Interested in what makes a product salable and approvable? Interested in an insider’s view on what gets your device approved at FDA? Or how to navigate the regulations and use them to your advantage? How will recent developments to the United States Food and Drug Administration regulations impact your healthtech business? Whether you’re a CEO, entrepreneur, investor, clinician, or a professional in the general industry, join us as Neil Di Spirito gives us an insider’s perspective and breaks down what digital health and device companies should know about FDA regulations.
Speaker: Cynthia Yee & Amrinder Singh, Vensana Capital
Thursday, April 28, 1:00 to 2:00 PM PT
A foundational element to building a successful company is strong leadership, which goes beyond a company’s management team to include its board of directors. The primary role of a company’s board of directors is to provide corporate oversight and governance for management and to represent shareholders’ interests. However, an effective board can also contribute to a company’s vision and strategy and ensure alignment on the vision for the business.
This session will discuss key considerations for entrepreneurs when building a board of directors as well as best practices for aligning incentives and engaging both independent and investor directors to maximize value for all shareholders.
Speaker: Liz Canis, Founder & CEO of The Pivot Group
Tuesday, April 5, 1:00 to 2:00 PM PT
The healthcare marketplace is populated with innovative solutions that improve patient care and the overall experience with the healthcare ecosystem. Payers are increasingly seeking emerging capabilities and companies for investments and partnerships – and a payer can provide a strong avenue to accelerate growth for emerging/early-stage companies. Learn the key components of the payer value creation model to determine whether a payer relationship may benefit your business and how to effectively articulate your solution to garner attention and interest.
Value-based contracts impose risk both on providers and payers. The appropriate structure of a contract is an important component of mitigating your risk as a provider and ensuring that you are paid correctly for the value that you create for a payer. Similarly, a payer wants to be sure that it pays for value and does not over-compensate the provider. The variability inherent in populations and claims, however, poses a risk for the parties. We will discuss different outcomes evaluation methodologies in value-based care contracts. Additionally, we will review a study of variability in outcomes in an accountable care organization contract that shows a considerable risk of under-or over-payment and discuss methods to mitigate the risk to the parties.
Speaker: Dan Brounstein, Senior Vice President & President, North America, Saluda Medical
Tuesday, March 15, 1:00 to 2:00 PM PT
This event has been rescheduled from its original November date.
Dan Brounstein has built and marketed products that have served thousands of patients throughout his career. In this talk, Dan will draw on over 18 years of experience at six different companies to describe the path of a product from idea to fundraising, through testing and clinical trials, ultimately culminating in sales. All questions answered.
Speaker: James Wall, Associate Professor & Pediatric Surgeon, Stanford University
Thursday, March 10, 1:00 to 2:00 PM PT
Who decides whether your technology is adopted by a hospital or healthcare system? It’s the “value committee,” whose members consider whether your solution delivers value that meets the needs of their patients and system. For an inside view of how this committee operates, join us to hear from James Wall, who chaired the value analysis committee at Lucile Packard Children’s Hospital for 5 years.
Launching a company in the health technology industry requires tremendous expertise in the technology and the marketplace as well as strong funding. However, success with all aspects of company building is dependent upon hiring, developing, and retaining the right team to deliver results. Building the right “people” foundation is a key first step in making sure you can manage your most important investment, in your human capital. Understanding the market for compensation, setting up payroll and an attractive set of benefit offerings, and building your talent acquisition and employee engagement practices, all while ensuring compliance with relevant employment laws and regulations, requires expertise in the world of human resources. This session will provide an overview of the key steps to building a strong “people” foundation when launching a new company from the ground up, as well as the best practices that support you in building an enduring culture and successful enterprise over the long term.
Speaker: James Wieselman Schulman, Global Design Lead, Evernorth Innovation/Cigna
https://www.youtube.com/watch?v=iz9_Nv3ZyZI
Thursday, February 17, 1:00 to 2:00 PM PT
There is nothing greater for a start-up than partnering on a pilot with a large multi-national corporation. Or is there? Giant companies have nothing but money to spend on innovation and a deep bench of talent and resources to draw from. Or do they?
In this talk, James will share insights from his years working with incubators and start-ups around the globe to drive innovation at a Fortune 15 company. He will share how they source and engage with start-ups across business units and will focus on how start-ups can set themselves up for success. He will share several key lessons learned that all start-ups should consider when partnering with large corporations.
He will share both the highs and the lows of his experience working with start-ups and how setting expectations can lead to a great partnership.
Speaker: Amy West, Head of US Digital Transformation & Innovation, Novo Nordisk
https://www.youtube.com/watch?v=FXt00h8grWw
Thursday, January 27, 1:00 to 2:00 PM PT
Emerging technology has unlocked an unprecedented level of innovation in the last decade. Moreover, it has elicited a radical new way we view and interact with the world and solve problems as individuals, businesses, and communities. Healthcare has been largely impacted by technology but remains ripe for innovation that will continue to transform the economy of the industry with improved patient outcomes.
In this talk, Amy will provide insight for organizations navigating the ripe innovation landscape in healthcare. She will provoke end user-first go-to-market strategies and share patient-centered considerations that companies should maintain when developing new solutions built upon or inspired by emerging technology.
Co-sponsored by the UCSF Cyber-Champion Team as part of their 2021 Protecting Your Digital Self Series.
Building a new product has never been easier or less expensive. Engineers can jumpstart development with 3-D printers and advanced manufacturing techniques, software tools like Jira, Salesforce, and Quickbooks help companies get things done more efficiently, and developer tools like AWS, Google Cloud have revolutionized the way companies are formed and products are brought to market.
Working in the medical device space is an entirely different story. Due to the regulations and compliance elements involved with medical device development, the process is expensive, slow and difficult. There are also fewer “off the shelf” tools available to help navigate the process.
During this talk, Sabrina Varanelli, a robotics engineer specializing in surgical robotics and the founder of Nemedio, will help you make sense of what is required when planning to commercialize your medical technology. Topics will include: FDA Product Classification, Regulatory Pathways, Quality Management, and an overview of engineering and compliance activities required for clearance.
Learning Objectives:
Understanding FDA device classification
Overview of the paths to clearance
Intro to quality management and quality management systems
How and why agile development teams can and should start quality and regulatory activities earlier than they think
