Conference



Attend this year’s medical device conference to learn how to accelerate new product development, hear examples, and get practical advice for applying lean methods. Product designers and developers in the medical device industry will have the opportunity to network, while learning how to be innovative and competitive. Learn the latest in robotics applications for surgery and prosthetics - where these new techniques are saving and improving people's lives.   Hear examples and practical do's and don'ts for accelerating new product development in the challenging medical regulatory environment.  Enjoy 3D printing, laser, and robotics demonstrations.  Explore opportunities for career development and pathways into the biomedical device industry as well as gather information on financial incentives for R&D and manufacturing.  This is a special event that you won't want to miss, held in conjuction with the Design 2 Part show.

Gain new ideas, meet people who share your interests, and learn how the Bay Area continues to innovate and respond to global competition in the following areas:

  • Bay Area medical device manufacturing
  • Robotic trends in medical industry
  • Robotics in surgery
  • Career pathways to the medical device industry
  • 3D printing, laser, and robotics demonstrations
  • Lean product development and regulatory compliance in medical devices
  • Accelerated new product development
  • Do's and don'ts for apply lean tools
  • "Regulatory Fog" avoidance
  • Financial Incentives for R&D and manufacturing
  • Connections with sponsors and Design 2 Part trade show
This conference is held in collaboration with the Design-2-Part Show www.d2p.com  as well as with the SME North Bay and SME Sacramento chapters.  Other local  organizations that support SME include IEEE-CPMT, ASME-SCVS, ASQ Northern CA Biomedical Division, SJSU BMES, SWE-SCV, San Jose State University, Laney College, and DeAnza College.  For more information or if you have registration issues, please contact the Conference Chair, Joanne Moody   at sme098@gmail.com.

Who Should Attend?

The SME Silicon Valley Chapter 098 is hosting an exciting one day conference for people in:

  • Product development engineers, "makers", designers, manufacturing professionals, technologists, manufacturing engineers, and managers.

  • Students and professionals interested in advancing their knowledge in design, prototyping, making, 3D printing, additive manufacturing, robotics, and networking.

  • Quality and regulatory affairs professionals with strong interest product design, manufacturing, and medical devices.
Register

Program


PDF to be attached (TBD)



Schedule - subject to change.

8:00 - 8:30 am Registration, Coffee, Tea, Fruit, and Danishes

Morning Session (8:30 - 11:30 am) -  Medical Device  Opportunities in the Bay Area

8:30 - 8:35 am  - Introduction - Conference & SME  SV (5 min)

  • JoAnne Moody - 2015 Conference Chair,  SME Silicon Valley Chapter 98

  • Bill Browne - 2015 Master of Ceremonies, MANEX Consulting

8:35 - 9:05 am -  The Bay Area Biomedical Device Manufacturing Opportunities (30 min)  - Keynote Speaker

Learn about the East Bay Area Biomedical network and opportunities for business assistance, technology transfer, education and training, and economic development.

  • Dr. Gregory Theyel - Program Director - East Bay Biomedical Manufacturing Network

9:05- 9:30 Trends in Prosthetics (25 min)

Learn about prosthetics trends and helping our veterans.

  • Keith Sardo - Area Clinic Manager, Hangar Prosthetics, Co-Owner 17 & M Designs

09:30- 10:30 am - Career Pathways for Workforce Development -  Panel Discussion (60 min)

Learn about the programs to provide technology and manufacturing awareness to our young people, providing educational pathways for job growth in product development and manufacturing.

  • Raya Zion - Director of College Relations,  SME Silicon Valley Chapter - Panel Leader
  • Harry Wachob - President & Founder, Bio2Device Group 
  • Guna Selvaduray - Ph.D.,Biomedical Engineering Coordinator, Professor, Materials Engineering, College of Engineering, SJSU
  • Wendy Plew - Career Technical Education Specialist - California Teachers Association
  • Theresa Rowland - Career Ladders Project
  • Natalie Lowell - SME CMfgT Manager, Member Engagement

10:30 - 10:50 am - Break (20 min)

10:50 - 11:20 am - Building Robotics for Medical (30 min)

Learn about the surgical robotics benefits,  challenges, and new developments.

  • David Robinson, Sr. Dir Systems Engineering, Intuitive Surgical Inc.

11:20 - 11:30 am - First Robotics Overview (10 min)

Learn about robotic program innovations that our Bay Area High Schools.  How can you help create the future?
  • Angelo Riccardi - 1st Robotics

11:30 am - 1:15 pm - BREAK for Design-2-Part Tour, Technology Demonstrations,  and Sponsor Interactions (Lunch not included)

  • Interactive 3D Printing, Laser, and Robotics demonstrations available at the conference

Afternoon Session (1:00 - 3 :30 pm) -  Accelerating Medical Device Product Development

Explore common misconceptions about lean methods and regulatory requirements for medical device development.   Learn practical approaches to apply lean methods to accelerate medical device development and improve regulatory compliance.


•   Geetha Rao - CEO, Springborne Life Sciences
•   Roger Tang - Principal, H R Tang Consulting
•   Aaron Joseph - Engineering Mgr, Intuitive Surgical


1:00 - 1:25 pm – Lean & Compliant Part 1  (25 min)

1:25 - 1:40 pm – Interactive Exercise: Identifying Knowledge Gaps (15 min with break)

1:40 - 2:05 pm – Lean & Compliant Part 2  (25 min)

2:05 - 2:20 pm – Interactive Exercise: A3 Method (15 min with break)


2:20 - 3:00 pm – Lean & Compliant Part 3 with Q&A  (40 min)

3:00 - 3:15 pm  - Break

3:15 - 3:45 pm  - Financial Incentives for Manufacturing and R&D  - Panel Discussion (30 min)
Learn about available government funding and subsidies for manufacturing and R&D.

Panelists:

  • Bill Browne - MANEX Consulting, Panel Leader
  • Justin Currie - Senior Business Development Specialist, GO-Biz (Governor's Office)
  • Robert Meyer -ETP
  • Jesse Wutke - Senior Manager, Gallina LLP

3:45 - 4:00 - Closing & iPad Drawing - JoAnne Moody (15 min)

REGISTRATION 

Conference Links


Register Here 

Conference Advertising Card

Conference Press Release

Conference Program

Speaker Bios

Sponsors


Speakers & Panelists

  • Gregory Theyel - E. Bay Biomedical Mfg Network
  • Bill Browne - MANEX Consulting
  • Keith Sardo - Hangar Prosthetics
  • Harry Wachob - Bio2Device Group
  • Guna Selvaduray - SJSU
  • Windy Plew - CA Teacher's Association
  • Theresa Rowland - Career Ladders
  • Justin Currie - Go Biz
  • Angelo Ricardi - First Robotics
  • Jessie Wutke - Gallina
  • Raya Zion - SME Silicon Valley Chapter
  • David Robinson - Intuitive Surgical
  • Geetha Rao - Springborne Life Sciences
  • Aaron Joseph - Intuitive Surgical
  • Roger Tang - HR Tang Consulting
  • Robert Meyer - ETP, State of CA
  • Natali Lowell - SME
  • JoAnne Moody - Event Director
  • Cynthia Cook - Chapter Chair

Diamond Sponsors

  • MANEX Consulting

Platinum Sponsors

  • Intuitive Surgical
  • NUTEK Corporation

Gold Sponsors

  • Gallina LLP
  • Product Realization Group
  • Hawk Ridge Systems

Silver Sponsors

  • General Foundry Service
  • DEG

Program Committee

  • JoAnne Moody, Conference Co-Chair
  • Hong Xu, Technical
  • Cynthia Cook, SME SV Chapter Chair
  • Phil Ogaz, Treasurer & Logistics
  • Bill Browne, MC for conference
  • Rob Eichner, Design-2-Part Show VP
  • Raya Zion, Laney College
  • Thi Ngyen, ASQ Northern CA Biomedical group
  • Geetha Rao, Springborne Life Sciences
  • Aaron Joseph, Intuitive Surgical
  • Michael Keer, Product Realization Group
                                                                                                                           

Extended Committee

  • Diana Helka
  • Natalie Lowell

Professional Societies

  • SME North Bay Chapter
  • SME Sacramento Chapter
  • SJSU BMES
  • ASME-SVCS
  • ASQ Northern CA Biomedical Division
  • IEEE-CPMT
  • SWE - SCV

Links

Gold Sponsors

  • Product Realization Group

Bios

 



Gregory Theyel - Program Director of Biomedical Manufacturing Network and Advisor for the Tech Futures Group- Keynote Speaker

Mr. Theyel has worked for over 15 years with large and small biomedical technology companies assisting with business, technology, and production planning. Gregory earned a doctorate from Clark University, has published widely in operations and management journals, and teaches courses in industrial engineering and business strategy.

Bill Browne - Director of Economic and Workforce Development - Manex Consulting - Master of Ceremonies

Mr. Browne has over 32 years of extensive manufacturing experience and expertise in general management, manufacturing operations, quality systems, engineering, product development and continuous improvement initiatives, including Lean Manufacturing and Six Sigma. He has led numerous process improvement initiatives resulting in top-line and bottom-line growth across a range of industry sectors and geographies, including China, Hong Kong and the UK. Prior to joining Manex, Mr. Browne was General Manager at Triangle Coatings, Inc. where he was responsible for managing two manufacturing operations. Mr. Browne has also held executive management positions with Morgan Crucible, Consolidated Container Company and Mattel, Inc.  Mr. Browne has led numerous Lean Manufacturing, quality (ISO 9001, 8D), product optimization, consumer pricing and workforce development programs that achieved dramatic improvements in productivity and competitiveness. Mr. Browne has also achieved the Six Sigma Master Black Belt (SSMBB) and Certified Design for Six Sigma (CDFSS). Mr. Browne holds an MBA from the University of Detroit, and a BS in Engineering Arts from Michigan State University.  Return to Schedule

Geetha Rao, Ph.D. - CEO, Springborne Life Sciences and CEO, Technology Frontiers Collaborative

Dr. Geetha Rao has over 25 years of experience in high-risk technologies with a focus on emerging business challenges and operational excellence that meets best-in-class, international standards. She is an internationally recognized expert in medical device quality systems and risk management and has established, audited, remediated, and maintained quality system processes and documentation for clients. She supports international regulation and policy bodies, and standards development organizations with establishing standards and guidance documents in quality systems and risk management. 

Dr. Rao has served on the faculty of FutureMed at Singularity University, Stanford University’s Biodesign Innovation Program. She supports several academic institutions on technology commercialization, including the University of Chicago’s Innovation Network for the Physical Sciences Division, UCSF surgical innovations advisory board, and Ryerson University Office of Research and Innovation. She was a contributor on the 2013 World Economic Forum research project on Sustainable Health Systems, a TEDMED scholar, and has addressed numerous industry forums and the press. Previously, for 6 years she produced MedTech Frontiers, an educational forum exploring the intersection of leading-edge science and technology with medicine. 

Dr. Rao holds a doctorate from MIT and a masters from Stanford University’s Graduate School of Business.

Justin Currie - Sr. Business Development Specialist,  CA Governor's Office of business & Economic Development (GO-Biz)

Justin Currie serves as the Senior Business Development Specialist in the Governor's Office Business & Economic Development (GO-Biz) for the Bay Area.  In this capacity, Justin works with local state and federal officials, and private sector service providers to assist companies doing business, in California.  As such, Justin exercises a high level of technical expertise and manages economic development opportunities to help businesses establish and/or expand their operations within the state.

Justin has a wide range of Executive Branch policy experience.  Prior to joining the GO-Biz team in 2011, Justin served in Governor Schwarzenegger's Administration as a key member of his Cabinet staff.  As the Governor's liaison to state agencies, responsibilities included working with department directors, agency secretaries, and other top administration officials to implement the Governor's over all agenda, assist in budget development, policy implementation, crisis management and long term policy goals.

Prior to joining the Schwarzenegger Administration, Justin was a successful small business owner in South Texas. 

 

Robert Meyer - Director of Economic Development - Employment Training Panel (ETP)

Robert has over 20 years with ETP and leads the development and implementation of the Panel’s statewide interagency engagement and marketing strategy. Prior to this role, Robert gained extensive experience working with the Panel’s strategic planning, policy, eligibility, and contract development functions.  Robert also represents ETP as a primary point of contact for the Panel’s workforce and economic development initiatives.  Robert plays and referees a lot of soccer and tries to keep up with his two children, Shay and Colm (Coll-um).  He lives in East Sacramento.


JoAnne Moody - SME SV Conference Co-Chair, 
Zeta Scientific LLC

Ms. JoAnne Moody, SME SV Conference Co-Chair, has over 35 years experience in adhesives, coatings, smart materials, and medical device materials.  Ms. Moody has worked for 3M, Boston Scientific, Raychem Corporation (now Tyco Electronics),  EndoSonics Inc., and Liquidity Corporation.  As principal at Zeta Scientific LLC, Ms. Moody's industry experience includes medical devices, electronics, and  consumer product companies - from  startups to large international corporations. Ms. Moody has a special talent at providing creative assistance to companies in early phase product development, design for manufacturing as well as design transfers to manufacturing.

Ms. Moody earned her BA degree in Chemistry from Hamline University, St. Paul, MN and MS degree in Chemical Engineering & Material Science from the University of Minnesota, Minneapolis, MN. Ms. Moody has served as Silicon Valley SME Chair, Conference Chair, Chair-Elect, and Newsletter Editor as well as delegate board member for the Silicon Valley Engineering Council (SVEC).   Return to Schedule

Harry Wachob - Founder and President,  Bio2Device Group

Harry Wachob is the Founder and President of the Bio2Device Group. The B2DG is 12 years old and has over 1600 members who are in various life science industries and corporate positions.  Harry is an experienced engineering leader in materials science, biomedical device engineering and R&D. He has directed and mentored multidisciplinary teams in solving complex technical issues in order to improve the safety, reliability, and performance of medical devices. Previously, he was the Managing Materials Scientist at Xoft, and Director of Engineering for Aerogen, a biopharmaceutical company specializing in novel aerosol drug delivery. Prior to that, Harry was Managing Engineer at Exponent/Failure Analysis Associates where he guided research and development, and product failure investigations covering a broad range of medical and industrial applications. He received a BS, MS and PhD in Materials Science & Engineering from Cornell University.

H. Roger Tang, PhD - Principal, H R Tang Consulting

Roger has spent his entire professional career applying engineering principles to creating tools for studying biology and solving medical problems. Currently, he specializes in providing Project Science, Engineering, and Management support to  life  sciences  and  medical  technology companies  as  an  independent consultant. Previously,  Roger  managed  the  Research  Group  and  ideation  activities  at Molecular  Devices.   The  Research  Group’s  primary  mission  is  to  provide scientific guidance and support in developing hardware and software tools to meet the unique needs of biology research scientists, primarily utilizing optical detection, imaging, and electrical measurement technologies. Roger's industrial career started in 2001 at a biotechnology startup, Signature BioScience, which developed some of the first label-free assay technologies based on bioimpedance.  Signature’s technologies were eventually commercialized as the CellKey® 96 and 384 Systems, currently part of the Molecular Devices portfolio.  Before his industrial career, he was an Assistant Adjunct Professor in Radiology at the University of California, San Francisco, where his research focused on cancer imaging (primarily using x-ray CT and molecular imaging).   Roger received his PhD in Bioengineering from the Joint Graduate Group in Bioengineering at the University of California at Berkeley and San Francisco in 1998.  He also holds an MS in Optical Sciences from the University of Arizona and a BS in Applied Physics from the California Institute of Technology.

Aaron Joseph - Biomedical Engineer, Intuitive Surgical, Inc.

Aaron is a biomedical engineer with over 15 years of experience in medical device development over a wide range of technologies, from complex capital equipment to disposable devices.  His product development experience includes a digital x-ray fluoroscopy system, laser eye surgery system, heart-lung bypass machine, robotic catheter system, drug inhaler device, x-ray catheter for brachytherapy, and endoscopy instrument with RF ablation.  Aaron specializes in product validation, risk management, and other design controls for medical device development.    At Intuitive Surgical, he helps engineering teams comply with quality system requirements while developing new surgical tools and software for robotic-assisted surgery.  Previously as a consultant, Aaron worked with product development teams in performing risk analyses, designing test plans, developing new test methods, writing and executing test protocols, refining product requirements, supporting regulatory submissions, and training R&D staff.  He has broad experience implementing and managing design controls at large and small companies.  He received a BS degree in Electrical Engineering from Rice University and a MS degree in Bioengineering from the University of Washington.

Raya Zion - Career Services and Biomedical Engineering Technology Program Manager, Laney College

RAYA ZION has been in workforce development for the past 20+ years, starting as a manager of a staffing agency, moving from there to recruiting in the biotech industry, then into work at local county government agencies specializing in the job placement of retrained workers.  While employed by the San Mateo County Central Labor Council, Raya was the job developer and business services representative for the Biotech Workforce Network (BWN) which focused on retraining dislocated workers via a collaborative which included Skyline College, Ohlone College, Alameda County WIB and San Mateo County WIB. This Biotech Workforce Network facilitated the re-training and employment of over 600 people into technician level positions with in the life sciences industry sector. Due to the Biotech Workfoce Network's achievements, the Alameda County WIB won the national award from the U.S. Department of Labor for "Building an Industry Driven Workforce Investment System."  After six years with San Mateo County workforce development, she was tapped by Alameda County to lead their CleanTech and BioTech initiatives.

Presently, at Laney Community College, she engages with life sciences companies in providing industry education and job opportunities for graduates from Laney College's Biomedical Engineering Technology, as well as its Bio-mandufacturing Certificiate programs.   Her workforce development experience is supplemented by her love of music. In addition to hosting a weekly radio show, she is the lead vocalist and manager of the Tribal Blues Band and The Groove Objective.  She holds a Bachelor of Arts degree in Industrial Organizational Psychology from San Francisco State University.

Guna Selvaduray - Director - SJSU Biomedical Engineering

Guna Selvaduray, director, Biomedical Engineering, joined San Jose State University in Fall 1984.  He obtained his M.S. and Ph.D. degrees in Materials Science & Engineering from Stanford University, and his B. Eng. Degree in Mechanical Engineering from Tokyo Institute of Technology.  Prior to joining SJSU he worked in industry for 10 years.  His research interests include materials issues for biomedical implants, Pb-free solders, corrosion, and surface and interfacial interactions, among others.   He has been leading the College of Engineering’s development of curricula and research capabilities in biomedical engineering and biomedical devices, including the B.S. and M.S. Biomedical Engineering programs.  His research and scholarly activities have attracted funding from a variety of government agencies and private companies.  He has over 100 publications and has made over 120 technical presentations.  Guna is also a consultant to industries in the USA and Japan.  

Theresa Fleischer Rowland - Senior Director, Pathway and Sector Development, Career Ladders Project
 
Theresa has over 25 years experience in education and human services. Her expertise focuses on large-scale initiatives which increase the capacity of community colleges and their partners to leverage regional and statewide assets to prepare a diverse and inclusive workforce. She leads statewide initiatives centered on access to high skilled, high wage careers with multiple partnerships, including instituting Communities of Practice across industry sectors such as manufacturing, transportation, health, public service and law. Theresa works with faculty, administrators, employers, and community organizations to implement evidence-based practices which enhance accelerated adult learning and promote college and career advancement opportunities. Before joining CLP, she served as Vice President of Economic Development at De Anza College, Executive Director of the Occupational Training Institute for the Foothill–De Anza Community College District, Assistant Employment Coordinator at Long Beach City College and on the counseling faculty at Pasadena City College, San Diego City and Mesa Colleges. Theresa has provided leadership for many educational collaboratives serving regional communities, including the Bay Area College IT Consortium, Bay Area Workforce Development Deans, and the Carl Perkins Vocational and Technical Education Act 2000 State Plan Committee. She has authored, staffed and administered over $20 million in grants with public and private foundations, and provided oversight for programs and operations in higher education. She holds an M.A. in Counselor Education from San Diego State University, a B.S. in Education from the University of Southern California, and a certificate in Community College Administration through the University of California at Los Angeles.

Wendy Plew - Career Technical Education Specialist - California Teachers Association


Wendy  Plew is a former Science and Robotics teacher who now works as a Career Technical Education specialist for the California Teachers Association.  An important piece of her work is helping to foster new Manufacturing career pathways and help to connect together education and industry throughout California.  As a school board trustee in Campbell Union High School District she has been successful in assisting the district in obtaining a California Career Pathways Trust grant to start a “Design for Manufacturability” pathway from two CUHSD school, articulating to De Anza College or San Jose State.

Jesse K. Wutkee - Senior Manager, GALLINA LLP

Jesse is GALLINA LLP’s firm-wide Tax Credits & Incentives (“TC&I”) Practice Leader. His primary focus involves developing new and maintaining existing client relationships and serving as the Firm’s technical resource on TC&I matters. Specifically, Jesse and the TC&I practice focus primarily on research and development tax credits, hiring credits, 179D and cost segregation studies, and Interest Charge – Domestic International Sales Corporation (“IC-DISC”) studies.

Though based out of GALLINA’s Roseville office, Jesse oversees projects spanning all twelve GALLINA offices throughout the western United States, including northern and southern California, Nevada, Utah, and Washington. In addition, Jesse’s role has him overseeing the technical and soft-skills training and development of professional staff and the implementation and compliance of best practices within the TC&I practice.

Prior to joining GALLINA, Jesse began his career with a Big 4 Firm in the Sacramento area where he gained valuable experience working on medium and large sized corporate income tax compliance projects.  He graduated with a B.S. in Accounting from James Madison University and is a member of the American Institute of Certified Public Accountants (AICPA), and the California Society of Certified Public Accountants (CalCPA).

Rick Riccardi - FIRST Robotics

Rick Riccardi is an advocate for hands on experience learning as a complement to traditional academic classroom.  Rick has been a Project & Systems Engineer involved in the design and development of fighter jet cockpit displays and ground vehicle updates for the defense industry for more than 30 years.   Since 2008, Rick has also been a volunteer for student robotics experiences in FIRST and SeaPerch programs.  As founder and continuing mentor for Prospect, Westmont and Gateway High School Robotics FRC Teams, Rick shares his knowledge, experience and decision process to students in the 'sport of the mind' that provides both learning and exciting real world experiences.  Rick and students provide a short overview of the FIRST program that was founded by Dean Kamen as a way to enrich and prepare the next generation of technologists.

Cynthia Cook - Chair - SME Silicon Valley Chapter Chair

Cynthia Cook is the Chair of the SME Silicon Valley Chapter, a 401(c) non-profit. Ms. Cook is focused on acquiring and providing knowledge and connections for leading edge product development, manufacturing, student outreach and workforce development in the community.  Ms. Cook has over 17 years in manufacturing including lean, quality and new product introduction with Acuity Lighting, and Carrier Corporation.

Ms. Cook earned her Bachelor degree in Industrial Engineering from the Georgia Institute of Technology, Atlanta, GA and MS degree in Management Science from the University of Dayton's School of Engineering, Dayton, OH. Ms. Cook has served as Silicon Valley SME Chair-Elect.  Ms. Cook is a senior member of the Institute of Industrial Engineers, served in several leadership positions within the Dayton, OH chapter, and holds a SixSigma green belt. Ms. Cook is a member of ASQ.   Return to Schedule


Links

How 3D printing will radically change the world

3D Printing in Dental Martket

With Google's Robot-Buying Binge, A Hat Tip To The Future - NPR

The Economist 14-page Special Report: Rise of the Robots

10 Robots to Watch in 2014 | Robin Raskin

CNN - What's Next in Robotics

BAE Systems 3D prints jet parts for the RAF

10 game changing 3d printing materials - from chocolate to skin

California Network for Manufacturing Innovation

Stanford 3D printing breaks new ground

3D Printing in Space

Made in Space

NASA to launch 3D printer into space to supply astronauts

3D Printing from Fantasy to Reality

FATHOM 3D Printing Newsletter

Getting 3-D Printing and Next-Generation Manufacturing to the Factory Floor [Video]: Scientific American

3D Scanner Demo - Creaform Go!Scan3D

 

 











Robert Meyer - Director of Economic Development - Employment Training Panel (ETP)

 

Robert has over 20 years with ETP and leads the development and implementation of the Panel’s statewide interagency engagement and marketing strategy. Prior to this role, Robert gained extensive experience working with the Panel’s strategic planning, policy, eligibility, and contract development functions.  Robert also represents ETP as a primary point of contact for the Panel’s workforce and economic development initiatives.  Robert plays and referees a lot of soccer and tries to keep up with his two children, Shay and Colm (Coll-um).  He lives in East Sacramento.