Driving Success: How to Accelerate Medical Device Product Dev by Optimizing Early Stage Strategies


Chicago Booth Alumni Club of San Francisco

The University of Chicago Alumni Club of Italy

May 21, 2015: 12:00 PM - 1:30 PM

A roadmap for navigating an ever changing healthcare environment, managing talent resources and partnerships with cross-functional and cross-institutional teams


Knight Management Center at Stanford Graduate School of Business
Room G102 in the Gunn Building
655 Knight Way
Stanford, California

Driving Directions:

Event Details

At the session, we will focus on anticipation, identification and management of early stage need-to-concept and concept-to-prototype challenges and pitfalls. Come and learn from a sharing session with cardiovascular medical business industry leaders and startup veterans on what it takes to succeed and how to learn from failure. From cutting edge, pioneering technologies to revamping of existing medical device products, lessons and warning flags.

Some key discussion points which will be framed into a road map:
• uncovering unmet clinical needs
• technical feasibility
• patent research, IP protection and mapping the competition
• finding the right talent resources and research partners, team augmentation
• business model alignment and financing
• containment of $-to-market


No Charge


Register Online

We are providing a light lunch. Please sign up in order for us to plan accordingly.

Deadline: 5/19/2015

Speaker Profiles

Luca Leone (Panelist) '06
CEO, Albelissa Engineering

Luca Leone is CEO at Albelissa Engineering where he is currently responsible for global growth and expansion of company's core competencies in new verticals.

Albelissa delivers just-in-time engineering, industry specific technical recruitment and staffing, and outsourcing of business processes (IT, recruitment, accounting and finance). Albelissa offers various workforce solutions and business processes to increase company's flexibility, improve internal competencies, create efficiency in operations and in distribution of human resources, catalyze product development innovation and drive progress.

Before Albelissa, Luca was EMEA IT Director with General Electric Corporate. His responsibilities at GE included cost out and expense targets, strategic planning, re-engineering and optimization of operations, deployment of global support teams across multiple lines of business, negotiation with third parties, offshore outsourcing, operations management, startup operations, staff management, third-party services integration, change management, client and vendors relations.

Including roles prior to GE, his background embraces over 20 years of experience interfacing with technology-intensive customer environments, providing advice and project management for very large-scale deployment of IT support services.

Luca holds a MBA from the University of Chicago Booth School of Business, a MA of Economics from California State University East Bay and a BS in Financial Services and Economics from Saint Marys' College of California.  


Marta Gaia Zacchi (Panelist)
Founder & Managing Director of Medinnovo LLC, Medinnovo LLC

Dr. Zanchi is Founder and Managing Director of Medinnovo LLC, a consultancy firm established to support the entrepreneurial community of Silicon Valley, and Lecturer with Stanford University's School of Medicine in the Biodesign Program, where she participates in the strategic planning activities of the Biodesign Leadership Group and is the Lead Director of "Biodesign for Mobile Health," an entrepreneurial course. Under Medinnovo, Dr. Zanchi has worked as consultant, advisor or Board member with companies in the cardiovascular, imaging and mobile health industry, for some in acting executive positions joining the leadership teams at critical times of the company's earliest stages. She is an advisor to student teams at Stanford University and a mentor at StartX, a startup accelerator.

In previous years, Dr. Zanchi was the Chief Executive Officer of RenovoRx, an Entrepreneur In Residence with The Angels Forum (TAF), the co-chair of the Connected Health Safety Initiative (CHSI), a Medical Device Fellow with the U.S. Food and Drug Administration (FDA), and has held positions as system design and product management engineer with privately held semiconductor and wireless technology startups (both acquired).

Dr. Zanchi is a top graduate in biomedical engineering (BS) and electrical engineering (MS, PhD) from Politecnico Di Milano (Italy) and Stanford University. Her work at both universities focused on the development of innovative medical devices and systems for the diagnosis and staging of diseases. She was awarded the Politecnico Di Milano's highest student honor and two fellowships from Stanford University. She was trained in entrepreneurship (Ignite) and holds an award from the Stanford Graduate School of Business. When she is not engaged in the entrepreneurial community of Silicon Valley, Dr. Zanchi can be found enjoying life with (and, taking innumerable photographs of) her adoptive son, her foster daughter, and her husband of nine years.

Paul Friedrichs (Panelist)
Senior Engineering Manager, Medtronic

Paul Friedrichs has more than 20 years of experience in medical device product development, planning, staffing and company infrastructure development. In the last four years, he has been with Medtronic where he has held the position of R&D Program Manager and lastly of Senior Engineering Manager. Before he held different positons at Ardian, Mirabilis Medica and Therus and Calypso Medical.

At Ardian, he was responsible for product development of an energy delivery device used for treatment of hypertension, congestive heart failure, and end stage kidney disease.

At Mirabilis his role encompassed product concept development work involving numerous pre-clinical studies using in vivo tissue and ex vivo human tissue. He also set up the HIFU acoustic test lab set-up and drove test method development.

At Therus, he led technical program management requiring oversight of multiple on-going projects for the development of a highly complex acoustic hemostasis device for sealing punctures in the femoral artery following cardiac catherization procedures.

At Calypso, he worked on the development of a magnetic tracking system used for tracking human implantable "beacons" for tumor and organ movement detection.

Paul holds a BS in Electrical Engineering from the University of Texas – Austin.

Shaun Bagai (Speaker)
CEO, RenovoRx

Shaun Bagai brings over 15 years of medical technology expertise with a proven track record in leadership roles in clinical research, sales, marketing and market development. He has launched new technologies into regional and global marketplaces in both large corporations and growth-phase novel technology companies.

Currently, Bagai is CEO at RenovoRx, an early stage startup focused on innovative solutions for targeted delivery of therapeutic agents to selected sites in the peripheral vascular system.

Prior to RenovoRx, he led Global Market Development for HeartFlow, Inc. which included directing Japanese market research, regulatory/payer collaboration, and Key Opinion Leader development to create value resulting in a company investment to form HeartFlow-Japan. He also successfully orchestrated their largest clinical trial and contracted HeartFlow's first global customers. HeartFlow is a software as a service company focusing on non-invasive cardiac diagnostics.

Bagai was an integral part of Ardian's global market development and sales team. He was instrumental in developing the European market for renal denervation which led to the acquisition of the first renal denervation (interventional hypertension treatment) company, Ardian, Inc. by Medtronic in 2011.

At Medtronic Vascular, he held roles as Senior Coronary Sales Representative and Clinical Marketing Manager.

At TransVascular, Inc. he was the Clinical Research Manager, responsible for all aspects of multi-center, multi-national clinical research trials. TransVascular focused on less invasive vascular technologies and was acquired by Medtronic in 2003.

Bagai is a graduate from the University of California, Santa Barbara with a BS in Biology/Pre-med, High Honors.

Fletcher Wilson (Panelist)
Founder and CEO, Intervene, Inc.

Fletcher Wilson is the founder and CEO of Intervene, Inc., an innovative medical device start-up company that has developed the first non-implantable, catheter-based, vein valve creation therapy to treat chronic venous insufficiency (CVI) in the deep veins for people who are unable to efficiently pump blood back to their heart from their deep venous system. The catheter-based platform is based on an Italian surgical predicate procedure, and involves a controlled, sub-intimal dissection of the inner layer of the vein wall to create autologous valves in the deep veins. The company raised a $5.9M Series A in March 2015, and plans to utilize this funding for a two stage OUS clinical feasibility trial.

InterVene arose out of the Stanford Biodesign Fellowship, an interdisciplinary program working to train and create entrepreneurs for the future of Med Tech with direct end goals of new company and product creation. As a fellow, Fletcher was able to focus on need finding and technical feasibility, narrowing down from 300+ needs to 1, building a business plan robust enough for early angel funding to support product development. The current product has gone through 3 years of design development, moving from extremely lean with a lot of contract groups and individuals, to slowly building the team and accelerating design development into first in human stage. Experienced in building the patent portfolio and mapping the space, Fletcher is concurrently managing the licensed IP originally filed within Stanford, and the Intervene developed portfolio.

Fletcher is a graduate of Stanford University with a MS in Mechanical Engineering with a Biomechanical concentration.

Sam Roosz (Moderator)


Luca Leone, '06 

Other Information

We are in the process of adding more speakers to the panel and all from Silicon Valley.

Please stay tuned for more updates in the following weeks.