The Designer Pulse survey conducted in January 2014 collected insights from 35 experienced medical device design professionals regarding their design goals, challenges, and expertise. Key findings revealed that reliability and efficiency are top design goals, with regulatory compliance as the biggest challenge faced in development. The survey also noted significant expected growth in mobile and wearable medical devices over the next few years.

1. Designer Pulse
Medical Device Developers Survey
January, 2014
Sponsored by eInfochips

2. Designer Pulse
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.
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3. IT Pro Survey Methodology
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The IT Pro Survey was conducted in January, 2014.
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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:
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Participant Profile
Medical Device Design
Development Platforms
Critical Engineering Expertise
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4. Selected Organizations Represented
MicroPort Orthopedics Inc.
3M
Invacare Corp.
St. Jude Medical
IDEXX Laboratories
CR Bard
MPE Inc.
Hill-Rom
B. Braun Medical Inc.
Hologic Inc.
Zimmer
Terumo Cardiovascular Group
Baxter Healthcare
Eli Lilly
Toshiba Medical
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5. Highlights
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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 outinnovating, 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%).
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6. Summary Analysis
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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.
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7. Your title or job description is best described as:
40%
Engineering Manager
31%
Other (please specify)
23%
Engineering Director
Hardware Engineer
3%
Packaging Engineer
3%
Engineering VP/CTO
0%
Test Engineer
0%
ASIC Engineer
0%
Firmware Engineer
0%
oftware Engineer
0%
0%
20%
40%
60%
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8. Which of the following segments does your company
produce medical devices in? (select all that apply)
Telemedicine
Lab Instruments
Other (please specify)
11.4%
14.3%
20.0%
Surgical Instrument
28.6%
Monitoring
28.6%
34.3%
Homecare
37.1%
Implantables/Infusion System
40.9%
Diagnostics
0%
20%
40%
60%
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9. In which segment of Medical devices do you
have expertise in? (select all that apply)
Telemedicine
8.6%
Lab Instruments
20.0%
Homecare
20.0%
urgical Instrument
20.0%
22.9%
Other (please specify)
25.7%
Monitoring
34.3%
Diagnostics
42.9%
Implantables/Infusion System
0%
20%
40%
60%
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10. The medical devices manufactured by your company
are used in the following medical specialties (select all
the apply)
Toxicology
Other (please specify)
Neurology
Microbiology
Ophthalmic
Chemistry
Physical Medicine
Pathology
Immunology
Dental
Obstetrical and Gynecological
Hematology
Gastroenterology and Urology
Ear, Nose, and Throat
Anesthesiology
5.7%
8.6%
8.6%
8.6%
11.4%
11.4%
14.3%
14.3%
14.3%
14.3%
17.1%
17.1%
17.1%
17.1%
20.0%
25.7%
General and Plastic Surgery
31.4%
34.3%
34.3%
Radiology
Orthopedic
Cardiovascular
51.4%
General Hospital
0%
20%
40%
60%
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11. How many years of experience do you have developing
Medical Devices?
more than 40
0.0%
30 to 40
2.9%
20.0%
20 to 30
37.1%
10 to 20
22.9%
5 to 10
14.3%
1 to 5
Less than 1
0%
2.9%
10%
20%
30%
40%
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12. What is the most important design goal for the medical
devices you work on?
Cost
0.0%
Other (please specify)
Time to market
Inventing a feature that did not
exist before
3.2%
6.5%
12.9%
25.8%
Leading edge feature set
51.6%
Reliability
0%
20%
40%
60%
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13. What is the most important design goal for the medical
devices you work on?
Other (please specify)
3.2%
Save time for the doctor and/or
patient
3.2%
Easing anxiety/stress encountered
by patients
9.7%
19.4%
Ease the effort of the doctor patient
29.0%
Provide reliable services
Improving efficiency of the doctor
and/or hospital staff members
0%
35.5%
10%
20%
30%
40%
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14. Product engineering at my company will expand in the following
medical device market segments (select all that apply)?
Other (please specify)
6.5%
Lab Instruments
19.4%
Telemedicine
19.4%
22.6%
mHealth mobile applications
Implantables/Infusion System
25.8%
Surgical Instrument
25.8%
Monitoring
29.0%
Wearable devices
29.0%
32.3%
Diagnostics
38.7%
Homecare
0%
10%
20%
30%
40%
50%
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15. Our biggest challenge in completing development of
new medical devices is?
High Quality Marketing Requirements
0.0%
Production Test Automation
0.0%
Well defined Architecture
3.2%
UI Development
3.2%
Hardware Design
3.2%
Other (please specify)
6.5%
Software Based Control
6.5%
Software Development
9.7%
12.9%
Design Verification Test Development
19.4%
Replicating all use case scenarios
35.5%
Regulatory Compliance
0%
10%
20%
30%
40%
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16. By which year will your company derive revenue from
some type of wearable medical device?
16.1%
Other (please specify)
35.5%
Never
2018
2017
3.2%
6.5%
9.7%
2016
2015
3.2%
2014
3.2%
We already get revenue from wearable
devices
0%
22.6%
10%
20%
30%
40%
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17. How important is medical device security for you?
Other (please specify)
0.0%
Not Important at all
Not very Important
3.2%
6.5%
19.4%
Critically important
25.8%
Important
45.2%
Very important
0%
10%
20%
30%
40%
50%
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18. What does telemedicine mean to you?
Other (please specify)
Enabling mobility of doctors to
move within hospital premises
9.7%
6.5%
Ability of doctors to communicate
remotely with patients
16.1%
Ability to diagnose and prescribe
medication remotely
29.0%
Ability to assist patients from a
remote location
0%
38.7%
10%
20%
30%
40%
50%
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19. What is most critical to your success of your medical
device designs in the future?
Other (please specify)
4.50%
12.90%
Reducing our time to market
Lowering development costs to
compete globally
9.70%
Lowering product cost to compete
globally
19.40%
9.70%
Improving quality
Transitioning to products tailored
for the mobile health (mHealth) era
3.20%
Continuing to out-innovate our
competition
0%
41.90%
10%
20%
30%
40%
50%
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20. We use the following operating systems in our medical
devices (select all that apply)
VxWorks
7.4%
Android
25.9%
Linux
25.9%
37.0%
Other (please specify)
59.3%
Windows
0%
20%
40%
60%
80%
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21. Percent of our medical devices that will ship with a
mobile operating system
29.5%
in 36 months
23.8%
in 24 months
3X
18.3%
in 12 months
today
0%
10.9%
10%
20%
30%
40%
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22. What processor platform is your company currently
working on?
Qualcomm Processor Core
0.0%
TI Processor Core
0.0%
25.9%
ARM Core
33.3%
Other (please specify)
40.7%
Intel Processor Core
0%
10%
20%
30%
40%
50%
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23. Percent of our medical devices that will ship with a
general purpose mobile processor
31.10%
in 36 months
26.20%
in 24 months
2X
21.70%
in 12 months
13%
today
0%
10%
20%
30%
40%
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24. Percent of our medical devices that will be wearable
13.50%
in 36 months
10.70%
in 24 months
2X
7.40%
in 12 months
6.10%
today
0%
5%
10%
15%
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25. What part of your medical device's design makes it
stand out most?
Other
11.50%
Software Design
11.50%
Hardware Design
15.40%
Both Hardware Design and
Software Design
0%
61.50%
20%
40%
60%
80%
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26. Which set of technical skills and experience are most
important to the success of your medical devices?
Chip Design
0.0%
Firmware Design
7.7%
OS Software Engineering
7.7%
Test Engineering
15.4%
Application Software Engineering
15.4%
19.2%
Other
34.6%
System Design
0%
10%
20%
30%
40%
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27. Engineers with this technical skill and experience are
most highly compensated
Test Engineering
0.00%
Chip Design
3.80%
Other
11.50%
OS Software Engineering
11.50%
Firmware Design
19.20%
26.90%
Application Software Engineering
65.40%
System Design
0%
20%
40%
60%
80%
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28. I want to receive the results of this and future medical
device developer surveys?
24.00%
NO
76.00%
YES
0%
20%
40%
60%
80%
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29. About the Authors
Shane Walsh, IT Brand Pulse
A 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, eInfochips
A 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.
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