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The science fiction of yesterday is the reality of today. Imagine your driverless car pulling up to your house. You get out of the car and walk to your front door, you unlock your smart lock with just your thumb. The smart lights come on automatically as you walk through the house, the temperature is regulated by your smart thermostat. Your glucose monitoring system beeps, warning you that your glucose level is low. You say ‘Alexa, play some Bach’ and music fills the room as you start to prepare a snack…    

The Internet of Things (IoT) and artificial intelligence (AI) are rapidly transforming many aspects of our daily lives. With everything from virtual assistants like Siri and Alexa, to blood pressure monitors and other wearable devices, to smart locks, smart lights, smart thermostats and other smart appliances, to connected and autonomous vehicles, few of us in the developed world can claim to be unaffected.

Wearable technology is part of this exciting and quickly expanding sector. According to Grand View Research, the global wearable technology market size was valued at US$ 32.63 billion in 2019 and is projected to expand at a compound annual growth rate of 15.9% from 2020 to 2027. Wearable fitness devices, such as activity trackers and smartwatches, are increasingly popular among consumers. An example of this trend is Google’s acquisition of Fitbit, Inc. (US consumer electronics and fitness company) for a hefty US$ 2.1 billion. But it’s not just the big players who can reap the benefits, there are many exciting opportunities for both start-up and mature companies.

More and more, wearable technology is moving towards the healthcare sector and the line between wearable devices and wearable medical devices is not always clear. There is potential for companies to join this growing market, but it may seem difficult and complicated. There are regulations and standards that need to be respected, which means that companies developing wearable technology need to be clear about what wearable medical technology is, and whether they are crossing the line into that domain.

So, if you are thinking of entering this market, here are a few points to consider:

Know what a wearable device is

Wearable technology, wearable devices or wearables are smart electronic devices worn on or close to the skin to detect and monitor body signals such as vital signs and ambient data, giving feedback to the wearer. They are in fact tiny wearable computers. A popular example are activity or fitness trackers. These devices or apps measure activity related data such as distance covered, heart rate and calories burned, helping the wearer meet their daily fitness goals.

Know what a wearable medical device is

A medical device must have a medical purpose. According to the EU’s Council Directive 93/42/EECof 14 June 1993 concerning medical devices, a medical device is “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”.

Some examples of wearable medical devices are:

• Wearable devices for diabetics. They include continuous glucose monitoring systems (CGMs) that provide real-time glucose readings and automated insulin delivery systems such as insulin pumps that automatically adjust background insulin (example Medtronic).
• Wearable cardioverter-defibrillators (WCD) for heart patients who are at risk of sudden cardiac arrest. The WCD can detect dangerous arrhythmia and deliver high-energy shocks to save the patient’s life.

Understand that software can be considered to be a medical device

As can be seen in the above-definition of a medical device, software could be considered to be a medical device. Directive 2007/47/EC states that “it is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Stand alone software for general purposes when used in a healthcare setting is not a medical device”.

What this comes down to is:

1. Software embedded in medical devices must meet the same
2. criteria and certification as medical devices.
3. Stand alone software for generic devices can also be considered to be a “medical device” (as defined above – Council Directive 93/42/EECof 14 June 1993 concerning medical devices). So if you create an app that is used for diagnostic and/or therapeutic purposes, it will be considered a “medical device” and subject to the same regulations and standards as medical hardware devices.  
4. General purpose software, even when used in a medical environment, is not considered to be a medical device. For example an app providing reference information for a patient or physician; an app connected to a wearable fitness device to monitor the general well-being of someone and not a specific disease; and software for non-medical purposes such as e-mailing, word processing, web messaging etc

Certification process

The production of medical devices requires compliance with regulations and standards that ensure the safety and efficacy of the devices.

In Europe, the most relevant regulation for this category of devices is Regulation (EU) 2017/745 on medical devices (MDR). In the United States, the U.S. Food and Drug Administration (FDA) has the Quality System (QS) Regulation.

ISO 13485 is an internationally recognized Quality Management System (QMS) standard for producing medical devices. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

In 2018, the FDA annoucned its plans to harmonize the FDA QS Regulation and ISO 13485.

If you’re involved in the development, design, distribution or servicing of medical devices, being ISO 13485 certified demonstrates that your company’s QMS is designed to deliver consistent, high quality products.

As is the case with other ISO standards, organizations wishing to obtain the formal ISO certification need to go through a learning process, then put in place the adequate management systems and seek certification through an accredited body. This can be a lengthy and costly process.

Partners can help

All this may seem like a lot to take in and quite complex, especially when it comes to regulation and certification. But, did you know that if you want to design and make medical devices, you could also work with a certified partner?

Thaumatec is ISO 13485 certified to build software for medical devices.

So, if you’re planning on designing a medical wearable – or transforming an existing wearable into a medical wearable –  but do not have the necessary certification, get in touch with us and we’ll use our knowledge and certification to help you out.

In our next blog post we’ll take a closer look at regulations and standards, in particular, ISO 13485 and the EU MDR.

The pandemic struck in 2020.  Corporate strategies morphed from focusing on development to survival.  Items like allowing employees to work from home and online e-commerce became a strategic IT priority. Hence, despite the pandemic, it was business-as-usual.  The concept of working remotely made many organizations realize that the proximity of their business partners and suppliers is not that crucial as it was thought to be. In most cases, local partners and suppliers were favoured over international companies. A local business partner has the advantage of being in the same jurisdiction, observing the same laws and regulations, operating the same currency, and speaking the same language.   

However, in most situations, looking for the best partners internationally can bring huge benefits to a business in optimizing quality, availability, and cost. This is especially true when it comes to software development.

Initially, there were technical concerns but improvements in the quality and availability of international links and supporting technologies such as Zoom have reduced them significantly. 

There is a concern that working remotely can bring communication and coordination issues, particularly in multi-cultural environments.  We have been working in the international arena for over fifteen years, gaining significant experience and have developed a 10-stage approach that we apply to each project to ensure maximum cooperation. 

The 10-step approach is as follows:

1. Start with a test project with measurable goals and objectives. 

A successful international cooperation initiative starts with self-contained, relatively brief projects with clear requirements.  Application module projects where costs or time-to-complete schedules are known to provide an excellent means for testing the deliverables and measuring results.

2. Ensure internal buy-in and involvement. 

Without the buy-in and active participation of internal stakeholders, it is impossible to create the type of collaborative environment that characterizes successful international cooperation initiatives.  The continued involvement of internal stakeholders with the knowledge of potential risks and rewards of international cooperation is important.

3. Review and document internal processes. 

A common problem in working with international partners is that internal organizations often operate under informal processes described in the local language, making it difficult to collaborate with outside suppliers. Before selecting a third-party supplier, a company should assess its internal processes and identify and document where functions intersect. The company should also document how information flows throughout the internal software development life cycle.  This will provide an opportunity to refine and adjust internal processes where necessary. 

4. Assign a dedicated project manager. 

Assign a dedicated client project manager, a single point of contact, to serve as the focal point throughout the entire project life cycle right from the planning and request for proposal (RFP) phase to acceptance testing and implementation.  Additionally, this individual should be an experienced manager to work closely with the international counterpart to solve day-to-day operational issues.

5. Ensure organizational fit. 

It is also important to virtually meet with the individuals who will be working remotely to get a sense of how they will fit into the internal culture.  Reviewing the qualifications of prospective team members should be part of the process. 

6. Fulfilment of documentation. 

Even with close and informal collaboration, it is important to have well-documented roles and responsibilities stating precise project requirements and clear project milestones.  A clear statement of deliverables is needed for project closure. 

This practice also applies to project tracking and oversight, configuration management activities such as version control, backup, and recovery and all other facets of the process. 

7. Establish a secure infrastructure. 

Co-operating internationally requires a secure communication infrastructure and the use of collaboration tools such as email, chat, and intranet-based project Web sites. Choosing how work will be distributed and the specific development and network infrastructure should be done in line with the client’s security policies and development processes.

8. Allow ample time and resources for knowledge transfer.

Knowledge transfer is a vital part of the process.  It not only ensures that the supplier’s staff members understand the client’s software but also contributes to the creation of a collaborative work environment that continues even after the completion of the project.  Additionally, long-term contracts that specify a periodic rotation of staff create a flexible yet knowledgeable base from which resources can be quickly drawn as needed.

9. Acknowledge that cultural understanding is a two-way street. 

It is an absolute necessity in multi-cultural environments that employees be able to adapt and work effectively in other cultures. However, multi-cultural enterprises need to be aware of cultural issues such as if disagreements can be raised and how they are resolved. Some companies conduct internal cross-cultural training to create awareness around such issues. 

10. Organize meetings and monitor performance and stakeholder satisfaction. 

Regular project status meetings in which the client and supplier team members review schedules and deliverables and resolve open issues are an essential part of international cooperation. They enable clients to stay on top of and maintain control over projects as well as track supplier performance.

RustFest Conference in  Barcelona came to an end, so here is a summary of it.

Saturday

Saturday started with a keynote about the benefits and pitfalls of Rust adoption. The economic gain from the safety Rust offers is now beyond question but some new potential problems are just around the corner. One of the most interesting challenges discussed was what will happen and how to react when the language becomes mainstream and it won’t be used just by a group of loyal enthusiasts but also by unaware developers who happened to join a project based on this sometimes very demanding and difficult language.

A big surprise was to hear about the process of Rust adoption in China which sadly isn’t going well. All the beloved Rust tools like cargo, rustup, and crates.io are literally unusable there because of the Great Firewall. What’s worse the Chinese online Rust community is heavily fragmented because of the monopoly and constrains of certain web communicators.

The first day concluded with a workshop session. I was lucky to book a place on the introduction to embedded development in Rust which received a great deal of interest, causing a long wait-list to emerge. In my case, bare-metal programming with Rust on LPC845 board turned out to be a partial success: the LED was blinking, the state of the button remained a secret.

Sunday: Strange Surprise

Sunday started with a great talk about crowd-sourced, Rust-based train schedule information service from South Africa. What stuck to my mind was that there was no need to back up the state of the service in a database for the possibility of a crash, because the service simply never crashes and it’s only restarted every couple of months because of updates. Great advertisement for Rust! Not to mention the memory usage after switching from Kotlin to Rust was reduced by the factor of 40.

Strange as it may sound RustFest day 2 included also a live music concert! The music was generated using commands of a simple DSL typed by the presenter in the browser running a Rust+WebAssembly web page of his creation.

The Best Comes to Those Who Wait

The conference took place just after the long-awaited async/. await feature had been stabilized so of course, this hot topic was also present in the program. First, the audience learned about the basics of async-std which is, as the name suggests, asynchronous implementation of the Rust standard library, in which not a single potentially long-running operation is blocking until specifically asked to. Just after that, we received a deep insight into how the Rust compiler optimizes the async functions and makes them zero cost.

The day ended with another workshop session and this time I was implementing a 2D game starring (obviously!) a crab – the Rust mascot.

The goal of this project was to experiment with Rust bare-metal programming by implementing a simple game. The chosen hardware platform was STM32F4DISCOVERY. It is similar to F3 DISCOVERY from the official embedded Rust tutorial however, it has some additional features like analog-digital converter required for the snake to be controlled with a joystick. The game is displayed on a 96×64 OLED screen using the SSD1331 controller and SPI interface. In the process of development and debugging two additional versions of the game were created: one with text-based UI for running the game in a terminal and the other one using a game engine called Quicksilver. Quicksilver is capable of targeting WebAssembly, which means the same game can be played both on the microcontroller and in a web browser. Implementation of the game. Embedded HAL  hides a lot of details and allows us to interact with the hardware on a relatively high level of abstraction.
Some remarkable issues are:

* Development without OS and allocator requires #![no_std] flag but Rust’s native test framework depends on standard library facilities. To keep unit tests in the same file as the source code (which is Rust’s convention), a conditional compilation was required.

* Lack of dynamic memory allocation makes it difficult to parameterize application code with the size of “things” – everything has to be set at compile time. It is a problem when unit testing or targeting different screen sizes. The easy solution for this would be to use a feature named “const generics“ which, unfortunately, is not yet fully implemented in Rust. Luckily there is a workaround in the form of crate generic_array, but overall Rust still has to catch up with C++ in this subject.

* Important thing one has to remember when developing with Rust is that the difference in performance between debug and release versions is huge. In the case of this game and microcontroller, the debug version was unusable.

For more information follow the link below:

Once again Microsoft does it again, just yesterday they revealed a “brand-new limitless analytics” called Azure Synapse. The grand revelation took place at Ignite 2019. However, the real question is what does this brand new Azure Synapse do?  As Microsoft would say, “Azure Synapse brings together enterprise data warehousing and Big Data Analytics”. Nevertheless, organizations can use their data quickly, by pulling together insights from all data sources, data warehouses, and big data analytics systems.

Pros of Azure Synapse

1. Azure Synapse Analytics makes building and operating analytics solutions a simple, intuitive and no-code experience.

2. It empowers users to analyze data quickly while bringing high performance and unmatched scale.

3. Project timelines can be measured in hours not months.

4. Enabling Power BI and Azure machine learning is simpler.

5. It provides a unified workspace for data preparation, data management, data warehousing, big data, and Artificial Intelligent tasks.

Feel no Fear

However, you might feel worried about how your business will adapt to this new technology? Feel no fear, your business can continue running with its current data workloads in production today with Azure Synapse and will automatically benefit from the new capabilities. Azure Synapse is all about putting in the information a lot faster, productively and securely. Pulling together insights from all data sources, data warehouses, and big data analytics systems. Integration is a must!

What Lies for The Future

Azure Synapse is breaking boundaries, they want to make data accessible, usable and actionable to organizations, furthermore, they want to make professionals deliver that information as swiftly as possible on a large scale.

Last Words

In the world we live today, the role of IT and developers is becoming increasingly important, however, here at Thaumatec, we are up-to-date in new revelations and technologies so we can deliver them to you. After all, we make the future matter and connect to you.

Rust is one of the most talked about languages in recent years, as the Firefox browser is gradually being rewritten to use it and more and more companies are starting to use it. While its most prominent feature – borrow checker – has been discussed numerous times, there are also many smaller features, which provide a comfortable experience while developing in Rust.

Convenient switching between toolkit versions
One of the most common issues that affect Rust programmers is that the most tempting language features are always available only in nightly. On the other hand, for professional development, it’s a good idea to keep the ecosystem quite stable, with one toolkit version that is expected to make our codebase work, and which will be supported for as long as possible. Is it possible to seamlessly switch between different releases of the Rust toolkit?

Enter rustup – the Rust toolchain installer. It’s the tool that allows not only for installing, but also updating and switching between different toolchains.

The main rustup website is rather minimalistic, but anyone in need of more information can find it in a quite extensive rustup project’s README.

Module system
Project’s source code rarely can be contained in a single source file. Different programming languages have different approaches to solving this problem – one of the most known in the embedded programming world is the C/C++ way – #include, which essentially causes the referenced file to be directly pasted in its entirety by the preprocessor.

This solution is simple to implement, easy to understand and usually works. There are pretty severe issues with this approach though: any changes made in one file can spill into all others which include it – directly or indirectly. It can be a rogue #define which changes the behaviour of the code or using a namespace directive.

There’s also a risk of including one file more than once, that would cause things to be defined twice – and every C/C++ developer has the include guard already in their muscle memory or editor templates. Rust solves the problem differently – by using a module system.

Modules in Rust can work inside of one file in a way similar to namespaces in C++, with the additional possibility of default privacy of module contents – anything that needs to be visible outside of the module needs an extra pub keyword.

But when a module itself is prepended with a pub, then it can be used in other source files, while being completely independent of them. More information can be found in The module System to Control Scope and Privacy chapter of the Rust Book.

Crates
Almost all software developed stands today on the shoulders of giants by using at least one third party library. Most modern programming languages provide an easy way for the code to depend on a given version third-party library, which can be automatically downloaded and built by the build system. Rust isn’t different in this matter – cargo, build system used by Rust, gets the current project information from Cargo.toml file, where dependencies on other libraries (called crates) and their versions can be also stored. Then, during the build process, crates are downloaded and built.

Crates can be browsed using Rust Package Registry, which also conveniently provides a snippet that can be pasted into the Cargo.toml to use the chosen crate.

As an interesting side note, cargo and crates are both references to Cargo Cult. Knowing current development practices of stitching libraries together until it works, it’s a pretty humorous touch.

Integrated testing
Software testing is one of the basic elements of modern code hygiene. There are testing frameworks for almost all programming languages, but Rust decided to be a step ahead and a simple test framework is provided with the language itself. Citing a simple example that can be found in the Writing tests chapter of the Rust Book:

#[cfg(test)]
mod tests {
#[test]
fn it_works() {
assert_eq!(2 + 2, 4);
}
}

In this example, module tests will be available only during the test execution, and the it_works function is marked as a test, therefore it will be run when the cargo test command is invoked.

But that’s not all – it’s possible not only to test the correctness of our program, but also to benchmark it. To do that, it’s needed to create a function marked as bench, taking a Bencher object, which will do the measurement. Thanks to that initialization of objects can be done outside of the measured code fragment. At the time of writing this text, benchmarking is an unstable feature and needs to be enabled using the test flag. More information can be found in the test library features in the Unstable book.

Documentation tests
Rust also provides rustdoc, which is an automatic documentation generation system, similar to Doxygen or Sphinx. But one of the most common problems when documenting the rapidly moving codebases is to keep the documentation up to date. Rust tackles the issue by allowing one to include code samples with assertions, which can be easily compiled and evaluated. More information can be found in the rustdoc documentation.

Summary
Rust provides not only a lot of nice programming constructs, but also a really comfortable ecosystem that aims at solving practical problems that programmers have in their daily jobs; therefore, it shapes up to be not only an academic-only curiosity, but a tool that could be used in long running commercial projects. If you haven’t played with it, then try it out – Rust is not only a useful tool, but it’s also lots of fun.