Medical Device Engineering

Medical Device Engineering

Jim NiederjohnApril 2, 2014

Discuss the role that engineers play in the medical device industry

Purpose

Jim’s Background◦ Education◦ Career History◦ Medical Devices & Projects

Medical Device Engineering◦ Engineering Roles & Responsibilities◦ How to develop and release a medical device to market

Advice◦ Career◦ College

Questions

Agenda

Moved to Newark, CA in 1984 Graduated from Newark Memorial High

School in 1990 Graduated from CSU Chico in 1994

◦ BS Mechanical Engineering Graduated from Santa Clara University in

2000◦ MBA

Who’s Jim?

A *medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United

States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions,

or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

What is a medical device?

*http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm

95 ‘00 ’05 ’10 ‘15

Career HistorySt

artu

pBi

g co

mpa

ny

AcquisitionAcquisition

CRYOVASCULAR SYSTEMS

Manufacturing Engineer (1994 – 1998)◦ Support all activities related to building product◦ Make sure that the production line is meeting

throughput and yield goals◦ Skills developed

Product assembly knowledge Problem solving / troubleshooting – root cause analysis Fixture Design Process Development & Optimization Design of Experiments (DOE) Manufacturing Documentation Engineering Change Orders (ECO) Product non-conformities and dispositioning Protocol and report writing

R&D Project Engineer (1998 – 2001)◦ Perform development activities to release products to

market◦ Skills developed

Component design Injection molding familiarity Project planning / Schedule development Coordination of activities with other team members Product Qualification familiarity

Biocompatibility testing Sterilization Validation Design Verification (DV) testing Accelerated Aging DV testing Design Validation testing Manufacturing Process Validations Packaging Validation

Regulatory requirements for gaining approval

R&D Manager (2001 –2003)◦ Project Manager responsible for releasing

products to market◦ Supervise team of R&D engineers & technicians◦ Lead team of cross functional resources◦ Skills developed

General Project Management Getting “buy in” on decisions Setting expectations when working with others Holding individuals accountable

Developing (Coaching & mentoring) team

Manufacturing / Project Manager (2003 –2007)◦ Production supervisor responsible for achieving

manufacturing goals◦ Supervise production operators and mfg. engineers◦ Oversee development of Next Generation Device

Process Development Manager (2007 – 2009)◦ Manage team of process development engineers

and technicians Develop manufacturing processes for new products Perform all manufacturing deliverables to qualify device

CRYOVASCULAR SYSTEMS

R&D Manager (2009 – present)◦ Manage team of R&D Engineers and

technicians Develop and release new products to market

◦ Employee Career Development◦ Skills developed

Design For Manufacturability Larger scale program management Strategic level planning for product pipeline

Medical Devices & Projects

“Off Pump” Coronary Artery Bypass (OPCAB) Grafting – Minimally Invasive approach

Medical Devices

“Off Pump” CABG DevicesStabilizer

Xpose

Coronary Shunt

Blower / Mister

Cryoplasty Catheter◦ “Cooling therapy”

treatment for blocked leg arteries

RF Ablation Catheter◦ Treatment to destroy

small areas of heart tissue to prevent abnormal heartbeats

Medical Devices

UROLIFT System◦ Deliver implant(s) to

relieve prostate obstruction and open the urethra directly by retracting the obstructing prostatic lobes

Medical Devices

MitraClip – Percutaneous mitral valve repair◦ Treatment of Mitral Regurgitation (MR) - blood flows

backward from the heart’s left ventricle to the right ventricle

Medical Devices

MitraClip System

Medical Devices

MitraClip

Engineering Roles

Engineering Roles / Responsibilities

Research & Development Engineer

- Research: Identify a clinical need and evaluate concepts to meet need

- Development: Develop a concept into a device and release to market

- Solid modeling (CAD) to design parts

- Build & test prototypes- Interfacing with customers

(physicians)- Solving technical issues- Qualification testing of product

- Sustaining: Run the business design changes to existing products

- Corrective and Preventive Action (CAPA) projects

- Same as Development (above)

Manufacturing Engineer- Sustaining: Support manufacturing line to

achieve throughput and yield goals- Address manufacturing line down

issues- Continuous improvement projects to

reduce costs (improve cycle time, reduce # of rejects, etc.) & improve reliability

- New product support: Develop manufacturing processes to support new product development

- Fixture & equipment design - Process capability studies / DOE’s- Qualification testing of processes- Developing manufacturing

documentation

Engineering Roles / Responsibilities

Quality Engineer- Sustaining: Audit and monitor the

quality of product built to ensure that it is meeting the customer’s expectations and all the internal requirements

- Address non-conformities with components and assemblies (incoming inspection & production)

- Monitor product performance based on complaint analysis

- Corrective and Preventive Action (CAPA) projects

- Support audits by regulatory bodies

- Projects / New Products: support development teams who are making design / process changes

- Compliance to internal procedures for making changes

- Risk Management / Failure Mode Effects Analysis

Supplier Quality Engineer- Sustaining: Audit and monitor supplier

performance and ensure that they have capable processes that produce components that meet all the requirements

- Address line down issues related to component issues

- Perform supplier audits- Projects / New Products: Develop and

qualify suppliers for design changes / new products

- Develop robust and capable inspection methods

- Supplier capability assessments- Qualification testing of supplier

processes

Engineering Roles / Responsibilities

Project Manager- Manage activities to achieve program

goals- Develop and execute on project

plans to achieve project timeline- Facilitate cross functional team

activities- Manage high risk activities related

to the project and develop plans to address

- Communicate project status to management

New Product Development Process

5 Design Control Phases◦ “PASS” gates to move on to the next phase

How do you release a medical device to market?

Concept Development• Define clinical need• Identify goals• Identify and evaluate concepts

• Recommendation for further development

Design Freeze• Finalize specifications

• Converge to one concept

• Finalize design and show evidence of achieving requirements

Design Verification & Validation• Complete functionality testing

Manufacturing Readiness• Complete full process validation testing

Market Launch• Complete all design control requirements

• Gain regulatory approval

• Build product for launch

Advice

Early Years (1st couple of years out of school) Be a sponge – learn as much as you can! Set daily / weekly goals for yourself (i.e. complete task X by

Friday) & prioritize based on importance Put your personal life “on hold” when you are working Be clear on your manager’s expectations and understand what is

important to him/her Be pro-active and do more than what is expected Develop good working relations with the team you are working

with Find a mentor (engineer) and meet semi-regularly to get input

and feedback Don’t be afraid to make a mistake… you’ll learn from it Force yourself to do the things that are hard for you Find out what you really like to do

Career Advice – How to succeed

Early Years (1st couple of years out of school) Be a sponge – learn as much as you can! Set daily / weekly goals for yourself (i.e. complete task X by Friday) &

prioritize based on importance – attend classes, complete assignments on time

Put your personal life “on hold” when you are working on school projects Be clear on your manager’s expectations and understand what is

important to him/her you Be pro-active and do more than what is expected Develop good working relations with the team you are working with Find a mentor (engineer) and meet semi-regularly to get input and

feedback Don’t be afraid to make a mistake… you’ll learn from it Force yourself to do the things that are hard for you Find out what you really like to do Do homework and assignments with a team of 3 to 4 people Go to your professor’s office hours Enjoy the college experience!

Career Advice – How to succeedCollege

College

your classmatesprofessor

Questions