Tag Archives: medical device

What is a FPGA-Based System Design?

FPGA-based design refers to Field Programmable Gate Arrays, or FPGAs, that are used in the place of microcontrollers to execute sets of functions instead of having a lot of sequential steps and controllers that don’t create a unified process. This design process is common in medical device development and can help create more effective designs than other methods of prototyping. In this guide, we’ll take a closer look at what FPGAs are and what their design entails.

What is an FPGA?

A Field Programmable Gate Array is a semiconductor device that is comprised of logic blocks. These logic blocks are specifically programmed to execute certain functions. They can be interconnected using a matrix, and their structure is a two-dimensional array that connects input and output signals for easy operation. FPGAs are also entirely reprogrammable, which means that they can be modified to serve a different function if they’ve completed their first task.

So, what is FPGA design? The FPGA design process includes:

Design: Designing the semiconductors to perform the necessary actions based on the code with which they are written.
Verification: Verification of the design to ensure that all functions work and can be repeated properly.
Implementation: Implementation of the new FPGAs, which take over certain processes and operations in various devices, including medical devices.

FPGA design and development is something that is best left to the experts because of its unique nature. However, understanding it is simple for just about anyone.

The Benefits of FPGA Design

Several benefits come from choosing FPGA design over other methods. For starters, it is faster and more efficient because it allows actions to occur simultaneously, providing much better processing solutions for things like graphics and FFT. The high-speed options that this design offers also make it a better choice for things like LVDS and HDMI protocols.

FPGA design is flexible and agile. Configurable logic blocks make it easy to change hardware configurations, and as long as logic elements are available, you will never run out of timers. Being able to reconfigure elements down the road will also offer flexibility in product lifecycles and provide room for change when requirements and technology change.

FPGAs do what microcontrollers can’t. They can be uniquely programmed and coded to deliver on several functions and tasks, and they work as a whole with embedded system development for things like medical devices. From prototyping to execution, FPGA design is a useful tool for this industry and others like it.

How it Works

The next question many people have is what does an FPGA design engineer do, and how does the process work? First, the team works together to come up with a design entry, which they create using HDL or Hardware Description Language. The schematic-based technique is used for design entry, making it easy to read and comprehend for all users involved. Once the design entry is completed in the form of code and entered into the system, the synthesis process begins.

Synthesis involves making sure that the functions actually do what the designer intended them to do. The gates, flip-flops, and other elements are added to the circuit, and the input is turned into a netlist, giving users a full list of the logic elements they’ll need for the project. Once this is complete, the implementation begins.

Implementation involves three steps: Translate, Map, and Place and Route. The FPGA tools used are most effective because they know how to translate things effectively and place them where they should go. There may be some trial and error here, but that’s where the final step, timing verification, comes into play.

Timing verification can be done through a static timing analysis or a timing simulation, either of which can be done at certain stages in the process. Depending on whether you want a partial or full analysis, these verifications should be done after the mapping, placing, and routing and elsewhere in the process.

What is HDL Design?

HDL, or Hardware Description Language, is the use of system specifications and hardware details to design the hierarchy of an FPGA or other device or component. Using this language is ideal for digital systems that require more hierarchy division and simple instructions that inform the FPGA design and implementation process. This design can be divided into as many sub-modules as needed, which makes it easy to use it as part of the FPGA design process.

The Bottom Line

FPGA design is revolutionizing the way that medical prototyping and other device development take place. It allows for custom programming with reprogrammable features built in, allowing end users to get more from their device development. Contact Device Lab to learn more about FPGAs and their design process.

Timeline Overview for Designing Medical Devices

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Designing medical devices can be challenging, especially if you’re unfamiliar with the standards governing their production and use. This timeline overview of medical device design will help you become familiar with the process, including all the steps necessary to go from idea to final product in clinical and research settings. Follow along as we cover everything from concept design to usability testing and how you can speed up the process.

Medical device development steps

Designing medical devices is no small task. Creating a safe and effective product requires a great deal of planning, research, and testing. The timeline for designing a medical device can vary greatly depending on the complexity of the device, the type of medical field it will be used in, and the regulatory requirements. The roadmap for medical device development involves

Intellectual Property Support
Product Design
Risk Management
Manufacturing
Human Factors and Usability
Compliance and Regulatory Support

Each of these steps is crucial when developing an efficient and reliable medical device that improves patient care and provides a competitive edge for manufacturers. Let’s dig into three ways to save time on medical device development timelines.

Speed up with a modular approach

Designing medical devices is a complex process that involves multiple stages, from the initial concept to the final product. Developing a timeline for the entire project can be daunting, as there are many steps and variables to consider. However, a modular approach can help speed up the timeline by enabling teams to work in parallel.

A modular approach divides the development process into several distinct stages. Each stage includes specific activities related to the overall design of the device. This makes it easier to identify areas that need to be focused on first while other stages can proceed in parallel. It also helps ensure that teams focus on tasks essential to completing the project on time.

Each stage in the modular approach also has a timeline associated with it. This allows teams to plan and manage their tasks accordingly. For example, if the design and engineering stages must be completed before moving on to manufacturing, teams can plan and prioritize their tasks based on this timeline.

The modular approach speeds up the timeline for designing medical devices and reduces the risk of unexpected delays. By breaking down the project into manageable chunks, teams can better identify and address any potential issues that could cause delays. This ensures that each stage of the project is completed on schedule.

Focus on supplier relationships

When it comes to designing medical devices, having strong supplier relationships is essential. Suppliers are responsible for providing critical components and materials necessary to complete your design. Clear expectations and a solid relationship ensure that the parts you need are delivered on time and of the highest quality.

When it comes to the timeline of designing a medical device, it is important to take into consideration supplier relationships. Many different suppliers are involved in developing and manufacturing medical devices.

One of the first steps in establishing a new supplier relationship is finding out what they specialize in and their capabilities. Some suppliers may have more experience or capabilities than others, so choosing which supplier will help you with your project is important. It’s also imperative that you establish clear expectations with each of your suppliers, so they know exactly what needs to be done by them and by when. Communication between all parties involved in the project is crucial in ensuring that deadlines will be met and production will go smoothly without any hitches or delays.

Expand your product development ecosystem

At every stage of product development, numerous tasks must be completed to meet the highest quality and safety standards. From initial concept creation to final production, each step must be carefully planned to stay on track and meet all regulatory requirements.

Consider expanding your product development ecosystem to include experts from different industries that can offer new perspectives on design and manufacturing processes. This will allow you to have experts available for any stage of the product’s lifecycle. Experts on hand will save you time and money by helping you make strategic decisions and identify possible solutions to unexpected challenges as they arise.

These experts also serve as excellent sources of knowledge about how specific components function or how other organizations perform their processes so that they can tailor their approach based on what is most efficient and effective for your organization’s needs.

What is the Medical Device Life Cycle?

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The medical device industry can be confusing to many, particularly when trying to understand the life cycle of medical devices. This article introduces what the medical device life cycle means and how it affects the design of new medical devices and their marketing, production, distribution, and sale.

Product life cycle phase 1: Concept

The first phase of the medical device life cycle is a concept. This is when the idea for the device is first conceived and developed. During this phase, the product design and specifications are created, and the device concept is tested and validated to ensure it meets all requirements. During this phase, the feasibility of the device is established, and a prototype may be created. An overall market analysis may also assess potential sales and customer demand. Ultimately, at the end of this phase, a decision is made as to whether or not the device should move forward into production.

During this phase, it is also important to consider the regulatory environment for the device. A risk assessment should be conducted to determine potential risks and the necessary precautions to take. Additionally, any legal or patent requirements should be addressed. It is also important to establish quality control standards for the product to ensure that it meets all safety requirements and customer expectations.

Product life cycle phase 2: Planning

The second phase of the medical device life cycle is the planning stage. During this phase, the device manufacturer develops detailed plans for the device’s design, development, and production. In addition, regulatory and compliance issues are addressed to ensure that the device meets all applicable requirements.

This is a critical life cycle phase as it sets the foundation for all subsequent phases. During this phase, the manufacturer determines the cost, timeline, and resources necessary to bring the device to market. The manufacturer also develops detailed specifications for the device and its components. This information is then used to develop detailed plans for the device’s design, development, testing, and production.

Product life cycle phase 3: Design

Design is the third phase of a medical device’s life cycle. It involves creating a product that meets specific criteria and is capable of meeting the needs of its intended use. This phase is focused on tasks related to product design development and the manufacturing process. This will include

Design verification and validation
Evaluation of usability
Biocompatibility
Electrical safety

Risk management will be prepared during this phase to avoid any harm or injury to users once they start using the product. It’s crucial to consider all the potential regulatory requirements the medical device must abide by.

Product life cycle phase 4: Validation

The fourth phase in the medical device life cycle is known as validation. This phase is extremely important as it ensures that a medical device meets its intended use and functions correctly, safely, and reliably.

This step involves different activities such as:

Process validation, mainly based on the IQ/OQ/PQ technique
The clinical investigation, based on the claims associated with the device
Final labeling, including IFU
Regulatory Submission
CE marking or other market authorizations

By ensuring that all applicable regulations are met during the Validation phase, medical device companies can help to provide safe and effective products to their customers.

Product life cycle phase 5: Product Launch

Product launch is the fifth stage of the medical device life cycle. The medical device is made available to healthcare professionals and patients during this phase after regulatory approval.
During the product launch, the marketing team ensures that the medical device is properly promoted and marketed to create awareness. The sales team then ensures the product is sold to its target audience. This may involve educating healthcare professionals about the product, demonstrating samples, and launching promotional campaigns.

Product life cycle phase 6: Post-Market Activities

The Post-Market phase of the Medical Device Life Cycle is the final phase in the process, and it covers all activities that occur after a medical device has been released to the market. It includes various activities such as product support, customer feedback tracking, post-market surveillance, and continued development.

Post-market activities are essential to the product life cycle because they help ensure that devices remain safe and effective for patients. During this phase, manufacturers must consider data from various sources, such as customer feedback, market analysis, clinical trials, and safety studies. This data helps identify potential problems or issues with the device and can inform the development of corrective actions.

By engaging in post-market activities, medical device manufacturers can ensure that their products are safe, effective, and reliable for their intended use. Through these activities, manufacturers can maintain product quality and meet customer needs over time.

How Do You Design and Develop Software for a Medical Device?

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If you’re new to the world of medical devices, then you may not be aware of how important software development is to your product or service. An integral part of the design, development, and testing process, the software informs each step of the process and enhances many aspects of the finished product. Let’s take an in-depth look at how you can design and develop software that meets the strict requirements of a medical device and its users, so you can make sure your product is safe and effective before putting it on the market!

Types of Software for Medical Devices

Embedded coding and SaMD (Software as a Medical Device) are different approaches to designing and developing software. To understand their differences, let’s look at each one individually. Embedded coding is where programmers write code closely with developers who build hardware. SaMD involves writing software that’s separate from (and acts on) an existing hardware product or system.

When SaMD is used, it’s because there isn’t an existing product to work from—it’s writing code from scratch. This distinction is important because embedded coding requires close coordination between hardware developers and software engineers, while SaMD uses that connection only when necessary (for example, if updates are needed).

Examples of embedded coding in medical devices are pulse oximeters, electronic defibrillators, automated infusion pumps, glucometers, and more. It’s a very common practice in the medical field to have embedded coding in medical devices.

Software as a Medical Device generally performs functions related to medical data being visualized, processed, and stored. SaMD includes medical devices that help surgeons perform surgery remotely, software that helps make sense of electrocardiograms (ECGs), artificial intelligence systems that analyze brain scans, automated diagnostics systems that process genetic information, and more.

Software designed specifically for SaMD can be used across multiple platforms because it’s written separately from existing hardware—it isn’t bound by pre-existing physical components or constraints like embedded coding.

Process of Building Custom Medical Device Software

First, every project needs to begin with clear objectives. Even if these are general or vague goals, they outline what should be accomplished. But taking your first step toward developing custom medical device software is more than simply knowing what kind of program you need; it also requires identifying your user base to meet their needs. The next stage involves laying out what’s required from your hardware/operating system combination and any specialized requirements that will be necessary to fulfill your objectives.

Once those questions have been answered, it’s time to start planning your development cycle. When is your project deadline? How long will it take to build? What kind of testing will be necessary, and how should that be approached to optimize results? All of these factors influence what your team will need from both a technological standpoint and their skillsets.

Choosing a Development Partner

Once your project has been defined, it’s time to start putting together your team. This will depend on what kind of skills are required but is largely governed by one simple rule: The more experienced members you have on your team, the less supervision they require. They will be better able to define how they want their work environment to operate, so you won’t have to step in unless there’s a problem.

When choosing your team, it’s important to find out how they communicate with each other. A good medical software development partner will have made their processes transparent so that everyone knows what needs to be done when it needs to be done, and why it needs to be done.

Your development partner should have experience with medical devices as the field is very specialized. You will want to ensure they are familiar with any standards your product must adhere to. Make sure that they know how to work within those standards, too. In addition to ensuring they understand all of these things, it’s also important to ask about their working style. Do they prefer Agile or Waterfall methodologies? Do they use source control? How frequently do you meet with them? What kind of reporting structure does their company have in place? Can you talk directly to anyone on their team if needed, or will everything go through management first?

DeviceLab’s Experience Creating Healthcare Device Software and Systems

DeviceLab worked with several medical device companies to create life-changing medical device designs. By developing custom applications to control hardware, DeviceLab has demonstrated that it is feasible to produce quality products while saving money on development costs.

Below Are Some Examples of Our Work:

DeviceLab was also responsible for creating user interfaces (UI) and experiences (UX) and implementing firmware in embedded systems. These tasks are extremely important because they can make or break your product. The UI/UX of your product is what people will see first when they use it, so it’s important to get it right!

DeviceLab’s specialties are digital health, wireless & wearable, laser & LED technologies, IVD diagnostic instruments, and patient monitors & advanced medical systems. With experience in developing firmware in embedded systems, designing user interfaces (UI) and experiences (UX), as well as implementing firmware in embedded systems, it’s no wonder we’re a leader in the industry.

DeviceLab is experienced with making life-changing products possible by developing custom applications to control hardware, resulting in cost-effective solutions that improve people’s lives.

Conclusion

As with anything that uses an embedded system, it’s important to consider all necessary safety precautions. Depending on your project, communication lines, wireless capabilities, display size/resolution, and touch input may be crucial parts of your development process. And even if it isn’t, your customer is sure to have their own requirements that can make or break your product—ensure you keep those in mind during each step of development. Hire a reputable company that provides healthcare software development services like DeviceLab to help you through the entire process.

Advanced Care & Alert Portable Telemedical Monitor (AMON)

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Wearable medical devices have allowed patients the freedom to perform their normal daily tasks without feeling constricted by their illnesses. Some illnesses like diabetes and atrial fibrillation have forced patients to schedule their lives around dosing medications or performing testing. However, wearable forms of traditional equipment have allowed patients to discreetly monitor their health or take medication. Researchers have been evaluating how wearable devices can be useful to monitor and store vital patient data. They believe there is a lot of potentials to monitor health without keeping patients confined in the hospital and a lot of potential benefits from continuous monitoring.

The original health watch wearable was called “AMON.” The goal of the advanced care and alert portable telemedical monitor (AMON) device was to evaluate how continuous monitoring can provide high-risk cardiac and respiratory patients freedom to live their life while still having access to a higher level of care. Vitals for these patients can fluctuate suddenly which is a big indicator of disease progression. When this happens, patients need to immediately seek medical attention. However, they may not always feel any physical symptoms to indicate a change in their vitals. The AMON device was designed to alert the patient and provide support.

The First Multi-Parameter Medical Detection Device

The AMON device was the first multi-parameter medical detection device and paved the pathway for all modern health watch wearables like the Apple Watch and FitBit. The AMON was able to monitor 2-lead ECG, heart rate, blood pressure, heart rhythm, O2 blood saturation, body temperature, and skin perspiration through biosensors. This data was collected, stored, and analyzed to immediately alert patients of any changes. The AMON device was well researched with a full clinical validation study.

While the AMON device is no longer available, it created the concept for all current smartwatches. The AMON device was advanced and monitored multiple parameters using advanced biosensors. Current health wearables are often similar but may only monitor one or two parameters and may not provide emergency detection. Because of the AMON project, researchers have received funding to continue developing wearables and received several grants to do studies. Wearables are an important mainstay in digital health technologies that are driving patient-centric personalized healthcare. In fact, 70% of clinical trials will incorporate some type of wearable by 2025, leveraging both longitudinal data as well as an application across broad therapeutic areas. The overall market for wearable devices is expected to reach close to $1 billion by 2024 growing at more than 20% annually.

DeviceLab and Wearable Technology Development

Wearable technology is currently being evaluated by researchers all over the world who are in different stages of development. A milestone marker in the digital health landscape was the launch of the Digital Health Center of Excellence by the FDA in September 2020. This signals that wearables are here to stay for the long term. DeviceLab is highly specialized in wearable technology and is here to help researchers. Contact us today to schedule your personal free and confidential consultation.

Medical Device Needs to Support Telemedicine

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Previously, we wrote about COVID-19 making telemedicine a new normal and that it has a strong potential to remain in high usage beyond the pandemic. Telemedicine was once a niche model of health care delivery but has become more mainstream as an answer to providing healthcare during the COVID-19 crisis. Even with re-opening and the return to non-critical doctor visits, telemedicine remains prevalent and in use at a level significantly higher than pre-COVID.

While telemedicine increased significantly because of COVID, the practice was quickly on the rise prior to the pandemic. It was making its way into the mainstream, and the future of telemedicine looks bright. Compared to 2019, patient adoption of telemedicine use rose by 33% in 2020, and funding has also been trending upward, with the market estimated to grow to $185.6 billion by the year 2026.

Over the past few years, patients have shown an increased comfort level with using technology for health services, and online resources have overtaken word-of-mouth referrals. More patients also prefer online booking and digital communication over traditional phone calls. Even as more doctors are accepting in-person appointments, patients are continuing the trend of seeking virtual solutions through telemedicine. This shows us that telemedicine is here to stay.

The Challenges of Telemedicine Adoption

The surge in telemedicine has stressed the unprepared system, practices and highlighted deficiencies and aspects that need improved reliability. This not only poses huge opportunities for vendors and patients alike, but it also presents us with significant challenges. One such challenge includes researchers’ predictions that telemedicine will be able to provide better patient outcomes with the use of more remote diagnostic equipment and user-friendly sensors. They also see more opportunities for care through the practical application of AI robotics, with advancements like interactive virtual assistants.

Providers need to make substantial investments in hardware, software, and the training of personnel in how to use telemedicine. More hospitals are beginning to develop in-house software that nicely integrates with their existing electronic medical records system. However, this software development and implementation can take time to ensure it works properly and is secure to east privacy concerns.

Another area of deficiency for the effective implementation of telehealth is the lack of medical devices in the home. Every office, emergency room, and hospital visit starts with the standard patient vital measurements. Although there may be a few reasons for this, the most important is that the results are indicators of potential medical problems for the patient. The lack of medical devices in the home limits the effectiveness of telemedicine doctor’s visits, monitoring, and treatment.

Valid Telemedicine Concerns

Telemedicine devices will need several technologies to support the growing practice. Each medical device, possibly as simple as a thermometer or weight scale, will need wireless connectivity. The device will need to transmit information to the medical provider to be recorded into the patient file. The transition, likely through the patient in-home hub, will need to support end-to-end encryption for privacy and meet HIPPA compliance. The device will need an internal function to support encoding and decoding the encryption. One less considered function of biometric or diagnostic measurements is that health care providers and insurance companies want trained professionals to take and record these measurements to ensure accuracy, correctly read and interpreted data from properly applied medical devices. Someday there may be requirements to detect the “real” patient is being monitored through means like biometric identification.

An example of telemedicine concerns relative to basic patient measurements comes from the Centers for Medicare & Medicaid Services (CMS). Throughout the COVID health emergency, the CMS made compromises and allowed patients to self-report via telehealth their vital signs and other biometric data during Medicare annual wellness visits (AWV). There has been some concern about obtaining accurate needed biometric data (e.g., weight, height, blood pressure, etc.) after CMS enabled telehealth to be administered to patients at home during the COVID emergency. The medical devices described prior will alleviate the concerns.

These dynamics are leading to the telemedicine medical device market that requires more capability, connectivity, security, and mobility technologies to be adapted to support the remote healthcare trends. Hence, the rush to provide more home-use biometric measurement and diagnostic medical devices is on.

The Future of Telemedicine

Companies looking to develop such devices but lacking expertise or bandwidth can turn to companies like Devicelab for product realization. Devicelab, foreseeing this demand and telemedicine trend, has invested years developing high-tech, secure remote medical device platforms based on state-of-the-art wireless connectivity, electronics, and medical device technologies. This includes software that ensures privacy and security measures that meet HIPPA regulations. Their proven platform can be leveraged to reduce time to market, enable telemedicine for patients and practitioners, capitalize on the increasing telemedicine demand, alleviate the current limitations in this practice and improve remote healthcare.

Telemedicine may have entered a tipping point during the COVID emergency, seeing a spike in its usage, and it could continue to gather the momentum needed to be sustainable once the crisis is over. This will be supported by improvements and access to personal mobile technology, the proliferation of 4G and 5G networks, a digitally-savvy population, and changing regulatory and reimbursement structures. These shortcomings are sure to be addressed in time. Devicelab can be a partner for solving telemedicine medical device and software demands.

FDA Medical Device Classification

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FDA has a public obligation to regulate and control the distribution of medical devices for public safety. To do this, medical device manufacturers provide information and data about their product to the FDA to assess the product for safety and effectiveness. However, not all products require the same level of review by the FDA. A low-risk product like a tongue depressor does not require the same level of regulatory oversight as a pacemaker.

There are three categories of medical device requirements or regulatory controls. The type of applicable regulatory controls is based on medical device classification. FDA medical device classifications are based on risk to the user. Class I medical devices are the lowest risk products (i.e., the tongue depressor), and Class III devices carry the most risk (i.e., the pacemaker).

Class I Medical Devices

FDA defines Class I medical devices as “not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness or injury.” Examples of Class I medical devices include products like stethoscopes, bandages, and wheelchairs. These products are typically only subject to general controls.

General controls are requirements around adulterations, misbranding, registrations, banned devices, notifications, and other remedies, records, and reports. These are requirements a manufacturer must meet prior to marketing the medical device.

The FDA does not typically need to review safety or performance data regarding the safety and effectiveness of these products because these general controls are sufficient to provide a reasonable assurance of effectiveness and safety or because the device fits the definition of a Class I device.

Class II Medical Devices

Most medical devices are considered class II devices and present a moderate risk to the user, such as ultrasonic diagnostic equipment, x-rays, and needles. Class II medical devices are always subject to the same general controls as the class I devices.

Special Controls of Class II Medical Devices

Typically, class II medical devices are subject to special controls. Special controls are device-specific requirements and include compliance with performance standards, quality system regulations of 21 CFR Part 820, post market surveillance, patient registries, special labeling requirements, and premarket data requirements. Prior to marketing, data is submitted to the FDA through a premarket notification or a 510(k) submission. Upon review, the FDA notifies the manufacturer that the device is legally marketable.

Class III Medical Devices

Medical devices that cannot establish safety and effectiveness through general controls and special controls are class III devices. These devices are of the highest risk and include products such as balloon catheters, pacemakers, and heart valves.

Class III devices require a premarket approval application (PMA) from the FDA to thoroughly evaluate the medical device. PMAs typically requires clinical data and have a longer review process. Once the review is complete, the FDA will approve the medical device. Class III devices are typically life-sustaining, life-supporting, or long-term implantable devices.

Contact a Qualified Medical Device Design & Development Company Today

At DeviceLab, we are committed to delivering medical devices that achieve regulatory compliance. If you need a medical device designed, we can take your idea from concept to market and work with outside regulatory partners to handle clinical trials and submissions. Contact us today for your free and confidential consultation.