2022 Master Class Conference
Day 1: Start-Up Series
BIOMEDevice is teaming up with MassMEDIC to bring you the Master Class Start-up Series. This conference program will feature finance focused content tailored to what growing companies need to know in this evolving marketplace. Join us in the Master Class Start-up Series to receive an overview of the medtech investment landscape, an inside look at various funding vehicles – from strategics, to venture capital – and everything in between, and connect with those who have done it to hear their tips for success.
Time | Session |
|---|---|
| 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 Speakers: 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. |
| 12-1 p.m. | Lunch & Learn Session: The State of M&A – Partnering with Strategics Moderator: Dave Sheppard, Co-Founder and Managing Director, Medworld Advisors Panelists: 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. |
| 1-1:15 p.m. | Break |
| 1:15-2 p.m. | Fundraising: Planning Your Attack Moderator: John Harmon, PhD, PE, Shareholder, Wolf Greenfield Panelists: 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. |
| 2-2:15 p.m. | Break |
| 2:15-3 p.m. | Fundraising: Thinking Outside the Box Moderator: Angus McQuilken, Industry Relationship Executive, Life Sciences, McDermott Will & Emery Speakers: 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. |
| 3-3:15 p.m. | Break |
| 3:15-4 p.m. | Fundraising: Raising with VCs Moderator: Laurie Burlingame, Partner, Goodwin Speakers 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. |
Day 2: Cybersecurity Series
Brought to you by Velentium, the goal of the Cybersecurity Series is to educate as to what is expected and required for cybersecurity in today's medical device manufacturing environment. Topics that will be addressed include what’s missing in most medtech companies’ current development efforts but will be needed for regulatory approval. This series is tailored for the medical device manufacturer, including project managers, system engineers, software engineers, and device developers.
Time | Session |
|---|---|
| 10:30-11:15 a.m. | 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. |
| 11:15-11:30 a.m. | Break |
| 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. |
| 12:15-12:30 p.m. | Break |
| 12:30-1:15 p.m. | 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. |
| 1:30-2:15 p.m. | Keynote |
Site Links
Helpful Links
#BIOMEDevice
