Sterling Medical Devices is your Partner in Medical Device Development
System Design, Development and Test
- Software and Electronics Experts
- Any Phase
Risk planning and hazard identification
DHF Remediation
Project Rescue
Quality System Consulting
450+ Medical Projects, 125+ Clients
Mobile Testing: What—and What Not—to AutomateTechWell
Organizations are moving rapidly into mobile technology, which has significantly increased the demand for testing of mobile applications. David Dangs says testers naturally are turning to automation to help ease the workload, increase potential test coverage, and improve testing efficiency. But should you try to automate all things mobile? Unfortunately, the answer is not always clear. Mobile has its own set of complications, compounded by a wide variety of devices and OS platforms. Join David to learn what mobile testing activities are ripe for automation—and those items best left to manual efforts. He describes the various considerations for automating each type of mobile application: mobile web, native app, and hybrid applications. David also covers device-level testing, types of testing, available automation tools, and recommendations for automation effectiveness. Finally, based on his years of mobile testing experience, David provides some tips and tricks to approach mobile automation. Leave with a clear plan for automating your mobile applications.
Training Opportunity: Certified Mobile App Professional (CMAP) TestingITpreneurs
Downloaded an app onto your phone lately? With app downloads mounting into the billions each year, there is a need for general standards in the creation and usage of mobile technology – and this provides a great opportunity for training companies: Meet Certified Mobile App Professional (CMAP). CMAP is a certification from the International Software Quality Institute (ISQI) specifically designed for anyone involved in Mobile App Testing. A great next step for those with Foundation Level certificate as “ISTQB Certified Tester” (CTFL).
Agenda:
Introduction: What will you learn today?
About CMAP
The Challenges of Mobile App Testing
Business Needs
Go-To-Market Strategies for CMAP
How to Get Started
Questions & Answers
Mobile applications testing (challenges, tools & techniques)Rakesh Jha
Device Fragmentation is a Big Challenge
Devices Vary in Screen Size, Memory, Processing Power, Hardware Features etc.
Apple iPhone is Least Fragmented among All Mobile Platforms
Testing on All Target Handset/Devices
Almost Impractical if Number of Target Handsets is Large
Testing on All Target Operator Networks
Almost Impractical if Number of Target Operators is Large
Network Operator may Impose Certain Constraints
Mobile Testing: What—and What Not—to AutomateTechWell
Organizations are moving rapidly into mobile technology, which has significantly increased the demand for testing of mobile applications. David Dangs says testers naturally are turning to automation to help ease the workload, increase potential test coverage, and improve testing efficiency. But should you try to automate all things mobile? Unfortunately, the answer is not always clear. Mobile has its own set of complications, compounded by a wide variety of devices and OS platforms. Join David to learn what mobile testing activities are ripe for automation—and those items best left to manual efforts. He describes the various considerations for automating each type of mobile application: mobile web, native app, and hybrid applications. David also covers device-level testing, types of testing, available automation tools, and recommendations for automation effectiveness. Finally, based on his years of mobile testing experience, David provides some tips and tricks to approach mobile automation. Leave with a clear plan for automating your mobile applications.
Training Opportunity: Certified Mobile App Professional (CMAP) TestingITpreneurs
Downloaded an app onto your phone lately? With app downloads mounting into the billions each year, there is a need for general standards in the creation and usage of mobile technology – and this provides a great opportunity for training companies: Meet Certified Mobile App Professional (CMAP). CMAP is a certification from the International Software Quality Institute (ISQI) specifically designed for anyone involved in Mobile App Testing. A great next step for those with Foundation Level certificate as “ISTQB Certified Tester” (CTFL).
Agenda:
Introduction: What will you learn today?
About CMAP
The Challenges of Mobile App Testing
Business Needs
Go-To-Market Strategies for CMAP
How to Get Started
Questions & Answers
Mobile applications testing (challenges, tools & techniques)Rakesh Jha
Device Fragmentation is a Big Challenge
Devices Vary in Screen Size, Memory, Processing Power, Hardware Features etc.
Apple iPhone is Least Fragmented among All Mobile Platforms
Testing on All Target Handset/Devices
Almost Impractical if Number of Target Handsets is Large
Testing on All Target Operator Networks
Almost Impractical if Number of Target Operators is Large
Network Operator may Impose Certain Constraints
This presentation gives an overview of different application delivery techniques including presentation virtualization, desktop virtualization and application streaming
Introduction
Mobile Trends
Mobile Evolution
Top Ten Trends
Mobile Ecosystem
Smartphone Trends
Mobile Application Testing
Application Option
Approach to QA
Challenges
Implementation
With advancement in Technology, Smartphones and mobile networks have created an ecosystem today to enhance information insight for users. With this rapid development, Mobile Applications have become integral part of daily life of people and enterprise. The complexities have increased many-fold due to manufacturers unveiling new mobile devices, OS and integrations with other systems. The need for testing mobile application has grown substantially; has become more challenging due to market competition, platform complexity and rapid customer adoption for such Applications.
Ta3s team has extensive experience in mobile application testing and automation for mobile apps. We provide functional testing, installation testing, test automation services using latest commercial and open-source tools coupled with home-grown robust automation framework, compatibility testing, regression testing, performance testing, usability testing, accessibility testing and security/vulnerability testing, interrupt testing, certification and App Store approval testing. Ta3s enables customers deploy application for mobile with confidence and quality. We not only test on simulators / emulators but also on real devices. Ta3s has partnered with world-class device vendors to provide customers the ability to test their application on-demand.
Ta3s Advantage
• Real device, real network, real OS testing
• Customer specefic robust test automation framework
• Test automation suite created for execution on real or on simulator devices
• Availability of high calibre experts and engineers
• Maintanable and reliable Automated Test Suites to conduct effective regression tests
• Integration to TA3SALM providing requriements to defect tracibility and reporting
• Best practices and seamless knowledge transfer
Software Assurance, LLC a Dallas-based Testing-centric Company offers specialized Mobile App Testing - We define your Mobile Apps Strategy - Faster, Better & Economically.
Highlights of the new value proposition for metering personnel at their respective utility companies in a post-AMI world. Examples of issues which have arisen or been identified over the course of various deployments and in the immediate aftermath of an AMI deployment.
Presented at SWEMA 2013.
Highlights of the new value proposition for metering personnel at their respective utility companies in a post-AMI world. Examples of issues which have arisen or been identified over the course of various deployments and in the immediate aftermath of an AMI deployment. 11/2014
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
We Got a Warning Letter – Now What? How to Keep Calm in a Compliance StormDesign World
Warning Letters – 483 observations – CAPAs from a regulatory inspection! They happen to even the best of companies. And when they do happen you’ve got only 15 days to respond. A late or inadequate response could be disastrous to the company.
Wherever the remediation effort has been triggered, there are immediate steps you should take in order to help your firm navigate the remediation. This webinar will provide you with the steps necessary to reach a successful outcome.
This webinar is intended for medical device executives or those in industry who want to be prepared to deal with compliance issues or may be faced with a remediation project.
This presentation gives an overview of different application delivery techniques including presentation virtualization, desktop virtualization and application streaming
Introduction
Mobile Trends
Mobile Evolution
Top Ten Trends
Mobile Ecosystem
Smartphone Trends
Mobile Application Testing
Application Option
Approach to QA
Challenges
Implementation
With advancement in Technology, Smartphones and mobile networks have created an ecosystem today to enhance information insight for users. With this rapid development, Mobile Applications have become integral part of daily life of people and enterprise. The complexities have increased many-fold due to manufacturers unveiling new mobile devices, OS and integrations with other systems. The need for testing mobile application has grown substantially; has become more challenging due to market competition, platform complexity and rapid customer adoption for such Applications.
Ta3s team has extensive experience in mobile application testing and automation for mobile apps. We provide functional testing, installation testing, test automation services using latest commercial and open-source tools coupled with home-grown robust automation framework, compatibility testing, regression testing, performance testing, usability testing, accessibility testing and security/vulnerability testing, interrupt testing, certification and App Store approval testing. Ta3s enables customers deploy application for mobile with confidence and quality. We not only test on simulators / emulators but also on real devices. Ta3s has partnered with world-class device vendors to provide customers the ability to test their application on-demand.
Ta3s Advantage
• Real device, real network, real OS testing
• Customer specefic robust test automation framework
• Test automation suite created for execution on real or on simulator devices
• Availability of high calibre experts and engineers
• Maintanable and reliable Automated Test Suites to conduct effective regression tests
• Integration to TA3SALM providing requriements to defect tracibility and reporting
• Best practices and seamless knowledge transfer
Software Assurance, LLC a Dallas-based Testing-centric Company offers specialized Mobile App Testing - We define your Mobile Apps Strategy - Faster, Better & Economically.
Highlights of the new value proposition for metering personnel at their respective utility companies in a post-AMI world. Examples of issues which have arisen or been identified over the course of various deployments and in the immediate aftermath of an AMI deployment.
Presented at SWEMA 2013.
Highlights of the new value proposition for metering personnel at their respective utility companies in a post-AMI world. Examples of issues which have arisen or been identified over the course of various deployments and in the immediate aftermath of an AMI deployment. 11/2014
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
We Got a Warning Letter – Now What? How to Keep Calm in a Compliance StormDesign World
Warning Letters – 483 observations – CAPAs from a regulatory inspection! They happen to even the best of companies. And when they do happen you’ve got only 15 days to respond. A late or inadequate response could be disastrous to the company.
Wherever the remediation effort has been triggered, there are immediate steps you should take in order to help your firm navigate the remediation. This webinar will provide you with the steps necessary to reach a successful outcome.
This webinar is intended for medical device executives or those in industry who want to be prepared to deal with compliance issues or may be faced with a remediation project.
Deploying the Voice of the Customer in the Development of a New Medical DeviceKrisDekom
Using the Voice of the Customer to create new medical devices leads to mcuh better products for the customers.
I successfully used this methodology in the development of a complex new device (hemodialysis machine) for Baxter Healthcare.
This is the presentation from the Management Roundtable Conference in Boston, 2004
Thomas Kauders - Agile Test Design And Automation of a Life-Critical Medical ...TEST Huddle
EuroSTAR Software Testing Conference 2010 presentation on Agile Test Design And Automation of a Life-Critical Medical Device by Thomas Kauders. See more at: http://conference.eurostarsoftwaretesting.com/past-presentations/
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Beyond FDA Compliance Webinar: 5 Hidden Benefits of Your Traceability MatrixSeapine Software
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
5 Tips for Using TIA Portal V14 to Decrease Safety Development Time DMC, Inc.
Presenter - Ryan Landwehr
The release of Totally Integrated Automation Portal V14 made significant improvements to SIMATIC STEP 7 Safety. We will demonstrate how these new features can decrease development time and significantly decrease wiring while maintaining or improving the SIL or PL.
This presentation will discuss how to use these new features, including S7-1200F PROFIsafe communication and distributed safety using F-I-Device communication. We will also explore ways to program your Siemens safety PLC effectively and efficiently through reusable safety function blocks, PLC data types, and built-in Siemens safety blocks.
How to use Bluetooth® Smart to control your embedded device with a mobile deviceAnaren, Inc.
This presentation explores the challenges facing OEMs trying to achieve wireless control of their embedded applications via Bluetooth mobile devices -- and several tips for overcoming those challenges. At the session’s conclusion, he will also touch on how Anaren's online development tool (Atmosphere) simplifies the embedded-to-mobile-device code authoring experience.
Industrial Ethernet, Part 1: TechnologiesControlEng
Industrial Ethernet implementations continue to gain traction on the plant floor and in process plants. What are the key industrial Ethernet technologies being installed today and why? Learn from automation system integrators about criteria used to choose types of switches, cabling, and topologies being applied for industrial Ethernet applications. Ethernet survey results are discussed. An exam and certificate are available for one professional development hour (PDH), according to Registered Continuing Education Program (RCEP) rules from the American Council of Engineering Companies.
Internet of Things - structured approach to the physical plant network - Rock...Carotek
The convergence of new technologies that securely connect plant information with enterprise systems can bring greater productivity, better utilization of assets, and improved decision-making to industrial companies. By bridging the gap between factory-level systems and enterprise systems, Rockwell Automation and Cisco can show how the connected enterprise offers ease of use, lower total cost of ownership, and improved operations.
Third Party Security Testing for Advanced Metering Infrastructure ProgramEnergySec
In July 2010, BC Hydro, the electric utility and grid operator of British Columbia began implementation of its AMI program, formally known as the Smart Meter & Infrastructure (SMI) program. The SMI program transformed BC Hydro from a traditional metering utility to a smart metering utility by implementing smart meters on the customer service points. It was the first step in the smart grid transformation.
The SMI program required the introduction of many new devices and applications into BC Hydro’s infrastructure. Some of these had never been deployed before anywhere in the world. Many were field deployed, outside of BC Hydro’s physical security perimeter.
The SMI Security Delivery Team was formed to deliver on these commitments and to take responsibility for the end to end security of the SMI program. The Team implemented a multi-pronged approach to securing SMI including security risk assessments, security penetration testing by the team, design reviews, whole project risk assessments and third party security penetration testing.
A standards based approach was required to ground the test plan both in best practice and in a common set of principles that BC Hydro and its vendors could accept. The Advanced Metering Infrastructure (AMI) Risk Assessment document prepared by the Advanced Metering Infrastructure Security (AMI-SEC) Task Force was used as a basis for the test plan. This document has since been passed to the National Institute of Standards and Technology (NIST) Cyber Security Working Group and was integrated into NIST IR 7628. NIST IR 7628 contains a comprehensive list of possible threats to AMI systems.
The program was highly successful. Test results informed BC Hydro’s deployment decisions and allowed the manufacturers to improve their products. Lessons were learned about how best to conduct third party security testing. A full lessons learned section is included in the presentation.
Experitest & Capgemini held a co-webinar on the topic: A Secure Mobile Testing Cloud Resource - Accessible Anytime Anywhere. This interactive webinar will help you to learn more about a Cloud solution that offers features, functions and benefits for each member of the mobile-applications development team:
* For developers an easy reproduction of bugs and the ability to reserve a time slot;
* For QA managers, how to plan in advance device usage and control applications under test;
* For device lab managers a 24x7 continuous testing environment;
* For manual QA testers learn to emulate keyboards for devices and script automation;
* For automation engineers, automate tests via desktop, reserve devices, & generate reports;
* For the security team, resource access from the cloud within your company firewall;
* For executives – reduce user-device procurement costs, speed time-to-market, and improve user/customer experiences.
Security is a high priority when developing and testing mobile apps for companies that are sensitive to security. Access to a provider’s Cloud-hosted testing resources may be convenient and cost-effective, but the security of that environment falls under their control. What was originally a solution becomes a risk to your institution’s data and information.
Among other challenges faced by developers and testers using generic Cloud testing resources:
* Securing a location for devices.
* Concentrating a central pool of devices accessed by offsite development and testing teams;
* Distribution of work across geographically isolated teams;
* Specific device identification and availability;
Curiosity and Sauce Labs present - When to stop testing: 3 dimensions of test...Curiosity Software Ireland
This webinar was co-hosted by Curiosity Software and Sauce Labs on the 28th of September, 2021. Watch the webinar on demand today: https://opentestingplatform.curiositysoftware.ie/stop-testing-test-coverage-webinar
A definition of “done” is one of the hardest and most valuable things to come by in testing. Faced with fast-changing, massively complex systems, there’s no time to test everything in short sprints. Even defining “everything” is hard enough, given the vast and often unknown system logic, user devices, and integrated technologies that must be factored into rigorous testing. Too often, a lack of measurability combines with unsystematic test design, forcing testers to guess or hope that testing is “done”. This introduces uncertainty with every rapid release. Tests leave logic exposed to costly bugs and performance issues, while untested devices warp UIs and user experiences.
This webinar will set out how testing can rapidly identify, generate, and run the tests needed to de-risk rapid software releases. It will define functional test coverage in three dimensions, considering the system logic and data that must be tested, the optimal device mix, and the need to test across different system tiers. James Walker, Curiosity’s Director of Technology, and Marcus Merrell, Senior Director of Technology Strategy at Sauce Labs, will then demonstrate how in-sprint testing can target tests based on this multifaceted measure. You will see how:
1. Generating optimised tests, data and scripts from visual flowcharts avoids slow test creation and maintenance, while testing system logic rigorously based on time and risk.
2. Pushing tests to cloud-based device labs minimises environment and device limitations, enabling the right mix for each stage of the testing lifecycle.
3. Updating central flows regenerates tests in-sprint, targeting impacted and risky logic across APIs, UIs and back-end systems.
A motivated, flexible professional with experience in IT and Telecommunications testing technologies. Held government clearance for Department of Energy (DOE), Department of the Defense (DOD) and Department of Homeland Security (DHS). Provide test planning, test execution, and test management and reporting to ensure software products and hardware solutions meet the specified requirements per client. User Experience and User Interface evaluation and Public Safety knowledge/experience. Proficient in the use and support of CDMA and GSM hardware and software applications. Strong interpersonal, analytical and customer service skills, performing to Service Level Agreement (SLA) performance levels. Investigating and resolving test, instrumentation and production issues cross-functionally with the Customers and Original Equipment Manufacturers ’(OEMs). Can-do attitude with strong work ethics. Ability to motivate team members and co-workers to achieve positive result and meet customer expectations.
Mobile Medical Devices: A Trip to the Trenches of Design and Test
1. Mobile Medical Devices
A Trip to the Trenches of Design and Test
Medical Device Summit, Boston, MA.
February 25, 2014
Daniel Sterling, President
2. What we do:
o System Design, Development and Test
Software and Electronics Experts
Any Phase
o Risk planning and hazard identification
o DHF Remediation
o Project Rescue
o Quality System Consulting
450+ Medical Projects, 125+ Clients
Who is Sterling?
ISO 13485
FM 543438
Registered
IEC 62304 Compliant
Your Partner in Medical Device Development
There when you need us!
3. Design and Test Risks
The more things change…
• Requirements not well defined
• Design team too large or too small
• Design team does not have enough experience
in the technologies being used
• Design Decisions Not Clearly
Documented/Captured
• Challenges around user preferences
– ‘Sexy GUI’ vs. battery life/recharging frequency.
4. Design and Test Risks
… but, Now There’s More
• Obsolescence/Configuration Control
• Tradeoffs More Difficult
• Data Transport Specific Challenges
5. Design and Test Risks
… but, Now There’s More
• Obsolescence/Configuration Control
– Mobile product obsolescence – phones and wifi-only devices like
iTouch and Android devices come and go rapidly compared to the
lifespan of medical device systems.
– HHDs (Hand Held Devices) Part Dependency - if you are using parts
that are popular for phones and the phone is then discontinued, the
availability of parts tend to dry up pretty quickly, or become rather
expensive since the volume disappears. This can put a real glitch in
a mfg schedule / device cost; plus the mfg often has to purchase
enough inventory of the current part to hold the product in
production until a redesign can occur.
6. Design and Test Risks
… but, Now There’s More
• Obsolescence/Configuration Control
– Life cycle management of the selected product will be key not only
during development but during production.
– The manufacturer (Apple, Motorola, Samsung) could make slight
changes which have a –severe- impact on the final design.
7. Design and Test Risks
… but, Now There’s More
• Difficult Tradeoffs
– Feature Richness vs.
– Battery Life vs.
– Communication Robustness vs.
– Validation Requirements vs.
– Security Considerations…
When a good portion of the design is out of your control,
How to best integrate the mobile device into your medical system
8. Design and Test Risks
… how do you Integrate?
WiFi
• Robustness across a variety of LAN configurations requires more system
planning
– Home use devices – To support the average, non-technical users, requiring
advanced configurations like port forwarding may be unworkable
– Server technologies can be implemented to circumvent network address
translation issues and to enforce Security to prevent unauthorized access
9. Design and Test Risks
… how do you Integrate?
WiFi
• Server to prevent unauthorized connections –
– by authenticating all users of the iPhone app, and to facilitate
secure connection pairing. The peer-to-peer connections are
authenticated using session keys generated by the server.
– to ensure maximum security all ports that are not used by the
system should be closed.
– all communication encrypted.
10. Design and Test Risks
… how do you Integrate?
Bluetooth/BLE
• For Short Range
• They are not the same
– On the device side, implementing one and then switching is time consuming and
costly, so plan ahead
– BLE has less compliance requirements from Apple
• Hardware Considerations
– Modules (pre-certified) vs. Raw chips
• Raw implies FCC Certification will be needed
– Modes supported (client and/or server)
11. Design and Test Risks
… how do you Integrate?
Bluetooth/BLE
• BLE, Reduced Power Consumption – Sleeps Most of the Time
• iOS has CoreBluetooth – Need to Understand Restrictions
• Off The Shelf Stacks May be Unstable – Need to be able to modify
12. Design and Test Risks
… how do you Integrate?
Cellular
• 2G/3G/4G choice:
– Need to balance cost, coverage, and lifespan of technology
– 2G – Frequencies compatible with all carriers in a given region (only 4 bands
worldwide), lowest cost, widespread coverage throughout the world. 2G service
will be deactivated by 2018 in many regions. Extremely slow data rates.
– 3G – Higher cost, slightly more “fragmentation” on the frequencies used across
carriers. Good coverage and good data rates for most applications. Cost of
implementation is higher than 2G but expected to go down as time goes on.
Will probably live beyond 2020.
– 4G – Highest cost, antenna design more difficult due to band fragmentation
among carriers (e.g. Verizon, ATT, and T-Mobile all have different LTE bands that
only partially overlap). Limited coverage outside of major metro areas.
13. Design and Test Risks
… how do you Integrate?
Cellular
• Module vs Discrete IC implementation:
– Modules are expensive and physically large and may have higher power consumption
due to on-board processor not required in a discrete implementation.
– Modules can be cheaper when adding in development costs, because you can re-use
part of their FCC certification (but not all). How much depends on your
implementation details. Expect to perform, at least, EMC testing to FCC Part 15.
– Modules may have higher levels of conducted harmonics than the best discrete
implementations, making it more difficult to pass EMC testing (PTCRB or
Verizon/Sprint approval).
– Discrete implementation requires significant RF expertise on staff, longer
development time, and may require work with the cellular carrier directly for
approval. FCC submission significantly more burdensome as there will be no existing
submission to leverage.
14. Design and Test Risks
… how do you Integrate?
Cellular
• EMC testing difficulties:
– Due to the high power levels of cellular transmitters (up to 2W / +33 dBM),
there are very real concerns about both RF ingress to other circuits in the
device, and harmonic emissions due to interactions with other components in
the device.
– Must pass PTCRB certification in the US market if you are using a GSM carrier
such as AT&T and T-Mobile. Verizon and Sprint have their own similar
requirements. Carrier certifications have extremely strict limits for emissions,
much more difficult than the FCC requirements.
– Expect to have to use a custom / tuned antenna design to meet carrier
requirements. Off the shelf antenna designs will often lead to emissions failures
or power levels below required limits.
– Plan to do pre-compliance testing early and often
15. Design and Test Risks
… how do you Integrate?
RF Communications
• Used for Legacy I/O – We have created Bluetooth <–> RF
“translator” interfaces
• Transfer Power (along with I/O)
• Can Have Cost, Risk Advantages
• However, Not Available On Smart-Devices
16. Compliance Challenges
OTS Mobile Devices
• Inability to verify if OTS mobile devices comply with
IEC60601 and IEC 62133 (electrical and battery safety)
• May not pass:
– Particle and Liquid Ingress (IPXX)
– Drop Testing per 60601-1-11
• Use UL Approved Devices
– Premium cost but may save valuable time late in project
• OTS OS, Software
– Controlled, Validated
17. Thanks to the follow for their valuable contributions:
Bruce Swope Lawrence Bischoff
Chris Bradley Keith Handler
Steve Hartman Jamme Tan
John Campbell
Mobile Medical Devices,
A Trip to the Trenches of
Design and Test
18. Contact for more information:
Erik Hilliard
Director of Business Development
Sterling Medical Devices
201-227-7569 x155
ehilliard@sterlingmedicaldevices.com
www.sterlingmedicaldevices.com
Mobile Medical Devices,
A Trip to the Trenches of
Design and Test
19. Design and Test Risks
… how do you Integrate?
WiFi
• To create a peer-to-peer connections over the internet without
requiring the user to configure port forwarding we used a primary
connection method with a more reliable fallback method:
– The first method is UDP hole punching - This method has been shown to
work on the majority of commonly used routers and, if successful, allows a
direct peer-to-peer connection across NATs without requiring port-
forwarding.
– The second method is to relay all packets through a central server. Each
device (the iPhone application and the medical device) makes an outgoing
connection to the server which relays all packets between the two.
Editor's Notes
General/System:
Non-mobile –
Requirements not well defined
Design team too large or too small
Design team does not have enough experience in the technologies being used.
Not clearly documenting the design decisions
Challenges around what users like (e.g. color screens) vs. battery life/recharging frequency. Especially with Class C/II devices.
Dan> your point here is that a consumer device may be optimized differently than a medical device, right?
That is part of it; the next point below is more important here though.
Dan> I want to make sure I know what you mean by Class C/II… are you talking about 62304 Class C?
Yes, and it was supposed to be a class III device; life support type – the point being that getting the most out of the battery life may sometimes be more important than having a ‘sexy’ GUI that draws a lot of current…something like that.
Mobile – Specific –
Obsolescence/Configuration Control
mobile product obsolescence – phones and wifi-only devices like iTouch and Android devices come and go rapidly compared to the lifespan of medical device systems.
There are mfg issues with either mobile phone type devices or even HHDs (Hand Held Devices) where if you are using parts that are popular for phones and the phone is then discontinued, the availability of parts tend to dry up pretty quickly, or become rather expensive since the volume disappears. This can put a real glitch in a mfg schedule / device cost; plus the mfg often has to purchase enough inventory of the current part to hold the product in production until a redesign can occur.
Life cycle management of the selected product will be key not only during development but during production. The manufacturer could make slight changes which have a severe impact on the final design.
Difficult Tradeoffs
Fancy GUI vs. Battery life, more of an issue in mobile because you have less design control with off the shelf components.
When a mobile device is used as part of a medical device system, one of the questions that need to be addressed is: “how to integrate the mobile device with the rest of the system?”
Two common technologies that can be used are Bluetooth and Bluetooth Low Energy. If battery life is a concern, Bluetooth Low Energy may be the right choice there
Technology Related –
Mobile – Specific –
Obsolescence/Configuration Control
mobile product obsolescence – phones and wifi-only devices like iTouch and Android devices come and go rapidly compared to the lifespan of medical device systems.
There are mfg issues with either mobile phone type devices or even HHDs (Hand Held Devices) where if you are using parts that are popular for phones and the phone is then discontinued, the availability of parts tend to dry up pretty quickly, or become rather expensive since the volume disappears. This can put a real glitch in a mfg schedule / device cost; plus the mfg often has to purchase enough inventory of the current part to hold the product in production until a redesign can occur.
Life cycle management of the selected product will be key not only during development but during production. The manufacturer could make slight changes which have a severe impact on the final design.
Difficult Tradeoffs
Fancy GUI vs. Battery life, more of an issue in mobile because you have less design control with off the shelf components.
When a mobile device is used as part of a medical device system, one of the questions that need to be addressed is: “how to integrate the mobile device with the rest of the system?”
Two common technologies that can be used are Bluetooth and Bluetooth Low Energy. If battery life is a concern, Bluetooth Low Energy may be the right choice there
Technology Related –
Mobile – Specific –
Obsolescence/Configuration Control
mobile product obsolescence – phones and wifi-only devices like iTouch and Android devices come and go rapidly compared to the lifespan of medical device systems.
There are mfg issues with either mobile phone type devices or even HHDs (Hand Held Devices) where if you are using parts that are popular for phones and the phone is then discontinued, the availability of parts tend to dry up pretty quickly, or become rather expensive since the volume disappears. This can put a real glitch in a mfg schedule / device cost; plus the mfg often has to purchase enough inventory of the current part to hold the product in production until a redesign can occur.
Life cycle management of the selected product will be key not only during development but during production. The manufacturer could make slight changes which have a severe impact on the final design.
Difficult Tradeoffs
Fancy GUI vs. Battery life, more of an issue in mobile because you have less design control with off the shelf components.
When a mobile device is used as part of a medical device system, one of the questions that need to be addressed is: “how to integrate the mobile device with the rest of the system?”
Two common technologies that can be used are Bluetooth and Bluetooth Low Energy. If battery life is a concern, Bluetooth Low Energy may be the right choice there
Technology Related –
Mobile – Specific –
Difficult Tradeoffs
Fancy GUI vs. Battery life, more of an issue in mobile because you have less design control with off the shelf components.
When a mobile device is used as part of a medical device system, one of the questions that need to be addressed is: “how to integrate the mobile device with the rest of the system?”
Two common technologies that can be used are Bluetooth and Bluetooth Low Energy. If battery life is a concern, Bluetooth Low Energy may be the right choice there
Technology Related –
Mobile – Specific –
Technology Related –
Wifi –
uncovered several ways transfer can be limited using wifi so more system planning would be necessary.
Home use devices requiring direct communication over the internet. To support the average, non-technical, user server technologies have to be implemented to circumvent network address translation issues. Furthermore, safeties have to be in place to prevent unauthorized access.
To create a peer-to-peer connection over the internet without requiring the user to configure port forwarding we are implementing a primary connection method with a more reliable fallback method:
The first method is UDP hole punching. This method has been shown to work on the majority of commonly used routers and, if successful, allows a direct peer-to-peer connection across NATs without requiring port-forwarding. If a TCP connection is required this method can still be used, but it will be slightly less reliable. This method offers a performance advantage over the second method since all connections are direct.
The second method is to relay all packets through a central server. Each device (the iPhone application and the device) makes an outgoing connection to the server which relays all packets between the two. While this method is more reliable, it is also lower performance and requires load-balanced server technologies capable of handling large amounts of data from many concurrent connections. If large amounts of data are transmitted regularly costs can be extremely large. We chose Amazon Web Services to host the relay server as it provides all required server technologies in a very cost effective and reliable manner. (Amazon Web Services is certified HIPPA compliant, and is perfect for any client that doesn’t want to handle the overhead of setting up and maintaining, or paying for physical server solutions. Let me know if you would like more information.)
For a medical device this can be used for a wifi device in a patient’s home that could be accessed by their physician over the internet. This presents additional security concerns to prevent unauthorized connections. The central server is used to authenticate all users of the iPhone app, and to facilitate secure connection pairing. The peer-to-peer connections are authenticated using session keys generated by the server.
For the server, to ensure maximum security all ports that are not used by the system should be closed.
Of course, all communication should always be encrypted.
Mobile – Specific –
Technology Related –
Wifi –
uncovered several ways transfer can be limited using wifi so more system planning would be necessary.
Home use devices requiring direct communication over the internet. To support the average, non-technical, user server technologies have to be implemented to circumvent network address translation issues. Furthermore, safeties have to be in place to prevent unauthorized access.
To create a peer-to-peer connection over the internet without requiring the user to configure port forwarding we are implementing a primary connection method with a more reliable fallback method:
The first method is UDP hole punching. This method has been shown to work on the majority of commonly used routers and, if successful, allows a direct peer-to-peer connection across NATs without requiring port-forwarding. If a TCP connection is required this method can still be used, but it will be slightly less reliable. This method offers a performance advantage over the second method since all connections are direct.
The second method is to relay all packets through a central server. Each device (the iPhone application and the device) makes an outgoing connection to the server which relays all packets between the two. While this method is more reliable, it is also lower performance and requires load-balanced server technologies capable of handling large amounts of data from many concurrent connections. If large amounts of data are transmitted regularly costs can be extremely large. We chose Amazon Web Services to host the relay server as it provides all required server technologies in a very cost effective and reliable manner. (Amazon Web Services is certified HIPPA compliant, and is perfect for any client that doesn’t want to handle the overhead of setting up and maintaining, or paying for physical server solutions. Let me know if you would like more information.)
For a medical device this can be used for a wifi device in a patient’s home that could be accessed by their physician over the internet. This presents additional security concerns to prevent unauthorized connections. The central server is used to authenticate all users of the iPhone app, and to facilitate secure connection pairing. The peer-to-peer connections are authenticated using session keys generated by the server.
For the server, to ensure maximum security all ports that are not used by the system should be closed.
Of course, all communication should always be encrypted.
Mobile – Specific –
Technology Related –
Bluetooth/BLE -
The BLE component was not used in the implantable but in the external RF charger for the implant (Energizer neck collar). Theoretically, they could have used Bluetooth in this case, but decided on using Bluetooth Low Energy because Apple has certain restrictions for apps that integrate with Bluetooth. By going to BLE, they avoided having to get their iPad application certified (not sure how much more thorough the certification process would have been).
BLE devices provide the added benefit of reduced power consumption. This is because the BLE radio is in low powered mode (sleeping) for most of the time. Although BLE and Bluetooth share a common name, they are completely different technologies that require different firmware (minimal code can be ported from one implementation to the other). So a switch from one to another can be very costly – basically starting from scratch, so you would want to invest time up front deciding on the right choice for your project.
With Bluetooth development, it’s important to select the correct chip configuration and manufacturer for your device. Some chips are pre-certified as modules, while others are raw chips which will need to be integrated into your system. The manufacturers provide reference designs to aide in this integration, but because it is a raw chip, you will need to add your own antenna and subsequently have your medical device FCC certified for Bluetooth. Additionally, with Bluetooth low energy (although maybe this applies to Bluetooth also), you will want to be careful with the specific chip you select because some chips may not support the intended use of your medical device. E.g. the original BLE component on the Energizer was a blue radio BLE module. That BLE chip only supported the peripheral configuration (meaning it is a client consumer of data) out of the box**. This was not sufficient for the Energizer, because the Energizer was meant to be a central device (a server of data). Because of that incorrect chip selection (by client), which we identified, we needed to spec out a new chip which caused revs of the hardware.
An added benefit of selecting Bluetooth as a technology is that it is regularly found on the latest consumer mobile devices. These devices and their operating systems provide libraries that simplify development. e.g. iOS 7, which comes with the latest version of CoreBluetooth on the iOS. There are certain restrictions with CoreBluetooth, so it is important to understand those.
There are hardware considerations with integrating BLE or Bluetooth into your medical device system.
In terms of integration of Bluetooth, we did run into some connectivity issues with the use of OTS stack software for the Bluetooth chip on the wand board. Modification needs to be made in order for the device to be more stable and reliable.
Mobile – Specific –
Technology Related –
Bluetooth/BLE -
The BLE component was not used in the implantable but in the external RF charger for the implant (Energizer neck collar). Theoretically, they could have used Bluetooth in this case, but decided on using Bluetooth Low Energy because Apple has certain restrictions for apps that integrate with Bluetooth. By going to BLE, they avoided having to get their iPad application certified (not sure how much more thorough the certification process would have been).
BLE devices provide the added benefit of reduced power consumption. This is because the BLE radio is in low powered mode (sleeping) for most of the time. Although BLE and Bluetooth share a common name, they are completely different technologies that require different firmware (minimal code can be ported from one implementation to the other). So a switch from one to another can be very costly – basically starting from scratch, so you would want to invest time up front deciding on the right choice for your project.
With Bluetooth development, it’s important to select the correct chip configuration and manufacturer for your device. Some chips are pre-certified as modules, while others are raw chips which will need to be integrated into your system. The manufacturers provide reference designs to aide in this integration, but because it is a raw chip, you will need to add your own antenna and subsequently have your medical device FCC certified for Bluetooth. Additionally, with Bluetooth low energy (although maybe this applies to Bluetooth also), you will want to be careful with the specific chip you select because some chips may not support the intended use of your medical device. E.g. the original BLE component on the client Energizer was a blue radio BLE module. That BLE chip only supported the peripheral configuration (meaning it is a client consumer of data) out of the box**. This was not sufficient for the Energizer, because the Energizer was meant to be a central device (a server of data). Because of that incorrect chip selection (by client), which we identified, we needed to spec out a new chip which caused revs of the hardware.
An added benefit of selecting Bluetooth as a technology is that it is regularly found on the latest consumer mobile devices. These devices and their operating systems provide libraries that simplify development. e.g. client used iOS 7, which comes with the latest version of CoreBluetooth on the iOS. There are certain restrictions with CoreBluetooth, so it is important to understand those.
There are hardware considerations with integrating BLE or Bluetooth into your medical device system. client and client have examples of them. I, Steve, or Donovan can elaborate.
In terms of integration of Bluetooth, we did run into some connectivity issues with the use of OTS stack software for the Bluetooth chip on the wand board. Modification needs to be made in order for the device to be more stable and reliable.
Mobile – Specific –
Technology Related –
Cellular –
Module vs Discrete IC implementation:
Modules are cheap, and you can re-use part of their FCC certification but not all. How much depends on your implementation details. Expect to perform, at least, EMC testing to FCC Part 15.
Modules are expensive and physically large and may have higher power consumption due to on-board processor not required in a discrete implementation.
Modules may have higher levels of conducted harmonics than the best discrete implementations, making it more difficult to pass EMC testing (PTCRB or Verizon/Sprint approval).
Discrete implementation requires significant RF expertise on staff, longer development time, and may require work with the cellular carrier directly for approval. FCC submission significantly more burdensome as there will be no existing submission to leverage.
2G/3G/4G choice:
Need to balance cost, coverage, and lifespan of technology
2G – Frequencies compatible with all carriers in a given region (only 4 bands worldwide), lowest cost, widespread coverage throughout the world. 2G service will be deactivated by 2018 in many regions. Extremely slow data rates.
3G – Higher cost, slightly more “fragmentation” on the frequencies used across carriers. Good coverage and good data rates for most applications. Cost of implementation is higher than 2G but expected to go down as time goes on. Will probably live beyond 2020.
4G – Highest cost, antenna design more difficult due to band fragmentation among carriers (e.g. Verizon, ATT, and T-Mobile all have different LTE bands that only partially overlap). Limited coverage outside of major metro areas.
EMC testing difficulties:
Due to the high power levels of cellular transmitters (up to 2W / +33 dBM), there are very real concerns about both RF ingress to other circuits in the device, and harmonic emissions due to interactions with other components in the device.
Must pass PTCRB certification in the US market if you are using a GSM carrier such as AT&T and T-Mobile. Verizon and Sprint have their own similar requirements. Carrier certifications have extremely strict limits for emissions, much more difficult than the FCC requirements.
Expect to have to use a custom / tuned antenna design to meet carrier requirements. Off the shelf antenna designs will often lead to emissions failures or power levels below required limits.
Make provisions for shielding all active circuitry in the device, especially anything near the antenna. With 2W of RF in the device, even simple components such as diodes or thermistors can be sources of harmonic radiation (via rectification of the carrier signal). Plan to do pre-compliance testing early and often.
PCB layout must follow RF design principles to pass EMC testing. Typically the top and bottom layers must be solid ground planes with signal traces buried in inner layers.
Mobile – Specific –
Technology Related –
Cellular –
Module vs Discrete IC implementation:
Modules are cheap, and you can re-use part of their FCC certification but not all. How much depends on your implementation details. Expect to perform, at least, EMC testing to FCC Part 15.
Modules are expensive and physically large and may have higher power consumption due to on-board processor not required in a discrete implementation.
Modules may have higher levels of conducted harmonics than the best discrete implementations, making it more difficult to pass EMC testing (PTCRB or Verizon/Sprint approval).
Discrete implementation requires significant RF expertise on staff, longer development time, and may require work with the cellular carrier directly for approval. FCC submission significantly more burdensome as there will be no existing submission to leverage.
2G/3G/4G choice:
Need to balance cost, coverage, and lifespan of technology
2G – Frequencies compatible with all carriers in a given region (only 4 bands worldwide), lowest cost, widespread coverage throughout the world. 2G service will be deactivated by 2018 in many regions. Extremely slow data rates.
3G – Higher cost, slightly more “fragmentation” on the frequencies used across carriers. Good coverage and good data rates for most applications. Cost of implementation is higher than 2G but expected to go down as time goes on. Will probably live beyond 2020.
4G – Highest cost, antenna design more difficult due to band fragmentation among carriers (e.g. Verizon, ATT, and T-Mobile all have different LTE bands that only partially overlap). Limited coverage outside of major metro areas.
EMC testing difficulties:
Due to the high power levels of cellular transmitters (up to 2W / +33 dBM), there are very real concerns about both RF ingress to other circuits in the device, and harmonic emissions due to interactions with other components in the device.
Must pass PTCRB certification in the US market if you are using a GSM carrier such as AT&T and T-Mobile. Verizon and Sprint have their own similar requirements. Carrier certifications have extremely strict limits for emissions, much more difficult than the FCC requirements.
Expect to have to use a custom / tuned antenna design to meet carrier requirements. Off the shelf antenna designs will often lead to emissions failures or power levels below required limits.
Make provisions for shielding all active circuitry in the device, especially anything near the antenna. With 2W of RF in the device, even simple components such as diodes or thermistors can be sources of harmonic radiation (via rectification of the carrier signal). Plan to do pre-compliance testing early and often.
PCB layout must follow RF design principles to pass EMC testing. Typically the top and bottom layers must be solid ground planes with signal traces buried in inner layers.
Mobile – Specific –
Technology Related –
Cellular –
Module vs Discrete IC implementation:
Modules are cheap, and you can re-use part of their FCC certification but not all. How much depends on your implementation details. Expect to perform, at least, EMC testing to FCC Part 15.
Modules are expensive and physically large and may have higher power consumption due to on-board processor not required in a discrete implementation.
Modules may have higher levels of conducted harmonics than the best discrete implementations, making it more difficult to pass EMC testing (PTCRB or Verizon/Sprint approval).
Discrete implementation requires significant RF expertise on staff, longer development time, and may require work with the cellular carrier directly for approval. FCC submission significantly more burdensome as there will be no existing submission to leverage.
2G/3G/4G choice:
Need to balance cost, coverage, and lifespan of technology
2G – Frequencies compatible with all carriers in a given region (only 4 bands worldwide), lowest cost, widespread coverage throughout the world. 2G service will be deactivated by 2018 in many regions. Extremely slow data rates.
3G – Higher cost, slightly more “fragmentation” on the frequencies used across carriers. Good coverage and good data rates for most applications. Cost of implementation is higher than 2G but expected to go down as time goes on. Will probably live beyond 2020.
4G – Highest cost, antenna design more difficult due to band fragmentation among carriers (e.g. Verizon, ATT, and T-Mobile all have different LTE bands that only partially overlap). Limited coverage outside of major metro areas.
EMC testing difficulties:
Due to the high power levels of cellular transmitters (up to 2W / +33 dBM), there are very real concerns about both RF ingress to other circuits in the device, and harmonic emissions due to interactions with other components in the device.
Must pass PTCRB certification in the US market if you are using a GSM carrier such as AT&T and T-Mobile. Verizon and Sprint have their own similar requirements. Carrier certifications have extremely strict limits for emissions, much more difficult than the FCC requirements.
Expect to have to use a custom / tuned antenna design to meet carrier requirements. Off the shelf antenna designs will often lead to emissions failures or power levels below required limits.
Make provisions for shielding all active circuitry in the device, especially anything near the antenna. With 2W of RF in the device, even simple components such as diodes or thermistors can be sources of harmonic radiation (via rectification of the carrier signal). Plan to do pre-compliance testing early and often.
PCB layout must follow RF design principles to pass EMC testing. Typically the top and bottom layers must be solid ground planes with signal traces buried in inner layers.
Mobile – Specific –
Technology Related –
RF (Radio Frequency) –
Another technology, although nothing new, that can be used for communication between implantable device and a programmer is good ole RF modulated communication. It is nice because RF can be used for charging as well as communication, but this isn’t something that is supported by consumer mobile devices. In the client project, there are 3 parts of the system: (1) An implantable, (2) a charger, and (3) a programmer. The RF communication was between (1) and (2). The BLE communication was between (2) and (3).
Can be used for, power transfer, security or legacy reasons
Mobile – Specific –
Technology Related –
Wifi –
uncovered several ways transfer can be limited using wifi so more system planning would be necessary.
Home use devices requiring direct communication over the internet. To support the average, non-technical, user server technologies have to be implemented to circumvent network address translation issues. Furthermore, safeties have to be in place to prevent unauthorized access.
To create a peer-to-peer connection over the internet without requiring the user to configure port forwarding we are implementing a primary connection method with a more reliable fallback method:
The first method is UDP hole punching. This method has been shown to work on the majority of commonly used routers and, if successful, allows a direct peer-to-peer connection across NATs without requiring port-forwarding. If a TCP connection is required this method can still be used, but it will be slightly less reliable. This method offers a performance advantage over the second method since all connections are direct.
The second method is to relay all packets through a central server. Each device (the iPhone application and the device) makes an outgoing connection to the server which relays all packets between the two. While this method is more reliable, it is also lower performance and requires load-balanced server technologies capable of handling large amounts of data from many concurrent connections. If large amounts of data are transmitted regularly costs can be extremely large. We chose Amazon Web Services to host the relay server as it provides all required server technologies in a very cost effective and reliable manner. (Amazon Web Services is certified HIPPA compliant, and is perfect for any client that doesn’t want to handle the overhead of setting up and maintaining, or paying for physical server solutions. Let me know if you would like more information.)
For a medical device this can be used for a wifi device in a patient’s home that could be accessed by their physician over the internet. This presents additional security concerns to prevent unauthorized connections. The central server is used to authenticate all users of the iPhone app, and to facilitate secure connection pairing. The peer-to-peer connections are authenticated using session keys generated by the server.
For the server, to ensure maximum security all ports that are not used by the system should be closed.
Of course, all communication should always be encrypted.