covid-19, but also the long term view of how the landscape will be changed by the increased use of technology in trials and the move to trial virtualization.

The talk will cover:

• Considerations for adjusting data collection strategies in the middle of ongoing studies
• Trial virtualization and how the move to decentralization will only accelerate in a post-Covid-19 world

• Examining the role self-monitoring can have in improving a patient’s ability to monitor their diabetes and the wider benefits self-monitoring can have to the healthcare industry
• An overview of the regulations that apply to the rapidly adapting wearable device industry
• Exploring the wearable technology that is being developed in non-invasive glucose measurement devices
• What does the future hold? What possibilities for future innovation are enabled by developments in non-invasive technologies?

We welcome Bill Edelman, Chairman of the Board at Paragonix to provide this case study discussion of how this device was brought from conception to commercialization. Including: 

• The importance of planning: how budgets were maintained and keeping to the timeline of device trials
• An exploration of how best to manage limited resources – how do you make decisions on what to outsource and what to keep in house? Which technologies and systems should you invest in?
• The leap to commercialization: how it was managed and lessons learnt
• Knowing your market – do you distribute your device locally or aim for the global market?

• Breaking down the Investigational Device Exemption and different types of IDEs to understand a premarket approval application
• Discovering how the Early Feasibility Studies IDE has been a game changer for the US device industry; explaining the concept of EFS IDE, status of the program at FDA and how this has fostered innovation in US versus Europe
• An in-depth look at how to successfully transition from EFS IDE to Pivotal IDE
• Learn innovative approaches that medical device companies can take to get EFS IDE approval from the FDA

• Breaking down the various challenges that accompany outsourcing to CROs in Latin America and Asia Pacific
• Hear real-life examples of CROS management from clinical trials in Australia, New Zealand, and Mexico

• Can we rely on patients accurately reporting their own data? What is the potential for dishonest / accidental mistakes in data reporting in your trial and the technology we can use to mitigate the risk of inaccurate data reporting
• Keeping the data safe – a dive into compliance to GDPR and other regulations
• Clinical trial models taken to ensure the BioSticker innovative device was thoroughly tested for safety and efficacy