Medical Device Software Application Development requires many artifacts to satisfy requirements of regulatory bodies and industry standards. Often Software teams don’t think they can leverage modern ways of developing software due to the constraints of these regulations. Nextern’s software engineering team focuses creating modern solution by developing robust, easy to use solutions for connected medical devices and digital health management.
"Adapting modern software engineering practices to the rigor of the regulated processes required by the industry and international standards has challenges but enables more responsive and rapid software solution development."
About the author
Kevin Kopp
Kevin has more than 20 years of experience developing medical device software and systems that connect and enhance the functions of medical devices. He has led teams creating and maintaining embedded medical device software, implementing Windows-based medical device software accessories, and developing private cloud systems to manage devices.
Stay in Touch
Sign up to receive updates and information about Nextern!
At Nextern, we know that creating the best quality medical devices means fostering a culture that supports our partner’s needs. As a collaborative medical device company, we provide design expertise, engineering and manufacturing for your next medical device project.
Our foundation is built upon three core pillars: Inspire, Impact, and Integrity. These core values guide our work, allowing us to accelerate partner projects while delivering quality products to the market. Our commitment to fostering a culture of partnership ensures your medical device project’s success.
Inspiration
At Nextern, we believe in the power of Inspiration. Sparking creativity and pushing us to think beyond the norm, envisioning possibilities with fresh perspective. In our workspace, inspiration flows freely, offering insights into innovation to all who engage. Our commitment to fostering an environment where inspiration thrives allows us to continuously push boundaries and explore new possibilities in medical device technology.
Impact
The driving force of our work is the impact we make in partner projects and patient lives. Each medical device we design, develop and manufacture with our partners carries the potential for improved outcomes, empowering healthcare professionals and patients alike.
Integrity
We know the importance of quality medical devices, that’s why we always act with integrity. Adhering to the highest ethical and regulatory standards, we recognize that trust is established through transparency and accountability. We prioritize the significance of top-tier medical devices, which is why integrity is at the core of everything we do.
Applying Inspire, Impact and Integrity to our work
Our values aren’t just words; they define our culture, influencing how we work and collaborate. At Nextern, we are a place where individuals inspire with passion, impact with significance, and act with integrity. From the iterative stages of development to the precision-driven design and manufacturing of cutting-edge medical technology, the Nextern team is ready to assist every step of the way. With our commitment to inspire innovation, impact patient care positively, and uphold the highest standards of integrity, our ultimate goal is to empower you to deliver optimal patient outcomes.
Learn more about how Nextern can be your partner in your medical device project. If you’re ready to work with Nextern on your next venture, contact us.
Medical Device Enabled
Nextern enables partner medical device innovators to plan, design, build and manufacture medical devices that are changing the world. Our team of experienced engineers, technicians, and designers collaborate to bring ideas, prototypes or existing products to market faster.
Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
The medical device industry is constantly evolving. Rarely do engineers see a project and consider it finished. Instead, they constantly seek new ways to enhance a device to improve the user experience, optimize the efficiency and accuracy of the instrument or deliver increasingly better patient-centered care.
New medical technology, and improvements on existing devices, is always in the works. As engineers implement the use of 3D printing, AI, precision laser cutting and other enhanced capabilities, they are able to create innovative medical devices that keep the patient at the focus.
Here are five innovative medical devices that are already making a difference in the lives of patients and caregivers.
Insulin Delivery Systems
Patients with diabetes have seen huge strides in the treatments that have become available to them. Historically, insulin delivery systems were an incredibly involved process, with multiple devices and needle pricks required each day. New insulin delivery systems have streamlined the ability to monitor a patient’s blood sugars and adjust the amount of insulin being delivered into the patient in real-time with a single device. Patients can use this new medical technology to consolidate the number of devices they need to carry around, and they do not need to receive as many pricks or injections daily. New insulin delivery systems are the epitome of patient-centered care, as it is now easier to treat diabetes in a way that prioritizes real patient experiences and makes life easier and more comfortable.Breast Cancer Inhibitors
Approximately 1 in 8 women will develop breast cancer sometime in their life. As the most common form of cancer among women, doctors and scientists are always looking for ways to improve the treatment of cancer, as well as to prevent a diagnosis in the first place. The development of aromatase inhibitors (AIs) have changed the way physicians see and treat breast cancer among patients. In fact, AIs have proven to lower estrogen levels that can lead to the growth of breast cancer cells. Ongoing research and development are continuing to target the underlying causes of cancers in patients, and aromatase inhibitors are leading the way to achieve this. New medical technology, including medication such as AIs, offer patients and families a new peace of mind, especially for patients who are typically more at-risk for breast cancer and other common diseases.3D Printed Tissues and Organic Parts
While 3D printing technology has been used in medical device manufacturing for years now, the capabilities have quickly expanded to incorporate biocompatible devices and organic components that can fill in areas as needed. Patient-centered care is aligning with new technologies to augment treatments in ways never thought possible. For example, tissue can be bioprinted to enhance STEM cell research, modify muscle and joint connectivity and reinforce efforts in lab research and transplant operations. This directly provides opportunities for innovative medical devices to be developed, while also indirectly improving patient care by catapulting research capabilities to new possibilities and a greater understanding of tissue and organic systems without interfering with patient treatments.Easy-Access Catheters
Structural developments for catheters and intravenous instruments require a refined understanding of metal alloys and post-processing to ensure they are easy-access, biocompatible and low-profile. These catheters, stents and tubes have become increasingly refined and catered to both the patient and caregiver experience. New medical technology, including precision laser cutting and post-processing steps, enable engineers to create instruments with a more exact finish. This has resulted in easier access for nurses and doctors, and a less-invasive and painful experience for patients.Remote Patient Monitoring
Wearable devices that can track and record a patient’s activity and health are making waves in patient-centered care. Offering telehealth options and providing wearable devices enables patients to receive clinic-quality care from the comfort of their homes. Remote patient monitoring has increased in popularity and efficacy in recent years. New medical technology has made it a viable alternative to patients who need to complete regular therapy, need quick check-ins with their providers or who live in more rural areas. Accessible medicine and care can make all the difference in a patient’s treatment and long-term health.Innovating the Next Generation of Health Care
Medical technology and innovative medical devices are evolving every day. With enhancements in development approaches, including through the use of 3D printing and remote technology, engineers are able to create state-of-the-art products more quickly and with a higher quality than ever before. At Nextern, we are leading the way to improving patient care through innovative technology and world-class medical devices and instruments. Our team of developers and engineers work side-by-side to deliver your project to market. Create the next generation of medical devices and make a difference in the world around you. Contact us today.Follow us on linkedin!
Medical device engineering positively impacts patients, caregivers and doctors around the world. New medical devices, instruments and technology are constantly in the works, incorporating the latest user designs and software to refine the capabilities and improve patient experiences.
Bringing a new medical device to market requires extensive prototyping processes to ensure the final product is safe and effective. But before you can get to the prototyping stage, you need to invest in a trusted partner and a years-long process.
Prototyping Requires a Comprehensive Plan
Before beginning the engineering and prototyping process, creating a plan is essential. Your project needs to take a comprehensive approach, considering aspects including UX/UI, improving patient care and practicality of the device. Creating a strategy for medical device engineering is the first step in a successful project. Working with designers who specialize in medical device prototyping and patient use can expedite the process and move your project to beta testing stages and market availability quickly and efficiently. With a road map in hand, your medical device project can get off the ground with minimal issues and will move through the entire process with ease.Prototyping Is Iterative and Cyclical
Patience and collaboration are key for medical device prototyping. Beta testing is an exciting process during medical device engineering projects, allowing you to see, hold and use your device in real situations. But beta testing also requires collaboration and oftentimes redesigning and restructuring the device. When you put your prototype through beta testing, know that you will often receive feedback and information that will feel like setbacks. Before getting your device approved, however, you need to ensure that it is safe and effective for patient use. Medical device prototyping is iterative and cyclical by nature, and this step is essential in finalizing the design and approach of the product.Prototyping is Easier With a Partner
Finally, medical device prototyping is expedited and refined with a proven engineering partner. With a facility, engineers and materials designed specifically for medical device engineering, you can design and develop your product more quickly and with a finer level of quality than doing it in-house. Undergoing the entire medical device engineering process can take years to complete, from initial concepts, design, prototyping, optimization and final approval. With a partner who understands the process and can provide a full team of support, your product will receive expert refinement and ongoing development.Invest in a Prototyping Partner
Nextern has facilities located around the world, partnering with clients who want to invest in the future of medical device technology. We have vetted partners and suppliers to manage our supply chain, and our state-of-the-art facilities enable us to deliver effective medical device prototyping services to optimize your design and conduct beta testing on your product. If you want to invest in your idea for a new medical device, contact Nextern and see how we can help you.Follow us on linkedin!
Advances in healthcare technology in the last decade or two have dramatically improved the care patients receive. Outpatient home care, clinical care and inpatient treatments are continuing to evolve and advance to cater to a higher level of standard and quality for patients of all backgrounds. Technology trends in healthcare have been accelerated as a result of the COVID-19 pandemic, as well as rapid tech advancements in other industries.
This technology has made its way into the healthcare sphere and is making new healthcare equipment patient-friendly and more effective in delivering treatments and care everywhere. The patient experience continues to improve, and these new healthcare trends are quickly becoming commonplace in new devices, instruments and equipment throughout the industry.
Internet of Things
Medical technology is made more accessible, secure and effective thanks to the continuous implementation of the Internet of Things (IoT). Technology trends in healthcare are rapidly centering around IoT to deliver new healthcare capabilities to patients around the globe. IoT has made remote healthcare possible and secure for clinics and hospitals. Remote healthcare has emerged as one of the biggest healthcare trends in recent years, and there is no indication or reason to believe that it will go away. Cloud capabilities, in part due to IoT integration, augment the patient experience and enable physicians and clinics to connect with patients in remote environments. Patients can send data directly to their clinic or hospital. As more medical devices and new healthcare equipment are developed, IoT will play a large role in the creation and optimization. Patients and physicians alike will continue to expect and rely on IoT capabilities for more effective and efficient care.Wearable Sensors
More technology trends in healthcare are giving rise to wearable sensors that augment and supplement traditional care and treatments. Remote patient monitoring has emerged as a leading alternative to traditional in-person physical therapy programs and has proven to be as effective. New healthcare technology such as this is designed to improve the patient experience and provide care centered around the patient’s existing lifestyle and routine. By implementing wearable sensors and other similar trends in healthcare technology, clinics and hospitals can treat more patients more effectively. Remote patient monitoring and sensors aid physical therapy and other treatment plans that can realistically be completed remotely. This tech gives guidance to patients, sends data to clinics and enables flexibility in a patient’s routine. The future of healthcare devices will continue to focus on bringing the clinic and physician to the patient in new ways, such as wearable sensors. While house calls may have faded out of practice, the idea seems to be returning thanks to emerging technology trends in healthcare.Enhanced Patient Experience
Medical device manufacturers and engineers are looking for new ways to further enhance the patient experience in new iterations of medical equipment. Because IoT and remote patient monitoring technology are becoming more prevalent in the industry, manufacturers can refine how patients receive care. Rather than prioritizing the raw results of care, developers can focus on care as well as the overall patient experience. Remote clinics and telehealth are increasing in popularity and prevalence, making receiving virtual care and prescriptions easier than ever. UX/UI design is rising in focus groups and manufacturing facilities, as well. The patient’s lived experience is driving product iterations and enhancements. With more data coming in from prototype testing, digital trials and other remote collaboration methods, medical device manufacturers can implement new advancements that focus on improving the patient experience, making their devices all the more effective and useful. The emerging trend in healthcare equipment to deliver better patient care, rather than simply focusing on delivering a treatment or medicine, is changing the way patients interact with their health. Data is going far beyond the numbers of efficiency and laboratory analysis; it is improving the everyday lives of patients and physicians.Follow the Trends
Technology trends in healthcare inform generations of research and manufacturing. Developers, manufacturers and UX/UI specialists are constantly keeping up with healthcare trends to improve the patient experience and deliver better healthcare equipment. These devices and equipment are bigger than numbers on a sheet in a lab. Healthcare trends impact real people and patients in their everyday lives. That is what makes new medical equipment so effective and important. Nextern invests in ongoing research and development to stay ahead of new technology and healthcare trends to ensure each partner project is optimized for use in hospitals, clinics and homes. Our designers, developers and manufacturers collaborate to implement user-friendly design and technology to deliver better care around the globe. Partner with a medical device manufacturer who understands the importance of evolving technology and medical device trends. Contact Nextern and learn how we can work together to develop the next generation of healthcare equipment.Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
Time and budget are of utmost importance during the prototype development process for new medical devices. Maintaining projections for new medical equipment is critical for medical device manufacturers and designers who are looking to bring a product to market quickly and efficiently. Creating a medical device prototype requires deliberate and specific steps and processes to ensure it is safe, effective, and of high quality for patients and other end users.
This phase during the development process can take months to years to complete. During medical device prototype development, testing and optimizing take place to further reinforce the structure, functionality and user experience. Many factors can impact the timeline of a medical device prototype, and they are important to keep in mind during early conversations and initial projections to set realistic expectations.
Product Design
Medical device design begins in early iterations of a product and does not end until the final product goes to market. Effective design is constantly inspected, reconsidered and improved. To develop looks-like, works-like prototypes, the design needs to be as close to finished as possible. This is easier said than done. There are a lot of factors that go into medical device design, including UX/UI, functionality, size and reliability considerations. New medical device products need to meet certain standards and solve existing problems for patients or other end-users. The design of a device informs the prototype and requires plenty of time to ensure it is at its highest level of quality possible.User Experience
User experience is one of the most important factors in medical device design. During prototype development, engineers will consider how real users, including patients, doctors and surgeons, will use and interact with the product. If the prototype design indicates that the product is difficult to use for any reason, or if it does not act like it is designed, the product needs to be redesigned. Prototype development is an iterative process that is meant to hold a real product in your hand. This enables engineers and designers to determine how the user experience will develop and if the product is ready for testing and production.Supply Chain
Supply chain challenges have been prominent among medical device manufacturers, along with countless other industries, for years now. Without the proper supplies or materials, medical device prototype development is difficult. Engineers can navigate supply chain concerns by diversifying their operations, as well as looking to other methods for prototype development. Technology such as 3D printing enables engineers and manufacturers to create high-quality products and looks-like, works-like prototypes without relying on specific materials or other processes. 3D printing streamlines prototype development and allows engineers to conduct tests much more quickly.IoT Integration
Depending on the medical device design, IoT may be a factor to consider during prototype development. Prototypes need to work as similarly as possible with the final iteration of the product. If connected technologies are to be incorporated into the product, they need to be replicated into the prototype as well. IoT integration can delay prototype development, though necessarily so. By ensuring the connected technologies work in the prototype, engineers and developers can align on future refinements and iterations for the final product.Alpha Testing
Testing prototypes can also influence the timeline of the product. Alpha testing is the first stage of testing new devices, and it is often a long process. This stage of prototype development is meant to identify as many issues and concerns as possible so that future iterations of the device are more refined and exact. Alpha testing may or may not include end users, but it will require research and data gathering to inform engineers of opportunities to optimize the device.Create Your Medical Device Design and Prototype
The timeline to create a new medical device design and prototype varies based on the type of device and the requirements of the product. More complex designs will take more teams to conduct research, development and testing. Simpler designs may be streamlined, though they still need to go through a development process that ensures safety and efficacy. Designing new medical equipment requires teams of expert medical device manufacturers with experience using state-of-the-art technology and processes. Nextern’s engineering team is equipped with the expertise and technology necessary for the next generation of medical equipment. With proven design, supply chain, manufacturing and testing strategies, we invest in meaningful medical device projects that will impact the future of healthcare. Contact Nextern and get started on bringing your prototype to life.Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
New or improved medical devices, including wearable sensors, intravenous needles, or other equipment and instruments are important developments for the industry and the care of patients around the world. While many existing devices are helpful currently, improvements can be made to optimize the experience of the user.
But simply creating a new medical device isn’t a fast process.
It can take anywhere between 3 and 7 years to get your device to market.
The process is rigorous, iterative and requires diligent testing and improvements to ensure the final product is the best it can be.
The medical device development process consists of three main steps: Design, Prototype and Approval. These steps have dedicated requirements and steps along the way to bring a device to market on time and with the highest degree of efficacy and quality possible.
Design and Plan
The first step in the medical device development process is to design the idea. This includes collaborating with UX/UI designers, engineers, and other developers to create a plan to move your project forward. The planning process should include representatives from every discipline your project will require. Early input from a UX designer, along with an engineer who will be implementing these ideas, needs to come to the forefront of the conversation as early as possible to reduce potential snags and issues later down the road. Designing and planning your medical device project can take anywhere from a few months to a year. This aspect of getting your medical device to market should be given plenty of time to prevent bigger issues from coming up during the development stages.Develop and Optimize
Developing and optimizing a medical device is easily the longest process to get your medical device to market. This is where engineers and developers hit the ground running in creating prototypes of your product and bringing it to life. The development stage is an exciting one, but it can also be rigorous and cyclical. Just as the design phase requires enough time to start the project on the right foot, so too does the development phase necessitate diligence and plenty of time to accurately and effectively create a working medical device that will improve patient care. Once your medical device is turned into a prototype, you can start testing the product and figuring out the kinks and issues that come to light. This is an iterative process, where you may have to redesign or recreate various components to optimize the final product. Testing your device can take months or years to complete. Overall, the development and testing phase is estimated to take anywhere from 1-5 years.Final Test and Approval
After the prototyping and testing phase, you can send your medical device for FDA approval. Depending on the class type of your invention, there are different ways to file for approval. While the least restrictive approval process can take a few weeks to 3 months, the most intense and restrictive FDA approval process for medical devices can take up to a year. This part of getting your medical device to market is critical and takes careful planning to complete the application process.How To Get Your Medical Device to Market
Once you have met the regulations set by the FDA, you can send your device to market and sell it to your end-users. Whether you are marketing your device to patients, doctors, clinics, or others in the medical field, completing the device development process is rewarding. After the development and approval of your project, the work has only begun. Getting your product into the hands of those who will benefit takes another kind of strategy and discovery process. Learn who your device will benefit and where they live. Conduct research into the medical device market and the trends, processes, and practices that will be most effective for you. When you partner with a medical device market expert, you will be able to efficiently and reliably sell your product and begin to improve the quality of patient care around the world. Nextern has become an industry leader in the medical device development process, and we have experience getting medical devices to market around the globe. Contact us if you want to begin developing, or start marketing, your next great device idea.Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
In recent years, the Internet of Things (IoT) has taken the manufacturing industry by storm. Thanks to the intelligent systems that enable users to share data, access information and streamline various processes via cloud operating systems, manufacturing has become increasingly automated and optimized. The medical device manufacturing industry is no exception.
As engineers continue to learn how to make the most of IoT, the practice has become an industry standard. IoT is now regarded as a reliable method within the medical manufacturing industry, and developers are leveraging IoT to maximize the process of getting new devices to market. IoT in the healthcare industry is an innovator’s friend, and leveraging IoT in medical device manufacturing is essential for better practices, procedures and results. From initial brainstorming and ideation sessions to prototype development to finally putting a device into the hands of an end-user, IoT can improve the entire healthcare industry and make medical device manufacturing more effective.
1. Optimize Production Processes
IoT is an amalgam of integrated items that work together in a shared system. In the context of medical device manufacturing, this can drastically improve the development and production processes. IoT in the healthcare industry enables users to collaborate remotely, and share information quickly and securely. This allows for a designer in one part of the world to transfer files to an engineer in another part of the world in a matter of seconds or minutes. Leveraging IoT in medical device manufacturing often comes in the form of automation. This has been successfully implemented in a few key applications already, notably through software development and quality assurance testing. Automation — whether it is in the form of robotic mechanics precisely putting together device components, or by alerting users to possible defects in a prototype — optimizes the entire medical device development process. Thanks to the integration of IoT with existing processes, developers and engineers are able to complete more work and be more precise with their final product.2. Leverage Data Analysis
Another benefit of IoT in the healthcare industry is the use of robust data analytics. Users suddenly have access to incredibly detailed data that can inform their development strategies and improve their product. With different connected devices and operating systems working at every stage of the development process, engineers can understand on a more micro level how the engineering techniques or development operations will be impacted. These statistics and data can then be used to better inform later steps in the development process. Leveraging IoT in medical device manufacturing then improves the quality and efficiency of a project at the same time through precise measurements and more accurate readings of prototypes, materials and other machinery. Operating techniques such as 3D printing and laser cutting are just two examples of how development and engineering can be improved with the use of IoT in the healthcare industry.3. Enhance Patient Care and Experience
Finally, leveraging IoT in medical device manufacturing can directly impact the end user experience, including for patients. Remote sensors, for example, can help track and treat patients who may not have direct, reliable access to a clinic. Wearable sensors and other remote patient monitoring capabilities rely on accurate and secure connections with clinics, hospitals and caregivers to deliver necessary care instructions and assistance. IoT capabilities allow entrepreneurs, developers and caregivers to interact with patients on a remote basis with reliable connectivity and security. Monitoring capabilities and interactive features give patients more autonomy over their own care and improve the patient experience from the comfort of their own homes. Thanks to the implementation of IoT in the healthcare industry, both patients and doctors are able to achieve their goals in a more comfortable and collaborative setting.The Future of IoT in Healthcare
As IoT integration becomes more common and its capabilities demonstrate improvement among users in the healthcare manufacturing industry, the future of IoT will become even brighter and more essential. Engineers and developers have begun to see IoT as a standard practice in medical device manufacturing. Thanks to the optimization of procedures, the refinement of data analysis and improved patient care, medical device manufacturing is constantly at the forefront of breakthrough opportunities. Leverage IoT in medical device manufacturing with engineers and developers who maintain a dedicated focus on learning and integrating new connected technologies every day. Nextern’s team of software engineers, medical device developers and user experience experts know how critical efficiency and quality are in the healthcare industry. We can partner with you to optimize your device and improve the quality of life for patients and caregivers around the world. Contact our team to get started on developing a new kind of medical device.Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
While the medical device manufacturing process is extensive and can often take years to complete, the project is not done after the final iteration is refined and approved. Getting the device in the hands of those who need it — the doctors and patients and other end users — takes just as much effort and consideration. Developing a medical device distribution plan is an essential component of a successful medical device project.
Oftentimes, medical devices receive international attention and demand. Preparing a comprehensive international distribution plan for a medical device enables project managers and entrepreneurs to expand their reach and make the biggest impact possible to users everywhere.
Understand Your Buyer
The first consideration when developing an international medical device distribution plan is to understand the scope of potential buyers your invention can attract. Creating buyer personas is a strategy many commercial companies employ to fully understand target demographics they want to sell to. This is a critical aspect of your medical device distribution strategy to fully achieve your project’s potential. By creating buyer personas, you can better understand the goals and needs of who is purchasing the product. As international medical markets differ, you will have to conduct comprehensive research to understand the buying habits and best practices of each target market. Learn if your product is best sold directly to end users, including hospitals and clinics, or if working through distributors is more effective. Developing an international medical device distribution plan necessitates initial target market and buyer research. Equipped with this information, you will be able to move forward with your marketing and distribution strategy.Learn the Market
In tandem with your buyer personas is general market overview research. Just as each individual persona will vary in their approach, goals and buying practices, so too will international medical markets differ. Learn the markets you are planning to sell in. How does purchasing work for them? In some cases, direct buyers are the only way to sell, and they often come in the form of government entities. A large part of your international medical device distribution plan will be conducting research into individual markets and learning how they operate. Consider tax practices, legal requirements and procedures in getting federal approval, as well as currency and financing regulations. These key considerations will affect how you market and distribute your medical products, and will likely vary significantly between global markets. Partnering with a trusted international advisor will assist in the research and navigation of distributing your project internationally.Develop a Distribution Process
Once your distribution plan has been laid out, you can develop a process for getting your product from dock to dock. Understanding international shipping logistics and regulations is essential. International distribution is more than just sending a handful of products overseas. More often than not, this part of the process can take weeks or months to complete, ensuring you have the right quantity, and are paying the proper tariffs, sending to the right destination and complying with other shipping and handling regulations. Work with your team to develop an international distribution process that can be replicated in other countries and through varying sales cycles. The dock-to-dock process can initially be challenging, but when you are equipped with previous research and experience, you will be able to achieve reliable transportation and distribution of your product.Continue To Develop Your Marketing Strategy
Marketing and distributing your medical device are ongoing efforts. Continue to conduct research into your target markets, understand the goals and needs of your buyers, and stay on top of marketing trends and distribution strategies. As your product begins to reach and assist end users around the world, you will likely find there are ways to further improve your project, your marketing and distribution strategy, and the lives of patients and caregivers. Continue to develop your marketing research and distribution strategies. When further innovations and product ideas come to mind, you will have already established means of distribution and development. And when you are ready to begin your next medical device project, you can contact the expert engineers and manufacturers at Nextern. With facilities across the globe, we are set up to assist entrepreneurs and device developers with the design and development of the next great medical device. Contact us to get started on bringing your ideas to the international market.Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
There is a lot more that goes into manufacturing medical devices than simply designing or prototyping. The entire process to bring a new medical device to market can take anywhere between 3 – 7 years. While most of that time includes discovery, iterations, prototyping and testing, undergoing the medical device approval process can take up to nearly a year.
To better understand how to get a medical device approved, it is important to identify the three main classes of medical devices. Almost every device falls under one of these categories and paves the path to federal approval in the United States.
Class I
Class I medical devices are considered low-risk to patients. They require minimal regulation and include items such as tongue depressors, band-aids and non-electric wheelchairs.Class II
These are medium-risk devices for patients. The FDA considers contact lenses, syringes and pregnancy tests as Class II.Class III
Class III parts are more complex, higher-risk and invasive to patients. Examples include implants and prosthetic components. Once you know your project’s classification, you can start the medical device approval process and be on your way to getting your invention to the market.Self-Registration
Self-registration is one of the simpler FDA approval processes. Generally, those with class I instruments are able to register with the FDA going this route. Self-registration consists of three steps to get a medical device approved:- Pay the registration fee.
- Submit the listing and registration information with the FDA.
- Receive an email confirmation and approval from the FDA.
510(k) Process
For Class II, the FDA needs to ensure medium-risk patient devices and instruments are safe and effective. The 510(k) process is designed to ensure anything going to market achieves a set of safety standards and regulations for patients and end-users. During this process, the FDA requires the developer to prove what is called substantial equivalence. This is a whole process in itself, where, according to the FDA, the entrepreneur must prove their device has the “same intended use and same technological characteristics as a legally marketed device.” The majority of new devices and instruments that go through the FDA approval process are considered Class II. Because of this, the process takes longer — around six months to be specific. Prepare with plenty of time to undergo this medical device approval process to ensure you can get to market within your desired timeline.Pre-Market Approval
Finally, one of the more involved ways to get a medical device approved is through the pre-market approval process. This is often reserved for Class III devices to test the safety and efficacy through scientific evidence and trials. The FDA points out that it is critical to ensure that the “possible benefits to health from the intended use of a device outweigh the possible risks.” Pre-market approval is a refined process to determine that the device in question will significantly help a large portion of the target population. Even so, surprisingly, this process only takes an average of eight months. Keep in mind that complex medical devices may take longer. This medical device approval process often demands proven scientific evidence and often clinical trials to prove its safety and efficacy.Hit the Market With Your Ideas
Each class of medical devices requires a different FDA approval process, with each taking anywhere between a few weeks to several months. If you are looking for how to get a medical device approved, plan for it to take up to a year, often with various documents and sometimes scientific studies backing you up. Once you identify what class your project will fall into, getting your device approved is only a matter of time. The team at Nextern has collaborated with partners to develop new ideas and bring innovative medical devices to the market. We have established industry-leading practices in facilities in Minnesota, Vietnam and Costa Rica to assist with your project development at all stages, including through the medical device approval process. If you are preparing to start a new project or are ready to get your device to the market, we can help. Contact the engineering team at Nextern and find new ways to innovate.Follow us on linkedin!
Stay in Touch
Sign up to receive updates and information about Nextern!
