Medical Device Networked Launched
The Medical Device Network, a pre-cursor to Stanford Biodesign, begins. Paul Yock (pictured) catalyzes a group of faculty who are interested in the development of medical devices to host medtech-oriented seminars, workshops and “invention challenges.” Sandy Miller provides early administrative direction.
Fogarty Lecture Series Initiated
The first annual Fogarty Lecture sponsored by the Department of Surgery and (eventually) Biodesign features Thomas Fogarty himself (pictured).
MDN Gains Notoriety
David Cassak reviews the Stanford Medical Device Network in Start-Up magazine (pictured).
Yock and Makower Team Up
Paul Yock and Josh Makower meet over breakfast to discuss the possibility of launching a medtech-oriented fellowship at Stanford (pictured here as a re-enactment of that meeting). With Josh’s previous experience in creating and leading the “PfreshTech” training program at Pfizer, the two agree that this would be a good model for a university-based fellowship.
Biodesign Founded as Part of Bio-X
Led by Paul Yock, the Medical Device Network faculty group (pictured) convinces Stanford University School of Medicine Dean Philip Pizzo and School of Engineering Dean Jim Plummer, along with leaders of the emerging Bio-X initiative, that the Medical Device Network should be part of Bio-X. “Biodesign” is a name suggested by School of Engineering Professor Scott Delp to conform with the Bio-X nomenclature (the “X” in this case standing for the design of biomedical technologies).
First Sponsors Get On Board
Guidant and Johnson & Johnson (logos pictured) sign on as first sponsors of Stanford Biodesign. They will continue to fund the program (Guidant later as Abbott) every year through the present day.
The Birth of “Biodesign Green”
The program is initially housed in Stanford’s Center for Clinical Sciences Research. The color of the hallway walls where the offices are located informs the choice of bright green as the “Biodesign color” (pictured here in one of the program’s early logos).
Innovation Fellowship Kicks Off
The first cohort of four Biodesign Innovation Fellows begins a year-long fellowship. Josh Makower (pictured with Paul Yock) leads the development of the fellowship curriculum, which becomes the model for teaching the “biodesign innovation process.”
Mentor Network Grows
Fellowship support and mentorship is contributed by icons in the medtech field, including Tom Fogarty, John Simpson, and Simon Stertzer (pictured).
Popp Joins Biodesign Team
Richard Popp (pictured) joins the Biodesign leadership team as Director of Ethics and Policy.
Biodesign Start-Up Founded
The first company from a Biodesign fellowship team is founded: Acumen Medical (logo pictured).
Biodesign Innovation Course Takes Off
Stanford Biodesign launches a graduate-level course for engineering, medical, and business students who learn a condensed version of the biodesign innovation process. Needs identified by fellows are used as a basis for student projects. Professors Yock and Makower (pictured) teach the new Biodesign Innovation course.
Biodesign Helps Spark Consortium of BME Faculty
Paul Yock and Christine Kurihara help launch the first Biomedical Engineering—Innovation, Design and Entrepreneurship Alliance (pictured). This consortium, known as BME-IDEA, holds an annual gathering of biomedical engineering professors from across the US to share best practices and collaborate to advance teaching in the field. The group develops BMEsource, an open-source indexing of resources to support training in biomedical technology innovation.
New Speaker Series Features Medtech Icons
Stanford Biodesign launches a speaker series entitled “From the Innovator’s Workbench,” which features renowned medical technology inventors interviewed by journalist David Cassak (pictured). Thomas Fogarty is the first featured speaker.
Biodesign Moves to Clark Center
Stanford Biodesign moves into ground-floor space in the new James H. Clark Center (pictured). David Kelley, founder of IDEO, helps design the brainstorming room. The biodesign “collaboratory” is an early medtech maker space in an otherwise research-intensive building.
Innovation Fellowship Adds Specialty Team
The Stanford Biodesign Innovation Fellowship adds the concept of “specialty fellows,” which allows the physician(s) on a team to focus on unmet needs in their specialty area (two specialty fellows from subsequent years are pictured).
Biodesign Initiates FDA Fellowship
After completing a pilot program in 2003, Stanford Biodesign formally initiates a “fellowship” (internship) program with the Food and Drug Administration (pictured) via its Center for Devices and Radiological Health. More than 20 Stanford students and postgraduates have participated in this program to-date.
Pietzsch Starts Tech Assessment Course
Stanford Biodesign support the launch of another graduate-level course entitled “Technology Assessment and Regulation of Medical Devices,” which is led by Jan Pietzsch (pictured). The course will continue to be taught to Stanford students and distance learners every year thereafter.
Krummel Brings Biodesign to Surgery
Thomas Krummel (pictured at center), Chair of Stanford’s Department of Surgery, introduces the biodesign innovation process to his surgical trainees during their research years. Surgeons are trained in the process through a newly created two-year Biodesign Surgical Fellowship (the first year is the Biodesign Innovation Fellowship, the second year allows these fellows to continue on their projects). Krummel will later become Co-Director of Stanford Biodesign.
Brinton Becomes Fellowship Director
Todd Brinton (pictured) joins the Stanford Biodesign faculty as Fellowship Director.
Linehan Joins Biodesign Team
Jack Linehan (pictured), previously Vice President of the Whitaker Foundation, moves to Stanford Biodesign as a Consulting Professor.
Biodesign Hosts Emerging Entrepreneurs Program
With the leadership of medtech veteran Jay Watkins, Stanford Biodesign offers a workshop entitled “Emerging Entrepreneurs.” The three-day seminar (pictured) features venture capitalists, medtech entrepreneurs, and other industry professionals providing “insider” insights into how to start and run a new medical technology company. A second workshop is held in 2007.
Wang Introduces Biodesign to Cardiovascular Medicine
The first annual Biodesign Arrhythmia Retreat (pictured) is organized and led by Paul Wang to provide electrophysiologists with insights into the biodesign innovation process.
Zenios Joins Biodesign Teaching Team
Professor Stefanos Zenios (pictured on left) from the Stanford Graduate School of Business joins the teaching team for the graduate-level Biodesign Innovation course and helps to organize and clarify the way the biodesign innovation process is presented.
Stanford Coulter Translational Program Launched
Stanford Biodesign partners with the university’s newly formed Bioengineering department to apply for and attain a provisional Coulter Translational Award for 5 years. The Stanford Coulter Translational Program is highly successful in this pilot phase, and the team (pictured) facilitates the award of a sustaining endowment of $20 million. Biodesign continues to administer the program with approximately 6-8 Coulter grants awarded every year to promising new medical technologies invented by faculty at Stanford.
More Start-Ups Founded
iRhythm becomes the seventh company to launch from Stanford Biodesign. iRhythm, with its ZioPatch technology (pictured) will go on to become the biggest company initiated from a Biodesign Innovation Fellowship project to date, impacting 400,000 patients by 2016.
Biodesign Initiates Global Exploration
In response to a call to action from Stanford University President John Hennessy to consider global health problems, Stanford Biodesign explores possibilities for partner programs in developing countries (pictured).
Fellows from Mexico Come to Stanford
Stanford Biodesign and a team (pictured) from Technologico de Monterrey, Mexico launch a pilot program. Two fellows from the university participate in the program that year.
Stanford-India Biodesign Founded
Through an introduction by Stanford University Associate Dean Harry Greenberg, discussions begin with the Department of Biotechnology in the federal government of India. A planning process concludes with the establishment of a joint Fellowship program called Stanford-India Biodesign and an annual Indian medtech summit, the first of which is held in December 2007. Rajiv Doshi leads the program as Executive Director (US) and fellowship alumnus Uday Kumar directs the fellowship training (pictured with other early participants). Each year, four Indian nationals are selected for six months of training at Stanford Biodesign and six months at the All India Institute for Medical Sciences in Delhi, India.
Gorodsky Becomes Biodesign “Shrink”
Julian Gorodsky from the Stanford University d.school (pictured at center) joins the Stanford Biodesign leadership group as the first fellowship psychologist.
Number of Biodesign Start-Ups Continues to Grow
By the end of Stanford Biodesign’s eighth year, 14 companies have been started out of the program by teams from the fellowship and class (one fellows team pictured here).
Jaipur Knee Gets Its Start
The Stanford Biodesign-sponsored project team (pictured) in Professor Thomas Andriacchi's “Biomedical Engineering in Research and Development” course develops a prosthetic knee designed to meet the needs of medically-underserved people. The “Jaipur Knee” is selected by Time magazine as one of 50 best inventions of 2009.
Biodesign Textbook Released
Stanford Biodesign faculty, with a major contribution from Graduate School of Business research associate Lyn Denend, publish a first-of-its-kind textbook entitled Biodesign: The Process of Innovating Medical Technologies (pictured). It quickly becomes the leading text in the medical technology domain for its publisher, Cambridge University Press. The first edition sells more than 10,000 copies worldwide. An open-source website, eBiodesign.org, is developed as a parallel resource for students and faculty.
Biodesign At TCT
Stanford Biodesign launches “The Biodesign Innovation Workshop” at the Transcatheter Cardiovascular Therapeutics Meeting, an annual event hosting nearly 12,000 interventional cardiologists (pictured).
Makower Testifies on US Regulatory Challenges
Josh Makower testifies before an Institute of Medicine panel on the challenges of building a successful medical technology company in the current US regulatory environment (pictured). With the help of Aabed Meer, Lyn Denend, the Medical Device Manufacturers Association, and the National Venture Capital Association, he later publishes the results of a medtech survey that assesses the US regulatory process as “unpredictable, inefficient, and expensive” and helps catalyze change in the industry.
CDRH Leader Comes to Biodesign
Stanford Biodesign launches a new roundtable event to initiate discussions on issues of interest to the medtech community. The first session addresses regulation with the leader of the FDA’s Center for Devices and Radiological Health (pictured with Phil Pizzo and Paul Yock), and the second covers patenting with the head of the US Patent and Trademark Office.
Singapore-Stanford Biodesign Formed
After two Singaporeans (pictured with Paul Yock and Chris Shen) complete the Stanford Biodesign Innovation Fellowship and return to their home country, the Singaporean government approaches Stanford Biodesign about a collaboration similar to the Stanford-India Biodesign program. The first four fellows arrive in January 2011. Christopher Shen leads the program as Executive Director and Uday Kumar directs the fellowship training.
Biodesign Expands Global Efforts
Stanford Biodesign is awarded $1.7 million through the university’s Consortium for Innovation, Design, Evaluation, and Action (C-IDEA, pictured) to provide students and faculty at the university with exposure to global problems, along with funding to explore potential solutions. Anurag Mairal leads the Biodesign Global Exchange program under this grant.
Biodesign Creates Regulatory Video Series
Stanford Biodesign releases a series of video tutorials on the regulatory environment in the US (pictured). The videos feature two regulatory experts sharing guidance, stories, and advice on what it takes to get a device through the FDA.
Global Biodesign Course Initiated
Stanford Biodesign launches its Global Biodesign course (logo pictured) — a graduate-level class examining opportunities and challenges related to medical technologies development around the world, featuring international experts in the field.
Biodesign Turns 10!
Stanford Biodesign celebrates its 10th anniversary at the fellowship graduation (pictured) with special contributions by John Abele (founder, Boston Scientific), Ginger Graham (President, Guidant), and other industry luminaries.
Biodesign Shares Expertise with Ireland Program
Ireland initiates a new Stanford Biodesign-like program as a joint project across five universities. Mark Bruzzi, Professor of Biomedical Engineering at the University of Ireland, Galway, spends three months with Stanford Biodesign learning the biodesign innovation process and our teaching methods. The program, BioInnovate, will become an official Stanford Biodesign affiliate in 2013 (logo pictured).
First Company Founded Out of India Program
The first company is founded out of the Stanford-India Biodesign program. Consure Medical (pictured), which was created to provide devices for the management of incontinence, will go on to earn FDA approval and launch its technology in 2016.
India Program Helps Establish Important IP Precedent
Stanford-India Biodesign executes an exclusive worldwide license to commercialize the technology between BCIL (the technology transfer organization for the Indian government’s Department of Biotechnology) and Consure Medical (pictured). The license serves as a template for future products emanating from the Stanford-India Biodesign collaboration.
Additional Courses Launched
Stanford Biodesign launches two new Stanford courses. The first is the Biodesign Capstone course for seniors in Stanford’s new undergraduate major in Bioengineering, led by Stanford Biodesign fellow alumnus David Camarillo as a new Assistant Professor of Bioengineering. The second is a course focused on Biodesign for Mobile Health Technologies (pictured), which is developed by Marta Zanchi in response to growing student interest in this area.
Visitors Flock to Biodesign
Interest in the Stanford Biodesign program translates to more than 90 visits per year (pictured) from more than 300 individuals representing universities, governments, industry, and nongovernmental organizations.
Biodesign Joins Forces with FDA
Stanford Biodesign signs a memorandum of understanding (pictured) with the FDA’s Center for Devices and Radiological Health for joint development of educational and training programs.
Biodesign Shares Fellowship Training Outcomes
Stanford Biodesign faculty and staff publish an article in the Annals of Biomedical Engineering (pictured) entitled “Outcomes from a Postgraduate Biomedical Technology Innovation Training Program: The First 12 Years of Stanford Biodesign.”
Biodesign Starts Executive Education Course
In response to requests from industry, Stanford Biodesign initiates our first Executive Education program entitled “Managing Innovation.” The program is held annually going forward, with teams of attendees from most major medtech companies attending. Stanford Biodesign faculty (including Jay Watkins, pictured) and fellowship alumni help the teams implement the biodesign innovation to address challenges facing their companies.
Saul Joins Biodesign Team
Gordon Saul (pictured at center) joins Stanford Biodesign in the newly created position of Executive Director. Later that year, Lyn Denend transitions from the Stanford Graduate School of Business to Stanford Biodesign into a role as Associate Director for Curriculum.
Biodesign Helps Catalyze BME Alliance in Europe
The annual BME-IDEA meeting of Biomedical Engineering faculty interested in innovation, design and entrepreneurship translates to Europe. The first BME-IDEA Europe includes 12 faculty members (pictured here with other participants). The meeting, which continues annually, will expand steadily to more faculty and universities across the European Union.
First Product From India Program Reaches Market
Stanford-India Biodesign has its first product launch when a low-cost lower limb splint designed by a Stanford-India Biodesign team is licensed to Hindustan Latex Ltd. The product, known as HiCARE LIMO (pictured) goes into production shortly thereafter. The technology will be distributed through government hospitals and ambulances.
Wall and Azagury Join Innovation Fellowship Team
James Wall and Dan Azagury (both Stanford Biodesign fellowship alumni) join the Stanford Biodesign leadership team as Assistant Directors of the Innovation and Specialty fellowship programs, respectively (pictured).
Rait Signs On to Help Biodesign Teams
Douglas Rait (pictured with two fellows) joins the Stanford Biodesign leadership in the role of Associate Director, Team Learning & Design.
Biodesign Starts Global Faculty Training Program
To address growing interest in global partnerships, Stanford Biodesign officially begins training faculty from outside the US in approaches to teaching the biodesign innovation process. Fumi Ikeno and Ritu Kamal take the lead in providing training and mentorship for the first class of Global Faculty Trainees (pictured).
35th Start-Up Launched from Biodesign
Stanford Biodesign sees its 35th company launch from the program (pictured here with other Biodesign company logos). As of 2014, these companies have collectively helped 250,000 patients and raised over $300 million in funding.
Venook Takes on Engineering Role
Fellowship alumnus Ross Venook (pictured) is appointed jointly in Stanford Biodesign and Bioengineering to lead training and develop coursework in engineering and prototyping.
2nd Edition of Biodesign Textbook Published
In response to the significant changes in the medical technology industry, Stanford Biodesign rewrites the Biodesign textbook with new emphasis on value and the globalization of the sector. The second edition (pictured) is published in January 2015.
Biodesign Initiates Faculty Fellowship
Stanford Biodesign launches a new program to train Stanford Faculty with an interest in medical technology development. The first class of Stanford Biodesign Faculty Fellows (pictured) includes six faculty members from medicine and engineering. Fellowship alum Ryan Van Wert takes a leadership role in helping launch the program and mentor the faculty fellows.
Biodesign Video Library Released
With financial support from the Coulter Foundation, Stanford Biodesign creates an open source website and video library (pictured), with over 300 video clips that expand upon and enliven content in the newly published textbook.
Biodesign Enters Partnership in Japan
Stanford Biodesign launches Japan Biodesign via a Program Development Partnership with Osaka University, University of Tokyo, and Tohoku University to train aspiring medtech innovators in that country. The partnership is announced at Stanford (pictured) during a visit from Prime Minister Abe of Japan.
India Program Becomes Independent
The initial phase of the Stanford-India Biodesign program comes to a close with the annual Medtech Innovation Summit (pictured). Led by Professor Balram Bhargava, Stanford Biodesign’s Indian counterparts launch the new School of International Biodesign based on the original Stanford Biodesign program, with fellows doing the majority of their training in India. The government of India provides funding to start up four additional Biodesign programs in country.
New Name and Status for Biodesign
Stanford Biodesign becomes the Byers Center for Biodesign (pictured) with a gift from long-time mentor Brook Byers and family. Brook’s brother, Thomas Byers, is a Stanford professor in entrepreneurship who helped with the creation of the original Stanford Biodesign Innovation course. The shift to a center allows for the centralization of finance and administration, as well as the creation of a formal development program to support Stanford Biodesign’s long-term sustainability.
Stanford Biodesign sees its 41st company founded out of the program. As of 2016, these companies have helped more than 500,000 patients and raised over $280 million in funding, to the delight of the founders (Yock and Makower, pictured) and the entire Biodesign team.
New Data on Fellowship Outcomes
Stanford Biodesign faculty and staff publish an article (pictured) in the Annals of Biomedical Engineering that quantifies the effect of the fellowship program on the career focus, leadership, and productivity of our alumni.
Fresh Focus on Undergrads
Thanks to a generous gift, Stanford Biodesign kicks-off a series of activities to strengthen the undergraduate educational opportunities including an extension funding program called Biodesign NEXT and an experiential needs finding program (pictured).
Launch of Founder's Forum in India
Led by Raj Doshi and Anurag Mairal, Stanford Biodesign initiates the “Founder’s Forum” in India to help local innovators (pictured) overcome challenges in taking new technologies “the last mile” into patient care.
First Health Technology Showcase
Stanford Biodesign holds its first annual health technology showcase to highlight solutions developed in our project-based courses and promote community-building among aspiring innovators (pictured) across campus.
Yock Wins Prestigious Gordon Prize
Stanford Biodesign's founder, Paul Yock (pictured), is named by the National Academy of Engineering as the 2018 recipient of the Bernard M. Gordon prize for innovation in engineering and technology education.
1.5 Millions Patients Helped
Technologies initiated by trainees during their time at Stanford Biodesign lead to 47 companies founded. Even more importantly, these technologies reach 1.5 million patients ... and counting!
Singapore Biodesign Launches
After eight years as a joint program, Singapore-Stanford Biodesign transitions to independent status as Singapore Biodesign. The new entity was kicked-off at festive a celebration (pictured).
Yock Honored with Russ Prize
Paul Yock (pictured with leaders of the NAE) is one of five innovators awarded the National Academy of Engineering’s Russ Prize for developing innovative medical devices that enable the minimally-invasive treatment of advanced coronary artery disease.
Biodesign Tackles Gender Diversity
Acknowledging the gender gap within its own programs, Stanford Biodesign formalizes an initiative to bring more women into its leadership ranks and help catalyze change across the larger health technology industry. Two important early activities include a national survey on gender-related issues and a Summit (pictured) to discuss the most prevalent barriers to gender equality and begin thinking about potential solutions.
Number of Patients Helped Passes 2.7 Million!
The total companies launched by our trainees during their time at Stanford Biodesign climbs to 50. And, more importantly, the tally of patients their technologies have helped exceeds the 2.7 million mark (pictured).
New Innovation Fellowship Leaders
As Todd Brinton moves on to an opportunity in industry, a new team (pictured) steps up to lead Stanford Biodesign’s Innovation Fellowship.
More About Us
From the story of our founding and growth to our promise for the future of health technology innovation, there’s so much to discover about Stanford Biodesign.