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Medical Device Design: Follow These Rules and Profit Embedded World Highlights Technology Focus: New USB 3.1 Continues to Change the World Real World Connected Systems Magazine. Produced by Intelligent Systems Source

Vol 17 / No 3 / March 2016

Innovative Medical Devices Perform Miracles An RTC Group Publication

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CONTENTS

Real World Connected Systems Magazine. Produced by Intelligent Systems Source

MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT 14

2.0: Medical Device Design: Follow these rules and profit! by John Koon, Editor-in-Chief

2.1: How to Beat the Odds of a Software-Related Medical Device Recall Jim McElroy, LDRA

by David Hirning, Lisa Gunther-LaVergne, and Virginia Lang

Medical Device Market Trends

22 26

EDITORIAL

Innovative Medical Devices continue to change our world

MARKET MATRIX

2.4: Engineered Success: The Engineer’s Contributions to FDA Medical Device Market Commercialization by Russ King, MethodSense, Inc.

Embedded Market Industry Leaders & Financial Market

2.5: Building Security Features Into Today’s Medical Wearable Devices by Andrew Caples, Mentor Graphics Corporation

SPECIAL REPORT ON MEDICAL DEVICES

2.6: Intellectual Property Can Make or Break the Best Ideas by Jarom Kesler and Irfan Lateef of Knobbe Martens

1.0: Medical Device Market Trends

1.1: Camera…Ready…Action! New 4K Ultra High Definition (UHD) Display to show bright colors in Operation Rooms.

by John Koon, Editor-in-Chief

EMBEDDED WORLD HIGHLIGHTS 38

by John Koon, Editor-in-Chief

2.3: Consensus standards – A Driving Force in the Delivery of Healthcare Technology by Charles Sidebottom, PPO Standards LLC

DEPARTMENTS 05

2.2: Human Factors and Medical Device Development

1.2: Biotechnology Innovation: Robotic Exoskeleton Systems Transforms Mobility for the Spinal Cord Injured by ReWalk Robotics

3.0: Product Highlights from the Show. by John Koon, Editor-in-Chief

TECHNOLOGY FOCUS: THE NEW USB 3.1 WILL CHANGE THE WORLD AGAIN 40

4.0: USB 3.1 continues to change the world of computing. by John Koon, Editor-in-Chief

4.1: New USB Connector Hits Homerun

4.2: Embedded Vision: Convergence of Stackable I/O, USB3.0 and ARM Processors

by Benoit Foret, STMicroelectronics

by Susan Wooley, Micro/sys, Inc.

RTC Magazine MARCH 2016 | 3

RTC MAGAZINE

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Vice President Aaron Foellmi, aaronf@rtcgroup.com

EDITORIAL

Eastern U.S. and EMEA Sales Manager Ruby Brower, rubyb@rtcgroup.com (949) 226-2004

Editor-In-Chief John Koon, johnk@rtcgroup.com

BILLING

ART/PRODUCTION

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TO CONTACT RTC MAGAZINE: Home Office The RTC Group, 905 Calle Amanecer, Suite 150, San Clemente, CA 92673 Phone: (949) 226-2000 Fax: (949) 226-2050 Web: www.rtcgroup.com

Published by The RTC Group Copyright 2016, The RTC Group. Printed in the United States. All rights reserved. All related graphics are trademarks of The RTC Group. All other brand and product names are the property of their holders.

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4 | RTC Magazine MARCH 2016

EDITORIAL

Innovative Medical Devices Continue to Change Our World by John Koon, Editor-In-Chief

Medical devices can sometimes perform miracles. An exoskeleton product code name Indego enables people who have been confined to a wheelchair to actually stand up and walk again. Having received FDA clearance in March, Parker Hannifin, maker of Indego, will be able to market the product in the USA for the first time for clinical and personal use.

innovative devices will be covered in the medical device Section 1 along with six experts sharing their experiences to help developers get their products to market faster in Section 2.

Highlights from Embedded World

I attended Embedded World 2016. Companies representing software, hardware, silicon, systems and consulting came from different parts of the world all gathered here to network and conduct business. I have to admit, meeting companies here was a pleasure as they served the best coffee. Due to the number of companies present, it would be impossible to meet with everyone. So I selected the most important ones to be included in section 3. There was one highlight on the show floor. An intelligent toy dinosaur got a lot of attention. Anaren used the moving, walking, noise-making Dino to show off their software and hardware development tools for creating functionality and remote control. Anaren’s Atmosphere software lets the user drag and drop codes that correspond with Anaren’s physical development board (in the toy), making it easy to change the movement of Dino on the

fly. With Anaren’s all-in-one product, developers don’t need to know every aspect of programming, hardware design, or the user interface in order to easily start and finish a project. This means potential savings for project development. I can’t wait to get a development kit to play with and see how easy it really is. Fig 2

How USB 3.1 changes your world again

USB speed has increased from 12 Mps in the early days to 5 Gps. Now it is about to double to 10 Gps with the introduction of USB 3.1 specification. Not only are the new connectors bidirectional, meaning you don’t have to flip the connector to make sure it is right-side-up before inserting into the socket, the new power specification would enable charging of a laptop much like what you do now with an iPhone. No more carrying a heavy AC adapter around. Good news indeed. In this issue, our Technology Focus section there will be articles discussing the new USB Type-C connectors, datapath design, stackable USB and more.

Figure 1 Weighs only 26 lbs., Indego can be worn by an individual who have been confined to the wheelchair to walk. Nothing short of a miracle!

Weighs only 26 lbs., Indego can be worn by an individual who wish to get out of the wheelchair to take a walk with just five sessions. “I have been training many individuals to walk again with the help of Indego and it just never ceases to amaze me to see the look on their faces after they take the first step,” commented Clare Hartigan, project manager for Shepherd. Hartigan has worked with Parker Hannifin from the beginning to the product receiving FDA clearance. To outfit an individual, it would cost approximately $80,000. Currently the Veteran Administration would pay for the solution if the applicant is approved. Private insurance at this point will not cover paying for the device. Other

Figure 2 Anaren’s Atmosphere software lets the user drag and drop codes that correspond with Anaren’s physical development board (in the toy), making it easy to change the movement of Dino on the fly.

RTC Magazine MARCH 2016 | 5

THE

MARKET MATRIX Event Season Signals Technology Shifts by Aaron Foellmi, The RTC Group

Its show season! As a publisher there is no more exciting time of the year than the spring event season. CES, Mobility World Congress, Embedded World, GTC and dozens more all bring excitement, new innovation and the promise of new market opportunities. For those not in the marketing trenches I can witness to the millions of man-ours that are devoted to taking great technology – and making sure it gets noticed. “THE SKY ISN’T FALLING, BUT THERE ARE SIGNS IT COULD BE QUITE A STORM.” Over the years I have seen the incredible results of impromptu show-floor and highly orchestrated back-room meetings in driving the economy of today’s advanced and industrial computing solutions. One of the keys to participating is the benefit of direct and tangible interactions with the market. As I walk the exhibition floor I pay special attention to which companies are getting asked to dance by excited and exuberant attendees and who’s still standing on the gym wall hoping someone will notice. With event season only about half over I have to say that so far I am a little concerned with the state of our market. The sky isn’t falling, but there are signs it could be quite a storm. RTC is no stranger to the comes-and-goes of technology fads. (Futurebus anyone?) We’ve covered all of the “killer” technologies and quite a few duds over the past 25 years, but 2016 appears to be a year of marginal and only incremental innovation – made shiny with a lot of redefinition. Whether this stagnation is being caused or only amplified by a trend of consolidation is still hard to say. But here are a few trends I’m seeing as I walk the floors and sit in dark rooms listening to CEO’s give their best vision pitch. 1) Software companies are transitioning to service companies. Microsoft has galvanized this new services philosophy into their updated mission statement, and Microsoft CEO Satya Nadella continues to emphasize the new direction at every opportunity. In a presentation at Embedded World Microsoft offered the benefits of Windows 10 IoT. The change in strategy was evident. Over the past few years Microsoft has navigated a slow transition from software tuned for specific verticals (remember Windows POSready?) to an OS that is custom built for integration into their larger service, analytic and cloud infrastructure. It’s not just Microsoft either. As

6 | RTC Magazine MARCH 2016

we’ll highlight in our May issue many traditional embedded OS and RTOS vendors are realizing that the world of IoT means that they have to interconnect, communicate and play with each other in a way that ten years ago would have been taboo. Watch 2016 be the year software companies become service companies. 2) The chip market is going to continue to consolidate as the need for custom and specialized chip design yields less final product differentiation. In broad terms IoT is pushing chip design to the edges. There is increased interest at one end, designs that focus on low-power small footprint designs fueling the edge-devices of the Internet of Things. ARM and its partners continue to dominate in this area. On the other end are energy hungry, dense high-performance computing (HPC) designs fueling the cloud and the advanced math required to make IoT intelligent. NVIDIA and AMD appear to be seated well to capitalize on this trend. Those in the middle are going to begin feeling the squeeze from the edges of the IoT market as low-power or intelligence based designs fuel final product adoption. 3) Standard SBCs will have to re-invent themselves in the new connected technology market. With the majority of interest coming at the small low-power or intelligent high-power ends of the spectrum, SBC vendors are going to have to find new ways to help clients differentiate their technology. Larger integrators, looking to fill the roll largely left to smaller custom SBC vendors, are beginning to fill in the custom design gap with extensive catalogs of off-the-shelf solutions. In one conversation with a large integrator I was told there is really no reason to design your own boxed or gateway device. With the integrator’s scale, access to partners and technical expertise an off-the-shelf solution for most middle range devices will be be far more economical for system developers. For custom SBC vendors this is not the time to sit on your laurels – the wolf may indeed be at the door. “THOSE IN THE MIDDLE ARE GOING TO BEGIN FEELING THE SQUEEZE FROM THE EDGES OF THE IOT MARKET AS LOW-POWER OR INTELLIGENCE BASED DESIGNS FUEL FINAL PRODUCT ADOPTION” Amid the chaos of event hype and hyperbole there were indeed a few stand-out innovations worth mentioning.

THE MARKET MATRIX

Embedded Market Industry Leaders & Financial Market

Deep Learning – I as given my first exposure – a push by folks like NIVIDIA – to drive real intelligence in today’s real world computing solutions. Although this technology is relatively fringe, first blush shows an enormous amount of potential for deep neural networks and the utilization of GPUs for a wide range of applications requiring network intelligence. Look for RTC to cover this in more depth later this year. LoRaWAN™ - One of the technical hurdles of empowering the Internet of Things is providing connectivity for the billions of proposed sensors and low-power devices at the end of the IoT. LoRaWAN™ supported by the LoRa Alliance provides an open specification for creating wide area networks supporting distances measured in kilometers rather than meters, and power requirements that support small battery operated sensors lasting years. It

is an interesting new technology filling an important void in the market today. Around RTC we always talk about the power of “creative-destruction”. My sense from the events our team has attended this year is most companies are either preparing for or are already in the midst of retooling for a seismic shift in our market. What Do You Think? Are We In The Midst Of A “Tipping Point” Moment In Our Market? Aaron Foellmi aaronf@rtcgroup.com

RTC EMBEDDED INDEX: 99.72 up +10.05 from January (as of March 14, 2016) Name

Symbol

Last Price

Currency

Currency/$ Last price $

Mkt Cap

52Wk High 52Wk Low

Eps

P/e 25.12

Adlink Technology Inc

6166

78.3

TWD

0.0306026

2.40

16.97B

123.5

65.4

NT$3.12

Advanced Micro Devices

AMD

2.7

USD

2.70

2.38B

3.06

1.61

-0.84

Advantech Co., Ltd

2395

235

TWD

0.0306026

7.19

148.20B

278

188

NT$8.06

29.16

Arm Holdings PLC

ARM

994.66

GBP

1.43019

1,422.55

14.01B

1332.5

811.5

£0.24

41.55

Arrow Electronics, Inc

ARW

61.18

USD

61.18

5.69B

64.98

45.23

5.21

11.74

Avnet, Inc

AVT

42.99

USD

42.99

5.78B

47.27

36.415

4.15

10.36

Concurrent Technologies

CNC

62.08

GBP

1.43019

88.79

45.03M

£0.04

16.41

Curtiss-Wright Corp.

70.73

USD

70.73

3.16B

77.57

4.06

17.44

Enea AB

ENEA

SEK

0.11975

11.02

1.51B

106.25

66.5

SEK5.22

17.61

Eurotech SPA

ETH

1.39

EUR

1.10852

1.54

49.26M

2.28

1.08

-€ 0.29

Imagination Tech. Group

IMG

165.35

GBP

1.43019

236.48

454.65M

266.25

101

-£0.09

Infineon Technologies AG

IFX

11.98

EUR

1.10852

13.28

13.55B

14.195

8.318

€ 0.57

21.01

Intel Corporation

INTC

31.5

USD

31.50

151.26B

35.59

24.87

2.34

13.49

Kontron AG

KBC

3.78

EUR

1.10852

4.19

210.20M

6.36

2.449

-€ 0.20

Mercury Systems Inc

MRCY

USD

17.00

609.16M

19.99

13.37

0.53

32.22

Microsemi Corporation

MSCC

34.77

USD

34.77

3.99B

39.56

28.24

0.92

37.71

Microsoft Corporation

MSFT

53.12

USD

53.12

428.90B

56.85

39.72

1.4

37.87

Nvidia Corporation

NVDA

32.08

USD

32.08

17.56B

33.94

19.09

1.07

30.08

Nxp Semiconductors NV

NXPI

78.54

USD

78.54

27.48B

114

61.61

5.84

13.44

Oracle Corporation

ORCL

38.69

USD

38.69

166.48B

45.24

33.13

2.08

18.63

Radisys Corporation

RSYS

3.6

USD

3.60

134.84M

3.62

1.93

-0.4

Super Micro Computer

SMCI

32.53

USD

32.53

1.58B

37.99

21.25

1.89

17.18

TE Connectivity Ltd

TEL

59.36

USD

59.36

22.21B

73.73

51.7

2.78

21.32

Xilinx, Inc

XLNX

46.99

USD

46.99

12.10B

50.72

38.7

2.03

23.15

RTC Magazine MARCH 2016 | 7

1.0 SPECIAL REPORT ON MEDICAL DEVICES

Special Report on Medical Devices by John Koon, Editor-In-Chief

In this issue of RTC Magazine, our special report will cover medical device market trends, break-through innovations and how to win in this space. Medical Device Market Trends

The overall healthcare market is changing in many ways. The healthcare market will rise from $3 trillion this year to $4.7 trillion 2024, the real per capita health expenditure growth rate will decrease from 4% to 1.5% according to BMI Research (www. bmiresearch.com), a market research firm covering medical devices. (Figure 1). In other words projected overall medical devices purchase will decrease. To compensate for the revenue short fall, medical device firms will diversify. This can be in the form of mergers and acquisitions. We have already seen changes taking place. In March 2016, the struggling Toshiba sold its Toshiba Medical Unit to Canon for $6.11 billion. Given Imaging, inventor of the swallowable camera was acquired by Covidien early 2014 for $860 million. (Not bad for an exit strategy. ) Medtronic later acquired the Ireland-based Covidien for $42.9 billion while Becton Dickinson acquired the San Diego based CareFusion for growth reason. This trend is expected to increase over the next few years. Another trend we expect to see is more and more innovative products and solutions coming from startups and smaller firms. Separately, wearable devices are gaining

momentum in the healthcare industry for process simplification such as clinical workflow and data analysis. According to Global Industry Analysts, Inc. (www.strategyr.com), a market research firm, the wearable devices market is expected to double from $2 billion in 2015 to $4.6 billion in 2020 worldwide with USA represents almost half of the market.

Break-Through Innovations Sotera Sets Future Trend Of Patient Monitoring Those who have stayed in the hospital overnight often complain it is difficult to get a good night sleep being woken up constantly for temperature and other types of diagnostic measurement. But there is good news. Sotera has introduced a wireless, wearable ViSi MobileÂŽ System (Figure 2) which can continuously monitor patientsâ&#x20AC;&#x2122; vital signs (ECG, HR/PR, SpO2, Blood Pressure, Respiration and Skin Temperature). This wireless monitoring device attached to the patient, continually transmits data to the nearby Wi-Fi / 802.11 access points while the patient sleeps uninterrupted throughout the night. Patients reported that they were much more comfortable with better

Figure 1 While healthcare market will rise from $3 trillion this year to $4.7 trillion in 2024 (blue bars), the projected overall medical devices purchase will decrease from 4% to 1.5% (red line) as projected by BMI. (Sources: World Health Organization (WHO), BMI. e = BMI Research estimate, f = BMI Research forecast

8 | RTC Magazine MARCH 2016

sure readings in 5 to 15 minutes depends on the complexity of the case. Then the doctor and patient can view, if any, the shape, size, hardness and location of the suspicious masses based on the pressure readings which can also be read over the cloud. This FDA cleared class II medical device has gone through more than 1,000 patient clinical studies and the 2014 San Antonio Breast Cancer Conference (SABCS) has concluded that the SureTouch approach is more sensitive than the conventional breast examination (CBE) in identifying potential breast cancer. Recently, the unit received a new category III CPT reimbursement code title “0422T-tactile Breast Imaging by Computer-aided Tactile Sensors, unilateral or bilateral”. With this device, there is less hassle for patients to go through breast examinations. Figure 2 FDA cleared ViSi Mobile Surveillance Monitoring System worn by patients can continuously monitor patients’ vital signs (ECG, HR/PR, SpO2, Blood Pressure, Respiration and Skin Temperature).

rest during the hospital stay. Additionally, the company is said to be working on a new method of measuring blood pressure. This non-invasive, cuffless (cNIBP) approach can measure blood pressure on a beat-to-beat basis with equal accuracy to the traditional approach. Pressure profile revolutionizes breast cancer detection To provide early detection of breast cancer, Medical Tactile, maker of the SureTouch system (Figure 3) has revolutionized the industry with a painless, radiation free approach with instant digital results. The traditional approach has limitation. More than 50% of cancers develop in the upper outer quadrant of the breast and can be difficult to detect with the imaging modalities. This new non-invasive examination involves applying the device with gentle pressure on an area of the breast to obtain the pres-

Figure 3 To provide early detection of breast cancer, Medical Tactile, maker of SureTouch system has revolutionized the industry with a painless, radiation free approach giving instant digital results.

Figure 4 Olympus’ Endocapsule 10 system, shaped like a vitamin pill, houses a very small, embedded camera and a battery to take photos as it travels through the patient’s gastrointestinal (GI) path.

Need a colonoscopy examination? Swallow a pill Thousands of Americans need examinations of disorders such as chronic constipation or diarrhea, bleeding, infections, cancers, ulcers, obstructions, celiac and Crohn’s disease. But most of us dread going to the doctor for a gastrointestinal (GI) checkup. We are afraid of the unknown, discomfort, the hospital environment and everything that goes with it. This may change. Olympus’ Endocapsule 10 system, shaped like a pill, houses a very small camera and a battery will do the job. (Figure 4). Here is how it works. As the patient swallows a vitamin-sized capsule the embedded camera moves through the gastrointestinal (GI) path, taking photos and transmits the images to a portable data recorder worn by the patient. When the recorder is returned to the hospital and the clinician can download the information for analysis. In a few days, the disposable capsule will be expelled from the body of the patient painlessly. Similar products are also offered by Given Imaging (now owned by Medtronic).

RTC Magazine MARCH 2016 | 9

1.1 SPECIAL REPORT ON MEDICAL DEVICES

Camera…Ready…Action! New 4K Ultra High Definition (UHD) Display to show bright colors in Operation Rooms. During the SAGES 2016 conference held in Boston, Olympus announced an impressive 4K UHD display to give surgeons a spectacular view of the tissue images of patients under surgery in brilliant colors. The Olympus’ VISERA 4K UHD Imaging System is a complete integrated image chain solution delivering images never seen before by surgeons. (Figure 1) by John Koon, Editor-In-Chief

Figure 1 Olympus’ VISERA full 4K (4096x2160) UHD display gives surgeons tissue images of patients under surgery in brilliant colors enables surgeon make better decision with increased accuracy.

10 | RTC Magazine MARCH 2016

WHY CHOOSE NOVASOM? In April of 2013 Sony Corporation and Olympus Corporation came together to form Sony Olympus Medical Solutions, a joint venture, to focus on medical and imaging solutions to help improve the endoscopy surgery procedure. The systems had been field tested and sold in Europe and Asia prior to the announcement in the USA. What is the difference between the standard high definition (1080 HD) and the 4K UHD system? Surgeons have been using the standard HD imaging system with 31 inch displays for years. The 4K UHD technology with 4 times the resolution of HD enables 55-inch displays to be used without getting a blurry image. We all enjoy our new mobile phones with built-in 8 megapixel cameras which are able to capture images so much sharper. Remember the time you tried to enlarge a photo taken with an old camera with lower resolution and got the disappointing blurry images? That is the difference between high and low resolution photos. The concept is similar. The standard HD is like the old camera and 4K UHD is like the new camera and more. It is capable of delivering a screen resolution twice in width and height, resulting in an image 4 times larger. The new minimally invasive procedure requires surgeons to cut a few holes on the patient’s body and with the help of small camera and small surgical tools to perform the procedure. But inside the body it is total darkness and operating surgeons rely on cameras to deliver video images on the screen to perform the surgery. They desire maximum amount of light and best color to determine if a patient’s bleeding is normal or excessively which can be fatal. To accomplish this, the VISERA 4K requires other components in the system to achieve optimal results. Olympus refers to this as an image chain which includes a light source, a telescope with built-in camera optimized to deliver high-resolution imaging and a camera control unit with special algorithm to process and project the digital signals to the display. Figure 2. Working together, the full 4K (4096x2160) resolution image chain is able to provide more pixel, better color and zoom capability for better visualization. The camera uses CMOS technology and optical transmission to deliver video images in almost real-time. “The sharper images and color enable me to make better decisions during surgery,” commented Dr. Ninh Nguyen, professor and interim chair, department of surgery at University of California, Irvine Medical Center. Note 1. No doubt, once a surgeon has tried the UHD system, it would be difficult to go back to using the standard 31 inch HD display.

Note 1: Dr. Ninh Nguyen is a paid consultant of Olympus

NOVAsom Industries provides the added value of design creativity, offering tailormade solutions to both industrial and multimedia markets. We specialize in proposing innovative options to improve productivity, time to market, and reach a truly competitive advantage. In addition to the embedded computing industry, NOVAsom is involved in the newest high level video technologies, including 4K displays. The 2 key differences that make us stand out are our 32/64 bit full architecture and the ability to provide interface to ANY display/sensor combination.

single board computer

smart delivery

full development kit

NOVAsom8© is a module card designed with a System On Module (SOM) architecture full development kit full development kit based on quad core ARM Cortex-A9 from 512MB to 4GB of 64 bit DDR3 Memory.

• Processor CortexA9 Freescale • IMX6 Quad Core full development kit • 4GB RAM Memory • 32GB FLASH Memory (eMMC) • USD memory slot • SATA II • Ethernet 10/100/1000 • USB host/device and OTG • HDMI (High-Definition Multimedia Interface)

Figure 2 The 4K UHD Imaging System is a complete integrated image chain solution which includes a light source, a telescope with built-in camera optimized to deliver high-resolution imaging and a camera control unit with special algorithm to process and project the digital signals to the display

www.novasomindustries.com

single board computer

Z single board computer RTC Magazine MARCH 2016 | 11 single board computer

1.2 SPECIAL REPORT ON MEDICAL DEVICES

Biotechnology Innovation: Robotic Exoskeleton Systems Transforms Mobility for the Spinal Cord Injured ReWalk Robotics, a manufacturer and developer of exoskeleton devices, uses cutting-edge technology to help members of the spinal cord injury regain mobility. by ReWalk Robotics

For many individuals who suffer a spinal cord injury, the question is not when, but if, they will ever be able to again stand and walk independently. What has seemed like a pipe dream for many people with paralysis is now a reality, thanks to recent advances in biotechnology. ReWalk is the first exoskeleton manufacturer to receive FDA clearance for rehabilitation and personal settings. More than 400 people around the world are using ReWalk systems each day to stand and walk. Marcela Turnage (Figure 1) is one of our U.S.based ReWalkers. She utilizes her ReWalk Personal 6.0 system at home and throughout her community. Marcela suffered a spinal cord injury in a car accident in 2002. In 2014, Marcela was introduced to the ReWalk system while attending therapy at the University of Maryland Rehabilitation and Orthopedic Institute. “Walking with ReWalk a few hours a day has changed my life in a positive way, especially in improving my health,” said Turnage. “The most incredible part of walking with ReWalk is that as a user I have control of the device. Using the system has inspired me to take on other challenges that I never thought were possible.” How the ReWalk system works: The ReWalk exoskeleton provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk. The system provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The weight of the device is not felt by the user; instead, the device weight rests on the footplates inside the user’s shoes. The user will stand up and bear his/her own weight with the support of the exoskeleton. The exoskeleton allows independent, controlled walking while mimicking the natural gait patterns of the legs, using method patented tilt sensors to respond to the user when they lean slightly forward in preparation to stand up or take a step. This

12 | RTC Magazine MARCH 2016

control is simply natural movements that exist for balance. The device is operated through a wrist watch-styled controller. Each ReWalk system comes with a main battery and a back-up battery, which should be charged every night. A warning light on the wrist controller indicates when the batteries are running low on power. “I never thought walking again was a possibility for me. ReWalk has given me a new outlook on life. It has restored my hope and reminds me that life is full of possibilities,” said Turnage.

ReWalker Marcela Turnage uses her ReWalk exoskeleton to stand upright and walk on her own.

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RTC Magazine MARCH 2016 | 13

2.0 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

Medical Device Design: Follow These Rules and Profit! by John Koon, Editor-In-Chief

Before a medical device can be successfully launched there are many hurdles to overcome. First you have to come up with the right idea. Then you need to fulfill all the requirements dictated by FDA in order to get the clearance. Additionally, safety and security standards need to be followed to minimize recalls and product failures. With all these considerations, how to develop sound medical devices and at the same time protect your engineering and IP investments? Six experts will share their experiences to help you optimize your development process. 1. How to Beat the Odds of a Software-Related Medical Device Recall? 2. Human Factors and Medical Device Development 3. Consensus Standards – A Driving Force in the Delivery of Healthcare Technology

14 | RTC Magazine MARCH 2016

4. Engineered Success: The Engineer’s Contributions to FDA Medical Device Market Commercialization 5. Building Security Features Into Today’s Medical Wearable Devices 6. What Medical Device Companies Need to Know about Intellectual Property

2.1 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

How to Beat the Odds of a Software-Related Medical Device Recall Jim McElroy, VP of Marketing, LDRA

Between 2008 and 2012, the US Food and Drug Administration (FDA) reported that software design failures were the most common cause of medical device recall, averaging about 15 percent of all recalls. And while those odds might seem beatable, the risks are significant: according to a report from the McKinsey Center for Government, a single major recall can cost a company as much as $600M (USD) in lost sales and legal fees, and can have a significant impact on stock prices. In fact, between 2000 and 2010, an average of one major medical quality event per year resulted in a 13 percent stock drop across the industry. Of course, quality is only one of many pressures on medical device manufacturers. Devices are more complex, with increasing requirements for connectivity, mobility, and lower power—all at lower cost and faster time-to-market. And in today’s connected medical device world, security concerns add new pressures. Software gives device manufacturers the flexibility to adapt to new functional requirements and hardware platforms, but added software complexity increases risk. One way to mitigate that risk is the use of cost-effective software development tools for traceability, software quality analysis, and software verification, in addition to an overall risk-based approach to software development and verification. In fact, the McKinsey Center for Government states “experience from other industries has shown that early adopters of quality best practices hold an advantage over competitors, while late adopters may risk the

demise of the company because the competition is already too far ahead.”

“Of course, quality is only one of many pressures on medical device manufacturers” This continues to highlight the importance of building safety and security into medical devices from the ground up, using approved standards and best processes. IEC 60601-1 serves as the primary standard to achieve medical device safety and basic performance. Along with this standard, the internationally recognized IEC 62304 standard prescribes the software development processes, activities, and tasks for effective medical device software development. IEC 62304 specifically calls out that the manufacturer must apply a risk management process complying with ISO 14971. IEC 62304 compliance requires a comprehensive audit trail, from the objectives the 62304 standard, to functional and safety requirements, to design, development, and verification artifacts and activities. Fortunately, there are cost-effective, proven tools to achieve each of these activities and

Figure 1 TBmanager lets you view relationships between levels of requirement to quickly highlight impacts upstream and downstream. You can display procedure mappings to the low-level requirements to see the impact of code changes on parent requirements. Interactive charts display assignments in the system for an at-a-glance view of where the core work is being completed.

RTC Magazine MARCH 2016 | 15

2.1 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT still meet competitive and time-to-market demands.

far better software quality and standards compliance. (Figure 1)

Requirements Traceability

Static Analysis

Requirements traceability is a fundamental area for process improvement and automation. It addresses one of the primary causes of defects in the development of embedded software— the continuous flux in requirements introduced by changes in product scope. Many errors can be avoided if a requirements traceability matrix (RTM) is used as the driving force of the development process. The RTM bi-directionally tracks a requirement, its implementation, and verification through the project’s lifecycle. As a requirement is realized in design, implemented in code, and tested, it is linked through each stage’s artifacts to ensure its correct implementation. Automated traceability tools link the various artifacts and activities associated with the realization of the requirement. Artifact data may reside in several forms such as text, graphical models, code, and various forms of test data. Traceability tools should be able to bridge these different mediums to link artifacts from the full range of development activities. Without traceability tools, components from different phases must be manually identified and their data collated in a single environment. Effective traceability tools also offer reports such as upstream and downstream impact analysis and matrix generation that enable users to leverage traceability information to better understand the impacts of change. For the medical industry, many of the product defects occur with product updates and upgrades. With automated requirements traceability, it is much easier to identify which parts of the code need to be changed and which parts need to be retested and/or recertified. This speeds development while also ensuring

Static analysis, although not a panacea, is widely recognized by device manufacturers and the regulatory authorities as a

“For the medical industry, many of the product defects occur with product updates and upgrades.“ useful tool for identifying and solving a particular class of software problems. Static analysis checks the syntactic quality of high-level source code and can be used to predict run-time or dynamic behavior without having to execute code. For medical device software developers, static analysis can automate the code-review process by automating the analysis of source code and highlighting potential flaws. This enables inspection early and often, which can save tremendous time, energy, and money associated with the equivalent manual process. In addition, static analysis can be used to ensure that the development team adheres to either a specific industry standard such as MISRA C or MISRA C++ or a corporate standard for quality by quickly analyzing the code for discrepancies between the standard and

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the code as written. This improves consistency, reusability, and code quality. However, not all static analysis tools are alike. Many differ in their level of depth of analysis. Some of the lighter-weight tools are capable of quickly skimming large code bases for the “easy to find” problems, whereas others are more rigorous and perform in-depth analysis for more difficult boundary conditions. The recommendation here is to be careful of tool vendors who claim to use common commercial parsing technology. This likely causes the vendor to lose development control and constrains product advancement. If the parser is not sufficient, what choice do they have to move their overall technology forward to address developers’ specific needs?

Dynamic Analysis

Dynamic analysis uses compilation and execution to either perform analysis on the executable code, on the host platform in a simulated environment or down on the target platform when it is available. Dynamic analysis enables execution traces to be captured and presented back at the source code levels as well as at higher levels of abstraction, such as control and dataflow graphics where it is easy to understand the behavior of the application at a higher level. When combined with static analysis, dynamic analysis can be used for unit, integration, and system-level testing with execution tracing. Test harnesses, procedure/function stubs, and regression suites can be automatically generated and executed. Combined with the trace history, it is very easy to understand the effectiveness of the generated test cases. With strong static and dynamic analysis, it is possible to analyze the code and automatically generate and execute a high-quality test environment that produces comprehensive code coverage analysis. This ultimately reduces risk associated with the use of the medical device itself. (Figure 2)

Assurance Case Development

To gain regulatory approval, medical device manufacturers must document their quality process and the resulting development and verification artifacts to help support the argument that their device is safe and effective. This is particularly true in areas under scrutiny, such as the infusion pump industry. Regulatory authorities such as the FDA are encouraging manufacturers to develop and produce an assurance case—or, more specifically, a safety case—which presents a defensible argument that a device is acceptably safe to use in a particular context. The safety case presents the argument, any assumptions, and the development and verification artifacts as evidence to support and defend the argument. Integrated requirements engineering and static and dynamic analysis capability—combined with automatic and traceable documentation—supports safety case development. It also mitigates risk with the ability to clearly state the objectives of the safety case, document the evidence where the objectives have been met, support the argument linking the evidence to the objectives, and document any assumptions, justifications, and the context. Furthermore, this integrated solution, as part of the argument for the safety case, enables the documentation of the identified hazards and the tracing of those hazards into the engineering control measures to show how the risks have been mitigated.

Beat the Odds

For many medical device applications such as patient monitors, defibrillators, infusion devices, and health hubs, rigorous development approaches help assure the manufacturer, the customer, and the end consumer that the device is safe and effective for use. Device manufacturers who employ proven software development quality standards and tools have a significant advantage in terms of beating the odds of a software-related defect.

Figure 2 The system call graph shown here illustrates calls between the system components and is overlaid with programming standards, metrics and coverage results.

RTC Magazine MARCH 2016 | 17

2.2 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

Figure 1 “Stacking the deck” in your favor: Human Factors and the FDA.

Human Factors and Medical Device Development “Stack the Deck” in your favor by integrating human factors early and throughout your product development lifecycle. Human factors can truly be a win-win for manufacturers, engineers, and consumers. by David Hirning, MS, Lisa Gunther-LaVergne, PhD, and Virginia Lang, PhD Medical Device Human Factors by HirLan, part of the HirLan Institute of Human Factors

Whether at the blackjack table or in the marketplace, it is preferable to have the deck stacked in your favor. Figure 1. Wouldn’t you rather play blackjack knowing you have a strong probability of winning?! The same is true with developing new products, and going to the FDA for final approval. With development and production costs continuously escalating and profit margins shrinking, anything that can be done to minimize development costs and maximize market preference will improve product profitability. When the FDA started requiring human factors/usability testing of medical devices, they were actually stacking the deck in favor of medical device manufacturers. Human factors/usability testing is a win-win for medical device manufacturers.

Human Factors and the FDA

Human factors engineering is grounded in scientific research methodology, statistics, human physiology, and cognitive information processing. It is the intersection of engineering, human phys18 | RTC Magazine MARCH 2016

iology, behavioral performance, and cognitive science. Human factors professionals use this foundational scientific knowledge to explain how humans interact with devices, products, and/or systems. Human factors engineers approach both hardware and software design with the USER as the focal point. Doing so assures devices, products and systems are Safe, Effective, and Usable by their intended users. The FDA requires medical device manufacturers to create a user-based risk analysis for products and related software. By creating the Human Factors Risk Analysis, medical device manufacturers complete a thorough examination of product(s) from the point of view of the user. This Human Factors Risk Analysis is the basis of all human factors/usability testing. One important component of the risk analysis is the proposed mitigations for high risk/high frequency tasks. According to the FDA, all proposed mitigations must be related to the device design since Instructions

for Use (IFU), User Training, and Product Information Leaflet (PIL) are not considered acceptable methods for risk mitigation. Once potential risk mitigations are identified, the trick is to determine which potential mitigations, if any, will actually deliver the expected result of risk mitigation. This is where a Human Factors Formative Test can save the day.

Human Factors Testing: Stack the Deck in your Favor!

To stack the deck in your favor, you can use Human Factors methods to place the device in front of users early in the product development cycle to evaluate risk mitigation ideas - when it is relatively inexpensive to make design changes. Early formative tests evaluate ideas, designs, and prototypes. Getting a product in front of end users early in the design phase will quickly tell if proposed risk mitigations are effective. In addition, it gives the opportunity to make required changes to product designs early in the product development cycle. As a result, the cost of design change is minimized. The first step in human factors testing is to identify all user groups, realizing that a user and a customer are often quite different. Customers are people who will buy a product and are the focus of marketing departments. Users are people who will personally use the product. There is often more than one user group for a product. A ventilator is a perfect example of a device, which has multiple different user groups: the technician who calibrates the ventilator, the respiratory therapist, the nurse, the caregiver, and the physician. Consequently, all user groups and how each user group will use the product must be identified. The FDA is interested in all user groups. However, they have a particular interest in the groups that are most at risk (e.g., children, untrained caregivers, home health aides). It is also advisable to include a mix of experienced/inexperienced users. Remember, usability testing is placing a product in the hands of actual end users to determine if the product design is safe, effective, and usable. Formative Tests are evaluative in nature and place product concepts, and/or 2-D/3-D prototypes in the hands of users. When conducting a Formative Test, the goal is to use five to eight users from the high-risk user groups focusing on the highest-risk/highest frequency task(s). For a Formative Test, you do not need five to eight of each user group â&#x20AC;&#x201C; you only need five to eight users from each user group that performs the highest risk/highest frequency tasks. Five to eight participants maximizes the return on investment during formative testing as using additional participants typically doesnâ&#x20AC;&#x2122;t yield substantially more data (Nielsen, 2012). A Formative Test can be designed to focus on a specific product design and/or specific primary operating task(s) to gather data on how a user group interacts with the device. Consequently, a Formative Test could use a few as 5 participants or as many as five times the number of user groups that could ultimately use the product/device. Manufacturers often fail to include the Caregiver User Group. However, the FDA considers caregivers to be one of the highest risk user groups, as they have no professional training. For this reason, Caregivers need to be considered, even if they just

monitor the device output. Formative Testing usually takes two weeks of preparation, two or more days of testing, and two weeks to obtain the data analysis and final report. That amounts to about five weeks (or more). Cost is a little more difficult to estimate as it depends on a number of different variables. If your user groups are medical professionals, it will cost substantially more for participant recruiting and incentives than if your user groups are caregivers or patients. There are also costs for the Human Factors Lab Facilities, creation of the test protocol, facilitation of the test, and the data analysis/report writing. Most Formative Tests cost between $50,000 and $75,000+ depending on the number and type of user groups. The FDA recommends Formative Human Factors Testing, but does not require it. So why conduct a Formative Test? Remember, the goal is to stack the deck in your favor to release a product that is safe, effective, usable, and approved by the FDA in the shortest time possible. Finding out about serious design problems with the device early in the development cycle will cost substantially less to mitigate, than finding the same design problems at the end of the product development cycle. (Figure 2). Typically, a product development cycle will include two or three rounds of Formative Human Factors Testing before the final Summative/Validation Test. Follow this practice and there should be no surprises in the Summative Test. Summative Testing is the final validation that a product design is safe, effective, and usable in the hands of ALL intended user groups. It is the final test that renders a pass/fail judgment on a device, product or system. Again, the basis for the Summative Test is the Human Factors Risk Analysis created by the Quality Assurance Team. All medium- and high-risk tasks identified in

Figure 2 Integrating Human Factors into the Product Lifecycle. The earlier manufacturers integrate human factors research into the design process, the more cost effective it will be.

RTC Magazine MARCH 2016 | 19

2.2 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT the risk analysis will be tested in a simulated real-world environment/situation. Test participants for the Summative Test, will be at least 15 users for each user group that could typically use the product. Consequently, the number of participants will range from 15 to many. It is quite clear the cost of a Summative Human Factors Test will be considerably more than a Formative Human Factors/Usability Test. Unfortunately, it is impossible to provide an estimated cost as the cost depends on many factors. For example, the number of user groups tested, the complexity of the device, whether or not training is required, the number of days in the lab, the complexity of the final analysis, etc. With that said, the minimum cost for a Summative Test is about roughly $70,000, but more likely in the $90,000 to $150,000+ range.

costs; maximize market preference – the result, PROFITABLE products. Sound familiar? How many iPhones are used every day? Embrace best practice, build Safe, Effective, and Usable products, Stack the deck. The FDA’s recommendations and requirements empower you to stack the deck in your favor.

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So imagine a blackjack table that allows you to turn over all the cards and actually arrange the cards before they are dealt. This is what the FDA has provided with the Human Factors Requirements. With each Formative test you get to arrange the cards. You will know early in the development cycle what the risks are and will have mitigated them – when the cost of change is still minimal. Run an evaluation study on the Information for Use (a formative test). You will then know the Information for Use is accurate, understandable, and easy to use. It’s now time to run the Summative test. How much did it cost to engineer/design your product? Don’t worry – let it ride, the cards are dealt – BLACKJACK! But you knew that, you stacked the deck. You submit your 510(k) to the FDA – BLACKJACK again! But again, you knew that – You stacked the deck, you followed Best Practice during the product design/development process. The recommendations and requirements of the FDA to do Human Factors/Usability testing are actually the same best practice for creating safe, effective, usable and PROFITABLE products in any industry. Minimize development

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2.3 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

Consensus Standards â&#x20AC;&#x201C; A Driving Force In The Delivery of Healthcare Technology Consensus standards have been an important, but often misunderstood, component of the system that produced the medical devices that have revolutionized the delivery of healthcare. The process by which they are developed can be equally mysterious. by Charles Sidebottom, PPO Standards LLC.

The consensus standards system has been important to the medical device industry for a very long time. The standards this system produces are important to the medical device industry as an aid to ensuring compatibility, interchangeability, or safety. They capture tried-and-true solutions to reoccurring problems to help industry address these problems in a way that is generally acceptable to all stakeholders. This frees resources to focus on areas where innovation can provide real benefit for patients. The medical device standards system we know today had its beginnings in the early 1960s. Over the next three decades, the development of standards for the medical device sector became a global proposition. Technical committees focused on medical devices and related technologies were formed in global bodies such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Today in ISO and IEC alone, there are over twenty committees that are developing standards that affect some significant aspect of the medical device sector. (Table 1). By the early 1990s, the medial device market had become truly global. To operate efficiently in this global marketplace, manufacturers and other stakeholders were pressing regulatory authorities and their political superiors to harmonized and streamline product review and approval processes. A new era in regulatory thinking was dawning as regulators in major markets around the globe began to see consensus standards as a practical way of harmonizing technical regulations. Regulatory authorities on both sides of the Atlantic turned to the consensus standards system as a rich source that could be mined for technical criteria. Other regulatory authorities have adopted consensus standards as an element of their medical device regulatory scheme. Countries such as Canada, Australia Japan, China, and Brazil have assigned consensus standards or national adoptions based on those standards an important role in their regulatory scheme. The way a standard is used to support regulation depends on how that standard is recognized by a particular regulatory authority. There are two basic approaches: 1) Voluntary approach â&#x20AC;&#x201C; This approach is sometimes referred 22 | RTC Magazine MARCH 2016

to as the presumption of conformity. In this approach, the manufacturer is free to choose to apply the standard to demonstrate conformity with some aspect of the regulation. Compliance with the standard is seen as a way, but only one way, to demonstrate Committee

Title

ISO/TC 42

Photography

ISO/TC 76

Transfusion, infusion and injection equipment for medical and pharmaceutical use

ISO/TC 84

Devices for administration of medicinal products and intravascular catheters

ISO/TC 85/SC 2

Radiation protection

ISO/TC 106

Dentistry

ISO/TC 121

Anaesthetic and respiratory equipment

ISO/TC 150

Implants for surgery

ISO/TC 168

Prosthetics and orthotics

ISO/TC 170

Surgical instruments

ISO/TC 172/SC 5

Microscopes and endoscopes

ISO/TC 173

Assistive products for persons with disability

ISO/TC 184

Industrial automation systems and integration

ISO/TC 194

Biological evaluation of medical devices

ISO/TC 198

Sterilization of health care products

ISO/TC 210

Quality management and corresponding general aspects for medical devices

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems

ISO/TC 215

Health informatics

ISO/TC 249

Traditional Chinese medicine

IEC/TC 62

Electrical equipment in medical practice

IEC/TC 66

Safety of measuring, control and laboratory equipment

IEC/TC 76

Optical radiation safety and laser equipment

IEC/TC 87

Ultrasonics

Table 1 ISO and IEC Technical committees in the medical sector

conformity with the regulation. 2) Mandatory approach – At times, a regulatory authority may choose to incorporate a reference to a standard into a law or regulation. For example, compliance with CAN/CSA-ISO 13485:03 is required for any medical device manufacturer that imports or sells most medical device in Canada. In a case like this, the manufacturer has few option. They can either fully comply with the mandatory standard or not market their product in that geography. If a standard is mandatory, then the manufacturer has to have a thorough understanding of its requirements and how they apply to their products. Even if use of a standard is ‘voluntary’ and the manufacturer chooses not to apply the standard, they still need to understand its requirements. That is because regulatory authorities frequently view a recognized standard as setting the minimum acceptable level of safety or performance. A term often used to describe this view is the standard documents the ‘generally acknowledged state of the art’. Manufacturers can expect to be asked how their design solution measure up against the standard even if they have chosen not to apply it to their product. Regardless of whether consensus standards are used as engineering tools to solve reoccurring problems or to support regulatory submissions, it is important that manufacturers understand what standards are relevant to the products they design

and build. The manufacturer needs a thorough understanding of the requirements in the standard and how they apply to their products. This requires developing subject matter expertise within the organization. These subject matter experts (SMEs) provide a resource the manufacturer can draw upon to analyze new or changing requirements and relate those requirements to the manufacturer’s products. For some standards, external consultants may be able to fill any knowledge gaps within the organization. However, for standards that are at the core of their business, the manufacturer should seriously consider developing internal SMEs who thoroughly understand a standard and how it applies to the manufacturer’s products. One well-established way to develop subject matter expertise is for the organization to participate in the process of developing the consensus standards that will affect the manufacturer’s products. No one understands a standard better than the people who were at the table while the requirements were being debated and decided. These are the people wo can answer the oft-asked question, “what were they thinking when they came up with this requirement?” Because applying the requirements in a particular standard to a specific set of circumstances can often involve some interpretation, it can be extremely useful for an SME have that background. While participating in the standards developing process is an

RTC Magazine MARCH 2016 | 23

2.3 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT excellent way to develop SMEs, no manufacturer can be expected to have the resources to be involved in the development of every standard that they use. They have to assess the consensus standard’s landscape, decide what are the key standards that most directly affect their products, and then focus their limited resources on those standards. Deciding to commit to participating in the standardization process is not a decision an organization should make lightly. Standardization is a strategic, not a tactical, activity, and any single project can take years to complete. Anyone contemplating a role in the standardization process should remember Chuck’s Rule: “The world is run by the people who show up regularly.” To maximize the benefit and have the greatest impact on the eventual outcome, one needs to participate meeting after meeting, year after year as well as spending time developing requirements and reviewing and commenting on draft between meetings. All this can require a considerable commitment in time and the out-of-pocket expense associated with attending the face-to-face meetings of the committee. In addition to the knowledge and insight about a standard gained from participating in the process, there are other benefits to be gained. Building relationships with other stakeholders can prove invaluable. Often it is during conversations in the hallway at coffee breaks or over a quite dinner after the meeting that the

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most difficult problems get solved. Such relationships take time to develop. Remember, Chuck’s Rule applies. Standards rarely remain static. The generally acknowledged state of the art is evolving and standards need to evolve with it. Consequently, most SDOs include in their process some sort of periodic review of their standards portfolio to verify that their standards are still relevant and accurate. A five year review cycle is typical. At each review, the responsible committee is required to examine the standard and either confirm, revise or withdraw the document. As the medical device industry has evolved over the last seven decades, the consensus standards system that supports it has grown and evolved as well. Today, consensus standards play a significant role in promoting safer, cost-effective medical devices. They have taken on an important role as a regulatory instrument promoting global harmonization of technical requirements. Manufacturers need to understand what standards are relevant to the products they design and build. They need to have an internal process to identify and track the relevant consensus standards regardless of whether they are used as engineering tools to solve reoccurring problems or to support regulatory submissions. In addition, manufacturers need to identify or develop subject matter experts (SMEs) who thoroughly understand the key standards and how they apply to the their products. An excellent way of developing subject matter expertise is to participate in the development of the key standards. The manufacturer has to determine the level of participation that is most appropriate for the standards of interest remembering that standardization is a strategic, not a tactical, activity. To be effective, the manufacturer needs to commit to participation over the long term. However the benefits can be substantial by developing an in-depth understanding of the rationale behind the standard. No one understands a standard better than the people who were at the table while the requirements were being debated and decided. Finally, given the significant role that consensus standards have taken in global regulation of medical devices, participation in the standardization process provides a unique opportunity to have a seat at the table when the rules that will govern the industry are being written. The standards are going to be written. If you are not at the table, your competitors will be. Do you want them writing the rules by which your products will be judged? Think about it.

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RTC Magazine MARCH 2016 | 25

2.4 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

Engineered Success: The Engineer’s Contributions to FDA Medical Device Market Commercialization The FDA approval process is an oft-told tale … but not from the engineer’s perspective. When it comes to regulatory compliance and public safety, most medical devices require the skills of a professional engineer. by Russ King, President, MethodSense, Inc.

The contributions engineers make to this industry are both critical and substantial. Medical devices must be designed to satisfy their intended use. Some medical devices are simple enough that a professional engineer may not be necessary for their design. However, a medical device always requires some level of engineering, and the bulk of medical devices require the skills of a professional engineer to ensure they safely and effectively fulfill their approved intended use. Without a doubt, the engineer is critical to fulfilling the regulatory requirements of a medical device company. Sadly, there is often a lack of gratitude toward the engineer when it comes to recognizing their role in regulatory compliance and public safety.

Preparing for and Anticipating the FDA Approval Process

One of the most common questions we hear from emerging medical device companies is, “When should we begin preparing for the FDA?” The answer is, “As soon as possible.” Emerging companies often devote their time, energy and treasure to product development driving toward the completion of their pre-clinical program or a final prototype. Licensees, acquirers and investors often express interest in deals with early stage companies and products. Moreover, the value of that deal can be enhanced or diminished depending on the condition of correct and readily available product documentation. During a pre-clinical or prototyping stage, it is not overly difficult or resource-intensive to have a few formal processes around the management and control of documents and records put in place. With a Design Control procedure and a Documents and Records Management and Control procedure (and perhaps one or two other procedures), those engaging in the early stage engineering of a product can begin building a credible Design History File (DHF) by formally authoring and approving Design Reviews

26 | RTC Magazine MARCH 2016

Product Requirements, Design and Development Plans, Product Specification Matrices and other DHF content. The benefits of this approach are numerous. In addition to establishing competence around FDA Design Controls, it positions a company to more easily transition to a compliant Medical Device Manufacturer. It further demonstrates the company’s competence as a potential partner who can support regulatory obligations.

Understanding the FDA Approval Process

As you are engineering your device, it is helpful to keep FDA requirements in mind. The FDA utilizes a risk-based approach when clearing medical devices for the US market. The FDA segments devices into three risk classifications. (Figure 1). The higher the risk, the higher the evidentiary threshold for demonstrating product safety and efficacy. Much in a device commercialization strategy’s cost and time to market is determined by the product’s risk classification. That is, a Class II product has a significantly easier path to market than a Class III product, and a Class I product has the easiest path to market. Determining the risk profile of any product is much more than simply developing a risk management policy. The correct risk approach must be applied with an intimate and detailed understanding of the product, which, in turn, means the product’s engineering team should be involved in the risk assessment process. Through collaboration, the device designers and the regulatory team will build a more detailed assessment with deeper knowledge of the product. In our experience, FDA regulations, guidances and internal review processes are designed to prevent ‘motivational judgements’ that stray away from appropriate medical device classification. If the FDA disagrees with your product classification, they will kick back the application without a care about the time and expense doing so costs your company. Utilizing the engineer’s knowledge

Figure 1 US Medical Device Classification Table

and capabilities to fully understand and correctly classify the product will save time and money and reduce risk. The most common pathway, and the one we field the most questions about, is Pre-market Notification or the 510(k). The 510(k) process is designed to demonstrate the substantial equivalence of an unapproved device to an already approved, or predicate, device. This means that rather than proving safety and efficacy via clinical trials, medical device companies can take the more efficient path of proving their device is as safe and effective as a device that has already been approved. This is done by showing it is substantially equivalent to a predicate device that has already been shown to be safe and effective.

Get an Early Practical Handle on 21 CFR Part 820

FDA product licensing carries with it the expectation that you will comply with all relevant regulations. For medical device companies, this typically means at least compliance with 21 CFR Part 820, also known as Good Manufacturing Practices (GMPs). GMPs are designed to ensure that a medical device manufacturer operates in a way that produces devices that are safe and what the FDA approved for the market place. You should know that 21 CFR Part 820: • Is an FDA-mandated system of product design • Requires you to document the evolution of the life of your product • Applies a market-first product development focus • Requires a team-oriented approach to product commercialization • As a process, tends to challenge product design to the point of improvement

Compliance is a necessary expense and typically involves all functional aspects of a company; don’t put yourself in a position where it costs more in dollars or opportunity than it should because you avoided compliance. Take extra care early on to develop processes that, when followed, meet your compliance obligations and support your business goals.

Design Controls Ensure a Quality Product that Safely and Effectively Meets a Real Market Need

21 CFR Part 820 prescribes specific design controls, or processes, for bringing Class II medical devices to market. Design controls should work as a risk prevention approach to the quality of your medical device. Risk prevention is an efficient and cost-effective way to control manufacturing processes and maintain quality. While it may not be possible to eliminate all potential risks, we consistently observe in our clients a very poor appetite for realized risk that was otherwise mitigatable. Design controls frequently overlap with what the engineers know, and more often than not, depend upon the engineer’s input. If implemented well, design controls create a number of surprising benefits, including a better-documented product that is more attractive to buy or acquire. They result in a more efficient development cycle due to a reduction of mistakes thanks to early analysis of key questions and a clear distribution of a team’s responsibilities.

Don’t Forget Safety Testing and the Value of Risk Management

Depending on the technology incorporated into your medical device, applicable safety standards must be identified during the design stages of the product. The most widely accepted benchmark for establishing safety for electrical medical devices is a standard called IEC 60601-1 3rd Edition and its collateral standards.

RTC Magazine MARCH 2016 | 27

2.4 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT Failing to conform to a safety testing standard is a sure way to halt a device’s commercialization progress. As a consequence, we see more and more engineers from medical device and medical device contract manufacturing companies work through what it means to satisfy safety testing requirements early in the design phase. Taking this kind of proactive approach can identify not only documentation needs, but also design requirements that must be met in order to satisfy Test Laboratory product evaluations. By building conformance to a safety standard into a medical device as early as possible, the medical device engineer saves their company the pain and expense of redesign work due to testing failures after the company thought the design was locked down. As always, an ounce of prevention out performs in money and efficiency a pound of cure!

Key Players in the Commercialization Process

Engineers play a vital role in the medical device approval process – a role that is often minimized or overlooked completely. Engineers can be more effective in this role by: • Familiarizing yourself with relevant compliance requirements and develop an understanding of what the FDA expects of a medical device company. • Communicating with the Quality Assurance and Regulatory

Affairs staff and understanding their needs as they seek to ensure products can get to market and your company’s legal compliance obligations are met. • Sharing your needs with the Quality and Regulatory team so they have the opportunity to enable you in kind. You might be surprised by their efforts to support your work. • Proactively working as a team, regularly exploring how collectively you might anticipate needs and seek to address those needs in a timely manner. Such needs may evolve around processes, documentation, design controls, intellectual property management, risk management, and much more. • BEING PREPARED TO COMPROMISE! Bringing a device to market is a lot of work, which only becomes harder and more expensive if individuals or departments become entrenched in a particular way of doing things that fails to dovetail effectively with other functions of a medical device company. As engineers, it is important to remember that you are not only an innovator, but you play a tremendous role in facilitating the commercialization process as well. Thinking of the commercialization strategy from concept through completion will enable you to develop processes that will bring your product to market faster, easier and quite possibly more affordably… allowing you to move on to your next brilliant idea!

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RTC Magazine MARCH 2016 | 29

2.5 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

Figure 1 The medical wearable device ecosystem is quickly becoming an integral part of our daily lifestyle.

Building Security Features Into Todayâ&#x20AC;&#x2122;s Medical Wearable Devices In the race to be first to market, manufacturers often overlook some of the most basic security features such as secure boot, crypto engines, and device partitioning. by Andrew Caples, Mentor Graphics Corporation

30 | RTC Magazine MARCH 2016

With the proliferation of medical wearable devices, personal data is being collected at an unprecedented rate and stored with little to no focus on security. The wearable device market is extremely competitive and compels device manufacturers to release feature-rich devices under the pressure of being first to market. The pressure to release within very short design cycles squeezes out the ability to focus on meaningful security. Further, as users sign up for web-based data hosting to monitor their health trends, the device-to-cloud solution is rife with potential vulnerabilities (Figure 1). Within the medical industry, it is essential that information be stored and transmitted in a format that provides real-time access while enforcing strong protections to prevent unauthorized access and use.

Medical wearables now part of our daily lifestyle

Medical wearable devices can monitor temperature, heart rate, pulse, blood pressure, glucose, respiration, pH, alcohol consumption, nicotine intake, and more. And the fact that devices can be implanted in the human body essentially allows for virtually all physiological metrics to be monitored and stored. Not only does the data provide a clear picture of daily patterns, it also provides a historical snapshot of the user’s health trends. Unfortunately, this data can be exploited by cybercriminals, or used by legitimate organizations such as insurance companies to

raise premiums or decline service. Additionally, wearable devices provide an opportunity for cyber criminals to intrude upon private networks and gain access to other devices attached to those networks.

Fitbit data not immune

The recent Fitbit hack in which cybercriminals allegedly used leaked email addresses and passwords from 3rd party sites to log into Fitbit accounts only accentuates the need for security. The attackers changed account details and attempted to defraud the company by ordering replacement items under the user’s warranty. In this case, the devices were not hacked; however, the highly personal nature of the data demonstrates the need for security that goes beyond usernames and passwords. In fact, researchers have demonstrated the ability to hack into a wearable device through a Bluetooth vulnerability not only to manipulate the data stored, but to use the device to distribute code to a computer to take the hack to the next level. Because of the personal nature of the data collected, trends suggest that government agencies and consumers will mandate higher levels of security on these devices. The onus will be on the device developer to design-in protections against common attacks that include eavesdropping, data modification, and device impersonation.

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RTC Magazine MARCH 2016 | 31

2.5 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT Hardware – it’s all about the hardware

When designing a wearable device, care must be taken to select the right silicon. With tight development cycles compressing the limited available time that can be dedicated to security features, processors with built-in security IP blocks establish a foundation to maximize device and data security. Today’s wearable Systemon-Chip (SoC) processors comprise the hardware features to authenticate software prior to execution, encode data at rest, sign data to maintain integrity, and partition the device to prevent malware from entering the system. Processor security features to look for include: secure boot, boot fuses, crypto engines, and device partitioning. SECURE BOOT: Storing security keys for encryption/decryption and hash functions on the silicon is an important aspect for a secure device. To properly ensure the software has not been tampered with software modules must be authenticated prior to execution. This starts with authenticating the boot code and transcends up through the operating system, middleware, and application to establish a hierarchical chain of trust (Figure 2). A chain of trust is design construct wherein the various software layers are hierarchically authenticated to validate integrity before control is handed over for execution. In some cases, secure data have to be decrypted in addition to integrity checking. The authentication and decryption of secure data is done based on security keys programmed into a device’s secure storage medium. Modern wearable SoCs offer features for security key storage for this exact purpose. Security keys can be hard-programmed into specialized secure memory and isolated to prevent tampering through the use of boot fuses. Boot modes for deployed devices can be controlled so that the system always boots in secure mode warranting authentication and validation of every software module being loaded/booted. CRYPTO ENGINES: Encrypting the data while at rest and during transit provides the highest level of protection for devices. For efficient cryptography operations, SoCs with crypto engines should be considered. The crypto engine is a self-contained module designed to off-load the encryption/decryption work from the core processor. Because the crypto engine is a self-contained IP block, hackers can find it difficult to derive techniques to gain access to the encryption process. The use of crypto engines can have a huge impact on the ability of the application to secure data quickly and efficiently.

Figure 2 The chain of trust model for security ensures that every file downloaded is signed and authenticated from the boot loader up to the application level.

32 | RTC Magazine MARCH 2016

DEVICE PARTITIONING: The ARM® TrustZone® (or secure memory) can be used to partition system resources for security key storage that will prevent access by rogue applications or malware. The hardware isolation can be extended beyond system memory to include memory-mapped I/O regions from devices. System resources can be masked as “secure” which allow access to only those secure applications running in the secure domain.

The life force behind any wearable device: the software

Selecting the right hardware with security features is an important step to building a secure medical wearable device. Without the right software, employing hardware security features may require the development of additional code that only adds to cost, time, and complexity. Or worse, the wrong software may result in security features being omitted altogether. An operating system (OS) with a framework that supports security IP blocks in the silicon including crypto engines and secure boot, and brings to bear common algorithms and ciphers is essential. The correct OS includes a framework to enable a chain of trust for software authentication prior to code execution. This is needed to verify the software has not been modified. Because personal healthcare information is vital and confidential, an OS with the ability to store data in secure files should also be considered. This goes beyond the use of password protection. Additional protection through the use of data encryption to ensure the data can only be read and modified by authorized reviewers is essential for device security. Because wearable devices are routinely resource-constrained, there is a need for small footprint crypto libraries that offer OpenSSL equivalent functionality. And because of limited memory, the operating environment must also support executing-in-place and dynamic loading for both the runtime and file system. Within the file system, there is need to support encryption and hash functions to protect the data from being compromised.

Upgradeable software a must

A key requirement among medical wearables is the ability to update the device with the latest security patches. Because of time-to-market pressures, SoC providers routinely put a version of a free real-time operating system (RTOS) or Linux® onto the chips, as well as other open source and proprietary components and drivers. The wearable device manufacturer selects the silicon based on price and features that includes the accompanying software. The problem with this process is if a security issue is identified, no one entity has the expertise, or even ability to patch the software once it’s shipped. The chip manufacturer is busy shipping the next version of the chip and may not have the process to update and patch older versions of software. And the operating environment may not provide a framework for dynamically updating a software module or the entire operating environment, if needed. A commercial OS with features that support software upgrades and updates to patch security issues as they arise is a very important component to wearable medical device security. Isolating software subsections Wearable devices are routinely designed with power-efficient SoCs. These cores contain Memory Protections Units (MPUs) that can be used to partition memory and provide access control

to memory regions. With the correct OS, the spatial domain partitioning capabilities of the MPU can be leveraged to isolate software subsections (Figure 3). Not only does this create added system reliability such as containing faults to a single process without degradation to entire system, but it also provides the ability to partition subsystems for software module loading and unloading for software updates. Support for spatial partitioning has been a mainstay feature in high-end, general purpose operating systems, such as Linux. However, the overhead associated with memory virtualization and lack of deterministic responses limited the use of embedded Linux in real-time systems. And of course, the large Linux footprint all but rules it out as a possible OS in MCU-based designs. A lightweight operating system with a process model can enable dynamic loading for wearable devices based on MCU or more advanced processors.

The right hardware with a full-featured OS

The pressure on device manufacturers to create compelling features to differentiate medical devices is driving a new wave of innovation. As hardware providers incorporate more security features in new SoCs, developers must select the right operating system; one that is highly scalable to address the requirements posed by resource-constrained devices, and yet the same OS must include a security framework that allows developers to enhance device safety. The Mentor® Embedded Nucleus® RTOS with a Pro-

cess Model Framework allows developers to build many of these security requirements and provides a significant advantage when developing today’s medical wearable devices.

Figure3 Nucleus Process Model is a light-weight approach for space partitioning that creates protected memory regions.

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2.6 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT

Intellectual Property Can Make or Break the Best Ideas Patents, trademarks and trade secrets are critical to medical device companies, but pitfalls abound. A few basic IP principals could very well save your company. by Jarom Kesler and Irfan Lateef of Knobbe Martens

Intellectual property (IP) rights are key to securing exclusivity and the ability to profit from a company’s innovations. Disruptive technologies always invite competition from larger or better-funded competitors and, without IP rights, it is very difficult to compete. IP rights have played a critical role in the development of many industries, from the revolver to the airplane to the so-called “smart phone wars.” The American patent system is a constitutional right authorized by Article One - “The Congress shall have Power...To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Generally, in the U.S., a patent is a right to exclude others from making, using, selling, importing, or offering an invention for sale for a limited time. In addition, a patent can be used to exclude others from exporting components to be assembled into an infringing device outside the U.S., inducing others to in¬fringe, offering a product specially adapted for practice of the patent, and a few other specific categories. Often, however, companies focus first on developing the next big product or solution and put off legal assessment of their innovation position, only to discover too late that significant hurdles to robust protection have arisen. The story is often the same: an ounce of early prevention can save a pound of painful cure. What, then, should every medical device company or start-up know from the outset? The list of the most common pitfalls is actually quite short, but the threats they pose are too significant to be ignored. First, confirm that the company actually owns its valued intellectual property. Employers commonly assume they own intellectual property rights developed by employees and consultants, but in the United States, sometimes the creator is the presumptive owner. Companies must therefore insure that employee agreements state that employees and consultants assign any and all intellectual property rights to the company. In addition to assigning the intellectual property rights, these agreements should also obligate employees and consultants to safeguard confidential information. Joint venture agreements (with other companies or universities) should also be carefully scrutinized to establish proper ownership. Finally, prior employment obligations of

34 | RTC Magazine MARCH 2016

employees could affect who owns certain intellectual property. In some situations, a current employee’s “inventions” may be owned by a former employer. Second, because medical device companies and start-ups are almost always based on a brilliant idea or solution, the nuclear option of intellectual property must be deployed: patent protection. Typically, trade secrets, copyrights and trademarks do not rival patents for the ability to prevent others from making or using an invention. Without patent protection, once the idea is publicized there is no way to stop an often larger, better-funded company from simply taking or copying your inventions. This is particularly true once FDA approval has been granted. FDA approval is expensive and time-consuming. To use a cycling analogy, a competitor can lurk in the peloton while your company leads the struggle to gain FDA approval, and emerge from the pack just in time to claim substantial similarity and gain streamlined FDA approval for its competing product. Without patents in place, this tactic may be perfectly legal, granting the competitor a significant financial advantage. Venture capitalists certainly know the value of a patent portfolio. Venture funding often hinges on the strength of a start-up’s patent portfolio and how effectively that portfolio protects the ideas behind the start-up. A family of strong patents is often the most persuasive and alluring ingredient in a sophisticated venture funding proposal. For example, (Figure 1) illustrates the relationship between patents and start-ups. From this we can see that start-ups have a higher percentage of patents in part because funding possi¬bilities increase with the number of patents. There are, however, some important pitfalls when seeking patent protection. The most important pitfall is a partial or complete forfeiture of rights caused by undue delay in filing a patent application. A patent application must be filed as early as possible and before a public disclosure or commercial activity. Avoid the trap of assuming that filing a patent application automatically results in enforceable rights: obtaining an enforceable, issued patent typically requires multiple rounds of negotiation with the Patent Office and can take two to five years. Another pitfall is the assumption that a single patent filing is sufficient. In fact, multiple patent families or groups are typi¬cally required for effective protection. Patents, no matter their

Figure 1 Source: High Technology Entrepreneurs and the Patent System: Results of the 2008 Berkeley Patent Survey, Graham et al., Berkeley Technology Law Journal, Vol. 24:4 (2008)

size, hinge on a few words found at the end of the patent in the “claims.” The claims define the scope of the invention and, consequently, what one company can prevent another from doing. Thus, competitors can use the information in a patent and nevertheless avoid infringement if they figure out a way around the language of your claims. The more patents and the more claims you have, the more dif¬ficult this will be. A large patent portfolio in and of itself often scares away would-be competitors simply because of the expense of figuring out how to get around the volume of protection. Third, patents are not like off-the-shelf, form contracts. Each patent is specifically tailored to the new idea it is meant to cover. In the world of patent drafting, the quality of your patent is driven by the quality of the drafter. It is possible to find attorneys who will lower costs by cutting corners, but more often than not your patent will suffer for it. Serious protection is not inexpensive and requires significant attention and care from your attorney. For example, a skilled patent drafter will strive to obtain not only strictly “defensive” patents—those that cover their own products in various ways, but also to obtain patents that cover the relevant

market and competitive alternatives, as in (Figure 2). Here, the hypothetical patent scope covers the commercial product that a company wants to market, but not the entire relevant market for that product. That means that another company could avoid the patent claims and enter the market. In this case, the company should have spent more time, and money, considering a broader patent claim scope to secure better protection. The goal of a robust patent portfolio is to protect a market space, not just a product. For example, consider the case of a hypothetical ECG device. There are many aspects of it that could be patented. (Figure 3) illustrates the varying aspects of the device that can be potentially patented. Because various aspects of a new product can be patented, companies should evaluate their patent strategy in light of their business plans. For example, if disposable sensor sales are going to drive profits, then it may be beneficial to invest more resources on patenting aspects of the sensors so that others cannot jump into that business. On the other hand, if the signal processing is the key to success, not only the company’s current implementation, but

Figure 2 The scope of a patent should be considered with a view to protecting the potential market, not simply the specific product

RTC Magazine MARCH 2016 | 35

2.6 MEDICAL DEVICES DESIGN: FOLLOW THE RULES AND PROFIT also variations should be patented. Companies should also keep in mind that patent protection may not extend to pure software and generally must be tied to a device. Fourth, search for patents that may pose potential infringement issues to you. A patent provides the right to stop others from using your invention, but it does not grant your company permission to actually use that invention. You may have a great idea to improve a product, but if that product is still covered by a valid patent, then your improved version may nevertheless infringe another patent ownerâ&#x20AC;&#x2122;s rights. This can and often does result in expensive litigation and costly settlements that a small start-up typically cannot afford. So, before marketing a commercial product, do the necessary diligence to discover what claims others may have made in that space. Typically this entails performing a search of patents that may cover aspects of your product. After gathering those patents, the company and the attorney can determine if there are

any issues. If there are, then the company can consider design alternatives to alleviate any infringement issues or by potentially obtaining a license to the patent. Finally, companies should systematically and reflexively employ robust non-disclosure agreements. Start-ups often talk to vendors, investors, suppliers, etc. about their innovations. However, these discussions can divulge intellectual property. Because these discussions cannot be avoided, companies should use non-disclosure agreements to preserve the confidentiality of trade secrets, pending commercialization, patent strategy, etc. Companies should not forgo negotiating NDAs in order to gain an audience. While the above discussion is not exhaustive, following its suggestions and identifying potential intellectual property issues early can save significant expense later on. When the time comes to consult a reputable intellectual property attorney, this knowledge will put your company several steps ahead of the competition.

Figure 3 Careful consideration should be given to aspects of a product that may be of particular value and/or subject to potential infringement if not properly protected.

36 | RTC Magazine MARCH 2016

RTC Magazine JANUARY 2016 | 37

3.0 EMBEDDED WORLD HIGHLIGHTS

Embedded World Highlights The common themes at Embedded World 2016 among many major silicon vendors including NXP, Cypress, Atmel and Xilinx are security, connected and wearable smart devices, future driverless automotive and, of course, IoT. by John Koon, Editor-In-Chief

NXP: After NXP acquired Freescale, they converted their demo bus and called it the Smart World Tour Truck. This time, the large truck was on display and housed many IoT and smart things. I was invited to view various wearable designs. It featured different flavors of fitness devices came with reference designs and layouts to make the developersâ&#x20AC;&#x2122; work easier. Separately, to address the future pharmaceutical market, NXP demonstrated a proof-of-concept of how future pills would be packaged. The switch /sensor simulated the presence of a bill. When a bill was taken, the sensor would count it as taken. So if a person forgets to take the bill by a specific time, a reminder will be sent to the person who was supposed to take the bill. A useful idea indeed. Also at Embedded World, NXP introduced the worldâ&#x20AC;&#x2122;s smallest chip about the size of a 2 cents Euro. The SCM-i.MX 6dual/6Quad comes in a small packaging of 17x14x1.7 mm ideal for applications that need small space such as wearables and portables. (Figure 1). NORDIC: Smartphones and wearable products can benefit from wireless charging without using the USB cable. At Embedded World, Nordic demonstrated the AirFuel wireless charging system which operates on the principle of magnetic resonance and is capable of charging more than one device from the same power source or place. (Figure 2). Some time ago, Wireless Power (AW4P) and Power Matters Alliance (PMA) came together to form AirFuel Alliance. Today they seem to be gaining momentum and have been doing pilot runs in multiple places including Starbucks where customers can charge their phones while dinking their coffee. Nordic also offers developers the nRF5 SDK for AirFuel which is a Software Development Kit for Airfuel-compliant wireless charging applications. AMD: AMD announced their new Embedded G-Series SoCs and the Embedded G-Series LX SoC series. They broadened their offerings and performance option. Based on the scalable x86 platforms, the offerings include entry-level and higher performing 3rd Generation G-Series. Many partners were present to demonstrate various applications. Q-Technologies, an AMD partner, demonstrated a form of computer vision. In the setup, a high definition camera can detect if the dollar bills were real or fake. This set up included Qtechnology A/S Camera QT5022S-M2 (Dual core 1.65GHz APU with a 2.2M pixel Monochrome sensor) running on the AMD platform with Mentor Embedded Linux (MEL) which also supported Yocto. The application software was written with less than 100 lines of code. (Figure 3). 38 | RTC Magazine MARCH 2016

Figure 1

Figure 2

Figure 3

MAXIM: Are you considering designing a wearable device to measure the vital sign of a person such as heart rate and oxygen saturation level, Maxim may have the solution for you. When designing wearable devices, the key is integration and low power. The MAX30102 pulse oximeter and heart rate integrated sensor module comes in a small package. (Figure 4). It uses 1.8V power supply and a separate 5V power supply for LEDs. With background in analog design, Maxim uses System-on-chip (SoC) and integration to replace many discrete components. “Maxim is committed to providing innovative wearable solutions for customers,” said Andrew Baker, Executive Director for Industrial and Healthcare Products at Maxim Integrated, “Our IP and knowledge for these applications allows us to integrate multiple technologies in a tiny, low power package.” The module integrates red and IR LEDs to modulate LED pulses for oxygen saturation (SpO2) and heart rate measurements.

Figure 4

DELL: Facing the decision of build or buy when coming to design-

ing a system using industrial computers, what would you choose? Dell wants to help you make that decision easier. At Embedded World, Dell introduced the industrial PC (IPC) products, Embedded Box PC 3000 Series and 5000 Series embedded PC. The fanless, ruggedized units (Figure 5) support Microsoft Windows 7 Pro, Windows 7 Embedded, Windows 10 Pro* and Windows 10 IoT Enterprise LTSB. The units also come with DIN-rail, VESA, or wall mount options. As shown in figure x, the unit is prepackaged so if you want to make modification, you can’t. What you see is what you get. But if your volume is high enough, they will listen.

Figure 5

ARM: Discussions with ARM are always interesting. Not surpris-

ing, a lot of ARM licensees were present. I had a chance to catch up on ARM’s future. Lately they focused a lot on security, wearable, trying to reach out new areas such as smart home, automation and more. New efforts include optimization of their 32-bit technology while introducing the 64-bit version. In the low power space, ARM is a formidable competitor of Intel. ARM has quite a bit to offer. There is not enough space to discuss all the ARM projects so I would devote more space in the future for this.

RTC Magazine MARCH 2016 | 39

4.0 THE NEW USB 3.1 WILL CHANGE THE WORLD AGAIN

Technology Focus: USB 3.1 continues to change the world of computing. by John Koon, Editor-In-Chief

Universal Series Bus (USB) made significant progress in the past 20 years. The new 3.1 with USB Type-C™ connector and cable is capable of 10 Gbps, a speed approaching Thunderbolt. The current USB 3.0 has a speed limit of 5 Gps. (USB 3.0 sometimes referred to as USB 3.1 gen 1 is capable of 5 Gps while USB 3.1 gen 2 is capable of 10 Gps). The USB 3.1 24-pin USB Type-C™ connector, unlike the USB 2.0 and 3.0, can be plugged in rightside-up or up-side-down. How big is the USB market? According to Brian O’Rourke, Senior Principal Analyst, Consumer Devices and MEMS & Sensors of IHS, a market research firm, “USB Type-C™ is forecasted to dominate mobile devices, PCs and other consumer electronics, with an estimated two billion devices by 2019”. Many developers rush to develop new USB 3.1 products. Recently Lattice Semiconductor and MediaTek teamed up to provide a solution allowing mobile devices including smartphones to output 4K to Ultra-High Definition displays, So a user can capture 4K video and view it on a larger screen. MediaTek recently released a reference design combining MediaTek’s Helio X20, the world’s first mobile processor supporting a Deca-core for lower power optimization, and Lattice’s MHL transmitter (SiI8348) and Lattice’s USB Type-C port controller (SiI7033) for signal processing and hand-shake negotiation. “Lattice’s port controller family is able to negotiate all required USB Type-C messaging to set-up the link to transfer audio, video, data, and

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power up to 20V, “ commented Abdullah Raouf, Senior Product Marketing Manager at Lattice Semiconductor, “making universal connectivity through a single connector possible”. Many Asian companies are also rushing to introduce the 10 Gbps-capable cables. Among them is ACON who has successfully obtained the USB 3.1 certification. Expect to see more suppliers to join in as demand grows. The updated Universal Serial Bus Power Delivery Specification also attracted attention. Many companies including Apple, Cypress, Dell, Intel, Microsoft, Foxconn, HP and even Google have worked together to define the details. It will use the USB 3.1 Type-C connectors and is capable of delivering up to 100 watts and 20V. But it will be a few years before it becomes main stream. “I expect that the PD 2.0 standard will lag the adoption of Type-C by a few years. It will roll out in small quantities in mobile PCs beginning in 2016, as well as PC tablets. It will move out from there into PC peripherals that can benefit most from greater power, such as monitors and external HDD. PD 2.0 will enable these devices to be completely powered from a PC, without the need for a separate wall plug,” commented O’Rourke. To help developers better understand USB 3.1, STMicroelectronics, Synopsys and Micro/sys will further expand on USB 3.1 relating to the new USB Type-C connectors, datapath design and stackable USB.

4.1 THE NEW USB 3.1 WILL CHANGE THE WORLD AGAIN

New USB Connector Hits Homerun; Adds Features, Simplifies Use, and With Proper Controller, Eliminates Potential Voltage Incompatibilities USB Type-C™ is a new physical connector defined in August 2014, and aimed at replacing existing USB connectors over time. The new connector offers significant new features and functions that will change end-user’s habits that today reflect mostly charging smartphones and tablets, while simplifying connectivity to power objects or transmit data or video over a single cable. It is also an opportunity for new entrants to introduce innovative products. by Benoit Foret, STMicroelectronics

The new USB Type-C™ connector offers a range of benefits. Figure 1 and 2. It is mechanically 10 times more robust than existing ones. It is also reversible (top/bottom) and identical on both ends of the cable. Figure 3. In other words, the cable is trivially simple to plug in. Obviously, it supports the latest generation of USB 3.0 and 3.1 communication protocols, and it is backward compatible with USB 2.0. USB Type-C™ introduces an optional dedicated 5V connector supply (VCONN) in order to support active cables (i.e. cables with Integrated Circuits inside the plug). But the true “re-evolution” of USB Type-C™ is

the support of the USB Power Delivery specification. Although optional, USB-PD offers breakthrough features, including increased and scalable power up to 100W, and uniquely, it offers this power bi-directionally. And because innovation often encourages further innovation, USB Type-C™ allows a USB connector to also be re-purposed to another electrically compatible communication protocol, for the 1st time. This feature is called Alternate Mode and enables the introduction of proprietary protocols over USB as well as well-known standard protocols such as MHL™

Figure 1 New USB Type-C connector has rounded edges and is completely reversible (top/bottom), making it trivially easy to use.

Figure 2 The application-side receptacle for USB Type-C connectors is backward compatible with both USB 3 and USB 2 connectors.

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4.1 THE NEW USB 3.1 WILL CHANGE THE WORLD AGAIN and Display Port™, among others. The USB Type-C™ connector also implements dedicated audio, accessory or debug modes, and authentication support will follow by the end of 2016. With so many new features, mixing all domains of electronics design - from high power to audio, high-bandwidth communication to encrypted data, the USB Type-C™ standard that was originally specified to simplify connectivity for end-user is likely to cause sleepless nights to Hardware and Software designers. They have to determine how to migrate from Standard-A or micro-B to Type-C connectors. They need to decide what is the minimal set of features to comply with. They need to figure out how to get their product certified at the end of the day. One solution is to adopt a USB Type-C™ companion chip. Working with any MCU on the market through a simple I²C interface, USB Type-C™ companion chips such as the STUSB16 (Figure 4) from STMicroelectronics offer a robust and straightforward solution to comply with the standard, while minimizing complex implementation issues and ensuring secure protection against non-compliant or defective accessories or high-power AC adaptors. Manufactured using ST’s 20V process technology, the STUSB16 controller IC integrates short-circuit, over-voltage, over-current protection to eliminate the need for external circuitry. Additionally, it offers plug power support (VCONN) with up to 600mA programmable current capability and, per the USB Power Delivery specification and integrates the BiPhase Mark Coded (BMC) Physical Layer (PHY) coding and decoding logic.

Integration of such features in a single-chip Type-C controller enables fast migration to USB type-C, while minimizing MCU-resource requirements compared to alternate solutions. Together these features simplify software development and reduce time-to-market while allowing ST customers to focus on their own added-value differentiators.

Figure 4 The STUSB16, manufactured on ST’s 20V process technology, minimizes implementation issues and protects against non-compliant or defective accessories.

Figure 3 USB Type-C cables are reversible, ports are significantly slimmer than legacy USB ports, and the specification supports data transfer speeds as high as 10 Gbps.

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4.2 THE NEW USB 3.1 WILL CHANGE THE WORLD AGAIN

Embedded Vision: Convergence of Stackable I/O, USB3.0 and ARM Processors Embedded designers often benefit from “hand-me-down” technology that is repurposed, repackaged and redefined to meet the needs of embedded system’s compact, rugged, low-power environments. Here is such a story. Susan Wooley, Micro/sys, Inc.

There are numerous examples in technology of the “adapt or perish” theory. Add USB to that list. Then add SOCs. Nowhere is this more apparent than in the fast-emerging market of embedded vision. The many different uses for USB has made it a ubiquitous PC consumer interface. Embedded users, however, have had a challenging and sometimes strained relationship with USB. Finding offshoots of this PC innovation that are appropriate for the demanding, harsh, rugged environments has not been easy. Yet, the cell phone, rugged enough to withstand most aspects of a teenager’s life style, found advantages to implementing USB in arguably the most universal of embedded device – a consumer cell phone. Since some of the initial applications for USB included consumer level products such as the keyboard, mouse, memory stick and webcam, embedded users were not highly convinced that adopting USB had much benefit, as these were not features high on the typical embedded user’s list of requirements. So, the initial impact of USB was less dramatic for the embedded market than for the PC consumer market. Significantly, USB had technical drawbacks for the embedded market. It is a complex serial protocol which uses multiple layers of firmware and software to form the foundation of the highly desirable “plug and play” I/O connectivity. Central to “plug and play” is a polling scheme where the USB host queries each USB client rather than using interrupts. The absence of interrupts, regarded as a desirable feature in real-time control, proved a difficult hurdle for embedded users to overcome. Adding to the technical drawbacks of USB was that the initial connectors and cabling were not considered robust enough for embedded applications. Central to the concept of embedded ruggedness is reliability—and USB’s plastic tab latch inside a metal case did not meet such a standard. Absent rugged connectors, USB would be the weakest link in an embedded application’s reliability.

Evolution to solve a real world problem: Combining USB with stackables to make a space in embedded

To increase USB connector and cabling reliability, some companies produced and patented USB connectors with locking mechanisms, however, the more significant development was the introduction of board-to-board stacking connector technology which could meet the data transfer speeds required by USB signals. Previous Generation System Characteristics

Current-Generation System Characteristics

Benefits for Embedded Users

Typically Intel-based.

Arm-based, heterogeneous CPUs.

Similar processor architecture and common tool availability.

Multi-chip solution. (CPU + North/South Bridge, + other optional bridge chips)

Single chip solution.

Smaller footprint, lower power, lower system latencies.

Additional image capture board required – frame grabber on PCIe.

Smaller footprint, lower power, lower system latencies, lower cost.

Higher clock rate with vector floating point unit.

Lower clock rate with vector floating point unit and image processing unit.

Lower power.

Windows-based, typically.

Linux-based.

Lower cost, better real-time performance through Yocto-based distribution.

Complex, sole sourced application programs.

OpenCV, GStreamer are open source.

Easy access to image processing software.

Complex camera interfaces required for high quality video.

High quality video available through plug and play interfaces.

Use standard I/O interfaces to connect.

Multiple, expensive cable links between multiple hardware units.

Single board to board stackable connection.

Improves system reliability and reduces cost.

Table 1 Highlights the cost and power savings with 2nd generation embedded vision systems

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4.2 THE NEW USB 3.1 WILL CHANGE THE WORLD AGAIN

Figure 1 The application-side receptacle for USB Type-C connectors is backward compatible with both USB 3 and USB 2 connectors.

Using stackable board-to-board connections, the new implementation industrialized USB and mimicked the stacking scheme popularized by PC/104 for ISA. Multiple specifications were introduced, among them were the PC/104 Consortium, Small Form Factors and StackableUSB™ from Micro/sys. USB could now reliably be implemented in industrial and embedded applications. With Micro/sys’ recent release of fully integrated embeddable vision kits, StackableUSB now implements USB3.0 in a version of the stacking format called CAMSTACK™, a quick and easy way to securely attach USB3.0 cameras to a single board computer via on-board stacking connectors. The wisdom in moving USB into a stackable format for embedded has become more apparent as USB has continued to evolve. Implementing USB in an embedded application will always be different than the stackable mentality of the PC/104 days, but for some specific areas, USB has become the most effective and efficient way to integrate functionality into an embedded system. This has become increasingly true as USB 2.0 has evolved into USB 3.0.

Evolution that moves successful technology from one market to another: USB3 Vision™ - High Bandwidth Vision Processing with Simple Connectivity The evolution of USB into USB 3.0 has kept right on going and led to the introduction of the USB3 Vision Standard which will ease the implementation of vision in the embedded board level market. The USB3 Vision Standard for camera connectivity and image processing lays out how to format, stream, and control the imaging and video data transfers over the bus on the hardware side and defines the interoperability of software and SDKs for the host computer on the software side, all while taking advantage of key distinct USB 3.0 advantages: •A ffordable and widely available USB 3.0 ports present on most embedded SBCs

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• High bandwidth in excess of 350 MB/s for fast image processing • Easy-to-use plug and play interface and interoperability between camera vendors • Secure cabling through passive power and data cables up to five meters, further distances with active cables and increased reliability with close proximity stackable configurations • Support via the industry standard GenICam™ generic programming interface USB3 Vision is one of several viable camera interfaces available for image processing. While embedded designers need to do a careful analysis to ensure they select the most appropriate camera technology for their application, USB3.0 Vision offers many advantages to embedded users. Users will typically find that USB3Vision fits nicely into the camera specification gap between a Gigabit Ethernet camera interface and a CameraLink camera interface or as a replacement for a Firewire™ camera. Some of the advantages of the USB3 Vision Specification are: • Low CPU Load when DMA is implemented • Variable image size • Low latency and jitter • System stability driven by secure physical connections to cameras

Evolution that Reduces Complexity: Heterogeneous Processors Ease the Burden of Implementing Complex Vision Applications

For a multitude of reasons, the ARM CPUs used in smartphone technology is influencing product offerings in embedded computing as this system-on-chip (SOC) technology brings key advantages to embedded users. The unquenchable demand for more performance and new, more advanced feature sets such as those in the consumer smartphones has driven a veritable revolution in SoC design.

Figure 2 Today’s system level implementation of an industrial inspection or active surveillance using a low-power, stackable ARM single board computer running Linux

Processor suppliers are racing to add hardware acceleration and to integrate diverse I/O channels into their processor designs in order to lower costs and improve battery life. This is great news for embedded users. Processors sporting increased SoC feature set are of immense interest to the embedded system designer, who is constantly striving for more processing power in a smaller, less power hungry package. As a result, ARM processors are making big inroads into embedded. Not surprisingly, these ARM processors include USB 3.0 in their feature set and multi-core CPUs, sometimes called heterogeneous CPUs. The field of embedded image processing and computer vision is a prime example of the impact of ARM technology and heterogeneous CPUs. A typical automated industrial inspection or active surveillance system from a few years ago might have looked something like (Figure 1). In this example a camera is connected to a frame capture card inside an Intel based PC. The captured video frames are sent via PCI Express to a single board computer (SBC) for processing and analysis. The SBC, in turn, utilizes off-board storage in the form of a hard drive or solid-state storage device, and passes its results to an operator station over Ethernet. In contrast, a current-generation system using an ARM CPU might look something like (Figure 2). While outwardly similar, the system in figure 2 provides significant cost and power savings over previous generation systems, along with lower overall system latency. This is provided largely by the increased integration achieved using the ARM technology which includes USB3.0 along with a processors that has specialized computational units which, in this case, implements a powerful NEON GPU graphic processor.

Blazing Frames™ SBC4661 single board computer. At the heart of the SBC4661 is Freescale’s System on Chip (SoC) i.MX6 multimedia processor. This CPU is augmented with a floating-point coprocessor, ARM’s NEON™ SIMD media accelerator, hardware accelerators for fast, power-efficient 3D and 2D graphics operation, and OpenGL® ES 2.0. Micro/sys adds to this impressive list by providing a Linux BSP with development and runtime image modes, turn-key vision firmware tools and the CAMStack connector for easy connection of USB3 Vision Cameras. The iMX™ processor family from Freescale is a popular CPU series which is offered on single board computer products from a wide range of embedded board level companies whose offerings are as diverse as partially populated, DIY kits to fully featured, turn-key development kits. For the embedded designer considering an embedded vision application, it is certain that the migration of the technology that fueled the camera revolution in cell phones will continue to move into embedded applications and combine with the stackable traditions in embedded and include the USB plug and play interoperability features to make the implementation of embedded vision applications easier and easier in the years to come.

Convergence of three evolving technologies: Stackables, USB3 Vision and ARM processors One example of how USB3 Vision, stackable board level products and ARM processors are being combined to enable simpler implementation of complex embedded applications is Micro/sys’

Figure 3 Micro/sys’ Blazing Frames SBC4661 Cortex-A9™ ARM single board computer hosting a Basler ace USB 3.0 camera via CAMStack™

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