Tag Archive for: IoT

safety

Like many industries, the semiconductor industry has seen a dramatic change over the past several decades. Simple, single function devices have evolved into complex multi-function devices with firmware, supporting software and, in some cases, full reference designs. While the products that the semiconductor industry sells are still integrated circuits (ICs), in many cases the supporting software, documentation and system-level understanding are just as important as the product themselves. A key example of this are the products produced for the automotive industry that must meet the Functional Safety requirements of ISO 26262. 

Early in the days of integrated circuit design, companies generally focused on developing single function products. The development focus was on continuously optimizing for different applications and in many cases improving performance metrics like power, speed, and bandwidth. Later came an increased focus on reducing product size and cost. The common thinking was that if team could build a product with better performance metrics than the previous generation, there would be a market for the product. For these teams the skill of circuit design and the capabilities of manufacturing were the ultimate competitive advantage. A great deal of system-level understanding is not required, although many teams had Applications Engineers with an understanding of the various applications their products would be used for. 

For many companies in the semiconductor industry, circuit design and manufacturing are still competitive advantages. For others, an increased focus on integration has encouraged them to think in terms of providing a complete solution, rather than just products. Increasing levels of integration is often driven by a goal to decrease size and cost of the solution but doing so requires a better understanding of the end application and more systems-level thinking in developing the solution. This understanding of the end application leads to a focus on clearly understanding and communicating the requirements to ensure successful product development. While in single function products the requirements are often simple and the circuit design is the challenge, in more complex products the requirements can become quite complex and truly understanding the need is just as critical as executing on developing a solution. 

No aspect of integrated circuit development increased functional complexity as much as adding firmware and software to the overall solution being provided. While adding software and firmware to a solution is often done to solve a specific problem, it quickly opens up such a wide range of functional possibilities that the complexity grows rapidly. While there are still teams focused on advancing the state of the art of circuit design, just as many (maybe more) teams are developing full solutions with a semiconductor element as well as firmware, software and even system integration. The ultimate representation of this trend is semiconductor companies providing complete reference designs that contain nearly all the engineering required to produce an end-product. 


RELATED: ISO 26262 vs. ASPICE


In the automotive industry, the trend of providing a complete system-level solution has not been as strong as in other industries like IoT or consumer, but another trend has emerged: providing a safe solution. Integrated circuits sold into automotive applications have long had to achieve some of the toughest reliability standards. Now it is increasingly common for vehicle electronics to impact the safety of the vehicle, so not just reliability is required, but also functional safety. Achieving functional safety requires a lot more than circuit design and process technology. It requires understanding of how failures in an integrated circuit can impact the system. It requires robust development processes not traditionally employed in the semiconductor industry. 

Nowhere was the need for this more strongly articulated than at the “Guidance & Application of ISO 26262 to Semiconductors” conference held virtually in August 2021. In the first session of the conference, several automotive OEMs joined forces to explain how important it is for semiconductor suppliers to develop pre-integrated, pre-certified and pre-tested solutions that meet the requirements of ISO 26262 and place the minimum burden on system integrators to integrate the solution into their system and safety case. Functional Safety adds a lot of overhead to vehicle development and receiving complete solutions from their suppliers goes a long way toward reducing that burden. 

While many semiconductor suppliers have been playing catch up to meet the requirements of ISO 26262, others are turning it into a competitive advantage. These suppliers are winning business on the strength of their functional safety competency. They have developed robust processes featuring robust requirements management, configuration management and safety analysis. As a result, they can provide their customers complete safety cases that save their customers significant time when integrating their solutions. Some are even furthering the state of the art in functional safety by participating in standards development. It is common for multiple suppliers to have technically equivalent products, so in these cases safety competence can become the deciding factor in which semiconductor solution an OEM or Tier 1 supplier ultimately selects. 

With the automotive industry working toward fully autonomous vehicles, the importance of developing safe products is more critical than ever. It will take the whole industry working together to furthering the state of the art in all areas to achieve the goal of full autonomy. That state of the art includes both skillful circuit design and robust process that ensure safety. 

Never has there been a time where it was more critical for the semiconductor industry to adopt new skills. Circuit design and manufacturing will always be the core competency of semiconductor companies, but for those focused on the automotive industry safety, it is increasingly necessary for safety to be a core competency. Developing this as a core competency can lead to increased market share in today’s exciting automotive market. 



On today’s fast moving road to innovation requirements management can feel like a burdensome, yet necessary evil. For those of you who manage requirements with spreadsheets, word docs and power point, this process can feel even more unwieldy. Possibly worse? Using a heavy-handed tool like DOORS that adds extra overhead and requires additional skillsets for an already complex process. As products get smarter and connected, requirements management will only become more necessary. But it doesn’t need to be evil.

How? One way is by making sure everyone is working from the same, up-to-date information. Doing so lessens the burdens around requirements reviews. You can eliminate the waiting for the necessary stakeholders to provide input, or give approval. Teams can understand change as it happens, and analyze the up- or downstream impact of that change BEFORE change happens.

Why does it matter? The increased burden of regulations and compliance adds additional overhead to the product development process. Especially in the automotive industry where we are seeing rapid growth and leaps in innovation.  Organizations who haven’t had to confront functional safety standards are having to learn regulatory standards, like ISO 26262, on the fly without missing deadlines or features to deliver on time for their customer.

Part of that additional overhead comes from how these teams are managing requirements and tracing validation & verification back to their requirements. Often times teams retroactively trace their data. With a solution like Jama you can pre-build your relationships, so traceability is automated, reducing the manual effort associated with building your traceability, and reducing your regulatory overhead in the process.

Bonus points for using a “fit for purpose” certified solution. A certified solution reduces the manual effort associated with validating your process for ISO 26262 Certification. As AFuzion CEO Vance Hilderman states: “Products labeled ‘safety-critical’ used to be a small niche, but today almost all devices are critical, with many requiring adherence to certification standards…We need to validate and qualify not just the software we build for our client but our development tools as well,” Read more about the Jama Validation and Software Compliance Kit.

In the end, the “old” way of working doesn’t fit the direction of the industry. Legacy tools and manual processes can’t keep up with market demands. You have too much to do to rely on an outdated way of working. If a modern requirements management solution can help you ease regulatory burdens by streamlining traceability, resulting in a more connected way of working that helps you understand the impact of change and can also provide a platform to shorten the requirements review process, isn’t that worth considering?

See Jama in action today! Check out our completely free 30-day Jama trial.

mdls-news-blog-featured-imageAs medical devices, software and technologies—and the risk management, regulations and recommendations concerning them—become more of a mainstream topic of conversation, we thought now would be a good time to round up a few newsworthy items. Check out key pieces from some recent articles and our takes on each, below. 

How Samsung Is Leveraging VR to Manage Pain

Article quote: “Los Angeles-based startup AppliedVR has developed a platform with a library of interactive games and relaxing landscapes to draw users attention away from their pain, reducing dependence on pain medications with Samsung’s virtual reality hardware Gear VR. ‘Clinical findings from Cedars-Sinai and AppliedVR have shown that VR results in a 25 percent reduction in pain, in many cases obviating the need for narcotics, and a 60 percent reduction in stress and anxiety,’ says Dr. David Rhew, Samsung’s chief medical officer.”

Jama note: In a compelling example of convergence and collaboration between three different organizations—multi-national and multi-industry giant Samsung, therapeutic virtual reality startup AppliedVR, and Cedars-Sinai and other hospitals—we’re seeing the application of a disruptive technology as a solution to several types of debilitating patient problems. Programs and innovations such as these require collaboration across organizational and departmental boundaries to ensure traceability in clinical studies, and to capture requirements that exist outside traditional product development.

Trump Calls for Lower Drug Prices, Fewer Regulations with Pharmaceutical Executives 

Article quote: “On Tuesday, Stephen Ubl, president of lobbying group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the industry is open to working with the Trump administration on ‘market-based reforms.’ ‘Our industry takes seriously the concerns raised about the affordability and accessibility of prescription medicines, Ubl said. ‘The current system needs to evolve to enable the private sector to lead the move to a value-driven health care system.’ Drug companies provide discounts on their drugs to companies that negotiate on behalf of insurers, and there is a growing discussion about the extent to which those rebates, granted in secret, trickle down to consumers.”

Jama note: At the same time that the Trump administration calls for pharmaceutical companies to make changes, medical industries face growing uncertainty as Congress puts the Affordable Care Act under its microscope. Consequently, many companies operate in “wait and see” mode, with the knowledge that change is coming but without the knowledge of what these changes are and how business will be impacted. While repealing certain regulations could benefit these companies by accelerating the time it takes to get products to market, the need for product safety still remains. As questions multiply and uncertainty mounts, the business value of capturing, managing and maintaining product requirements remains strong and will be increasingly important as companies navigate the changes ahead.

Web-Connected Medical Devices Are Great. Unless…

Article quote: “There are many benefits to having Internet-connected medical devices. They can monitor patients and transmit important data about them doctors. They also can provide remote control of medical devices such as pacemakers. Adjusting these devices through the Internet of Things can avoid additional surgeries or other procedures that carry the risk of infection. But remote control of such a sensitive piece of equipment can be a detriment. Anything connected to the Internet potentially is at risk of hacking — and when the device being hacked is a medical device, the risk could be fatal.”

Jama note: For every new opportunity the IoT creates, it seems a new reason to worry comes along with it, and there is no greater worry than when health and safety are at stake. As medical monitoring moves into the mainstream, enabling more efficient and responsive communication for patient care, we’re also approaching an era where trust in “the doctor knows best” isn’t enough. Doctors, hospitals and the patients using these devices will all share some degree of responsibility for security awareness. But the greatest pressure will be on medical device designers and manufacturers to design and build each new product, version and variant around changing definitions of patient safety and security. And for Internet-enabled medical technologies, good health begins with good requirements management.

the future of car sharing

Tim Navarrette gave up his car 11 years ago. At a recent Mobility Unplugged event hosted at Jama Software, Tim shared that when he was a teenager, getting a driver’s license meant freedom from adults, and driving a car was an extension of his social life. But when he moved to Portland, driving a car was frustrating. Tim couldn’t see the city and he decided he wanted to sell his car. He couldn’t shed the guilt until the first car sharing came to town. This is when he realized, he’d been spending $500-700 a month on car insurance and other fees, an amount he would never be able to spend monthly on any car sharing service. Today, he picks the service that’s most convenient for the type of errand he needs to run. He uses what he describes as a “transportation portfolio”.

Anything as a Service

What if we could take the “transportation portfolio” a step further. The past decade has seen a revolution in consumer electronics and technology. Mobile phones, for one, have been transformed — once little more than devices for making calls, they’re now miniature portable computers. Meanwhile, tech companies like Uber and Airbnb are leading the boom in the “sharing economy,” making travel easier for millions of people in the process.

Alongside this constant innovation and digitalization, we’ve seen the rise of the XaaS (anything as a service) business model, in which software products or access to hardware is provided over the internet for a fee. This service model is appealing to companies and consumers who prefer paying a subscription fee and not having to worry about hardware upkeep over investing money upfront in a solution that slowly degrades over time.

To a certain extent, we’re already seeing the expansion of the service model into consumer electronics, as people choose to lease their smartphones with the option to upgrade every year. But, what if it extended into transportation as well? What would it look like if we had “cars as a service”?

Smart, Efficient and Flexible

The exciting possibilities offered by the cars as a service model are nearly endless. Instead of buying a particular vehicle and leaving it in a garage for most of the year, consumers could use any vehicle they want when they want to. They might have a sports car delivered to their home for a trip to the beach, an SUV for a mountain excursion, a convertible for a cross-country road trip, or a pickup truck for making deliveries.

These days, our smartphones are connected to the Internet of Things (IoT), a massive network of devices, from kitchen appliances to thermostats, that share information with each other. Likewise, we’ll have “smart cars” that remember things about users as they switch vehicles — from frequent routes and favorite destinations to preferences for radio stations, seat height and air conditioning. Users would pay a monthly fee to use the service, with different plans available for different usage levels and the ability for car manufacturers or owners to optimize usage and dollars earned.
The growth in the cars-as-a-service model is also coming at a time when ride-sharing apps and self-driving cars are picking up steam. Rather than needing to own a car, or even a driver’s license, people will have affordable, efficient and timely transportation options that get them where they need to go.

Future Fast

It’s almost a certainty that cars as a service is coming soon. What remains to be seen is how manufacturers will build the cars of the future and how cities will plan their roadways and transportation networks around them. Better and faster product definition, change management and functional safety verification will certainly be crucial in this process. What are your thoughts on the future of car sharing?