BME COC2019 BME EDUCATION SUMMIT

MIKE HESS

VP & GENERAL MANAGER

MEDTRONIC MCS

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USING OUR EXPERTISE

Information based on Medtronic FY2016 reporting.

88,000+EMPLOYEES

9,000+SCIENTISTS AND ENGINEERS

4,800+PATENTS

400CLINICALTRIALS

65MILLIONLIVES IMPROVEDLAST YEAR

TO IMPROVE LIVES

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MEETING THE NEEDS OF PATIENTS AND PARTNERS AROUND THE GLOBE

~160 COUNTRIES

89MANUFACTURING FACILITIES

480+ LOCATIONS

Americas

Europe, Middle East, & Africa

Asia Pacific

Greater China

Headquarter Locations

Medtronic Operational Headquarters Minneapolis, Minnesota

Medtronic Principal Executive Office Dublin, Ireland

WHAT ARE PEOPLE WONDERING ABOUT?

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WHAT DO WE WANT TO TALK ABOUT

Why do I think BME is different than other engineering disciplines

How should we think about education of BME students to reflect their unique role?

Examples from the real world of applying BME skills to important problems

THE DIFFERENCES IN BME START WITH THE FUNDAMENTALS

BME Departmental Vision Statement (School A)To educate leaders who will integrate principles of both engineering and medicine to create knowledge and discoveries that advance human health and well-being. Our faculty and students play leading roles ranging from basic science discovery to the creation, clinical evolution, and commercialization of new technologies, devices, and therapies. In short, we are “Engineering Better Health.”

Mechanical Engineering Vision Statement (School B)The mission of the Department of Mechanical and Aerospace Engineering is the education of professionals in mechanical, aerospace, and nuclear engineering, the dissemination of knowledge and technology, and the development of innovative solutions to problems in these fields.

WHAT DO YOU TELL THE WORLD ABOUT BME?

OUR MISSION ALLEVIATE PAIN. RESTORE HEALTH. EXTEND LIVES.

Medtronic Mission: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.

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INTL1135 MCS Slide Deck | May 2017

Leaders Engineering and Medicine

Human Health

WE WORK IN THE MOST ELEGANT CLOSED LOOP “SYSTEM OF SYSTEMS” MOST OF OUR EFFORTS INVOLVE RESTORING/MAINTAINING THIS BALANCE

Good BME always remember the way their system fits into the systems of the patient and never assume they know too much

WE WORK IN THE MOST ELEGANT CLOSED LOOP “SYSTEM OF SYSTEMS” SYSTEMS ENGINEERS FOR THE HUMAN BODY

Circulatory System

Support

RepairCatheter

ValvesDefibrillator

BMES INTEGRATE ACROSS ENGINEERING DISCIPLINESFOCUS ON THE APPLICATION, NOT THE TECHNOLOGY

Example: How can we help with advanced heart failure?

SensorsTeleHealth

LV Assist

BMES INTEGRATE ACROSS ENGINEERING DISCIPLINESFOCUS ON THE APPLICATION, NOT THE TECHNOLOGY

Many disciplines to be included in any solution

Electrical Engineering

Materials Science

Software Engineering

Biochemistry

Mechanical Engineering

Modeling

Tissue Engineering

Chemical Engineering

Embedded Systems

Clinical Engineering

Information Technology

Anatomy and Physiology

BMES INTEGRATE ACROSS ENGINEERING DISCIPLINESFOCUS ON THE APPLICATION, NOT THE TECHNOLOGY

So are we engineers….. Or more like architects?

I nterface of Technology with Human needs Uses general building blocks of technology Requires multidisciplinary team Regulated High demands for quality Societal Impact Solution is focused, but may take different forms

ALWAYS BE LOOKING FOR THAT NEXT INNOVATION YOU CAN USEADAPTING DESIGNS TO THE LATEST TECHNICAL BUILDING BLOCKS

BETTER REAL-WORLD EXAMPLES OF ADAPTING TO TECHNOLOGY!

Architect doesn’t need to become an expert in HVAD design and operation, but they have to know how to use the new technology to bring forward better designs that meet their clients needs

KEYS FOR BME SUCCESSWHAT SETS A GOOD BME APART AND MAXIMIZES THEIR EFFECTIVENESS

Defining the Unmet NeedEthnography in the field, with clinicians

and patients

The technical liaison to marketing

Separate want from need, go past described solutions

Build the value proposition

Champion for innovation

“Research is about turning money into knowledge. Innovation is about turning knowledge into money”

WE WORK IN THE MOST ELEGANT CLOSED LOOP “SYSTEM OF SYSTEMS” MOST OF OUR EFFORTS INVOLVE RESTORING/MAINTAINING THIS BALANCE

Technology Scouting

Known enough about the relevant disciplines to be dangerous

Aware of advances in other areas that could apply to the project

Good a defining risk/readiness for different program approaches

Leverage, leverage, leverage the work of others. R&D= replicate and duplicate

WE WORK IN THE MOST ELEGANT CLOSED LOOP “SYSTEM OF SYSTEMS” MOST OF OUR EFFORTS INVOLVE RESTORING/MAINTAINING THIS BALANCE

Collaborative Leadership

Partition the system requirements out efficiently

Work at the interface of technology, marketing, clinical and regulatory

Step up to problem solve at the program level

Respect technical depth of the team leads but know when to push

WE WORK IN THE MOST ELEGANT CLOSED LOOP “SYSTEM OF SYSTEMS” MOST OF OUR EFFORTS INVOLVE RESTORING/MAINTAINING THIS BALANCE

Curiosity and Flexibility

Connect the dots between projects, therapies, industries

Career ambitions into different disciplines

Get to true underlying unmet needs

Be willing to move off your last solution/technology if something better is an option

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESBASIC REQUIREMENTS

Telemetry is required for clinicians to change the settings of the implanted device, and to retrieve diagnostic data either in the clinic, or while the patient is at home

The standard is access from about 10 feet away with no direct patient interaction required

The radios are custom as is the hardware and the frequency is reserved

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESPLATFORM FOR CHANGE

• Ease of Use – monitors in the home are in fixed location, a pain to transport

• Reliability – changing telecommunications landscape is a challenge

• Cost – custom monitoring equipment (and clinic instruments) are very expensive, and for the home see relatively little use (2-3 transmissions a year)

• Future platform flexibility - we are not setup to interact with patients, only inform them everything is “ok” or not

Option 1 – make a smaller, cheaper home monitor, with a bigger display so we can change the interface

Option 2 – abandon the monitor model and move to smartphone monitoring

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESMEDTRONIC TRANSITION

Defining the Unmet NeedMobility – not just bedside monitor

Ease of use

“Setup and forget”

Familiar for patients who may have infrequent use

Forward compatible with everyday technology

Create new patient benefit

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESMEDTRONIC TRANSITION

Technology Scouting

White paper on advances in Bluetooth, specifically BT LELow costLow current drainDeveloped security and co-

existence protocols

Vendors willing to work with us

Other technologies (NFC) evaluated and discarded

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESMEDTRONIC TRANSITION

Collaborative Leadership

Tackle regulatory challenges head on

Proof of concept for security

Engaging outside partners in app design and development, building new internal competencies

Excite marketing about the potential of the smartphone platform

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESMEDTRONIC TRANSITION

Curiosity and Flexibility

Relax “de facto” requirements

Discovering new potential patient benefit of the solution we chose

Iterate on the design based on early patient feedback

Declare when things are good enough to move ahead

Learn from other businesses and sectors what can apply here

REAL WORLD EXAMPLE – TELEMETRY FOR IMPLANTED DEVICESMEDTRONIC TRANSITION

CareLink™Network

Not experts in BT protocol design – but experts at the application and the cross-functional work to make it successful

Knowing the use conditions and user requirements is the key to success for a BME

BMES CAN LEVERAGE THEIR TRAINING INTO MANY DIFFERENT CAREERSNATURALLY SETUP TO WORK CROSS-FUNCTIONALLY

Quick search of Medtronic – “Biomedical Engineer”

Biomedical Engineer

Systems Engineering

Quality/Ops Engineering

Manager Titles (various, Mgr up to VP)

Strategy and BD

Clinical

Sales

Regulatory

Field Service/Education

Risk Management

Medical Writer

Marketing Roles (Various)

This was not seen with “Electrical Engineer”

SO WHAT’S THE BIG TAKE-AWAY?

Not “Junior” engineers who learned some core engineering and traded off other

engineering to get some physiology courses under their belts

Biomedical Engineers are integrators who understand physiology and bring core engineering principles to bear to solve

important problems.

MY ASK OF YOU

Team projects – lots of them – application focused problem solving. Define unmet needs

Observational research. Doesn’t need to be in a hospital!

Ensure BMEs Work with students from other engineering degree programsThank You