Finding Unmet Needs in Pulmonary/Critical Care Medicine

Finding Unmet Needs in Pulmonary/Critical Care Medicine

This is the first in a series of events in which we bring clinicians and medical device engineers to discover unmet needs in a specialized area of medicine. In this event physicians will describe how they treat conditions, some of the challenges they face in delivering quality medical care, and possible solutions; engineers will discuss what is feasible and suggest alternative approaches. Join us for an intensely interactive session focused on pulmonary and critical care medicine.

Where & When

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

About the Speakers

ajay+headshot 300.jpg

Ajay Dharia, MD, Principal, Medtech Venture Partners

Ajay received his medical degree from the David Geffen School of Medicine at UCLA after obtaining his engineering degree from UC Berkeley. He completed his residency and fellowship in internal medicine and pulmonary/critical care at UCSF Medical Center. After completing his fellowship, Ajay transitioned into a medical device lab working on the development of artificial organ technology. He continues to practice clinically during extended hours in two ICUs in the San Francisco Bay Area.

nick.kwaan 200.jpg

Nicholas Kwaan, MD, Pulmonary Medicine, Kaiser Vacaville Medical Center

Nicolas received his medical education from Albert Einstein College of Medicine in New York. From there, he went on to internal medicine training at UCLA and later to a pulmonary and critical care fellowship at UCSF. His goal is to ensure all of his patients receive quality care and to help them achieve their medical goals.

aartik.sarma 300.jpg

Aartik Sarma, MD

Aartik is currently a fellow in pulmonology and critical care medicine at UCSF. He studied biomedical engineering and public policy at Brown before completing his medical degree at Harvard and internal medicine residency at Massachusetts General Hospital. While at MGH, Aartik worked with MIT's Hacking Medicine to develop a framework for design thinking in healthcare, and helped organize a series of workshops and hackathons that have led to the creation of multiple venture-backed companies.

Suji1 300.jpg

Sujith Shetty, MBBS, Executive VP at Maxis Medical, and Acting VP, Clinical and Regulatory, BioCardia

Suji is current EVP at Maxis Medical, and Acting VP Clinical and Regulatory at BioCardia after more than 15 years working in clinical research and regulatory at a number of small companies. He holds and MBBS from KempeGowda Institute of Medical Science and worked as a research fellow for 4 years at USC Keck school of medicine in Cardiology and Pulmonary and Critical Care. After moving to Industry, he has participated in development of novel technology in Cardiology (Vascular Dynamics, Inc.), Pulmonary (Asthmatx and Pulmonx), and Neuro (Micrus Endovascular and Codman Neurovascular) and has provided significant strategic, scientific, and clinical leadership in all these fields. While working with the FDA on many projects, he has extensive experience in the breakthrough programs the FDA has offered over the past 10 years and has worked on projects through the EFS program, EAP process, Payor Communication Task Force, and multiple IDE projects.

Nada Hanafi, Experien Group. "Critical Success Factors for Regulatory Strategy"

Nada Hanafi, Experien Group: “Critical Success Factors for Regulatory Strategy”

Set yourself up for success in your startup's approach to effectively navigate the regulatory pathway to market and maximize your interactions with FDA. Join this seminar to hear from Nada Hanafi, Chief Strategy Officer of Experien Group, headquartered in San Jose, CA. This discussion will focus on the critical success factors that go into a comprehensive regulatory strategy and the benefits of FDA’s Q-Submission process for state-of-the-art medical devices and innovative technologies. Download Nada’s slide deck

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, April 23, 2019

About the Speaker

Nada - Experien Group HS-3838.jpg

As Chief Strategy Officer at Experien Group, Nada combines her institutional knowledge with innovative approaches to help companies develop actionable premarket strategies to guide programs through successful submission. Nada joined Experien in 2017 after dedicating 12 years at FDA’s Center for Devices and Radiological Health (CDRH). At CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women program, the Network of Experts program and the Patient Preference Initiative. She was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health and the Office of Minority Health. Nada holds an MS in Biomaterials, a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London, and her MPH from Johns Hopkins Bloomberg School of Public Health.

Kevin Chu, F-Prime Capital. "How a VC Sees the Current Medtech Landscape"

Kevin Chu, F-Prime Capital. "How a VC Sees the Current Medtech Landscape"

By being in a position to see hundreds of pitches a year, VCs benefit from the opportunity to formulate a unique view of the needs, opportunities, trends, and emerging technologies in a market. Want to get a VC’s perspective on the current state of the medtech landscape and how he anticipates making investment decisions in this environment? Join us on March 26 to hear from Kevin Chu of F-Prime Capital.

Download Kevin’s slide deck

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, March 26

About the Speaker


Kevin Chu is an Associate on the healthcare team at F-Prime Capital Partners. Prior to F-Prime Capital, Kevin was an Associate Consultant with IMS Consulting Group in New York, where he advised biopharmaceutical clients on development and commercial strategy across multiple therapeutic areas. Kevin currently works across the healthcare sub-sectors including therapeutics, med tech, and healthcare IT and services, and also works closely with Eight Roads Ventures China healthcare team to manage F-Prime’s existing and new investment efforts in China.

Kevin received his B.S.E. in Biomedical Engineering from the University of Pennsylvania.

Natalie Wisniewski, Profusa. "Empowered Health Through Biomaterials Innovation: Tissue-Integrating Sensors for Mobile Health Monitoring at Profusa"

Natalie Wisniewski, Profusa: “Empowered Health Through Biomaterials Innovation: Tissue-Integrating Sensors for Mobile Health Monitoring at Profusa”

Natalie Wisniewski, PhD, is co-founder and CTO of Profusa, which develops and markets real-time biosensors that provide unprecedented insights into our overall health status. Together, she and her co-founders, executive team, collaborators and advisors built the company road map, enlisted top talent, secured funding and turned innovative concepts into products. Join us to hear the lessons she has learned as a health tech inventor and entrepreneur.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Tuesday, March 12, 2019

About the Speaker

Nat in lab rectangle.jpg

Dr. Wisniewski’s research focuses on biomaterial-tissue interactions, specifically the foreign body response and how it affects implanted sensors. Her novel work on tissue-integrating sensors expands the paradigm of biocompatibility beyond surface chemistry to biomechanics and bioelectronics to enable long-term continuous sensors in the body. Dr. Wisniewski co-founded Profusa, Inc., a company that is revolutionizing continuous monitoring of body chemistries through in vivo biosensors and mobile health. Profusa has developed this technology from concept to clinic with tissue-integrating sensor in humans functioning for a landmark of 4 years. She is the Principle Investigator on $29M of NIH and DARPA research grants, and has over 100 papers, patents and invited lectures on biosensors, diabetes, tissue hypoxia, and implantable devices. She was awarded the NIH Transformative Research Award for her work on multi-analyte in vivo sensing for mobile health applications.

Dr. Wisniewski earned engineering degrees from Purdue University (B.S. in Chemical Engineering) and Duke University (Ph.D. in Biomedical Engineering. For her graduate work, she taught biomaterials and researched the mechanisms and effects of biofouling and the foreign body response on implantable biosensors). She worked in R&D and manufacturing for consumer products at Kimberly-Clark Corporation and in management consulting with McKinsey & Company. Before starting Profusa, she ran her own consulting firm in the San Francisco Bay Area specializing in technical, clinical and regulatory strategy. She currently serves on the Board of Directors and as Chief Technology Officer at Profusa.

Amie Borgstrom, Borgstrom Consulting Group. "Selling Beyond the OR: the Hospital Stakeholder"

Amie Borgstrom, Borgstrom Consulting Group. “Selling Beyond the OR: the Hospital Stakeholder”

You’ve developed a compelling value proposition for your physician stakeholders, but what about the hospital who will have to pay for your product? Well before commercializing, entrepreneurs need to consider both clinical and economic positioning for the hospital. How will hospital administration and value analysis committee (VAC) assess your technology and what will it take to get it approved? Join us on February 26 to learn more about selling to the hospital stakeholder with Amie Borgstrom, President of Borgstrom Consulting Group and a former Global Vice President of Marketing for Zimmer Biomet and for Baxano Inc, a venture backed medtech start-up.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Tuesday, February 26, 2019, 5:30 to 6:30 PM

About the Speaker

Amie head shot- Zimmer sales mtg_5.jpg

As President of Borgstrom Consulting Group, Amie leads a team of professionals offering deep expertise in market research, product launch, and training to help growing companies develop and execute data-driven commercialization plans. Borgstrom Consulting’s unique ability to quickly connect with a wide range of internal and external stakeholders and analyze market forces, results in collaborative product launches that ignite sales forces and surpass financial goals. Borgstrom Consulting partners with clients ranging from early stage venture-backed to large public life science corporations.

Amie has more than 15 years of leadership experience in the healthcare industry focused on strategic planning, product development, and the successful launch of innovative technologies. Prior to Borgstrom Consulting Group, Amie was Global Vice President of Marketing for Biomet Inc, Spine and Biologics division, where she led product pipeline, L&A, and commercialization efforts through the company’s acquisition by Zimmer. Prior to Biomet, she was Vice President of Marketing, Reimbursement, and Professional Education for Baxano Inc, a venture-backed medical device company, based in the Silicon Valley, through its acquisition. In addition, Amie has held various leadership positions within Johnson & Johnson.

Amie has worked closely with leading physicians worldwide to develop and successfully launch 11 novel technologies and is an inventor on 42 issued or pending patents. Amie received her MBA from the Stanford Graduate School of Business, MS in Mechanical Engineering from Columbia University, and BS in Bioengineering from the University of Pennsylvania. She and her family live in the San Francisco Bay area where they spend their free time outdoors skiing, biking and hiking and continually seeking new adventure travel across the globe.

Ali Samiian, Abbott. "How to Adapt to a Changing Market Environment"

Ali Samiian, Abbott. "How to Adapt to a Changing Market Environment"

If you are to succeed in commercializing a medical device, you need a clear path to reimbursement. However, the path is often nonintuitive, and increasing globalization has complicated matters. Payers now reference prices from around the world and employ health economics and cost containment tools first seen in pharma. Some companies have adapted by seeking revenue for services beyond the physical product. Join us to get the full briefing from Ali Samiian, Global Head of Market Access, Health Economics and Pricing at Abbott Diabetes Care.

Where & When

5:30 to 6:30 PM, Tuesday, February 5, 2019
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)

About the Speaker

Ali face outside.jpg

A lawyer by training, Ali has worked in government in the healthcare sector providing policy advice to the Minister of Health in Ontario, Canada on Pharmaceuticals, Diagnostic devices, and physician negotiations. He has over 10 years of experience working in the pharmaceutical and medical device sector in several roles of increasing responsibility, including market access, sales, and strategic planning in global, regional and country affiliate organizations.  He has launched products in Canada, Europe, US and several Asia Pac markets. 

Ali holds a JD from Osgoode Hall Law School, an MBA from the Schulich School of Business in Canada, and a MSc in Health Economics, Policy and Management from the London School of Economics.

He is currently the global head of Market Access, Health Economics and Pricing at Abbott Diabetes Care, managing a team to ensure global reimbursement of a new glucose sensing category.  He is a proud husband and father of 2.

Panel Event. Moderator: Terrie Firestone, BNY Mellon. "How to Maximize the Value of Your Business, Whether You are Building to Scale, Sell, or Merge"

Panel Event, Moderated by Terrie Firestone, BNY Mellon: "How to Maximize the Value of Your Business, Whether You are Building to Scale, Sell, or Merge”

To maximize value for stakeholders--and themselves--founders need to make the right decisions concerning financial and legal issues such as capital structure, transactions, scaling, possible exits and personal financial planning. The choices they make today, for example, may have unanticipated consequences with respect to capital raises, taxable income, and income taxes. Join us to hear from this panel of financial and legal experts as they discuss what founders should do to achieve the best possible outcome.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, February 12, 2019

About the Speakers


Terrie Firestone (moderator) is a senior wealth director for BNY Mellon Wealth Management. In this role, she is responsible for new business development in the Northern California region, and works with individuals and families to identify how BNY Mellon’s investment and wealth management capabilities can help them reach their overall financial goals and life goals.

Terrie Firestone has more than 20 years of experience in the investment and financial services industry. Previously, she was a Senior Vice President at US Trust in Private Wealth Management. Prior to that, Terrie was a Managing Director with Smith Barney, where she led the Software and Networking Investment Research Teams. She was a nationally ranked Technology Analyst on the Wall Street Journal All Star Team and the Institutional Investor Magazine All American Team for many years. Terrie brought over 25 companies public, including Cisco Systems.

Terrie received a Bachelor of Science degree from Brown University in Applied Math and Economics and a Masters in Business Administration from the Stanford University Graduate School of Business. She is a board member of the Palo Alto Financial Planning Forum, a member of the Santa Clara Estate Planning Council, a member of the UCSF Foundation Wellness Committee and the San Francisco City College auxiliary. In the past she has served on the UCSF Cancer Council, the Teach for America Gala Committee, and the Hillsborough Foundation Parent Giving Campaign.

carolyn linkedin.jpg

Carolyn Amster is a Partner of Tax at BPM. She has over thirty years of experience in tax planning, research and tax compliance. She focuses her practice on minimizing federal and state tax liabilities, stock option planning, estate planning, preparation of tax projections, analyzing alternatives, identifying and researching complex tax issues, and representing clients before the IRS and Franchise Tax Board. She represents individual, trust, estate, nonprofit, corporate and pass-through entities in industries ranging from public charities and private foundations to software, professional services, high-tech, biotech, venture capital and real estate management.

james huie.jpg

James Huie is a corporate and securities partner in Wilson Sonsini Goodrich & Rosati's San Francisco office. James advises life sciences and technology companies on general corporate matters, mergers and acquisitions, initial public offerings, strategic partnerships, and private equity and debt financings. He also has extensive experience in representing venture capital firms and other investors in private equity and debt financings.

justin miller.jpg

As a national wealth strategist at BNY Mellon Wealth Management, Justin Miller works collaboratively with other advisors to provide comprehensive wealth planning advice to clients and their families. He also is an adjunct professor at Golden Gate University School of Law, a Fellow of The American College of Trust and Estate Counsel (ACTEC), and a sought-after speaker on tax, estate planning and family governance topics for leading conferences throughout the country, including events hosted by the AAML, the ABA, ACTEC, CalCPA, Santa Clara University, Stanford University, the State Bar of California, the State Bar of Georgia, the State Bar of Texas, STEP, UCLA, the University of Notre Dame, Vistage International, the Washington State Bar Association, and YPO. In addition, he has published numerous articles in publications such as the California Tax Lawyer, the California Trusts and Estates Quarterly, State Tax Notes, Tax Notes, and Trusts & Estates, and he is frequently quoted as an industry expert in the media.

Justin has served as an executive committee member of the State Bar of California Taxation Section, an executive committee member of the Los Angeles County Bar Association Taxation Section, the chair of the Century City Bar Association Taxation Section, and the editor-in-chief of the California Tax Lawyer. Prior to joining BNY Mellon, he was an attorney at a major law firm, where he advised wealthy families, senior corporate executives and closely-held business owners regarding tax-efficient estate and business succession planning, trust law and management, and asset preservation.


Scott Taylor is a Partner in Assurance at BPM. He has over twenty-seven years of public accounting and private industry experience, including 10 years with a Big Four accounting firm. He provides both public and private technology, biotechnology, and healthcare, and nonprofit a variety of accounting and tax services, including financial statements, audit reviews, compilations, agreed-upon procedures and internal control evaluations. Scott also consults with management on complex accounting, tax, and SEC reporting matters.


Julie West chairs BPM's Corporate Tax Practice and the Firm's Life Science Industry Group. She was named one of San Francisco Business Times' 150 Most Influential Women professionals in 2012.

Julie works closely with biotech, pharmaceutical, medical device, software, social media, communications, and manufacturing companies. She began her career at Deloitte and understands the complex business needs of pre-revenue startups to consolidated publicly-traded companies.

She has over 14 years of experience in public accounting and deals extensively with tax provisions (FAS 109/ ASC 740), FIN 48 analysis for uncertain tax positions, Section 382 studies to determine limitations on tax attributes, and sales tax exposure. She has advised companies involved in a wide arena of transactions, including mergers, asset and stock acquisitions, tax-free reorganizations and foreign expansion. She consults and reviews a variety of tax returns with multi-state and international filings, and helps guide her clients through financings and IPOs. Julie is passionate about building and mentoring her team of outstanding professionals.

Caroline Corner, Westwicke Partners. "How to Position Your Story to Connect with the Right Investors"

How to Position Your Story to Connect with the Right Investors

It's important not just to get funding for your venture but also to ensure that you engage the right investors--people who genuinely want to help you grow and succeed. An expert in investor relations, Caroline Corner is Managing Director at the SF office of Westwicke Partners, a strategic capital markets advisory firm. Join us January 17 to learn what to include in your pitch deck, how to build credibility, and how to connect with quality investors.

Where & When

Room 212, Byers Hall, UCSF Mission Bay
5:30 to 6:30 PM, Thursday, January 17

About the Speaker


Caroline Corner, Ph.D., joined Westwicke Partners in 2016 as a Managing Director leading our San Francisco effort in Medical Technology. Caroline’s focus is working with both public and private companies in the medical device and diagnostics areas. Her expertise and extensive C-level industry relationships stem from more than 12 years working in sell-side equity research, various roles within device and healthcare companies, as well as her academic training in biochemistry, engineering and nanobiotechnology.

Ryan Pierce, Nine, Rock Health, & Stanford: "The First Dollar: Strategies and Ethics of Seed-Stage Fundraising"

Ryan Pierce, Nine, Rock Health, & Stanford: "The First Dollar: Strategies and Ethics of Seed-Stage Fundraising"

What is the right way to raise a seed round?  Even as founders strive to focus on innovation and execution, they must make myriad decisions, big and small, on fundraising.  Whom should I pitch first?  What's the smallest check I should accept?  Do I price the round or raise on a convertible note, and on what terms?  Join us as healthcare product designer, entrepreneur, and investor Ryan Pierce tests conventional wisdom against a survey of his peers, considers the ethics of taking early-stage money, and shares his own lessons from both sides of the table.

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, December 11


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

About the Speaker

pierce headshot.jpg

Ryan Pierce is Co-Founder and CEO of Nine, Entrepreneur-in-Residence at Rock Health, and Lecturer in Bioengineering at Stanford, where he teaches BIOE 70Q: Medical Device Innovation.  He has served as VP of Design and Innovation at Ventus Medical, VP of Business Development at Loma Vista Medical, a healthcare investor at De Novo Ventures, and a product designer at Concentric Medical and The Foundry/Zephyr Medical.  An inventor on over two dozen issued U.S. patents, he has designed FDA-cleared devices to treat sleep apnea and stroke.  Ryan holds mechanical engineering degrees from MIT and Stanford, and an MBA from Harvard Business School.

Rajan Patel, iO life science. "Learn About Experience Design for Medical Devices"

Rajan Patel, iO life science. "Learn About Experience Design for Medical Devices"

If your product addresses a viable market, it will have competition. Your commercial success can depend to a large extent on the good or bad experience that users--clinicians and patients--have while using your device or system. How can you ensure that users have a good experience? Join us to learn from Rajan Patel, founder and CEO of the firm iO life science. (Speaker info has been updated from the original)

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
Thursday, November 29, 2018, 5:30 to 6:30 PM


5:30 - 6:15 PM: Talk
6:15 - 6:30 PM: Q&A

About the Speaker

patel+lg 300.png

Rajan Patel is founder and CEO of io life science. He is a medical device executive who partners with healthcare brands to transform their design & development practices. After 30+ years of medical device development across drug delivery, diagnostic systems, surgical devices and digital medicine, Rajan knows what truly drives innovation of smart, connected and patient-centric devices. It’s about collaborating with partners who are dedicated to creating breakthrough therapeutic solutions to unmet patient needs. Rajan has held senior positions across such companies as Minimed, Heartport, Aerogen, M2 Medical, Cirtec Medical and Lunar, leading programs to develop & commercialize medical products. Rajan’s commitment over the past 15+ years has been to organizations dedicated to transforming lives through revolutionary drug delivery and medical device technologies. Rajan has led numerous research & development and manufacturing teams to successful execution and launch of life-impacting devices. Rajan holds a B.S. in Mechanical Engineering from MS University of Baroda and M.S. in Biomedical Engineering from UC Davis/CSUS.

Johnny Lam & Kyung Sung, FDA-CBER. "Meet the FDA: Regulatory Science Insights into Cell-Based Products"

"Meet the FDA: Regulatory Science Insights into Cell-Based Products"

Kyung Sung, Ph.D., Principal Investigator

Johnny Lam, Ph.D., Staff Fellow

Cellular and Tissue Therapies Branch, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research

This event is held in partnership with UCSF-Stanford CERSI.

Where & When

Room 2103, Mission Hall, UCSF Mission Bay (550 16th St., San Francisco)
2:00 to 3:00 PM, Friday, November 9

As described in the 21st Century Cures Act, products eligible for Regenerative Medicine Advanced Therapy (RMAT) designation include cellular therapies, therapeutic tissue engineered products, human cell and tissue products, or any combination products that use such therapies or products. Multipotent stromal cells (MSCs) and induced Pluripotent Stem Cells (iPSCs) have been popular sources for manufacturing RMAT products due to their ability to undergo lineage-specific differentiation. Despite great promise, successful clinical translation of such cell-based products is often hindered by manufacturing challenges and the lack of reliable markers that can predict the products’ in vivo performance. For instance, MSCs are very heterogeneous and responsive to their surrounding environment, resulting in distinct subpopulations of cells with potentially different amounts of qualities needed for product potency. Since there are numerous biochemical and biomechanical factors regulating the functions of MSCs, it is critical to develop reliable high-throughput assays that enable the efficient exploration of large and complex parameter spaces for evaluating cellular function. Microscale in vitro systems offer the practicality to fulfill this unmet need. Several simple microfluidic channel arrays have been successfully implemented in screening the influence of paracrine mediators and various tissue microenvironment components in the regulation of cellular functions. In addition, microphysiological three-dimensional organoids and tissue-like structures such as chondrogenic cell aggregates and blood vessels have been incorporated into high-throughput, cell-based screening platforms in efforts to provide functionally relevant in vivo-like conditions. This presentation will give an overview of practical microscale technologies that are simple to operate while enhancing throughput, relevance, and reliability. How such technologies could be employed in the assessment of cell-based products will be discussed.

About the Speakers

Johnny Lam.jpg

Dr. Johnny Lam is a biomedical engineer with expertise in biomaterials and in developing practical microscale in vitro tools for medical and biological applications. Dr. Lam’s main research interests involve studying multipotent stromal cells (MSCs, otherwise known as mesenchymal stem cells) and how their quality attributes relate to their functional potential using physiologically relevant, higher-throughput platforms. Dr. Lam received his Ph.D. in Bioengineering in 2015 at Rice University, where he developed and evaluated injectable multi-layered hydrogel composites for cell and controlled growth factor delivery for in vivo cartilage tissue repair. Following his graduate studies, Dr. Lam joined the Center for Biologics Evaluation and Research at the FDA as a post-doctoral researcher, where he now works as a Staff Fellow. His research now focuses on the development and adaptation of wide-ranging microphysiological platforms to evaluate various functional outcomes of MSCs toward improving the quality and potency of manufactured cell-based products.

Kyung Sung.jpg

Dr. Kyung Sung is a biomedical engineer with expertise in developing functional and practical microscale in vitro tools for medical and biological applications. Dr. Sung’s main research interests lie in studying cell-materials interactions and exploring cell behavior in various tissue microenvironmental conditions. Dr. Sung received her Ph.D. in Chemical Engineering in 2007 at the University of Michigan, and worked as a post-doctoral researcher in the Department of Biomedical Engineering at the University of Wisconsin-Madison, where she also worked as a Principal Investigator before she joined the FDA in 2015. She also worked as a patent examiner in Biotechnology at the US Patent and Trademark Office. During her previous research, she used principles from tissue and microsystems engineering to develop tissue-like structures such as blood vessels and mammary ducts in microfluidic channels to develop new practical tools to conduct cancer research in vitro. The microscale in vitro systems provide unique capabilities when studying complex interactions occurring in tissue microenvironment, by providing more precise controls of biochemical and biomechanical factors than traditional platforms. She has been able to create innovative opportunities and strategies for researchers to explore biology in different ways – particularly in understanding the role of the tissue microenvironment in regulating cellular functions.

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


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


About the Speaker


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.