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

• Medidata are constantly reviewing the impact of COVID-19 on clinical trials
• A review of the impact of the pandemic and each region’s recovery and response
• New patients entering trials during the pandemic – how to ensure your recruitment levels remain high
• Insights to Ongoing Data Capture in Clinical Trials during COVID-19

Medidata

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

We Welcome Oliver HCP to discuss how their high lever packaging is always designed to the industry’s highest level of quality, so that you can deliver longer, healthier lives. This talk includes:

• Managing the dynamics of each region: ensuring that the packaging is relevant for the local market
• Regulatory update: what you need to be aware of and how to ensure your product is suitably packaged
• Overcoming common packaging challenges

Oliver HCP

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.

Good technology empowers you to do more, faster. And so in this session Axiom will discuss how a unified eClinical Platform is key to running a successful medical device trial.

• Medidata are constantly reviewing the impact of COVID-19 on clinical trials
• A review of the impact of the pandemic and each region’s recovery and response
• New patients entering trials during the pandemic – how to ensure your recruitment levels remain high
• Insights to Ongoing Data Capture in Clinical Trials during COVID-19

Medidata

• 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?

• Getting the key players within the company to help identify the preferred vendor to achieve that clinical target and avoid any forthcoming concerns
• Establishing the common misconceptions in picking a CRO that unsuited to your values and trial credentials
• What resources from the CRO that are essential for your trial success?
• Managing that all important budget to avoiding overspending
• Patience is key: plan and meet the business development and clinical team to understand the process and see do they align with your goals

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