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|11:15 a.m.-12 p.m.|
State of Medtech Investments
Moderator: Patrick Connolly, Partner, Co-Chair, Emerging Companies & Venture Capital Practice Group, Foley Hoag
The last few years saw a tremendous influx in available capital and investments into medtech startups. As the market corrects and investments become more competitive, what does this mean for available capital? This session will examine today’s shifting fundraising marketplace with an eye for trends to be aware of and how best to prepare for the year ahead.
Lunch & Learn Session: The State of M&A – Partnering with Strategics
Moderator: Dave Sheppard, Co-Founder and Managing Director, Medworld Advisors
As the market corrects, how does this impact the way larger medtech companies think about capital allocation to M&A and licensing? Do short term dynamics matter in these initiatives? This session will feature the heads of M&A from leading industry OEMs who will discuss their companies’ perspectives on investments today and in the next 18 months.
Fundraising: Planning Your Attack
Moderator: John Harmon, PhD, PE, Shareholder, Wolf Greenfield
Successful entrepreneurs know the value of a well-coordinated effort when fundraising. From timing and messaging to prepping documents to lining up contacts, strong planning is key to strong results. In this session, attendees will hear from leaders of emerging companies who have recently closed successful funding rounds and will share lessons learned and tips for success.
Fundraising: Thinking Outside the Box
Moderator: Angus McQuilken, Industry Relationship Executive, Life Sciences, McDermott Will & Emery
The finance industry is growing in dynamism. As such, vehicles and players that are sometimes less prominently advertised may be attractive avenues for companies in various circumstances. In this session, we’ll discuss debt financing, family offices, and online investment platforms, and the pros and cons of each.
Fundraising: Raising with VCs
Moderator: Laurie Burlingame, Partner, Goodwin
Venture capital financing is all about return on investment. In this session, we’ll hear from VCs who will share how they develop valuations and how today’s marketplace is impacting what they do and how they do it. We’ll also dive into the differences between independent financial VCs and those who sit in-house at strategics to understand what each may be looking for to better prepare you to create the right profile for your next pitch.
How to Align Your Development with the Latest FDA Expectations
Presenter: Christopher Gates
In April the FDA released the latest draft of requirements for cybersecurity in pre-market submissions. In this presentation Christopjer will discuss the new medical device cybersecurity laws and regulatory requirements and review the new manufacturer's activities expected by the FDA, including the expected 41 cybersecurity deliverables. Most importantly, we will see how to add cybersecurity processes to your development lifecycle that will satisfy the FDA and secure your medical device system without generating massive cost burdens or development delays.
|11:30 a.m.-12:15 p.m.|
Shifting Sands of Medical Device Cybersecurity Regulation: Past, Present and Future Implications from a Practitioner’s Perspective
Presenter: Garrett Schumacher
Updated premarket submission guidance from the FDA. Model contract language from the Health Sector Coordinating Council. An executive order from the White House. The PATCH Act currently under consideration in the Senate. Plus, the full force of the European Union’s Medical Device Regulation (MDR) now in effect, and numerous cybersecurity updates to international standards (ISOs). When it comes to medtech cybersecurity regulation, the past two years have been busy! We’ve seen not only more regulation take effect, but also a host of new resources have been released to help medical device manufacturers (MDMs) be compliant and get a handle on this ever-changing aspect of healthcare.
In this session, Velentium Senior Cybersecurity Engineer Garrett Schumacher walks attendees through new and pending regulation, the evolving threat landscape, and introduces a bevvy of resources to help MDMs understand the state of the art and take proactive steps to secure their products, their business model, and their relationships with markets and regulators in the new decade of secure medical devices.
Software Supply Chain Security Mitigations for Medical Device Development
Presenter: Christopher Gates
The importance of supply chain controls is well-known when it comes to quality. But what about cybersecurity? Supply chain attacks have been on the increase in recent years, affecting both embedded and application products. Today’s medical device systems may include a wide array of elements, including embedded devices, mobile apps, PC applications, browser apps, and back-end server applications. All of these products are vulnerable to supply chain attacks, both upstream and downstream. In this presentation, Christopher Gates will review the environment, risks, best practices, and security mitigation tools available (including SBOMs) to enable manufacturers to secure their supply chains from threats to their customers, their patients, and their business model. Learn how this vulnerable aspect of development is evolving to be more secure, and what your company can do to get control of its supply chain.