Day 1 – Wednesday, 11th SeptemberWednesday, 11 September 2024 - EST/EDT (Eastern Daylight, GMT-4)

Medical device companies stabilized in 2023 after overcoming challenges from the three-year pandemic. Industry leaders reported positive Q3 2023 earnings and a strong operating environment. With an uptick in deals at the end of 2023, and early 2024, the medtech sector outlook remains positive, with valuations exceeding pre-pandemic levels. Analysts anticipate continuous growth and margin improvement driven by macro trends, including an aging population and technological advances. Amid peaking investor interest and new disruptors entering the space, medtech companies must prioritize innovation for sustained resilience and growth. This panel reviews 2024 so far and anticipates what the sector will bring in 2025.

• What is the current M&A appetite
• Current financial landscape for medtech
• Which medtech fields are taking off
• Innovation update for Tier 1 medtech – who are they looking for

Throughout 2023, considerable discourse unfolded regarding the prospective role of AI in the healthcare sector and its capacity to redefine healthcare delivery. From advancements in robotics, navigation, augmented reality, to the integration of remote sensors, digital technologies have demonstrated their capability to enhance clinical, operational, and financial outcomes. While this transformation has been evident in theoretical discussions and the emergence of pioneering medtech startups incorporating AI, a critical question persists: has the actual implementation and maturity of these technologies resulted in a sustained and disruptive impact on the healthcare industry?

• In what ways has AI propelled advancements in medtech
• What obstacles have been encountered during the implementation process
• Has the value and impact of the benefits justified the initial hype and rapid influx of funding

In the midst of challenging macroeconomic conditions, medtech firms pursuing later-stage funding need to showcase robust revenue projections and tangible growth to entice investors who prioritize companies with unique revenue models. A panel of seasoned investors will delve into the strategies employed by companies, discussing innovative financial structures with strategic partners and the utilization of venture debt as a catalyst for driving sustained growth.

• What trends or strategies do investors prioritize when assessing a medtech company's revenue outlook
• How do successful medtech firms attract later-stage funding amid challenging economic conditions
• Key considerations for medtech firms utilizing venture debt as a catalyst for sustained growth

The US medtech industry stands as a global leader, attracting both domestic and international companies. However, navigating the intricate regulatory landscape in the US, especially with recent changes in digital health and AI documentation, poses a formidable challenge. A panel of industry experts gathers to discuss building a robust regulatory strategy, and approaching the regulatory path with the mindset of market access and market success.

• Understanding FDA requirements and relationship building
• Building clinical evidence and exploring expedited pathways
• Developing a robust pre-submission strategy
• Approaching regulatory approval with market access in mind
• Building out your strategy – setting yourself up to win market adoption

The medical device industry has only recently started designing software-based products unrelated to traditional hardware devices. Despite their departure from conventional medical devices, Software as a Medical Device (SaMD) holds significant potential to enhance patients' quality of life, even though regulatory bodies worldwide still categorize them as medical devices. The panel will delve into the challenges of bringing software-based medical devices to the market.

• Regulatory need to know for SaMD/SiMD
• Commercialising SaaMD products
• Pathways for payment and coverage
• Ethical implications and security concern

The competitive medtech landscape requires organizations to not only secure 510(k) FDA clearance but also effectively communicate the clinical and economic value of their technology in the evolving landscape of value-based care. Essential strategies for success encompass showcasing value to diverse stakeholders and developing comprehensive market access plans. A panel of senior leaders in the world of market access, discuss what medtech companies need to know once they’ve achieved clearance or approval.

• Navigating post-market surveillance and evidence generation
• Establishing an entity in the U.S
• Reimbursement pathways and finding distributors

In the dynamic healthcare sector, market challenges and disruptions affect both new and established players. This panel explores how industry-wide collaboration, offering disruptive solutions, can address market challenges, enhance resilience, and drive long-term growth.

• Leveraging partnerships and collaborations within the industry
• Utilising AI and how to partner with providers of data
• Working with healthcare providers to create ‘beyond the product’ solutions
• Implications of out-sourcing needs

Medtech startups face challenges in fundraising due to a shortage of early-stage investors and obstacles on the path to commercialization. Despite substantial growth in venture funding for the medtech sector, there's a noticeable shift towards mid to later-stage investments, driven by reduced returns and complexities in reimbursement. Investors now prioritize ventures that combine security, innovation, and clinical success. Learn from early-stage investors about their evaluation criteria and discover effective strategies to cultivate relationships, improving the chances of securing seed or series A funding. This session explores how early-stage medtech firms can navigate the journey from initial funding to market success, aligning with investors' evolving expectations.

• Aligning with investor expectations
• Bridging the funding to viability gap
• Building investor-attractive foundations
• Creating a strong investment proposition