Outsourcing in Clinical Trials: Medical Devices USA 2021

Ninety-nine percent of devices never have to provide clinical trial data according to the FDA’s 2002 Medical Devices User Fee Act – but is this morally acceptable? In this session, we will debate that passing regulatory standards is not enough to be confident that your device is safe and effective.

The format of the debate is as follows:

• Moderator opening remarks
• Initial audience vote
• Arguments For  Arguments Against
• Interactive debate/Q&A
• Final audience vote

Our panellists will debate:

• Is just ticking the FDA’s boxes to put a device on the market good enough to ensure efficacy and safety? Would you let someone you love use a device on the basis of these trials alone?
• Should devices be trialed even if the FDA doesn’t require it? And, how vigorous should those trials be?
• The potential ramifications of not thoroughly testing your product – could additional tests be worth it?

In this session, Syntactx will analyse a case study of how clients count on them to synthesize the clinical evidence behind their innovative products for market approvals and broad market adoption

We welcome Dan Solis from the FDA’s division of West Coast Imports to discuss the importance of supply chain management and the import / export of devices and their components. This talk will include:

• Ensuring the correct documentation is in place to avoid any delays with the import / export of your product
• Exploring the best ways to communicate with all branches of the FDA
• The main mistakes the FDA sees sponsor companies making and the best practice to put in place to avoid them

Take the chance to visit vendors in the exhibitor hall and discover new solutions that will speed up your medical device trials

The process of dealing with an FDA advisory panel can be challenging and if not dealt with correctly can derail your device development plans causing expensive and time consuming delays. In this session we will look at Boston Scientific’s experience of passing a panel review and their advice on best practice. Including:

• What to expect from an ADCOM panel – understanding the process
• Determining who needs to be involved and advice for preparing your team in advance
• The importance of the transparency of communication at all stages of the advisory panel process
• Issues that we raised during the panel and how they were overcome

Premier Research will offer two case studies of clinical trials that were on the brink of failing and what they did to bring the study back on track.

Case study one: A company tried to run their trial internally but this was not done correctly resulting in an insufficient trial. Premier Research will look at the mistakes this company made when trialing internally and how the study was saved once they took it over.

Case study two: A sponsor company was initially using a vendor that couldn’t complete the study well either because it was too big or not good enough. We will look at how Premier Research took on this study and turned it around.

By Premier Research

• 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

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 role of biomarkers in early clinical development
• Benefits of incorporating a biomarker strategy into your clinical trial design
• Case studies demonstrating faster progress from the use of biomarkers

By Covance

In this session we will discuss the future benefits AI could bring to clinical studies – as well as its pitfalls and potential limitations

• Guidelines on AI and machine learning can’t keep up with the rapid progress these technologies are making and so how do we ensure the AI solutions we are using are safe and effective?
• A quick dive into how AI is being used in the pharmaceutical industry and lessons that we can take from this
• Exploring the potential use of AI in examining trial data – can machine learning spot an issue and flag potential pitfalls in your trial before they become costly issues?
• We will of course also discuss the feasibility of adapting AI into our trials – will it make the above processes any easier or is this a technology we can manage without?

• 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

We welcome NAMSA to share their expertise on seeing a medical device through the entire development process, focusing on commercialization and post-market requirements.

By NAMSA

• 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

We will begin the day with interactive discussions with your peers on a variety of topics. Each roundtable is hosted by an expert who is there to help guide the conversation around topics which are best covered through shared experiences in an intimate and open setting. Roundtables allow you to expand your personal network while also actively contributing. Each roundtable session lasts for 30 minutes, and delegates may attend up to two roundtables

Round Table 1:
Roundtable available for sponsorship

Round Table 2:
Ensuring Successful Start-up Trial Protocol
Join this table to share your experiences and get advice in ensuring a start up company puts the best protocols in place from the beginning of device development. Priya Janakiraman, Director Clinical Science, Johnson & Johnson Vision

Round Table 3:
Roundtable available for sponsorship

Round Table 4:
Roundtable available for sponsorship

• Exploring how telemedicine was used during the COVID-19 crisis and the various successes seen
• Should we be moving towards a more digital approach to our trials? Weighing up the potential benefits and disadvantages of this approach
• Exploring the reliability of remotely obtained data and the potential for dishonest / accidental mistakes in data reporting in your trial and the steps to mitigate the risk of inaccurate data reporting

• Exploring why it can be harder to outsource for medical devices than for pharma – are there any lessons we can learn from the pharma industry?
• Questions to ask your preferred partners so that you can ensure they have understood your needs
• How do we get the attention of CROs and encourage them to put more resources behind what the medical device industry needs as well as pharma?
• Factors you need to take into consideration when selecting a CRO in order to ensure they are best able to handle your study needs

As a medical device company transitions from a start-up to a larger business, what steps do we need to cover in order to manage this process effectively? In this session we will explore:

• When is the best time to expand and what resources do you need to have in order to ensure a smooth expansion?
• Exploring whether expanding your operations will mean you need to start to outsource more
• We will examine how to make decisions on which operations to outsource at each stage of a company’s growth
• Exploring regulatory compliance and whether they will affect you differently as you become a larger company

• Examining case studies of novel device products that were unable to bring their device to market
• Exploring the reasons for failure; what steps could have been taken differently?
• Discussing the solutions available for novel device companies and the options available that can most successfully bring a device to market

In this session, we welcome Long Doan to break down the various challenges and benefits that come with expanding into emerging markets – focusing specifically on China and India.

This will be an interactive session with plenty of opportunity for audience participation.

This session will cover:

• Regulatory considerations – exploring what American companies need to be aware of before submitting a trial in a foreign territory
• Unpacking the cultural differences and taking a realistic look into how this could impact your trial protocol and design
• Exploring the benefits such as large, treatment naïve populations, lower costs etc.
• The other side of the coin: downsides that need to be taken into consideration such as a lack of infrastructure, slower regulatory processes etc.
• Bringing the data back to the US – exploring how to translate data collected abroad to ensure it is acceptable to US regulators