Introduction
In 1958 an external pacemaker was introduced, 65 years later the leadless pacemakers are on the market. Over that period the volume of the pacemaker was reduced by 99.8%, the weight was reduced by 99.3%, all while adding additional functionality such as rate responsive pacing, wireless programmability, increased battery longevity, adding sensors, and MRI compatibility.
What is Miniaturization?
Miniaturization refers to the process of designing and manufacturing smaller versions of devices, components, or systems while maintaining or enhancing their functionality and performance. This trend is prominent in various industries, including electronics, medical devices, and bioelectronics, where advancements in materials, precision engineering, and technology enable the development of compact, lightweight, and efficient products. In the medical device industry, for example, miniaturization allows for the creation of smaller, less invasive devices, such as implantable sensors or bioelectronic devices, which improve patient comfort and reduce recovery times.
Why is Miniaturization Important?
One of the most important benefits of this incredible miniaturization of biomedical devices is significantly less invasive surgery for patients. In 1958, implanting pacemaker leads, or a pacemaker required open heart surgery which required cutting through the breastbone and spreading the ribs to reach the heart and carried a significant risk of complications and lengthy recovery periods. Today, leadless pacemakers can be placed via catheter through the femoral vein with reduced risk of complications, and significantly faster recovery periods.
Longer battery life is critical for patients. Leadless pacemakers have a median longevity of 16.7 years, which allows a single pacemaker to last for the lifetime of most patients, rather than having to undergo a pacemaker replacement surgery. In contrast, the early pacemakers lasted only hours when operating off batteries.
With miniaturization comes the possibility of adding in additional features such as rate adaptive pacing, which adjusts the pacing rated based on the activity level of the patient, increasing cardiac output during exercise. This feature is enabled by miniaturized sensors such as accelerometers, intrathoracic impedance measurement, and heart rhythm analysis. Other features such as wireless programmability, MRI compatibility, and heart rhythm data collection/analysis are also enabled by the ability to cram more functionality into a smaller form factor.
What technologies enable miniaturization?
Transistor Density
The primary driver of this miniaturization goes hand in hand with the significant advances in electronics and electronics packaging across all industries. The best-known example of this is “Moore’s Law” coined by Gordon Moore of Intel, which postulates that the number of transistors doubles roughly every two years. In the early 1970’s state-of-the-art semiconductor processing technology would allow transistor densities of up to 200 transistors per mm2, while transistor densities exceeding 100 million transistors per mm2 are possible with current semiconductor processing technology. This continual reduction in transistor size also benefits battery life, with less energy required to change the state for each transistor.
IC packaging
Along with the reduction in transistor size have come advances in IC (Integrated Circuit) packaging such as:
Technology
BGA (Ball Grid Array): allows the entire bottom surface of the IC package to be used for interconnection via solder balls
Chip Scale Packaging: a miniaturized IC packaging technology where the IC package is no more than 20% larger in area than the original die and is a direct surface mountable package
Flip Chip: a type of IC packaging where pads are metalized on the top surface of the chips, solder balls are applied, and then the chip is “flipped” so that solder balls are facing the external circuitry
Stacked die: Stacking of multiple dies within a single package
Package on Package: Stacking of multiple packages in the same footprint
Example Pictures
Ball Grid Array:
Chip Scale Packaging:
Flip Chip:
Stacked Die:
Package on Package:
PCB/Flex/Rigid-Flex
Advances in PCB (Printed circuit board), Flex Circuits, and Rigid-Flex Circuits are also required to take full advantage of the increasing density of Integrated circuit connections. Rigid-Flex and HDI (Density Interconnect) enables a single flat circuit assembly to be assembled with rigid sections for mounting components, and flexible interconnections without using bulky connectors to be folded into a small volume.
Batteries
In most bioelectronic systems, the batteries are the largest single component by volume, so reducing battery size is critical to miniaturization. Batteries come in two broad categories: Primary Cell (aka non-rechargeable), and Secondary Cell (aka rechargeable).
Wireless Communications
Over the last decade, Bluetooth Low Energy (BLE) has become the dominant wireless communication standard for wearable medical devices and some implantable medical devices, displacing other medical device-specific wireless standards such as Medical Implant Communication Service (MICS) Medical Device Radiocommunications Service (MedRadio), and Wireless Medical Telemetry Service (WMTS) due to its low power design, widely available hardware and software, ability to communicate directly with smartphones and tablets, and allowed usage outside of health care facilities.
Sensors
Miniaturization of sensors, especially so called Micro-electromechanical systems (MEMS) sensors, has allowed the inclusion of low power, low cost, smaller sensors than previous generations of medical devices. MEMS sensors fabrication technology has progressed in concert with semiconductor fabrication, which allows microscopic moving components. Accelerometers (measuring x/y/z-axis linear acceleration) are among the most commonly MEMS sensors in medical devices, enabling low-cost measurement positioning, respiration, heart rate, and activity level. Accelerometers are often combined with gyroscopes (measuring x/y/z-axis rotational acceleration) and/or magnetometers (measuring x/y/z magnetic field) to form inertial measurement units (IMU).
Figure 3 – MEMS Accelerometer (Image courtesy of STMicroelectronics)
Other common MEMs sensors found in medical devices include:
- Pressure sensors
- Humidity Sensors
- Microphones
- Temperature Sensors
How can Nextern help?
At Nextern, we have a dedicated team of expert electrical, software, mechanical, systems, and process engineers who can help optimize the size, battery life, and cost of your bioelectronic medical device.
With experience in developing compact, wearable, and implantable medical devices, we leverage advanced design and manufacturing processes to meet the growing demand for miniaturized solutions in the bioelectronics sector. Partner with Nextern to bring cutting-edge, miniaturized bioelectronic devices to market faster and more efficiently.
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Working with a medical device partner can bring you project flexibility, vertical integration, unique expertise, and reduced time to market. We answered the top questions organizations have when considering a Medical Device Contract Manufacturer.
What Are the Key Benefits of Using a Medical Device Contract Manufacturer?
Using a medical device contract manufacturer offers several key benefits, including cost efficiency, access to specialized expertise, and faster time-to-market. Contract manufacturers, like Nextern, provide the necessary infrastructure and regulatory compliance, reducing the need for in-house investments. We also bring extensive experience in medical device production, ensuring high-quality products that meet stringent industry standards. Partnering with a contract manufacturer allows companies to focus on core business activities while leveraging the manufacturing partner’s expertise in scaling production.
How Do I Choose the Right Contract Manufacturing Partner?
Choosing the right contract manufacturing partner for your medical device involves evaluating several critical factors. Look for a partner with expertise in your specific device category. Consider production capabilities, quality control processes, and ability to scale as demand grows. It’s also important to assess how communication practices and culture fit would integrate with your organization. A thorough due diligence process will help ensure that your chosen partner aligns with your long-term goals and can deliver reliable, high-quality manufacturing services.
What Regulatory Standards Do Medical Device Contract Manufacturers Need to Comply With?
Medical device contract manufacturers must comply with a range of regulatory standards to ensure product safety and efficacy. Key standards include ISO 13485, which sets global requirements for quality management systems in the medical device industry, and FDA 21 CFR Part 820, which applies specifically to the U.S. market. Compliance with these regulations ensures that the manufacturing processes meet the required quality and safety benchmarks. Contract manufacturers must maintain up-to-date certifications and undergo regular audits to ensure ongoing compliance.
What Is the Typical Timeline and Cost Structure for a Medical Device Contract Manufacturing Project?
The timeline and cost structure for medical device contract manufacturing can vary depending on several factors, including the complexity of the device, the stages of development necessary, and the volume of production.
Typically, the process involves several phases: design and development, prototyping, validation, and full-scale production. Each phase has its own timeline, with the entire process taking anywhere from several months to several years, and Nextern partners with companies in each of these phases. Take a look at Nextern’s process below:
Collaborator
A clinical problem to be solved and an idea to make things better.
Nextern
We ask the right questions, uncover blind spots, and offer new perspectives rooted in deep market knowledge to get things started right.
Collaborator
Well-defined business case, an understanding of market needs, clear priorities, and a project scope
Nextern
A detailed project plan is created based on discovery and our extensive experience getting products to market, taking into account cost, quality, timeline and risk, giving our collaborator the complete project picture.
Collaborator
Market expertise and clinical access to guide development to meet customer needs for commercial success.
Nextern
Top-notch engineers turn your vision into reality – contributing innovation and experienced insights along the way.
Collaborator
Provide input on requirements and test protocols, and guide any needed modifications prior to design freeze.
Nextern
Utilizing a risk-based approach to verification, confirm device meets all design inputs.
Collaborator
Regulatory is readying for submission and launch planning is in full swing.
Nextern
Ensure device meets user needs; perform all the testing and documentation required to support a strong regulatory submission.
Collaborator
Product is launched, sales begin, and revenue is realized. Post-market work is on-going.
Nextern
Flexible manufacturing with a tightly managed supply chain and robust quality system for ongoing support.
COLLABORATOR
A clinical problem to be solved and an idea to make things better.
NEXTERN
We ask the right questions, uncover blind spots, and offer new perspectives rooted in deep market knowledge to get things started right.
COLLABORATOR
Well-defined business case, an understanding of market needs, clear priorities, and a project scope.
NEXTERN
A detailed project plan is created based on discovery and our extensive experience getting products to market, taking into account cost, quality, timeline and risk, giving our collaborator the complete project picture.
COLLABORATOR
Market expertise and clinical access to guide development to meet customer needs for commercial success.
NEXTERN
Top-notch engineers turn your vision into reality – contributing innovation and experienced insights along the way.
COLLABORATOR
Provide input on requirements and test protocols, and guide any needed modifications prior to design freeze.
NEXTERN
Utilizing a risk-based approach to verification, confirm device meets all design inputs.
COLLABORATOR
Regulatory is readying for submission and launch planning is in full swing.
NEXTERN
Ensure device meets user needs; perform all the testing and documentation required to support a strong regulatory submission.
COLLABORATOR
Product is launched, sales begin, and revenue is realized. Post-market work is on-going.
NEXTERN
Flexible manufacturing with a tightly managed supply chain and robust quality system for ongoing support.
Costs are generally influenced by the complexity of the device, materials used, regulatory requirements, and production scale. A collaboration to establish a cost analysis and project timeline would be an early priority to ensure clear expectations and budget alignment.
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 – contact us today for your project needs.
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The full title of this article could have been None Shall Pass Until Thorough Software, Security, and Regulatory Compliance Reviews Ensure Conformance to Industry and Government Standards, but that doesn’t have the same ring to it.
The democratization of Artificial Intelligence has opened opportunities for a broader range of employees to jump into software development. Even those with little technical expertise can solve business problems using no-code platforms, Large Language Models (LLMs), and AI code assistants. This surge in creativity is fantastic for innovation, but it also brings significant risks, especially in regulated industries where the stakes are higher.
The ease with which non-technical users can now create and deploy systems poses a unique challenge: how to allow creativity and problem-solving without crossing the boundaries of regulatory compliance and security.
AI Empowerment in Regulated Industries
In regulated industries, the consequences of mistakes can be severe. Take healthcare, for example—if a system is poorly developed, it can lead to regulatory violations, hefty fines, compromised patient safety, or, in the worst cases, loss of life. Software as a Medical Device (SaMD) is a prime example of where AI-driven development must be carefully controlled. SaMD solutions are subject to strict regulatory requirements to ensure safety and effectiveness. If someone without the right expertise uses AI to develop a SaMD application, they might unknowingly create a product that doesn’t meet safety standards or regulatory guidelines. This could lead to serious problems like patient harm, product recalls, or even legal trouble for the company.
None Shall Pass: AI-Enabled SAmd
The temptation to move fast with AI must be tempered with the reality that in regulated industries, “None Shall Pass” without strict adherence to the rules. The FDA recognizes this challenge and has taken steps to address the responsible use of AI in medical products. In March, they released the paper Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, signaling a commitment to “advance the responsible use of AI in medical products” and to “cultivate a patient-centered regulatory approach that emphasizes collaboration and health equity”. Despite these efforts however, comprehensive guidance for AI use in SaMD might still be in the horizon. Companies need to establish their own governance and change control practices to protect both them and their users.
This doesn’t mean that you must ban AI completely. AI is just another tool in the toolbox, albeit a powerful one, and you want your brightest minds to use it. What you need is to make sure they’re using it properly. It is a fine balance to walk to allow innovation while managing risk.
Here are some strategies that could help you:
1. Enable AI to Define the Problem, Not the Solution
Let’s talk about communication. Is there anything harder for people? Anyone who’s tried to create a common language between business and technical teams knows the struggle. We’re just not that great at it—it’s not something that’s taught in schools, and many engineers don’t see it as important (spoiler alert: it is!).
Sitting in a meeting with 
domain experts isn’t always efficient. They often struggle to articulate what they need, while software engineers demand concrete answers. We walk out of meetings thinking we’re on the same page, only to find out later that we’re not. Could we leverage AI to help bridge this gap? A good strategy is to train domain experts in AI and no-code tools, letting them come up with quick solutions on their own. Will these solutions scale? Probably not. Will they be easy to modify or extend? Unlikely. Will they meet your security protocols? Doubtful. But what they build will clearly show how they’d approach the problem and highlight the most important aspects they need to solve. Whatever they create will be invaluable input for the software team.
2. Review Boards with Fast Feedback Loops
There’s definitely a place for architecture and security review boards, especially as your company scales and your engineering team grows. These boards can ensure that any application using AI technologies conforms to both company and regulatory guidelines. But beware—these boards can do more harm than good if not managed carefully. The architects on these boards should be pros at riding Gregor Hohpe’s Architect Elevator. They need to spend as much time down in the engine room with the team as they do in the penthouse, otherwise you risk running into more communication problems.
And then there’s the issue of feedback speed. Good teams have one thing in common: they move at a fast, sustainable pace. They know the best way to build software is to iterate quickly and get feedback from users. If your review boards meet once a month or take too long to provide feedback, your team will grow frustrated, innovation will stall, and eventually, you’ll lose your best people.
3. Collaboration, Collaboration, Collaboration
To minimize the risk of non-compliant software systems and avoid costly last-minute changes, it’s crucial to bring together domain experts, software engineers, security, and regulatory professionals from the very start. By fostering a collaborative environment where multidisciplinary teams work together early in the development process, you create a solid foundation for success.
Encouraging practices like ensemble programming not only helps to catch potential issues before they become problems but also build a culture of shared ownership and continuous improvement, reducing the likelihood of unexpected challenges later.
4. Leverage Automation
A robust Continuous Integration workflow is essential. Contrary to popular belief, CI/CD isn’t just about using GitLab, CodePipeline or similar tools. You should start with the process and culture first. However, there’s no reason not to leverage the myriad of technological solutions available. Companies like Snyk and Synopsys offer AI code analysis tools that can help secure your team’s AI-generated code.
5. Experiment While Building Supporting Systems
AI doesn’t have to be limited to your core domain. In fact, it can be a good idea to start by applying these new technologies to supporting systems. This allows your team to experiment, learn where the boundaries are, and establish processes for safe use. For example, AI can be leveraged to help HR or Sales teams with repetitive tasks or to automate business reports. Once you’ve gained confidence, you can then explore more complex applications in your core domain with a clearer understanding of the potential risks and rewards.
6. Use AI to Flex Your Team’s Regulatory Muscles
AI can also play a valuable role in helping teams navigate regulatory landscapes and compliance documents. While a strong Quality Management System (QMS) is essential in any highly regulated environment, these systems often contain hundreds of procedures and work instructions, making them challenging to navigate, especially for new employees. Additionally, there are standards and guidance documents from government and international organizations that add to the complexity.
By inputting these documents into a Generative AI model, your team can create a Q&A system that simplifies navigating regulatory documentation for employees. AI tools like Amazon Q and Microsoft’s Copilot make this process more accessible than ever.
As we chart the exciting yet challenging landscape of AI-driven innovation in regulated industries, it’s clear that technology is a powerful ally. AI can help us solve complex problems, streamline processes, and push the boundaries of what’s possible. But amidst all this excitement, let’s not forget the most crucial element of all: the human touch.
AI may be able to analyze data, automate tasks, and even generate insights, but it’s our human judgment and oversight that ensure these technologies are used responsibly and ethically. In regulated industries, where the stakes are high and the consequences of errors can be severe, having a team of skilled professionals overseeing and guiding AI applications is not just important—it’s indispensable.
Partner With Nextern
At Nextern, we understand the unique challenges and opportunities of AI-driven innovation in the regulated medical device industry. Our multidisciplinary team of highly skilled professionals brings years of experience and deep expertise to every project. From navigating complex regulatory landscapes to ensuring robust compliance and safety, we are dedicated to helping you leverage AI responsibly and effectively.
With our extensive knowledge and proven track record in the medical device space, we’re here to guide you through every step of your journey. Whether you’re developing new solutions or enhancing existing systems, our experts are ready to partner with you to achieve excellence and drive success.
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Wouldn’t you want to be sure that the pacemaker being implanted in your chest is held to a higher standard than the bandage covering your incision? So would we. Fortunately, the Food and Drug Administration (FDA), the leading authority in the U.S. medical device market, has established a system to ensure precisely that.
The FDA is responsible for determining not only whether a device is safe for human use but also whether it’s effective for its intended purpose. When bringing a new device to market, understanding its classification is crucial, as this determines the level of regulatory scrutiny and approval required.
Here are the 3 classes of devices and how the FDA validates that they are safe and effective.
Class I
Class I medical devices are the simplest and present the lowest risk to patients and users. These devices are generally designed for basic, non-invasive procedures and are commonly used in various healthcare settings. The FDA defines Class I devices as:
“Devices that pose minimal potential harm to the user and are often simple in design.”
Examples of Class I Medical Devices:
- Bandages
- Examination gloves
- Handheld surgical instruments
- Stethoscopes
- Manual toothbrushes
Regulatory Pathway for Class I Devices: Class I devices are subject to the least regulatory control. Most of these devices are exempt from the FDA’s premarket notification (510(k)) process, meaning manufacturers do not need to submit extensive data to demonstrate safety and effectiveness. Instead, manufacturers must comply with general controls, which include requirements for proper labeling, registration with the FDA, and adherence to good manufacturing practices.
Despite the lower regulatory burden, manufacturers of Class I devices must ensure that their products are safe for use and meet all applicable standards. About 47% of medical devices fall under this category, reflecting the large number of simple, low-risk products that are essential in everyday healthcare.
Class II
Technology that falls under Class II is more complex and carries a moderate risk compared to Class I devices. These devices are often essential in medical settings, but they do not usually support or sustain life. The FDA defines Class II devices as:
“Devices that require more regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. These devices generally present a moderate risk to the patient.”
Class II devices often have a greater impact on patient health and may be intended for more long-term use. As a result, they require a higher level of scrutiny, including additional regulatory controls such as special labeling requirements, mandatory performance standards, and post-market surveillance.
Examples of Class II Medical Devices:
- Powered Wheelchairs
- Surgical Drills
- Blood Pressure Monitors
- Catheters
- Contact Lenses
- Digital Thermometers
Regulatory Pathway for Class II Devices
Unlike Class I devices, which are largely exempt from premarket submissions, Class II devices usually require a 510(k) submission to the FDA. This premarket notification process ensures that the device is safe and effective by demonstrating that it is substantially equivalent to an existing device. Approximately 43% of medical devices fall under this category, and most must undergo this submission process to be legally marketed.
While Class II devices do not typically require the more stringent premarket approval (PMA) process the 510(k) process involves rigorous testing and documentation to prove safety and effectiveness. And in some cases if similarity to a predicate device cannot be proven, a Premarket Approval is required.
Class III
Class III medical devices are the most complex and carry the highest risk to patient safety. These devices are often life-sustaining, life-supporting, or implanted, and therefore, require the strictest regulatory controls. The FDA defines Class III devices as:
“Devices that usually sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury”
Class III devices undergo the most rigorous scrutiny by the FDA due to the potential risks they pose. They often are cutting-edge medical technology, with the potential to save or significantly improve lives.
Examples of Class III Medical Devices:
- Implantable Pacemakers
- Heart Valves
- Implantable Defibrillators
- Cochlear Implants
- Deep Brain Stimulators
Regulatory Pathway for Class III Devices
Unlike Class I & II devices, Class III devices are almost always required to go through the premarket approval (PMA) process. The PMA process is the most rigorous type of application required by the FDA. It involves a thorough review of clinical data to support the device’s safety and effectiveness.
- Premarket Approval (PMA): The PMA process requires manufacturers to submit extensive clinical trial data, technical specifications, and detailed reports on the device’s design, manufacturing, and testing processes. The FDA rigorously reviews this data to ensure the device meets the necessary safety and efficacy standards.
- Post-Market Surveillance: Even after approval, Class III devices are often subject to post-market surveillance to monitor their long-term safety and effectiveness. This may include mandatory reporting of adverse events, additional studies, and ongoing regulatory oversight.
In many cases additional submissions may be required even years after approval. This would occur in the case of new indications of use, significant device modifications or emerging safety concerns that would warrant new studies to reassess the device as safe and effective.
Nextern has become an industry leader in the medical device development process and getting medical devices through regulatory approval to market. With a global presence in Minnesota, Vietnam, Costa Rica and China, we collaborate with partners to bring their ideas to market. If you are ready to bring your device to market, Contact us to begin developing your next great device idea!
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We’re not just moving offices; we’re investing in the future of our people. This strategic relocation is an effort to consolidate our Minnesota operations under one roof. Together, we are laying the groundwork for a future filled with innovation and collaboration. See facility photos below.
Investing in YOU: Our Partners & People
Following our values to Inspire with passion, Impact with significance, and act with Integrity, has resulted in continued growth, making a move to a larger facility necessary. The Nextern Team is very excited about the expansion and its opportunity to further execute our strategy: Medical Device Enabled, through engineered solutions designed for innovation and manufacturability.
This new facility is our commitment to growing with our partners, providing a great environment for our people, and continually investing in our future. Adding more support to the belief that our employees and partners are the driving force behind our success. Our new office signifies more than just a change of scenery or consolidating our talented team: the state-of-the-art facilities in Maple Grove have been designed with employee and partner needs in mind.
The 125,000 sq. ft building will provide one consolidated location for all Nextern operations, including: dedicated innovation areas to support research & development, inspection and warehousing, continuous medical education & clean room assembly areas, and administration.
As we move to our new facility, we extend our deepest gratitude to all partners who have contributed to our success. We look forward to continuing to enable Medical Device technologies to reach the hands of physicians and patients worldwide by actively bringing them to market and overseeing their production.
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.
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We are excited to hear about your next innovative project this season at our tradeshows! Find us at any of the following tradeshows and our team of experts will be ready to talk about how we can help you achieve your next project. Here’s where you can find us this season:
MD&M, Minneapolis (2024)
Mark your calendars for Wednesday October 16th and Thursday 17th. Sign up for MD&M here.
Where: Minneapolis Convention Center, Booth #3621
Show Hours: Wednesday, Oct 16, 10am-5pm and Thursday, Oct 17, 10am-4pm
BIOMEDevice, Silicon Valley (2024)
We will be in attendance Wednesday November 20th to Thursday, November 21st. Sign up for BIOMEDevice Silicon Valley here.
Where: Santa Clara Convention Center, Booth #734
Show Hours: Wednesday, Nov 20, 10am-5pm and Thursday, Nov 21, 10am-4pm
MD&M West, Anaheim (2025)
From Tuesday February 4th to Thursday February 6th. Sign up for MD&M West here.
Where: Anahiem Convention Center, Booth #2124
Show Hours Wednesday Feb 5, 10 am – 5pm and Thursday Feb 6, 10 am – 4pm
We want to hear about your project!
We know that great ideas deserve exceptional execution, and that’s where we come in. Whether you’re in the early stages of your medical device development or looking to refine and scale your existing project, Nextern is here to provide the expertise, resources, and support you need to succeed.
If you are unable to connect with us this season, contact us, and let’s discuss how we can collaborate. We can’t wait to see what we can achieve together.
Learn more about what we do here.
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Summary
Nextern has developed the knowledge and resources to design devices to a standard known as Ingress Protection (IP), which ensures protection from environmental elements. We can determine the level of ingress protection based on the device’s use case, develop design elements that will protect a device from certain levels of ingress, and test design elements to ensure the application functions as intended – protecting the device and users from harm. 
Introduction
What the standards say:
According to IEC 60601-1 Section 6.3, devices with enclosures must be classified with a rating of protection against harmful ingress of liquids and solids. Section 11.6 details the level of protection needed in different cases like normal use spills and leakage. Both sections point to a specific ingress protection rating defined by IEC 60529.
What you need to know:
Ingress Protection (IP) is a vital element to a device’s usability. It determines if a device will short circuit if it’s left out in a light rain or whether the device will make it safely to the bottom of the Mariana Trench (or anything in between). In terms of medical devices, IP ratings indicate if the device is safe from the expected normal use and beyond in homes or hospital rooms. It also describes if someone could stick their finger into a high voltage line inside the device or if it’s completely dust-proof. Essentially, IP Ratings describe how resistant a device is to both solids and liquids making their way inside and causing damage.
Background
As stated above, IP Rating is defined by IEC 60529, which describes a series of specified tests on a device. Based on the level of the tests a device passes, it’s given a two-number rating, with the first number being its solid ingress resistance and the second being for liquids. The number in each rating type corresponds to the highest level of each set of tests the device was able to pass.
See below for a breakdown of the IP Codes.
The Problem
The question then becomes what level of ingress a device will need to protect against. For example, devices that are used in indoor controlled environments such as a clinic or doctor’s office may only need an IP22 rating. Most devices that will be mounted in place outdoors may need an IP44 rating to protect against animals and heavy rain. Cellphones, as another example, are rated IP68 to protect against years of pocket dust and being submerged in water.
Ingress protection needs to be present for most medical devices if devices may encounter liquids and have potential to cause harm or electrical shock to patients.
So how do we design and internally test a medical device for a certain level of ingress protection? And how do we test medical devices to be certain there is no risk for the patient?
Conclusion and Solutions
Ensuring your medical device meets the correct ingress protection (IP) standards involves several considerations. With careful gasket structure, precise tolerancing, mechanical joints and interference design we can make any two parts fit together in a way that will keep out liquid and solids. Developing these components and manufacturing processes consistently can come down to trial and error.
With Nextern’s wide variety of 3D printing technologies, our team can repeatedly and rapidly prototype isolated features or whole devices until we find a design that holds up to the Ingress Protection standard that is necessary. We can then develop the production-level device and processes to guarantee the device will meet the same level of protection. But how do we confirm that these devices will withstand the environmental challenges they might face?
To reach liquid rating of 1 (IPX1), for example, the device needs to survive 10 minutes of light rainfall, a rating of 4 (IPX4) would mean it survived spray from small nozzles from all angles, and a rating of 7 (IPX7) means it survives being submerged in water for 30 minutes. To reach a solid ingress rating of 1 (IP1X) the device would need to protect itself from a large ball probe, a rating of 4 (IP4X) means it would keep out a wire, and a rating of 6 (IP6X) is only given to devices that keep out all dust as it’s blown around in a large air chamber.
With test chambers designed to put a device through its pace and subject it to the level of ingress protection we’re testing, we can verify that a device will survive not only up to, but exceeding the standard it needs for its use case.
Achieving ingress protection (IP) requires a combination of design, prototyping, and testing. Using precise engineering through validation, we can ensure that medical devices can withstand the harshest elements and provide reliable performance for critical healthcare solutions.
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At Nextern, we are thrilled to announce a significant milestone for our global manufacturing team. Our team in Costa Rica has recently grown to over 200 employees, reflecting their dedication, and hard work.
Celebrating a Milestone
A Growing Hub of Excellence
Our Costa Rica site is a strategic location for our vertically integrated global operations. The team’s innovative mindset and commitment to quality align perfectly with our mission to inspire with passion, impact with significance, and act with integrity.
The ‘Pura Vida’ Spirit
The phrase ‘Pura Vida,’ meaning ‘pure life,’ embodies the essence of Costa Rican culture – a positive outlook, resilience, and a sense of community. Qualities that resonate with the core values at Nextern.
"The launch of our Costa Rica operations in May 2021 was a great opportunity for Nextern. Since then, we have established ways of working based on principles and values, centered around the Pura Vida environment—a place where people are treated equally, with the highest respect and accountability, and fully engaged with our goals. In our first year, we closed with 45 employees, and today we are surpassing the 200 mark. We hold our people and culture at the core, aligning them with our business strategy and goals"
"When we started a little over three years ago, we defined our mission as becoming the first choice for developing and producing solutions for our clients. But our mission went beyond that; we also aimed to create the most Pura Vida workplace we have ever experienced. Reaching a team of 200 people confirms that we are well on our way to fulfilling this mission. Costa Rica is home to a hardworking team that strives to achieve all their goals - and there have been quite a few! I am personally very proud of what this team has accomplished and am excited about what the future holds"
Looking Ahead
The growth of our Costa Rica team is just one of the many milestones we anticipate achieving as we continue to grow. We are incredibly proud of the contributions made by our global team members and look forward to celebrating many more successes together. With a shared vision and a commitment to our mission – enabling medical devices, Nextern is poised to lead the way in medical device design, development and manufacturing.
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. If you want to invest in your idea for a new medical device, contact Nextern and see how we can help you.
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Nextern Walks towards Cardiovascular Health
At Nextern, we’re not just about innovative medical devices; we care about making an impact towards better solutions for cardiovascular health. Last year was Nextern’s first year taking part in the American Heart Association’s Heart Walk in the Twin Cities. Encouraged by the opportunity to make a tangible difference, we set our sights even higher this year. This year, Nextern stepped up again with a fundraising goal 3 times larger than what we raised last year.
We are thrilled to have surpassed our fundraising goal of $30,000 in donations towards the AHA’s mission: fighting heart disease and stroke, striving to save and improve lives. As we celebrate this milestone, we extend our heartfelt gratitude to everyone who contributed to our fundraising. Together, we’re not just raising funds; we’re making a significant impact towards better cardiovascular health.
By supporting the AHA, we’re contributing to a legacy of medical device innovation and breakthroughs that have revolutionized cardiovascular care. From pacemakers to cardiac stents and artificial heart valves, the funds raised through initiatives like the Twin Cities Heart Walk have fueled research and development for life saving medical devices.
With each step we take, we’re looking forward to a healthier tomorrow. Looking ahead, Nextern remains steadfast in our corporate values to inspire with passion, impact with significance and act with integrity.
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 contact us to see how we can partner.
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In an era where remote work is the new norm, software development teams seek methodologies that not only enhance productivity but also foster the Nextern environment of collaboration and innovation. Ensemble Programming emerges as a pivotal strategy in this context, offering a framework that leverages collective intelligence for software development. Nextern’s software engineering team has applied Ensemble Programming in remote team and utilized the approach’s benefits towards generating Connected Care software.
"Ensemble Programming is not merely a method of writing code together; it’s a transformative approach that aligns a team towards unparalleled collaborative efficiency and innovation."
About the author
Gabriel Castanaza
Gabriel is a passionate software developer with over 15 years of experience. He excels in crafting innovative solutions across mobile, web, and cloud technologies. Gabriel thrives in both leading and collaborating within teams, having successfully guided projects from concept to launch through the creation of impactful Minimum Viable Products (MVPs).
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