Tag Archives: medical device design

Timeline Overview for Designing Medical Devices

woman designing a medical device on a pc computer with a blue hue

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.

Does AI need FDA approval for Medical devices?

Ai Artificial Intelligence In Modern Medical Technology Iot And Automation

Advances in Artificial Intelligence have made possible some incredible medical devices, but the question of whether these devices should be FDA approved has surfaced in the medical community. The answer depends on what kind of medical device you’re working with, so let’s take a look at how AI impacts different kinds of medical devices.

What is Artificial Intelligence (AI)

According to Merriam-Webster, artificial intelligence is defined as the capability of a machine to imitate intelligent human behavior. But what does that really mean? Artificial intelligence is actually a pretty old term. In fact, you can trace its roots back over six decades to when mathematician John McCarthy coined it in 1955. Even then, it was clear that AI technology had massive potential to augment our lives and make all kinds of processes easier.

Over time, as AI continued to evolve and technology advanced, experts began to envision how AI could be used in conjunction with other technologies to increase their efficacy. This kind of combination approach has a wide range of applications across multiple industries, including healthcare.

Benefits of AI

We tend to think of AI as robots and computers talking in a human-like way or beating humans at strategic games. But actually, AI is also used in countless medical applications that have already saved lives and improved the lives of many patients around the world.

The real value of artificial intelligence is its ability to help humans make faster and better decisions. Think about your smartphone. Its predictive text function doesn’t actually write your text messages. It simply predicts what word you’re trying to type next so that you can quickly and easily send a message without having to type out each word letter by letter.

AI in Medical Devices

As research into artificial intelligence has increased, so too has it been adapted for medical purposes. Now, many hospitals are using artificial intelligence to assist with certain diagnostic procedures and checkups. Artificial intelligence is being used in both simple and complex ways: from diagnosing eye disease to reading radiographs—there’s even an artificial intelligence diagnosis tool that can predict cancers.

This has led to many wondering whether or not artificial intelligence requires FDA approval. The short answer is yes. All medical devices need to be approved by an accredited testing body and come with appropriate instructions for safe use. While it’s true that artificial intelligence can assist in diagnosis, there are still a number of questions surrounding its use. For example, should hospitals hire human radiologists as well as AI-based systems? And how much of a doctor’s job could be automated through artificial intelligence?

Regulating AI in Medical Devices

As technology evolves, the FDA evolves too. Regulatory requirements for AI in medical devices weren’t something as common as it is today. With the current FDA structure, AI and machine learning devices will need a premarket review even for software changes.

Over time the FDA plans to establish a “predetermined change control plan” that’ll require reviewing anticipated modifications to the software. This will minimize risks to patients and ensure compliance with regulations.

The FDA’s new guidelines are just another step in ensuring that medical device manufacturers remain compliant with regulations while also allowing them to incorporate innovative technologies into their products. As AI becomes more prevalent in medical devices, it’s important that regulatory agencies like the FDA keep up with technological advancements so they can continue to protect consumers from harm.

The FDA is working hard to ensure that medical device manufacturers comply with regulations while also incorporating innovative technologies into their products. The new changes make it clear that regulatory agencies like the FDA understand how technology is changing and are willing to evolve with it in order to protect consumers from harm.

The Future of Healthcare

Technology is constantly evolving. What has become normal today was unimaginable 30 years ago. Just think about how much healthcare can change in the future. The possibilities are endless. It’s an exciting time to be alive and see what new technologies will have an impact on healthcare. Whether it’s identifying and curing diseases or improving the time it takes to get test results, technology will continue to improve our lives. While there are plenty of benefits with advancements in technology, there are also risks that come along with them. With all these potential dangers, it’s important to have a governing body in a place like the FDA to ensure the safety of patients.

If you have any questions about your medical device, or need assistance creating it, contact DeviceLab today.

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

Medical device & equipment software concept

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.

TracPatch: a Medical Device Developed by DeviceLab Wins Best Wearable at Sensor Converge Expo 2021

TracPatch: a Medical Device Developed by DeviceLab Wins Best Wearable at Sensor Converge Expo 2021

Wearables are the go-to solution for people who want to closely track and manage their wellness. They can provide useful information such as tracking your temperature, blood pressure, blood oxygen, respiration rate, location, bodily movement, and so much more, including your body’s electrical activity. This includes the activity of the heart, muscles, brain, and skin, among others. 

Wearables are changing the world of healthcare for the better and are making it more possible than ever to stay healthy. Chief among these industry and device leaders is TracPatch, a recent medical invention created by DeviceLab. TracPatch is so revolutionary that it recently took home the award for Best Wearable Sensor at the 2021 Converge Expo. 

Interestingly enough, DeviceLab and TracPatch initially sketched the idea on the back of a napkin at a trade show, only to later walk away with an award for this incredible concept. Outside of developing the app that accompanies TracPatch, DeviceLab handled the device from start to finish.

Who is DeviceLab? 

DeviceLab was founded in 1999 with the purpose of changing the face of medicine. They are a full-service medical device development and design company in Orange County, California. Their goal is to take the top, up-and-coming medical devices in the country and turn them into household names. In their brief 22 years of existence, DeviceLab has helped develop 16 Medical Carts, 22 Table-Top Instruments, 20 Hand Held Devices, and 9 Single-Use/Disposable Medical Devices. 

Their goal is to take your product from concept to reality as quickly and effectively as possible. They have a wide range of expertise and the resources, contacts, and vendors necessary to take an unknown medical device straight to the top. 

What is the TracPatch? 

The TracPatch knee monitoring system is the number one wearable on the planet, according to the 2021 Converge Expo. It is changing the world of orthopedic care and making it easier than ever for doctors to take care of their patients. It manages to integrate into any healthcare system seamlessly. It keeps providers up to date with real-time data and information as the patient wears the device. 

Best of all, TracPatch is non-invasive, easy to use, and syncs seamlessly with the TracPatch mobile app and the provider web portal. This allows your doctor to stay informed and updated on your health and well-being. It also allows them to make the most informed decisions about the comprehensive care that you need. Here are some of the top reasons why TracPatch should be utilized throughout the medical industry. 

  • TracPatch offers personal service and empowerment to patients through recovery and treatment of their injury. 
  • TracPatch is cost-effective, comprehensive, and is thought of very highly by patients and doctors alike. 
  • TracPatch is excellent at detecting adverse effects and conditions such as arthrofibrosis, infections, and so much more. 
  • TracPatch provides instant information and medical updates to doctors to monitor their patients. 

How Does TracPatch Work? 

While it may sound complicated, TracPatch is actually quite simple. Immediately after a patient undergoes a total knee replacement surgery, they have a TracPatch wearable device fitted to the outside of their leg. As they go throughout their day, the device records their motions, movements, and activity levels and provides it to your doctor as it’s happening. 

Through the TracPatch app, you can submit your pain levels and take photos of the surgical site to ensure it doesn’t get infected. If your medical provider sees anything to be worried about, they know about it instantaneously and can provide the help necessary to mitigate the risk. 

Where is TracPatch Now? 

Since it hit the market, TracPatch has been at the forefront of medical device development, specifically for orthopedic purposes. Surgeons, physical therapists, and medical professionals across the spectrum love TracPatch for its ability to help them keep their patients healthy. Its success eventually led to the founding of TracPatch Health Inc., which is dedicated solely to maintaining and improving the TracPatch device. 

DeviceLab Help Patients Achieve Wellness 

Revolutionary devices like this are what make tracking patients’ health easier. The data helps identify issues early, create better treatment plans, and help patients achieve better wellness. DeviceLab is excited to continue the journey of creating medical devices that change the world of medicine for the better. Contact us to learn more

How Do You Develop Medical Equipment? 

woman testing medical device for development

Medical devices and wearables are among the most revolutionary developments in healthcare. Both are examples of modern and innovative medical equipment that require a significant amount of time and work to achieve.

The exact process of medical device development might vary from place to place and country to country. However, you’re expected to adhere to the rules and regulations of your area. However, the overall process is very similar no matter where you are. It typically starts with an idea, which grows into a concept, which turns into reality. However, the road between these three destinations is complicated and full of roadblocks. Let’s take a closer look at the medical device development process. 

Stages of Medical Device Development 

The medical field is one of the most complicated and safety-based industries globally. Because of that, any new medical devices that hope to hit the market have to go through a stringent design process. There are a series of tests and requirements to ensure that only the safest and most efficient devices make the cut. 

All medical devices require some level of FDA approval since their method is often the gold standard of medical device development. The FDA has five stages for processing and testing medical devices to determine if and when they’re ready for commercial use. If you hope to produce a medical device that becomes available for widespread use, here are the five stages of medical device development that you’ll have to pass. 

Initiation 

Medical device development starts with the initiation phase. During this development phase, your device’s potential impact on the medical field is examined. Potential problems and risk factors are also considered, and your device is adjusted accordingly. Risk management is the most critical aspect of medical devices. No matter how great or revolutionary a medical device is, nobody is willing to use it if there’s a chance that it could harm them. 

Formulation 

During this stage, there is a complete exploration of who will be using the device the most, how they’ll be using it, and where they’ll be using it. The overarching goal for a medical device is to be as practical and usable as possible. The more people who can implement your device, the more likely it is to make it in the medical market. 

Design and Development 

Design and development include all the technology, design work, engineering work, testing, and documentation into developing your device. It’s considered by some to be the most crucial step in the medical device development process. The goal is to ensure that the design output is greater than the design input and that your medical device is soundly designed and clearly defined. 

Launch Preparation

Preparing to launch your medical device is one of the most significant and most nerve-racking experiences that you’ll go through. All of your preparation, testing and countless hours of work have all been for this moment. 

Of course, before you can officially launch your device, you have to secure product validation and approval from the FDA. Your device will also have to pass through certain regulatory compliances, both nationally and internationally. 

Launch and Postlaunch Assessment 

Finally, after months or years of hard work, your product is ready for launch. In the period that follows the initial launch and testing, your medical device will be subject to assessment, studying, and careful examination. It must be determined whether or not your device delivered on its promise and lived up to its potential. If not, it’s back to the drawing board or onto a whole new device. 

Why Choose DeviceLab for Your Medical Device? 

If you’re serious about taking your medical device from a dream to a reality, contact us at DeviceLab. We use a foolproof six-step process that includes intellectual property support, product design, risk management, manufacturing, human factors and usability, and compliance and regulatory support to ensure that your product is ready for launch. 

We’ve been in the medical device development business for over 20 years and have made excellent contacts and partners along the way. Your journey will start with a simple discussion where you tell us your vision and goals. Our experts work with you to formulate a plan to begin the process of medical device development. Reach out to us today to schedule your initial consultation. 

Why Design Matters in Medical Software Development

Designing medical devices and medical development

Software development can happen very quickly. Software developers can make improvements and enhancements to software easily without the need for physical products. Medical devices have not historically been products that iterate very quickly. Largely, this is because of design controls. A manufacturer must identify the needs of their medical device and the medical device must meet those needs for a product to be considered successful. However, for software development in the tech industry, the marketed software may not meet the same needs as the original software. As medical devices begin to include more software components or software as a medical device, manufacturers must evaluate if their design process allows for the nature of software evolution but still allows for proper design control.

Design Controls and Medical Device Development

As per FDA regulation, manufacturers must establish a design control process. Design controls as a useful tool for manufacturers to ensure they stay on track and are developing the right medical device. Design controls are documentation activities like specifying the treatment (i.e. cardiac or diagnostic tool), defining the conditions for use (in hospital, outpatient, at home), or identifying the user (e.g. patients, surgeons, nurses). These activities help ensure that what was the initial solution is the focus of the design activities and are periodically reviewed during the product development. If at any time during the product development, the engineers and researchers decide to go in a different direction, typically they need to start their documentation activities over again. This is useful to ensure the scope of the development activities does not unexpectedly change or grow during the project.

Manufacturers have struggled to implement design controls for software development. While it is easier to evolve and expand the scope of software development activities, manufacturers need to be cautious about practices that are against design controls. Software manufacturers need to develop design control processes that allow for flexibility but still provide the structure needed from medical device design. Below are a few tips for a medical software design control process.

Tips for Medical Device Software Design Controls

More Structured Formal Meetings

In the typical design control process, there are three to five formal meetings about the product development. During these meetings, cross-functional leaders are presented with updates about the project and decide if the project should continue. For software development, more formal meetings can help ensure the project goals are being met or if they need to be revised. These meetings may help slow down the development of custom software and ensure alignment prior to moving forward.

Evaluation of Market Needs Throughout the Software Development Process

Typically in design control, the market needs are only evaluated at the beginning of the project. Because medical software has such a big impact on the user’s experience, the market needs should be evaluated throughout development.

Evolution of Scope and Resource Planning

It is unreasonable to expect software to develop and iterate like a medical device. Design control procedures should be more flexible and allow for an evolution of scope. However, whenever the scope is revised, the project should consider if there are enough resources to continue the project.

Contact DeviceLab’s Team for Medical Software Development Services

If you are looking to create a software design control process, reach out to DeviceLab. DeviceLab has experts who are ready to help implement the best design control structure for your organization.

Discussing Ways to Take Your Medical Device From Prototype to A Regulatory Approval

FDA appriving a medical device prototype for regulatory approval

What Are the First Steps to Take a Medical Device Prototype to Get Regulatory Clearance?

One of the most exciting moments for medical device developers is when their idea is brought to life through a prototype. After the first initial prototype, engineers will keep iterating the design and developing new prototypes. Because of the iterations in prototypes, this phase of medical device development is typically the longest. Prototypes can look like computer-assisted designs that will show a rotating image of the finished device or 3-D printed models, which are physical products that typically cannot perform functions. Once the engineers get closer to the final design, they will start building actual working units as prototypes and start testing the product.

User Needs and Design Inputs

Each iteration of a prototype is a good thing and essential to medical device development. With each new version of the device, the engineers are meeting more of the user’s needs and design inputs. User needs and design inputs are all of the device requirements for performance and safety. These requirements are defined prior to prototype development and guide all future iterations of the prototypes. Engineers will informally test prototypes to see if they are meeting user needs and medical device design inputs. Once engineers feel confident in a prototype’s ability to meet user needs and design inputs, then they will go into formal verification and validation testing.

Verification and Validation Testing

Verification and validation testing refer to a suite of testing that challenges the device to ensure the device performs as intended and reduced risks. The engineers will develop formal protocols with statistically significant sample sizes, defined acceptance criteria, and formal procedures for testing. The test cases in each protocol are designed to verify and validate that all user needs and design inputs are met. Verification and validation testing include bench testing, animal testing, and even human clinical trials. If defined as a user need or design input, verification and validation testing can include biocompatibility testing, sterilization testing, transit testing. If all acceptance criteria are met, the engineers can conclude that medical devices will meet user needs.

The bulk of any regulatory dossier will be the verification and validation test reports. Regulators want to review these reports to ensure all user needs and design inputs were tested, the test methods are acceptable, and the sample size is statistically driven. Engineers and medical device manufacturers should be careful about when they begin to formally start the verification and validation testing. Regulators are interested in reviewing test reports for the final finished medical device. It is important that all verification and validation testing is performed on the final finished medical device. The verification and validation testing are what will bring a prototype to a complete medical device with regulatory clearance.

No matter what stage of product development you are in, DeviceLab is here to help. DeviceLab has a specialized team of engineers and consultants who can answer your questions from prototype development, informal testing, or formal verification and validation. Contact DeviceLab today to schedule a consultation and learn more about our services.

Three Tips for Successful Medical Device Design

Medical Device Design process

Great ideas in medical innovation can come from anyone, from engineers, healthcare providers, and even patients. Some of the biggest disruptors in healthcare development did not necessarily start with a large fortune 500 medical device company. Developers in any field have to go through a lot of thought experiments, but in the medical industry, they have a lot more risks and liability concerns. The potential risks and regulatory hurdles can overwhelm even the most enthusiastic developers. Here we break down the top priorities and tips for medical device design experts to consider – and consider early to stay focused during product development.

Tip #1: Market Assessments

A revolutionary breakthrough medical device is only suitable if the market is ready for it. One of the first things you will need to assess is if the market will adopt the new technology or change. Medical device developers might use surveys, online forums, or focus groups with healthcare providers, patients, or even insurance providers to gather information on the market. Some questions to ask are:

  • What are the current challenges with this procedure?
  • What is the current standard of care?
  • What are your concerns with the current standard of care?
  • What are the best outcomes? What are the risks of complications?
  • How would (blank) change the patient’s experience?
  • How does insurance currently reimburse this type of procedure?

The goal of collecting this data is to evaluate the current market needs and whether this new innovative device meets those needs or is there a gap. Is there anything in this new product that can be modified to lessen the gap if there is a gap? The data gathered from the market assessment should feed into the product’s development.

Tip #2: Regulatory Considerations

The FDA and other global regulatory agencies regulate medical devices to ensure the health and safety of the public. It is essential for all medical devices to comply with regulatory agencies. Early in development, it is important to start understanding the regulatory environment for medical devices. Initially, developers might find themselves on FDA’s website or DeviceLab’s blog to find information on device classification and potential regulatory pathways.

Tip #3: Discovery

Discovery refers to taking the initial idea and creating prototypes. Often, discovery is the most prolonged phase of medical device development. Medical devices go through several rounds of prototypes. To create a prototype, engineers will create drawings and specifications. These drawings and specifications will become more specific with time. Initially, the prototypes may only be 3-D printed models or computer-assisted designs. As time goes, the drawings and specifications will begin to look like blueprints with specified the materials and dimensions of the product. Eventually, the engineers will reach a working model and test the use of that prototype.

DeviceLab’s Medical Device Design

DeviceLab is here to help bring any medical device idea to market. DeviceLab can help guide you during your product’s development and bring your medical innovation to physicians. If you have an idea and want to explore the development, contact DeviceLab. DeviceLab’s medical device consultants and experts are here to put your product in the hands of physicians and users. Schedule a consultation to learn more about how DeviceLab can help.

Design Controls for Medical Devices

technician designing a medical device

For medical device design, the US FDA is interested in what is the final finished medical device and the process that led the manufacturer to the final design of the device, the device design process. Specifically, FDA wants manufacturers to ensure that the original user needs are met by the final finished medical device. To ensure manufacturers are designing products that meet user needs, FDA requires medical devices to be designed according to design controls, as regulated under 21 CFR 820.30. Design controls regulations are a set of requirements that allow manufacturers to control the way a device is developed.

What are Design Controls?

Design controls are a set of quality procedures implemented by the manufacturer to control the design process. After discovery or early feasibility, manufacturers must begin documenting the progress on the device design. Manufacturers are required to document user needs and what are the device features (or design inputs) that meet those needs. As the device goes through prototyping and safety testing, manufacturers must monitor and record all changes and assess how these changes impact the user needs and design inputs. After the final device prototype is made the manufacturer must test to ensure all user needs and design inputs are met.

Once the manufacturer believes the device prototype meets all user needs then the device must be tested to determine if the final device meets the user’s needs as intended. This final set of testing is the “verification and validation testing.” Verification refers to all testing that verifies if the device outputs meet the originally intended device inputs (i.e. features of the device). Validation refers to all testing that validates if the device itself meets the needs of the user (i.e. delivery of therapeutic effect).

Why Does the FDA Regulate the Medical Device Design Process?

Design controls work by ensuring a device is manufactured to meet the needs of the patient or physician. Historically, manufacturers have set out to deliver a device with an intended purpose but during design, a different product gets developed. This type of product may not meet the customer’s needs. When that happens, there can be a misuse of the product, misbranding or labeling issues, or even recalls. Medical device design controls help ensure manufacturers have a development methodology that prevents these errors.

Design controls are a very useful tool for manufacturers because it formalizes the development process and provides teams a framework for medical device product development. However, this formalization may not be helpful for R&D engineers early in the research of the products because medical device design controls require heavy documentation and a very defined scope for development. FDA requires manufacturers to implement design controls after feasibility or once a prototype is ready for market.

DeviceLab and the Medical Device Design Process

The medical device design process is highly regulated to ensure the right products are brought to market. Because design controls are required per FDA regulations, they should be implemented as part of an integrated quality management system. DeviceLab can help with the implementation of design controls or the development of medical devices. Contact us today to schedule your personal free and confidential consultation.

How to Study and Market Your Device in Four Steps

Study And Market Devices Small

Medical device manufacturers can legally market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per the Federal Food, Drug, and Cosmetics Act.

  • Step 1: Device Classification as Per Applicable Regulatory Controls
  • Step 2: Determine and Prepare the Correct Premarket Submission Package
  • Step 3: Send Premarket Submission Package to FDA and Participate in the Review
  • Step 4: Comply with Applicable Regulatory Controls Post FDA Clearance or Approval

Step 1: Device Classification as Per Applicable Regulatory Controls

All FDA-regulated medical devices are assigned a classification based on the device’s risk profile. High-risk medical devices are labeled class III and include products like long-term implants and pacemakers. Class II devices have a moderate risk profile and include products like ultrasonic diagnostic equipment and some surgical equipment. Low-risk medical devices like tongue depressors and bandages are class I devices.

A device’s classification is a good indication of what regulatory controls are necessary to ensure a product’s safety and efficacy profile. Generally, devices of the same classification are subject to the same regulatory controls and premarket submission packages. Regulatory controls are requirements that a manufacturer and the device must meet to market the product. These requirements include labeling requirements, claims requirements, record keeping, and reporting requirements.

Step 2: Determine and Prepare the Correct Premarket Submission Package

A premarket submission package is information a manufacturer must submit to the FDA prior to introducing a device into the market. Generally, class I devices do not require any premarket submission packages, and manufacturers can begin marketing these devices once all the applicable regulatory controls are established. If no premarket submission package is necessary, then manufacturers can skip ahead to step 4. 

There are two main types of premarket submission packages for class II and class III devices: Premarket Notifications and Premarket Approval Applications. Manufacturers can determine their device’s premarket submission requirements using the FDA’s product classification database.

Premarket Notifications, also called 510(k)s, are generally used for class II devices. These applications rely on establishing equivalency to an existing medical device based on intended use, technological characteristics, and performance testing. The medical device used to establish equivalence is called a “predicate device.” 

Premarket Approval Applications (PMA) are typically used for class III devices. A PMA is different from a 510(k) because no predicate device is used to establish the product’s safety and efficacy profile. Manufacturers who submit a PMA will typically need to submit more performance data and potentially clinical data so that the FDA can evaluate the product’s safety and efficacy.

Step 3: Send Premarket Submission Package to FDA and Participate in the Review

Once a manufacturer has established all applicable regulatory controls and prepared the appropriate premarket submission package, they are ready to begin the FDA review process. Before submitting a premarket submission package, manufacturers must pay their Medical Device User Fees for the submission package. Once the fees are paid, the FDA will issue a “Medical Device User Fees Act (MDUFA) Cover Sheet.” This Cover Sheet should be included in the submission package. An electronic copy of the submission package should be submitted to the FDA according to the eCopy requirements.

Once the FDA receives the submission, they will perform an administrative review within two weeks to determine if the submission is substantially completed and ready for review. 510(k)s and PMAs are reviewed according to different timelines, and the FDA will contact the manufacturer with questions or requests for additional information through an “interactive review” process.

Step 4: Comply with Applicable Regulatory Controls Post FDA Clearance or Approval

Upon receiving FDA clearance or approval, manufacturers have a few more regulatory controls to meet before marketing the device. Manufacturers must complete establishment and registration requirements, manufacture according to cGMP, and meet labeling requirements.

Manufacturers are responsible for maintaining their FDA registrations and completing all post-market activities throughout the device’s lifetime. Step 4 is an ongoing step that manufacturers must assess periodically to ensure their product meets all FDA requirements.

If you have an idea for a medical device, DeviceLab can help you take it to production with our full-service medical device design. Regardless of whether your medical device is a Class I, Class II, or Class III, our team has the experience and knowledge to engineer your product so that it meets all FDA requirements. Contact us today to schedule your personal free and confidential consultation.