Cybersecurity for Medical Devices: Navigating New FDA Rules
Medical devices are reshaping the healthcare field as designers and manufacturers...
IoT devices are more than just a passing trend in the tech world. This technology continues transforming how we communicate, analyze data, interact with digital media, and more. It's even changing healthcare. The COVID-19 pandemic saw a meteoric rise in IoT adoption in healthcare, becoming the go-to technology for everything from patient monitoring to remote diagnosis.
This unique technology existed before the pandemic, but the healthcare challenges pushed it into the fast lane of mainstream success. The Internet of Medical Things (IoMT) market is poised to reach $158 billion by the end of 2022.
Globally, the number of installed IoT devices will reach 27 billion by the end of 2025. That includes everything from consumer-level gadgets to industrial IoT. This technology is here to stay, and the market is ready for new devices.
Voler Systems provides comprehensive services to bring your ideas to life. From initial research and prototyping to manufacturing assistance, our team is ready to help develop your IoT device.
Here are some of our best practices that continue to help us complete projects of any size and scope.
Every project starts with a list of requirements. The requirements detail the acceptable criteria for design and development. Think of it as a checklist that defines a device's functions, features, behaviors, and capabilities. It guides the design process and ensures that every puzzle piece fits perfectly. You don’t want the design engineers to guess at what was intended. Make it very clear.
Product requirements are more complex than most realize, and there are many different types of conditions to consider. For example, you might start with high-level market requirements to dictate the scope of what consumers want. Then, you might consider the business-focused needs of key decision-makers.
Then, there are matters of compliance. If you're designing a medical device, projects need more in-depth documentation to get FDA approval than non-medical devices. It's a complex process that requires careful consideration.
At Voler Systems, we always start with well-written requirements. They keep the project running smoothly and establish everyone is on the same page. We ensure every stakeholder is involved and use a strategic system to ensure requirements are testable, quantifiable, and explicit.
Implementing detailed requirements can seem like overkill. But, it prevents engineers from having to make critical design decisions. Furthermore, it helps you avoid project creep and ensures that budgets and deadlines don't get out of hand.
There are numerous risks involved in product development. That's the reality of creating new products. From market risks to manufacturing issues that threaten to derail the entire process, a lot can go wrong. Don't let that scare you away from your pursuit of innovation.
A significant tenet of product design at Voler Systems is risk mitigation. It's one of the most critical aspects of project management. Understanding what risks your project faces can make all the difference.
Research what potential problems could impact the development cycle. You can do market tests and feasibility studies to gather data about how your product could perform once released. You can also investigate technical and manufacturing risks to develop contingencies that keep things moving forward. A technical risk might require significant changes to your product, which is very expensive if done late in the design.
The goal is to understand what could happen and take the necessary steps to prepare for the worst-case scenario. Once you do that, you can address problems as they arise to avoid budgetary constraints and scheduling issues.
Good project management is necessary for a project like IoT device design and development. To say that these projects are demanding would be an understatement
Not only that, but it's a considerable investment. Think of the hours spent going over requirements, the documentation required to meet compliance regulations, and all the skills you need to tap into to bring ideas to life. Every detail matters, and it doesn’t take much for things to go downhill.
Development projects fail, and it's not uncommon for them to become sinking ships that take out entire companies. We're talking about multi-million development projects that can quickly go over-schedule and over-budget.
Solid project management keeps everything on track. It's about turning ideas into a precise set of actionable steps. To learn more, check out our Project Management series and Walt Maclay's book, "Highly Successful Engineering Design Projects."
IoT devices can do many things, but reliable wireless communication capabilities are at their heart. Devices can communicate with each other, smartphones, bridges, and more. Data transmission is what makes IoT devices unique. It facilitates everything from data analysis to monitoring.
One of the most critical decisions to make early in the design process is what types of wireless protocols your device will use. Understanding how the devices exchange data will help you develop the technology stack and possible interactions among sensors, gateways, servers, and user-facing applications.
There are many excellent protocols available. Some of the most popular wireless protocols for IoT gadgets include:
Voler Systems can help you determine which protocols are best for your needs. From there, we can move on to matters like power, security, and more.
Ask any average consumer, and they'll likely tell you that battery life is one of the most important factors when buying a new device. We live in an untethered world, and the ability to go long hours away from a charging cable is a must. It's not just about convenience. Some devices, such as healthcare monitors, rely on solid battery life to maintain their core functions.
When designing IoT devices, matters of power consumption are a balancing act. Trade-offs are inevitable because you must find the right mix of battery capacity, low-power design, product features, and a sleek form factor. Every detail affects the user experience and the device's functionality. Everything from data transmission to battery size comes into play, making this part one of the most challenging of the design process.
The best course of action is to calculate power consumption needs early in the architecture phase. That way, you're free to adjust as needed. Any later, modifying power elements can bring you back to square one.
Luckily, Voler Systems is well-versed in low-power design, and we can develop your product with your unique power needs in mind.
Here's another best practice that avoids problems later in the development cycle. Determining the overall size and footprint of the final product can help us choose components that work.
It doesn't matter whether you're doing a wearable device or one that sits in one place during use. These devices are complex, and you need to know how much room you have to work with on the printed circuit board (PCB), the size of the battery, and beyond. Knowing that information lets us choose appropriate components and fit them onto a PCB for essential prototyping.
Once again, estimating size at this stage helps avoid headaches and setbacks later. However, it goes beyond the PCB. Many sensors are available to implement into your device and collect data. Voler Systems has experience working with sensors that gather data on everything from temperature to nuclear radiation.
Understanding size limitations goes a long way in choosing sensors and defining the scope of the product's capabilities.
Security is something you cannot wait until the last minute to address. We're talking about Internet-connected devices that transmit valuable data over the air. Unfortunately, IoT electronics are a target for cybercriminals. If they were to gain access to that information, they could wreak havoc. Users are vulnerable, and you might have some form of liability.
Many security risks exist for IoT devices. If you're creating medical devices, you also must consider HIPPA violations, CE security requirements, and more complex requirements from the FDA. Apple and Google are starting to require a minimum level of security for apps in their app stores, so even consumer devices need security.
Don't make the mistake of treating security as an afterthought. It's best practice to take a secure-by-design approach. We can address security flaws, implement built-in security techniques, and create a more resilient product that reduces liabilities.
Software and firmware are just as important as the device itself. IoT devices can't function without software at the helm. But did you know that software issues are one of the leading causes of product recalls?
These are essential components that you, once again, cannot leave until the last minute to consider. Your device should have solid firmware from the outset, and the software needs efficient update processes to avoid headaches. Thankfully, wireless technology makes over-the-air updates easier.
Software engineering should be a top priority during the design phase to avoid problems later. There are extra steps to establish life cycle requirements for IoT devices. The challenge is even more significant if you're creating a medical device. We take care of these details early to avoid taking steps back later.
Are you ready to enter product development and turn your ideas into a reality? Turn to Voler Systems. We have more than four decades of experience and understand the complexities of IoT. Utilize our expertise for everything from wireless communication and sensors to low-power design to create a competitive device that meets your vision.
Voler Systems uses these best practices to complete projects successfully. We’ll help you stay on time and within budget, ensuring that you can smoothly move onto large-scale production and get your IoT device to market successfully.
Located in Silicon Valley and with more than 40 years of electronic design experience, Voler Systems continues to be a leading custom product design consulting company providing highly experienced electrical engineers and firmware developers. Voler Systems ensures delivery of quality products, on time, on budget, and with low risk. All projects are undertaken with good specifications, the right people, quality design, constant communication, and a smooth transfer to manufacturing.