Sean O'Donnell, Experien Group: "They're Not Optional: Quality Management Systems for Startups"

A Quality Management System (QMS) is a crucial part of a medtech startup's path to market. It demonstrates to the FDA that your company can provide safe and effective devices that meet all regulatory requirements and customer needs. A QMS comprises many interconnected elements. Do you know what they all are? Join us at this talk to get an overview from Sean O'Donnell, Chief Quality Officer at Experien Group, a consulting firm specializing in QMS, Regulatory, and Clinical support. Sean will detail the composition of QMS, explain how they interact with regulatory affairs, and describe how US agencies enforce compliance.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, February 13, 2018

Agenda

5:00 to 5:30 PM: Registration & Networking
5:30 to 6:30 PM: Talk and Q&A

 

About the Speaker

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Sean O'Donnell is the Chief Quality Officer for Experien Group, a medical device consulting firm headquartered in northern California that helps companies develop and execute successful FDA and international regulatory programs.  In addition to managing the Quality team, Sean holds particular expertise in software-based technologies as well as usability engineering standards for complex medical devices. He supports clients’ U.S. and international regulatory submissions and functions as Experien Group’s interface with regulatory agencies through audits and inspections. Sean has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485. He was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. Sean achieved a B.S. from San Jose State University in Chemical Engineering.

Adam Schoen, Brown Rudnick: "How to Build a Commercially Valuable, Unassailable Patent Portfolio"

A secure IP position is absolutely essential for a bioscience startup. It's a key factor in helping you win investment. But how exactly do you build commercial barriers to prevent competitors from entering your space? Join us to get the whole picture from IP attorney Adam Schoen of Brown Rudnick. Adam will cover what investors and strategics are looking for in IP diligence; how that frames portfolio development; classic pitfalls to avoid; and much more.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, December 5

Eventbrite - Rosenman D-Series: Adam Schoen. How to Build a Patent Portfolio

About the Speaker

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Adam Schoen advises life science and medical device companies regarding implementation of a patent strategy to further business objectives and business goals. Adam’s practice encompasses patent preparation and prosecution, portfolio development, product clearance, freedom to operate analysis and intellectual property due diligence. Adam works with public and private companies, investors, and academic institutions.

Adam has experience with a variety of technologies, such as next generation sequencing technologies, droplet based technologies, cancer diagnostics, medical device technology (ophthalmology, cardiology, orthopedics, neurology, spine) and medical imaging technology (IVUS and OCT), mass spectrometry, small molecule therapeutics, digital health, near field communication technology, and semiconductor technology. He manages patent portfolios of all sizes and develops strategies to maximize and protect intellectual property rights in both the United States and foreign jurisdictions.

Prior to law school, Adam was a scientist of analytical chemistry for ArQule Inc., a combinatorial chemistry and drug discovery company.

Conversation: Matt Likens, GT Medical Technologies

Join us on Thursday, November 9, when Rosenman Institute Director Christine Winoto will interview Matthew Likens, a serial startup CEO with a track record of impressive success. How do you lead a startup from its founding to IPO or acquisition? How do you keep investors on your side through the hard times? We look forward to seeing you at the next D-Series.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00-6:30 PM, Thursday, November 9

Eventbrite - Rosenman D-Series: A Conversation with Matt Likens

Agenda

5:00 - 5:30 pm: Networking
5:30 - 6:30 pm: Talk and Q&A

About the Speaker

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Matthew Likens is currently President and CEO of GT Medical Technologies, the makers of GammaTiles, with the goal of improving the lives of brain tumor patients.

After graduating cum laude from Kent State University, Mr. Likens began his professional career with Johnson & Johnson Corporation. He then spent more than twenty years in domestic and international sales, marketing and general management roles at Baxter Healthcare Corporation, culminating in the position of President, Baxter Biotech North America, followed by President of Baxter’s Renal Division in the U.S.

In July of 2006, Mr. Likens became President and CEO and the second employee of Ulthera, Inc., a venture capital-backed start-up company in energy-based aesthetics in Phoenix, AZ. After filing for an initial public offering in early 2014, Ulthera was acquired by Merz Pharma GmbH for $600M, an amount representing 6.6x trailing 12-months’ revenue. The Arizona Association for Corporate Growth (ACG) recognized this as Transaction of the Year for 2014.

Phoenix Business Journal honored Mr. Likens in 2012, naming him one of Arizona’s Most Admired CEOs.
In June of 2015, Ernst & Young presented Mr. Likens with the Entrepreneur of the Year for the Mountain Desert Region Award.

Mr. Likens is a member of the board of directors of Luma Therapeutics, an early-stage company with a promising treatment for psoriasis, and an adviser to Genteract, an early-stage genetics company. He is a member of the Greater Phoenix Economic Council Healthcare Innovation committee and a member of the City of Mesa Economic Development Council.

Interview: Justin Klein, NEA

Join us Tuesday, September 12, when venture capitalist Justin Klein of New Enterprise Associates (NEA) will give us an inside view on the current state of healthcare investing. Christine Winoto, director of the Rosenman Institute, will interview Justin.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

5:00-7:00 pm, Tuesday, September 12

Eventbrite - An Interview with Justin Klein of New Enterprise Associates

Agenda

5:00-6:00 pm: Talk and Q&A

6:00 pm onward: Networking

About the Speaker

Justin Klein joined NEA in 2006 and is a Partner on the healthcare team. He focuses on medical device, healthcare technology, and biopharmaceutical company investments. He serves as a director of Advanced Cardiac Therapeutics, Cartiva, ChromaCode, FIRE1, Intact Vascular, Personal Genome Diagnostics, PhaseBio Pharmaceuticals, Relievant Medsystems, Senseonics (NYSE: SENS), VertiFlex, Vesper Medical, and VytronUS. Justin’s past board memberships and investments include CV Ingenuity (acquired by Covidien), Nevro (NYSE: NVRO), Topera (acquired by Abbott), TriVascular (NASDAQ: TRIV), and Ulthera (acquired by Merz). He is also a member of the advisory boards for the National Venture Capital Association’s Medical Industry Group and its Medical Innovation and Competitiveness Coalition (MedIC), as well as a member of AdvaMed's Business Development Committee.

Prior to NEA, Justin worked for the Duke University Health System—reporting directly to the hospital CEO on health system strategy, finance and clinical service unit operations—as Duke built one of the nation's first and largest healthcare integrated delivery systems. Justin concurrently earned his MD from the Duke University School of Medicine and his JD from Harvard Law School. He has also served as a member of the Board of Trustees of Duke University, where he earned his AB in Economics and his BS in Biological Anthropology and Anatomy.

 

Marijke Annis, Ruckus Partners. "Reimbursement 101 for Medtech Startups"

Regulatory approval no longer guarantees market access. Payers control the health care dollar and ultimately if and how patients access new technologies. Understanding the reimbursement challenges your technology may face and setting a strategy early in the product development process will help ensure you can navigate payer challenges. Attendees will leave with an understanding of the current U.S. reimbursement system and how to navigate coding, payment and coverage.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

5:00-7:00 pm, Thursday, May 18

Eventbrite - D-Series: Marijke Annis, Ruckus Partners. "Reimbursement 101 for Medtech Startups"

Agenda

5:00-6:00 pm: Talk and Q&A

6:00 pm onward: Networking

About the Speaker

Marijke Annis, MSPH, Founder, is a reimbursement expert whose work has realized multiple, positive coverage and payment decisions for innovative medical solutions across devices and diagnostics. Having worked in payer relations for integrated health delivery systems, she offers a unique ‘inside-payer’ perspective that serves to shape these successful strategies. Prior to founding Ruckus Partners, she held leadership positions for companies and health care providers across the market - hospital and physician groups, diagnostics and medical devices and she knows cardiology, women’s health, oncology, hematology, pulmonology, and ophthalmology. Her former roles include reimbursement leadership for CardioDx, Abbott Vascular, and Guidant, and in managed care for Tenet Health Care.

Marijke received a MSPH from the University of North Carolina Chapel Hill and a BA from Emory University.

Laura Parmer-Lohan, Ruckus Partners. "So, You Want to Go to Market in Medtech. Now What?"

There are many decisions to be made from now until launch. This discussion will cover the role of product marketing in medtech and the critical milestones for preparing your product for launch, from crafting a compelling value proposition to developing strategies for the key stakeholders involved in the buying process. Attendees will leave with a clear overview of how product marketing can be used as a strategic element in a company’s long term success.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

5:00-7:00 pm, Thursday, April 13

Eventbrite - D-Series: Laura Parmer-Lohan, Ruckus Partners. "So, You Want to Go to Market in Medtech. Now What?"

Agenda

5:00-6:00 pm: Talk and Q&A

6:00 pm onward: Networking

About the Speaker

Laura Parmer-Lohan, MBA, is a founder of Ruckus Partners a consulting firm specializing in marketing and reimbursement for medtech innovation. She is a marketing leader who has demonstrated capabilities from product portfolio strategy development to product launch to revenue generating product lifecycle marketing. Laura specializes in uncovering customer needs and connecting this with the product marketing strategy to motivate the customer to action. She has led or participated in the launch of more than 24 products from cardiovascular therapeutic devices, type 2 diabetes first-in-class biopharmaceutical to specialty oncology reference lab test services and digital health apps.

Laura is an advisor for LaunchPad Digital Health, FAST program mentor for California Life Sciences Association, guest instructor for UCSF/UCB MTM Program and Haas School of Business MBA/MPH Program and the events co-lead for MedtechWomen.

Her former roles include marketing leadership at diaDexus, Sequenta, Genoptix (now Novartis), Amylin (now AstraZeneca), and Guidant (now Abbott Vascular). She received her MBA from UC Berkeley, Haas School of Business, and her bachelor of arts from UC Santa Cruz.

Greg Aper, Whipsaw. "How to Design a Medical-Grade Product for a Consumer-Grade Experience"

What makes for a rewarding “consumer-grade” user experience? Why does this matter for new medical products, even for those that may never reach the mass consumer? Join us on November 10 to learn from Whipsaw’s Greg Aper, an expert on industrial design and how understanding your user can increase both product appeal and product performance. Greg will tell us why established medtech companies are asking for "consumer" design for their products now more than ever before. He’ll also explain how to optimize your time when working with design teams and how to get the most from your design budget, and detail the key characteristics of the most successful startups he’s worked with.

Where and When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

5:00-6:00 pm, Thursday, November 10

Eventbrite - D-Series: Greg Aper, Whipsaw. "How to Design a Medical-Grade Product for a Consumer-Grade Experience"

Agenda

5:00-6:00 pm: Talk and Q&A

6:00 pm onward: Networking

About the Speaker

Greg Aper serves as the Director of Business Development for the award-winning product design consultancy Whipsaw. Greg is an industrial design consultant and product development strategy expert with an emphasis on the human-centered design of future technologies and the development of multi-disciplinary empathy in order to create revolutionary solutions. He has 17+ years of experience designing products and consulting for internationally recognized companies such as Bosch, Netgear, Dell, Philips, Cisco, Samsung, Panasonic, Google, Intel, and Apple. Greg is currently pioneering new business models at Whipsaw, where 40% of the company's work is presently accounted for by startups from around the globe.

Krista Donaldson, D-Rev. "How to Commercialize and Scale Your Product for Global Health Markets"

Bringing a device to the US market is challenging. But if you’re developing a solution for patients around the world, the challenge is even bigger. Join us to hear from Krista Donaldson, CEO of D-Rev. "Brilliance," D-Rev's phototherapy device for severely jaundiced newborns, has helped doctors in 40 countries treat more than 130,000 babies. Krista will discuss how D-Rev is developing new products based on the lessons learned commercializing and scaling Brilliance.

Where & When

Second Floor "Library," Byers Hall, UCSF Mission Bay
Thursday, March 10, 2016 

Eventbrite - D-Series: Krista Donaldson, D-Rev

Agenda

5:00-6:00 pm  Sign-in & reception
6:00-7:00 pm  Talk and Q&A

About the Speaker

Krista Donaldson, PhD, has driven innovation in product design, engineering, and international development for more than 15 years. As D-Rev’s CEO, Krista’s has led the release of Brilliance, a revolutionary technology treating neonatal jaundice, and the ReMotion prosthetic knee. Her leadership has won Krista acclaim as one of Fast Company’s Co.Design 50 Designers Shaping the Future, a TED speaker and a World Economic Forum Technology Pioneer. She has also been a Rainer Arnhold Fellow and a Pop!Tech Social Innovation Fellow.

Prior to D-Rev, Krista served as a Science & Technology Policy Fellow at American Association for the Advancement of Science, where, in the Diplomacy sector, she aided the US Department of State in economic policy and the reconstruction of Iraq’s electricity sector. Her work there earned recognition for its impact on bilateral relations. From 1998 to 2001, she worked as a design engineer and researcher with KickStart International (formerly ApproTEC) in Nairobi, Kenya. She also has worked at the product design firm IDEO.

A native of Nova Scotia, Krista holds a BE in Mechanical Engineering from Vanderbilt University as well as a MSE (Product Design), MSME and a PhD from Stanford University. Her doctoral work was among the first to focus on engineering and social entrepreneurship in less industrialized economies. Krista has taught at Kenyatta University in Nairobi, Kenya and South Africa’s University of Cape Town.

Fabien Beckers, Arterys. "How Cloud Computing, Artificial Intelligence and MRI Converged to Enable Improved Cardiac Imaging"

Where and When

Second Floor "Library," Byers Hall, UCSF Mission Bay
Thursday, March 10, 2016 

Focus

Cardiovascular disease is the leading cause of death. Using MRI to identify the underlying cause of CV disease has distinct advantages but can take hours, is reserved to elite medical institutions and is a complex procedure resulting in only partial diagnosis. Technology developed by Arterys, a company in QB3 incubator space at UCSF, reduces the complexity of this procedure and accelerates time to results. The Arterys SystemTM combines deep learning with cloud computation to provide highly accurate data to radiologists. They can make better-informed diagnoses using a non-invasive MRI procedure that is quick, accessible and easy for both radiologist and patient. On March 10, Arterys’s co-founder and CEO Fabien Beckers will tell us how he’s grown his company to this point and the future he envisions for Arterys.

Eventbrite - D-Series: Fabien Beckers, Arterys. "How Cloud Computing, Artificial Intelligence and MRI Converged to Enable Improved Cardiac Imaging"

Agenda

5:00-6:00 pm  Sign-in & reception
6:00-7:00 pm  Talk and Q&A

About the Speaker

Fabien Beckers is the founder of Arterys, a startup using cloud computation and deep learning technologies to transform healthcare. Fabien started his entrepreneurial career by creating a system to guide blind and visually impaired people, which led him to create Kameleon Technologies, a mobile marketing agency based in Paris. During his 7 year tenure as Founder and CEO he worked with several international brands across Europe, US, and Asia. Fabien earned a PhD in Physics (Quantum Physics) from Cambridge University and a Masters in Business from Stanford Graduate School of Business.

Meet the FDA: How Listening to Patients Can Help Speed Approval of Your Device

This event is jointly hosted by QB3 and UCSF-Stanford CERSI. Further details (bios, photos, talk summaries) will be added to this page as they become available.

Agenda

3:30 – 3:45 pm        Welcome & Introduction: Kathy Giacomini, PhD, Co-Director, UCSF-Stanford CERSI

3:45 – 4:30 pm      Overview of the FDA Center for Devices and Radiological Health (CDRH) and Patient Preferences in Regulatory Decisions: Kathryn O’Callaghan, Associate Director for Science and Strategic Partnerships, Center for Devices and Radiological Health, FDA

4:30 – 6:00 pm     Case Study and Panel Discussion
Moderator: 
Kevin MacDonald, Rosenman Fellow and Regulatory Consultant
Panelists:
Anindita Saha, Director, External Expertise and Partnerships, CDRH, FDA
Telba Irony, PhD, Chief, General and Surgical Devices Branch, CDRH, FDA
Martin Ho, MSc, Team Leader, Neurologic and Dental Biostatistics, CDRH, FDA
Leslie Wilson, PhD, Professor, Department of Clinical Pharmacy, UCSF
Michi Garrison, MS, Rosenman Fellow, VP Research and Development, Intervene

6:00 – 7:00 pm        Reception

Kevin MacDonald, "How to Navigate the FDA Regulatory Process and Achieve Approval for a Novel Medical Device"

In depth knowledge along with appreciation of the FDA approval process is critical for entrepreneurs developing medical devices. If your device is so novel that you must pave a new path to approval, and you hope to see it reach the market in a reasonable time, you need to understand the Agency’s expectations and build a strategic communication plan. On April 22, Kevin MacDonald, a 25-year veteran in obtaining FDA market approvals/clearances, will explain the FDA classification system and describe a case study of a novel medical device with a complex regulatory pathway. Kevin will relate the challenges he faced and the strategy that led to FDA clearance.

Schedule

5:00 – 6:00 pm       Registration + networking (drinks & refreshment will be served)
6:00 – 7:00 pm       Featured speaker: Kevin MacDonald

About the Speaker

Kevin MacDonald is currently a Regulatory, Clinical and Quality consultant working with small medical device startup companies. Kevin has more than 25 years experience and has a successful track record with achieving regulatory market clearances/approvals in the United States and abroad. Prior to his consulting role, Kevin’s recent experience includes Vice President positions at NeoTract and Concentric Medical. Earlier in his career, Kevin held various RA/CA/QA positions with Fox Hollow Technologies, Heartport, Cordis, Boston Scientific Corporation and CR Bard. Kevin graduated with a B.S. in Biology from Framingham State College.

Alex Tilson, "Loma Vista Medical: Lessons About Pivoting and the Hidden Dangers of Product Launches"

You may be familiar with “pivoting”: when an entrepreneur has to discard half of his or her concept and develop the other half for a different market. But uncertainty also lurks when a product is launched. Even though you may have tested a device at the bench, in animals, and on patients, in a real commercial launch it often meets unanticipated challenges, many stemming from outliers that only emerge in large populations. Staying close to your customers and acting on their feedback is crucial. Alex Tilson, founder and former CEO of Loma Vista Medical, will share the lessons he learned as his company commercialized its product—high performance flexible composite medical balloons—and made a successful exit.

Schedule

5:00 – 6:00 pm       Registration + networking (drinks & refreshment will be served)
6:00 – 7:00 pm       Featured speaker: Alex Tilson

About the Speaker

Alex Tilson is the founder and former CEO of Loma Vista Medical. Loma Vista Medical was a lean, dynamic, innovative and successful Silicon Valley based, venture capital funded medical device start-up. The company designed, built, patented, and sold (in both Europe and the US) the world’s highest performing medical balloons. Their products leverage a unique flexible composite platform and are utilized for TAVR (Transcatheter Aortic Valve Replacement). Alex took the company from inception to acquisition (by CR Bard in July of 2013).
Alex has spent the last twenty years leading high performance teams that build innovative, world-class products, including solar powered race vehicles (Stanford University, across the U.S. 2x and across Australia), film industry animatronic special effects (Edge Innovations (‘Free Willy’ and ‘Anaconda’)), surgical robotics (Intuitive Surgical), products for interventional cardiology (Guidant), implantable coronary devices (Converge Medical), and extended wear hearing aids (InSound Medical). He is a Stanford mechanical engineer and earned an MBA from Harvard. Alex is an avid cyclist (bicycled across the US 4x and across Asia), competitive distance runner (Olympic Trial marathoner and former American 50k record holder), and proud father.