Designer PulseMedical Device Developers Survey

January, 2014

Sponsored by eInfochips

Designer Pulse

2

This survey is part of the Designer Pulse research program designed to keep tabs on the pulse of the design engineering community.

Designer Pulse survey results are shared with the engineering community on the eInfochips and IT Brand Pulse pages at slideshare.com.

3

IT Pro Survey Methodology

• The IT Pro Survey was conducted in January, 2014.– Respondents were solicited from more than 600 members of our medical device designers

database and from our LinkedIn medical device designers groups membership totaling around 250,000 members.

– 35 medical device design professionals completed this survey.– Responses were collected using an online survey engine.

• The survey was segmented into four sections:– Participant Profile– Medical Device Design– Development Platforms– Critical Engineering Expertise

4

Selected Organizations Represented

MicroPort Orthopedics Inc.3MInvacare Corp.St. Jude MedicalIDEXX LaboratoriesCR BardMPE Inc.Hill-Rom

B. Braun Medical Inc.Hologic Inc.ZimmerTerumo Cardiovascular GroupBaxter HealthcareEli LillyToshiba Medical

5

Highlights

• About the Respondents – 83% of respondents have over five years in developing medical devices and 60% have over ten years.

• Design Goals – From two different answer sets, respondents were asked what was the most important design goal. In one question respondents chose reliability (51.6%), in another they chose increasing the efficiency of doctors and hospital staff (36%). Reliability in service was still strongly indicated, garnering 29% of the vote.

• Most critical to success - Out innovating competition was noted as, the most critical thing to success for device designers (41.9%). After out-innovating, 42% of respondents chose cutting costs or TTM (reducing design costs - 19.4%, reducing time to market - 12.9%, and reducing production costs - 9.7%).

6

Summary Analysis

• Biggest challenge - The biggest challenge in completing development of new medical devices was indicated to be regulatory compliance. (35.5%)

• What makes a product special – Overwhelmingly medical device designers perceive it is the combination of software and hardware design that make their products special (61.5%).

• Most valuable skill - System design was the most often chosen as the most valuable skill to medical device design (34.6%)

• Mobility - The usage of mobile a OS for medical devices is expected to grow 3x in the next 36 months, while the number devices using a mobile GPµ is expected to increase 2.5x.

• Wearable devices – The number of wearable devices is expected to double in the next 36 months.

7

Your title or job description is best described as:

oftware Engineer

Firmware Engineer

ASIC Engineer

Test Engineer

Engineering VP/CTO

Packaging Engineer

Hardware Engineer

Engineering Director

Other (please specify)

Engineering Manager

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

0%

0%

0%

0%

0%

3%

3%

23%

31%

40%

8

Which of the following segments does your company produce medical devices in? (select all that apply)

Diagnostics

Implantables/Infusion System

Homecare

Monitoring

Surgical Instrument

Other (please specify)

Lab Instruments

Telemedicine

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

40.9%

37.1%

34.3%

28.6%

28.6%

20.0%

14.3%

11.4%

9

In which segment of Medical devices do you have expertise in? (select all that apply)

Implantables/Infusion System

Diagnostics

Monitoring

Other (please specify)

urgical Instrument

Homecare

Lab Instruments

Telemedicine

0% 5% 10%15%20%25%30%35%40%45%50%

42.9%

34.3%

25.7%

22.9%

20.0%

20.0%

20.0%

8.6%

10

The medical devices manufactured by your company are used in the following medical specialties (select all the apply)

General Hospital

Cardiovascular

Orthopedic

Radiology

General and Plastic Surgery

Anesthesiology

Ear, Nose, and Throat

Gastroenterology and Urology

Hematology

Obstetrical and Gynecological

Dental

Immunology

Pathology

Physical Medicine

Chemistry

Ophthalmic

Microbiology

Neurology

Other (please specify)

Toxicology

0% 10% 20% 30% 40% 50% 60%

51.4%34.3%34.3%

31.4%25.7%

20.0%17.1%17.1%17.1%17.1%

14.3%14.3%14.3%14.3%

11.4%11.4%

8.6%8.6%8.6%

5.7%

11

How many years of experience do you have developing Medical Devices?

Less than 1

1 to 5

5 to 10

10 to 20

20 to 30

30 to 40

more than 40

0% 5% 10% 15% 20% 25% 30% 35% 40%

2.9%

14.3%

22.9%

37.1%

20.0%

2.9%

0.0%

12

What is the most important design goal for the medical devices you work on?

Reliability

Leading edge feature set

Inventing a feature that did not exist before

Time to market

Other (please specify)

Cost

0% 10% 20% 30% 40% 50% 60%

51.6%

25.8%

12.9%

6.5%

3.2%

0.0%

13

What is the most important design goal for the medical devices you work on?

Improving efficiency of the doctor and/or hospital staff members

Provide reliable services

Ease the effort of the doctor patient

Easing anxiety/stress encountered by patients

Save time for the doctor and/or patient

Other (please specify)

0% 5% 10% 15% 20% 25% 30% 35% 40%

35.5%

29.0%

19.4%

9.7%

3.2%

3.2%

14

Product engineering at my company will expand in the following medical device market segments (select all that apply)?

Homecare

Diagnostics

Wearable devices

Monitoring

Surgical Instrument

Implantables/Infusion System

mHealth mobile applications

Telemedicine

Lab Instruments

Other (please specify)

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

38.7%

32.3%

29.0%

29.0%

25.8%

25.8%

22.6%

19.4%

19.4%

6.5%

15

Our biggest challenge in completing development of new medical devices is?

Regulatory Compliance

Replicating all use case scenarios

Design Verification Test Development

Software Development

Software Based Control

Other (please specify)

Hardware Design

UI Development

Well defined Architecture

Production Test Automation

High Quality Marketing Requirements

0% 5% 10% 15% 20% 25% 30% 35% 40%

35.5%

19.4%

12.9%

9.7%

6.5%

6.5%

3.2%

3.2%

3.2%

0.0%

0.0%

16

By which year will your company derive revenue from some type of wearable medical device?

We already get revenue from wearable devices

2014

2015

2016

2017

2018

Never

Other (please specify)

0% 5% 10% 15% 20% 25% 30% 35% 40%

22.6%

3.2%

3.2%

9.7%

6.5%

3.2%

35.5%

16.1%

17

How important is medical device security for you?

Very important

Important

Critically important

Not very Important

Not Important at all

Other (please specify)

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%

45.2%

25.8%

19.4%

6.5%

3.2%

0.0%

18

What does telemedicine mean to you?

Ability to assist patients from a remote location

Ability to diagnose and prescribe medication remotely

Ability of doctors to communicate remotely with patients

Enabling mobility of doctors to move within hospital premises

Other (please specify)

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

38.7%

29.0%

16.1%

6.5%

9.7%

19

What is most critical to your success of your medical device designs in the future?

Continuing to out-innovate our compe-tition

Transitioning to products tailored for the mobile health (mHealth) era

Improving quality

Lowering product cost to compete globally

Lowering development costs to compete globally

Reducing our time to market

Other (please specify)

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

41.90%

3.20%

9.70%

19.40%

9.70%

12.90%

4.50%

20

We use the following operating systems in our medical devices (select all that apply)

Windows

Other (please specify)

Linux

Android

VxWorks

0% 10% 20% 30% 40% 50% 60% 70%

59.3%

37.0%

25.9%

25.9%

7.4%

21

Percent of our medical devices that will ship with a mobile operating system

today

in 12 months

in 24 months

in 36 months

0% 5% 10% 15% 20% 25% 30% 35%

10.9%

18.3%

23.8%

29.5%

3X

22

What processor platform is your company currently working on?

Intel Processor Core

Other (please specify)

ARM Core

TI Processor Core

Qualcomm Processor Core

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

40.7%

33.3%

25.9%

0.0%

0.0%

23

Percent of our medical devices that will ship with a general purpose mobile processor

today

in 12 months

in 24 months

in 36 months

0% 5% 10% 15% 20% 25% 30% 35%

13.10%

21.70%

26.20%

31.10%

2X

24

Percent of our medical devices that will be wearable

today

in 12 months

in 24 months

in 36 months

0% 2% 4% 6% 8% 10% 12% 14% 16%

6.10%

7.40%

10.70%

13.50%

2X

25

What part of your medical device's design makes it stand out most?

Both Hardware Design and Software Design

Hardware Design

Software Design

Other

0% 10% 20% 30% 40% 50% 60% 70%

61.50%

15.40%

11.50%

11.50%

26

Which set of technical skills and experience are most important to the success of your medical devices?

System Design

Other

Application Software Engineering

Test Engineering

OS Software Engineering

Firmware Design

Chip Design

0% 5% 10% 15% 20% 25% 30% 35% 40%

34.6%

19.2%

15.4%

15.4%

7.7%

7.7%

0.0%

27

Engineers with this technical skill and experience are most highly compensated

System Design

Application Software Engineering

Firmware Design

OS Software Engineering

Other

Chip Design

Test Engineering

0% 10% 20% 30% 40% 50% 60% 70%

65.40%

26.90%

19.20%

11.50%

11.50%

3.80%

0.00%

28

I want to receive the results of this and future medical device developer surveys?

YES

NO

0% 10% 20% 30% 40% 50% 60% 70% 80%

76.00%

24.00%

About the Authors

29

Shane Walsh, IT Brand PulseA graduate of California State University, San Marcos, Shane Walsh is an analyst who conducts technology research and authors industry analysis for IT Brand Pulse.

Renjith Ponnappan, eInfochipsA product manager responsible for medical device development, Renjith has a Bachelor of Engineering in Electronics & Communication from R. V. College of Engineering, Bangalore, an M.S. in Digital Signal and Image Processing from Ramaiah School of Advanced Studies, and a Master of Science (MSc) in Business Administration and Management from Essec Business School Paris.