Blog

Radiofrequency, a common energy used in ablation therapies, is used for treating damaged, diseased, or malfunctioning tissue with minimally invasive procedures. However, recent developments are leading to frequent comparisons of pulsed field ablation vs radiofrequency ablation; pulsed field ablation has become an attractive option in some cases over radiofrequency ablation.

While radiofrequency ablation uses heat to destroy the targeted tissue, pulsed field ablation takes a different approach by using high voltage, nano- to microsecond pulses to selectively damage cells through apoptosis.

The result is a non-thermal method for killing tissue. This non-thermal method reduces the risk of harming nearby healthy tissue, making pulsed field ablation (PFA) an appealing option in sensitive areas, such as the heart, where nearby tissues need to be spared.

In this article, we’ll dive deeper into the differences between PFA and radiofrequency ablation (RFA), exploring:

• How each method works
• Key differences between the two
• How medical devices are integral to RFA and PFA

What is Ablation? Understanding the Basics of Medical Ablation Techniques

The goal of ablation therapy is to kill problematic tissue, such as tumors, irregular heart tissue causing arrhythmias, or other diseased areas. It is often desirable to minimize damage to surrounding healthy tissue while ablating, including nearby organs, vasculature, or nerves.

It uses energy sources that can be applied to affected tissue, such as radiofrequency, microwave, ultrasound, or other energy waves.

Ablation procedures are often minimally invasive, involving small incisions or catheter insertions rather than high-risk and invasive surgeries.

Common Types of Medical Ablation

• Radiofrequency Ablation (RFA) uses heat generated by radiofrequency energy to destroy tissue. RFA is used to treat atrial fibrillation and other cardiac arrhythmias, liver tumors, and chronic pain conditions like nerve pain (e.g., facet joint pain).

• Laser Ablation employs focused light to burn away targeted tissue. Often used in dermatology for skin conditions, in neurosurgery for treating brain tumors, and in ophthalmology for vision correction (e.g., LASIK).

• Microwave Ablation involves the use of microwave energy to generate heat for tissue destruction and is primarily used to treat liver, lung, and kidney tumors.

• Pulsed Field Ablation (PFA) is a newer method that uses electrical pulses to create tiny pores in cells, leading to cell death through electroporation. PFA is primarily used for treating atrial fibrillation and other cardiac arrhythmias, with emerging uses in other areas being explored.

Both radiofrequency ablation and pulsed field ablation are commonly used to treat atrial fibrillation, a condition where the heart beats irregularly.

While RFA has been the standard for decades, PFA is a more recent innovation showing promise for more precise treatments with fewer risks and potentially better outcomes. Let’s explore the differences in these two technologies.

“While RFA has been the standard for decades, there has been recent innovation in PFA showing promise for more precise treatments with fewer risks and potentially better outcomes.” said Jeff Chininis, Engineering Director, Vantage MedTech.

How Does Radiofrequency Ablation Work?

RFA works by using radiofrequency energy to generate heat that destroys targeted tissue. The process begins with the insertion of a catheter, percutaneous probe, or other applied device, typically guided to the problem area using imaging technology such as X-rays or ultrasound.

Once in position, the applied device emits radiofrequency energy through an electrode in the form of high-frequency alternating current. This current causes the surrounding tissue to heat up to temperatures between 50°C and 100°C, which effectively destroys the cells by inducing coagulation necrosis.

The procedure relies on precise control of the heat generated by the radiofrequency energy to target only the abnormal tissue while preserving nearby healthy tissue. The duration and intensity of the energy application are carefully monitored to ensure the right amount of heat is delivered to achieve the desired therapeutic effect.

The heat alters the tissue structure, creating small scars or lesions that prevent problematic signals from passing through (in the case of arrhythmia) or eliminate abnormal growths (such as tumors).

The result is localized destruction of abnormal cells without the need for more invasive and destructive surgery.

Source

How Does Pulsed Field Ablation Work?

PFA is similar to RFA in that concentrated energy is used to destroy unhealthy tissues and is typically done minimally invasively. However, it uses short bursts of high-voltage electrical pulses, not heat generated by radio waves, to selectively target and destroy cells.

PFA targets cells more precisely than RFA as well as destroys cells in a different way. The process, called electroporation, creates microscopic pores in the cell membranes of the targeted tissue. This disruption in the membrane causes the cells to lose their ability to function, leading to cell death.

The procedure begins with the placement of a specialized catheter at the treatment site. Instead of generating heat like in Radiofrequency Ablation, the catheter delivers controlled, high-voltage electric pulses in rapid succession. These pulses affect the cell membrane, creating permeable openings.

The cells can no longer maintain their vital functions due to the loss of membrane integrity and eventually die.

A key reason PFA is gaining momentum over RFA, especially for AFib treatments, is that it does not rely on heat to destroy tissue. This allows for more precise targeting of the affected cells and reduces the risk of damage to surrounding critical structures such as the esophagus.

The electric pulses can be designed to selectively affect certain types of cells, making the process highly specific and reducing the amount of healthy tissue to be unintentionally destroyed in the procedure.

Source

Key Differences Between RFA and PFA

Although both RFA and PFA are effective in ablating targeted tissue, they differ significantly in their methods and impacts on the surrounding tissue.

AspectRadiofrequency AblationPulsed Field AblationEnergy SourceRadiofrequency energy (heat)High-voltage electrical pulsesMechanism of ActionDestroys tissue by generating heat and causing thermal damageDisrupts cell membranes through electroporation, causing cell death without heatTissue SelectivityNon-selective, can affect both targeted and surrounding tissue due to heatMore selective, primarily affects the targeted cells with minimal impact on surrounding tissueThermal EffectsThermal, risk of collateral damage to nearby structuresNon-thermal, reducing the risk of heat-related complicationsProcedure TimeGenerally longer due to the need for careful control of heat applicationShorter, as electric pulses are delivered rapidly and efficientlySafety ProfileWell-established but carries risks of heat-related complications, such as esophageal damage or nerve injuryEmerging with a strong safety profile, lower risk of collateral damage due to non-thermal approachInnovation StatusEstablished, widely used for decadesNewer technology, still under ongoing research and development in clinical applications

While the medical community continues to establish which ablation method is best for atrial fibrillation, both RFA and PFA remain viable technologies with unique advantages and potential.

As research progresses, the development of ablation devices tailored to specific needs will play a critical role in expanding the potential applications of each method, ensuring that both continue to serve as effective treatment options for a wide range of conditions.

Innovation Opportunities for RFA and PFA

Beyond cardiac care, numerous opportunities for innovative medical devices exist to harness the potential of PFA and hone existing RFA technology. For instance, combining traditional RF technology with cooling features is making bone tumor ablation possible. Explorations of the potential of PFA treatments are well under way.

However, In order to make any RFA or PFA treatment possible, a high-quality medical device to safely deliver these treatments are essential.

The Role of Medical Device Development in Advancing Ablation Therapies

To realize the full potential of both PFA and RFA treatments, the development of advanced medical devices is critical. These devices must not only deliver energy with precision but also ensure patient safety, ease of use for healthcare providers, and that regulations and compliance requirements are met.

Medical devices developed for ablation processes must always foster innovation in the following areas:

• Precision energy delivery: Devices must accurately target the abnormal tissue while minimizing damage to surrounding healthy tissue. This requires continuous refinement of energy delivery systems, whether thermal (RFA) or electrical (PFA).
• Safety and monitoring: Advanced monitoring systems are essential for real-time feedback during procedures. This can help practitioners adjust energy levels and catheter placement to optimize outcomes and prevent complications.
• User-friendly design: Devices need to be intuitive and adaptable for use in various clinical settings. Improvements in catheter flexibility, control systems, and interface design can make ablation procedures more accessible to a broader range of healthcare providers.
• Market conditions: No medical device can succeed if there isn’t a patient population large enough to cover the cost of its research and development. When building ablation tools, a careful understanding of who will inevitably benefit from the device must be considered.

Advance RFA and PFA Ablation Science with Vantage MedTech

As the field of ablation therapy continues to advance, the possibilities for innovative treatments are expanding rapidly.

At Vantage MedTech, we are proud to be leaders in ablation device development, pioneering cutting-edge technologies that empower healthcare providers to deliver exceptional care.

Our commitment to innovation and collaboration ensures that we stay ahead of the curve, helping researchers and manufacturers bring effective, safe devices to market that expand what’s possible in ablation therapy.

If you’re ready to partner with a trusted leader in medical device development, contact Vantage MedTech today.

Together, we can shape the future of minimally invasive treatments and improve patient outcomes worldwide.

Medical devices are integral to healthcare. Product development must be reliable, safe and effective, but also drive revenue. Therefore, when creating a new device for use in the USA, the FDA-regulated, 5-step medical device product development process must be followed. Knowing how to navigate these steps during the product development project is key to ensuring a new device is a medical and financial success.

Each of the 5 steps in the FDA’s medical device development process is designed so new devices not only meet rigorous safety and efficacy standards but also address market needs, regulatory requirements, and other risks that can lead to project failure.

75% of medical device start-ups in the US don’t succeed. You can avoid being part of this statistic by following the right measures.

In this article, we’ll help you build an understanding of the FDA’s medical device new product development process, broken into 5 steps.

What is the New Product Development Process for Medical Devices?

The medical device product development process is a structured sequence of phases the FDA requires to bring a medical device from concept to market. This ensures devices are safe, effective, and compliant with regulatory standards. It applies to a wide range of medical devices, from simple tools like bandages to complex technologies like pacemakers.

Companies involved in developing medical devices, including manufacturers, start-ups, and researchers, must follow these processes. This isn’t just a set of best practices but a regulatory requirement enforced by the FDA.

Types of medical devices that need to gain FDA approval:

• Class I: Low risk, such as bandages and hand-held surgical instruments (However, most Class I devices and some Class II are exempt from FDA approval).
• Class II: Moderate risk, including powered wheelchairs and some diagnostic equipment.
• Class III: High risk, such as implantable pacemakers and heart valves.

Following this rigorous process is essential for ensuring a medical device meets the high standards required for patient safety and efficacy – elements crucial for a device to launch on the market. All entities involved in medical device creation must adhere to these FDA-mandated steps to legally market their products in the USA.

Now, let’s explore the FDA’s 5 steps to medical device product development.

Step 1: Device Discovery and Concept

Device Discovery and Concept is the initial phase in the medical device development process. During this stage, innovators and researchers identify a medical need and conceptualize a device to address it.

For example, In 1963, Dr. Arnold Kadish faced a problem: He couldn’t stabilize insulin levels for his diabetes patients. He took steps to solve this by developing the first “wearable” insulin pump. It was an oversized, heavy, backpack – not user-friendly – but it paved the way for many other researchers to create the life-saving, modern-day insulin pump.

Stage 1 is also when a new idea is evaluated for usefulness and feasibility. After all, having a good idea doesn’t mean it’s a viable one worth investing millions of dollars and years of labor. This is where developers lay the groundwork and foundation for the device itself, as well as for creating clear pathways to take the device from a good idea to a profitable investment.

The key activities of stage 1 in the medical device product development process include:

1. Identify the need: Understand and define the medical problem that the device aims to solve.
2. Conceptualization: Brainstorm potential solutions and develop preliminary ideas for the device.
3. Research: Conduct background research to understand existing technologies, market needs, and potential barriers.
4. Feasibility assessment: Evaluate the technical and market feasibility of the device concept, including initial cost estimates and resource requirements.
5. Preliminary design: Creatine early design sketches or models to visualize the concept.
6. Intellectual Property (IP) considerations: Explore patentability and protect intellectual property through patents or other means.
7. Planning the path to success: Create a go-to-market strategy, explore supply chain issues, explore potential regulatory requirements, and look into what professionals need to be brought onto the project.

[dynamic_cta id=”27055″ title=”Turn Innovative Ideas Into Useful Medical Devices” desc=”We’ve helped hundreds of projects succeed. We can help yours too.” btn_text=”Contact Us” btn_url=”/contact-us/”]

Step 2: Preclinical Research – Prototype

After the initial spark of an idea and the foundational groundwork laid in Step 1, it’s time to bring the concept to life in Step 2: Preclinical Research – Prototype. This phase is about transforming the conceptualized idea into a tangible, working prototype to be rigorously tested to ensure it’s both safe and effective.

It’s also where real-world considerations take place. What will the end-users want in this device? What market will it be sold in and what regulatory requirements will it need to meet? Will parts need to be customized or are there readily available components that can be incorporated into the design?

During this stage, the prototype undergoes a series of rigorous tests in the lab, and if necessary, on animal models. These tests are designed to simulate real-world conditions and identify any potential issues. It’s a process of continuous improvement, where feedback from testing is used to hone and refine the device.

Key activities in Step 2 of the medical device product development process include:

• Prototype development: Create a working model or prototype of the device based on the initial concept.
• Laboratory testing: Conduct extensive bench tests to evaluate the device’s performance, safety, and reliability under controlled conditions.
• Animal testing: If applicable, perform tests on animal models to assess the device’s biological effects and gather preliminary data on its efficacy and safety.
• Refinement: Make necessary modifications and improvements to the prototype based on test results and feedback.
• Regulatory compliance: Ensure that all preclinical testing complies with FDA regulations and guidelines, preparing for the next phase of development.
• Design transfer preparation: Start the design transfer process during prototyping to make the transition from design to manufacturing less complicated and more efficient.

Step 3: Pathway to Approval

Step 3 is where the device proves it meets all the necessary regulatory requirements to proceed to clinical trials and, ultimately, to market.

This involves developing a robust regulatory strategy, assigning a classification to your device, engaging in pre-submission meetings with the FDA, and preparing an Investigational Device Exemption (IDE) application. The goal is to demonstrate that the device is safe enough to be tested in humans.

During this stage, risk management matters. The clinical trial design must be meticulously planned to gather comprehensive data on the device’s safety and effectiveness in humans. All preclinical data and proposed study protocols are compiled and submitted to the FDA for review.

Key activities in Step 3 of the medical device product development process include:

• Regulatory strategy: Develop a plan for interacting with regulatory agencies and determining the appropriate regulatory pathway for the device.
• Pre-submission meetings: Engage in meetings with the FDA to discuss the regulatory requirements and clinical study plans.
• Investigational Device Exemption (IDE): Prepare and submit an IDE application to the FDA to obtain permission to conduct clinical trials.
• Clinical trial design: Design clinical trials to gather data on the device’s safety and effectiveness in humans.
• Regulatory submission: Compile and submit the necessary documentation, including preclinical data and proposed clinical study protocols, to the FDA for review.

Step 4: FDA Device Review

This phase is where all the hard work culminates and the FDA evaluates whether the device can be approved for marketing. Once approved, a developer can start preparing marketing materials, hash out their product launch campaigns, and ensure production processes are in place.

This stage is crucial as it determines whether the device can be legally marketed and used in clinical practice, paving the way for its introduction to the healthcare market.

During Stage 4, the FDA examines the safety and effectiveness data, inspects manufacturing facilities, and may even convene an advisory committee of experts to provide additional insights. This thorough review process ensures that only devices meeting the highest standards are approved for market.

Key activities in Step 4 of the medical device product development process include:

• Submission of marketing application: Prepare and submit a comprehensive application to the FDA, including all preclinical and clinical data, manufacturing information, and proposed labeling.
• FDA review: The FDA conducts a thorough review of the submitted application, examining the safety and effectiveness data.
• Inspections: The FDA may inspect the manufacturing facilities to ensure they comply with regulatory standards.
• Advisory committee meeting: For some devices, the FDA may convene an advisory committee of experts to review the data and provide recommendations.
• Decision: The FDA makes a decision to approve, deny, or request additional information regarding the device.

Step 5: FDA Post-Market Device Safety Monitoring

After a device hits the market, ongoing work is still required. Step 5: FDA Post-Market Device Safety Monitoring ensures that the device continues to perform safely and effectively in the real world.

This stage is essential for maintaining the device’s safety and effectiveness throughout its lifecycle, ensuring it continues to benefit patients as intended.

During this stage, manufacturers are required to report any adverse events or malfunctions to the FDA. This helps in identifying potential risks early and mitigating them before they cause significant harm. Regular periodic reports summarizing the device’s performance, any adverse events, and any changes to the device or its labeling are also submitted to the FDA.

Key activities in Step 5 of the medical device product development process include:

• Post-market surveillance: Continuously monitor the device’s performance and safety in the real world through various post-market studies and data collection.
• Adverse event reporting: Participate in mandatory reporting of any adverse events or malfunctions to the FDA to identify potential risks early.
• Periodic reporting: Submit periodic reports to the FDA summarizing the device’s performance, any adverse events, and any changes to the device or its labeling.
• Recalls and corrections: Implement any necessary recalls, corrections, or updates based on the surveillance data and FDA feedback.
• Compliance with regulations: Ensure ongoing compliance with FDA regulations and guidelines, including quality system regulations.

Master the Medical Device Product Development Plan

Turning a good idea into a successful medical device is no small feat; it’s a process that requires painstaking care and consideration. Without the right measures and support in place, it’s easy for a good idea to never evolve into a useful product.

Partnering with a team that has the product development process for medical devices down to a tee can bolster your chances for success. At Vantage MedTech, our decades of expertise give you the advantage you need to turn your idea into a successful medical device. From concept to product launch – we help innovators get new medical devices across the finish line.

To learn more on how we can support your medical device initiatives, contact us today.

Bringing a medical device to market is an impressive feat. Strict regulations, fierce competition, and high development costs add complexities to the development journey unseen in other industries. Having a strong development and launch strategy by your side is crucial; a well-defined medical device go-to-market strategy is key to ensure a successful product launch.

Turning an innovative idea into a usable product is a critical component of advancing healthcare and improving patient outcomes. The global medical device market was valued at over $560 billion in 2023 and that number is nearly double – to $965 billion – by 2032. For those wanting to claim a percentage of that pie, a robust go-to-market strategy is a must.

A properly developed go-to-market plan serves to not only facilitate market entry for a new medical device, but it also maximizes the potential for a device to achieve long-term success – especially in an industry whose dynamics are continuously evolving.What we’ll explore in this article:

• What is a go-to-market strategy?
• The importance of a go-to-market strategy for medical devices
• The 5 essential components of a robust go-to-market strategy for medical devices
• How to confidently navigate the go-to-market strategy process

What is a Go-To-Market Strategy (GTM)?

A go-to-market strategy is the blueprint for successfully introducing a product to the market. It determines key objectives so the final product is well received and desirable to its intended customers. It’s the overarching plan used to ensure a product is:

• Competitively positioned
• Marketed to the right persona
• Able to launch with minimal risk
• Poised for profitability

In the medical device industry, establishing a go-to-market strategy is invaluable. As the average cost of developing a Class III medical device in the US is around $94 million, having the right product launch and marketing strategy is crucial to ensure those investments are secure.

The Importance of a Go-To-Market Strategy for Medical Devices

To successfully bring a medical device to market, you need to lay a firm, resilient foundation. Building a go-to-market plan early allows you to identify and mitigate foreseeable issues that could derail a device’s success. It encompasses every consideration to avoid failure, from feasibility to compliance, and from audience identification to risk management.

Below, we explore why having a robust go-to-market strategy is essential for developing a medical device.

Determine Feasibility

Innovation may be what drives the healthcare industry forward, but without a structured plan and clear goals, even the most groundbreaking ideas can fail to become viable medical devices.

A go-to-market strategy includes feasibility assessments and explores if a device has real potential to improve patient care and turn a profit. Knowing this information before beginning a lengthy and costly device development process ensures potential areas of failure are identified and remediated before major investments or project development stages take place.

Identify the Target Audience

Knowing who a device will appeal to is another key aspect that needs to be clearly understood to increase a new device’s potential for success. Sometimes, the ideal audience isn’t quite who a developer imagines it to be.

For instance, a doctor for high-performance athletes wants to create a device to monitor the cardiac activity of their athletes. However, after initial strategy assessments it’s determined the device will be more beneficial for cardiac patients who need continuous heart monitoring.

This information reveals a broader, more lucrative market for the device and makes it more appealing to potential investors.

Define Compliance Standard Goals

Navigating the complex landscape of regulatory compliance is crucial for the success of any medical device, especially Class II and Class III devices. A go-to-market strategy helps identify the specific regulations and standards the device must meet, ensuring a smoother path to market entry.

This strategic approach minimizes delays and costly redesigns that can arise from building a device that does not comply with regulations governing its use. By understanding the regulatory environment early on, developers can design their devices with such requirements in mind, enhancing their chances of approval.

Key considerations include:

• Regional regulations: Adhering to standards in target markets, such as FDA in the US or CE marking in Europe.
• Safety and efficacy: Ensuring the device meets stringent safety and performance criteria.
• Quality management systems: Align long-term security, compliance, and safety needs with a pre-defined QMS system assessment.
• Clinical trials: Planning and conducting necessary clinical trials to support regulatory submissions.

Evaluate the Supply Chain

Supply chain issues can greatly affect a medical device’s overall, long-term success. A recent McKinsey report suggests companies should expect supply chain disruptions lasting more than 30 days to occur every 3.7 years. Establishing plans on how to manage such disruptions needs to be addressed before a product hits the market.

A go-to-market strategy is vital for identifying and streamlining supply chain processes in medical device development. It ensures that all components are available when needed, and that manufacturing and distribution are efficient and cost-effective. This proactive planning helps avoid delays and shortages that could derail the project.

Risk Management

Cybersecurity and risk management must be incorporated into a device as early as possible. This helps to prevent lengthy redesigns downstream and is now an FDA requirement for all premarket submissions.

A GTM strategy helps identify potential cyber risks early, ensuring they are addressed proactively. This includes compliance with relevant security regulations required by the FDA, like HIPAA and GDPR, which protect patient data and device integrity.

The 5 Essential Components of a Robust Go-To-Market Strategy for Medical Devices

When preparing to create a GTM for a medical device development project, knowing the key components of a go-to-market strategy beforehand. This is crucial for establishing a strategy that serves to ensure your medical device is a success– from the day of launch and across its life cycle.

GTM ComponentComponent PurposeScopeMarket Research and AnalysisWhat are the market needs and what is the competitive landscape like?Understand the specific unmet needs your device addresses and ensure it aligns with market demand.Value Proposition DevelopmentWhat unique value does the device offer? What pain points will it solve for the user?Define and communicate the unique benefits to different stakeholders, ensuring successful adoption.Sales and Distribution StrategyHow will the device be distributed and sold?Develop a comprehensive plan for distribution channels and logistics to ensure market reach.Post-Market Surveillance and Feedback IntegrationHow will the device be monitored post-launch?Establish processes for ongoing performance monitoring and user feedback collection to improve the product.

Navigate The GTM Strategy Process with Confidence

Developing a go-to-market strategy for medical devices involves navigating a complex landscape of regulations, market dynamics, and technological requirements. While understanding the fundamental components is crucial, partnering with experts can significantly enhance the chances of success.

At Vantage MedTech, we’ve helped numerous medical device development projects succeed. From foundational strategizing to post-market monitoring, and everything in between, we know how to align each aspect of a project seamlessly.

Why partner with Vantage Medtech?

Our team of experts bring invaluable insights and experience to the table. They can help you:

• Tailor your strategy: Customize your GTM strategy to address the unique challenges and opportunities in your specific market segment.
• Ensure compliance: Navigate regulatory requirements seamlessly, ensuring your device meets all necessary standards and approvals.
• Optimize resources: Efficiently allocate resources and streamline processes, reducing time-to-market and maximizing ROI.

Contact us today. Turn your medical device vision into reality.

The global reliance on electronic components is ever increasing, and consumers today are accustomed to seeing electronic devices become obsolete in less than 2 years. However, for medical devices, the current climate of rapid obsolescence is unacceptable leaving OEMs struggling to manage the resulting medical device obsolescence risks.

The unpleasant reality is that when a component of a medical device is unavailable, or becomes obsolete, there can be serious repercussions. Device production may halt, delaying crucial patient treatments. Replacing the component may require costly redesigns and regulatory approvals. And in most severe instances, the device itself may be rendered obsolete.

Addressing this challenge is a crucial concern for today’s medical device companies.

What you’ll see in this article:

• The impact of component obsolescence on medical devices.
• Why has electronic component obsolescence become such a problem for the medical device industry?
• What OEMs can do to navigate component obsolescence challenges.
  • Obsolescence forecasting
  • Sustaining engineering
  • Supply chain management

The Impact of Component Obsolescence on Medical Devices

Health diagnostics, medical procedures, and chronic disease management are increasingly dependent on modern, electronic medical devices. For instance, approximately 3 million Americans live with a pacemaker, nearly 40 million MRI scans are performed each year, and 2.4 million rely on implanted glucose meters to manage diabetes.

When an electronic component of a device becomes obsolete, several negative effects on healthcare can occur, such as:

• Disruption of production: Obsolescence of a critical component can halt production lines, causing delays in manufacturing, impacting delivery schedules and even patient care.
• Increased costs: Managing and replacing obsolete components requires significant investment in redesign, requalification, and inventory management, straining the financial resources of manufacturers and the device’s end users.
• Regulatory compliance challenges: Devices that need to replace obsolete components may struggle to meet updated regulatory standards, leading to costly compliance and development issues.
• R&D setbacks: Obsolete components necessitate new rounds of research and development to find suitable replacements, delaying product innovation and time-to-market.
• Customer dissatisfaction: Frequent obsolescence can lead to frustration among healthcare providers and patients, damaging the manufacturer’s reputation and customer loyalty.

Why Has Electronic Component Obsolescence Become Such a Problem for the Medical Device Industry?

Electronic component obsolescence has become a significant problem for the medical device industry due to a combination of technological, regulatory, cybersecurity, and market factors that include the following.

Technological Advancement and Innovation

The electronics industry is characterized by rapid innovation, with new and improved components continually being developed. Medical devices, which often have long development and approval cycles, struggle to keep pace with this rapid turnover.

Shortened Component Life Cycles

The life cycle of many electronic components is relatively short. For instance, smartphones last 2 – 3 years on average. This contrasts sharply with the life cycle of medical devices, which are designed for long-term use and must remain reliable and safe over extended periods.

The mismatch between the short life cycle of electronic components and the long life cycle of medical devices creates a persistent obsolescence challenge.

Regulatory Compliance

Medical devices, especially Class III devices, are subject to rigorous regulatory standards to ensure patient safety and efficacy. Any changes in a device’s components, including those necessitated by obsolescence, require extensive testing, validation, and regulatory approval.

Cybersecurity Concerns

As medical devices become more interconnected and reliant on electronic components, cybersecurity has become a critical issue leading to new FDA requirements for medical devices. Components that lack the latest security features may be rendered obsolete.

Global Supply Chain Complexity

The supply chain for electronic components is global and highly complex. The global semiconductor shortage is a good example of the effect component shortage can have; it has impacted the production of many electronic devices, including medical equipment, leading to significant production delays and increased costs. Plus, 50% of electronic medical devices require semiconductors.

How Can OEMs Navigate Component Obsolescence Challenges?

Despite the challenges rapid component obsolescence presents to medical device suppliers, they can be managed effectively.

Obsolescence Forecasting

Obsolescence forecasting is a proactive strategy that helps medical device companies manage component obsolescence risks. By predicting when critical components may become obsolete, manufacturers can mitigate potential disruptions.

How it helps:

1. Early risk identification: Track the life cycle of components to foresee obsolescence.
2. Strategic planning: Develop alternative solutions and redesigns well in advance.
3. Cost management: Reduce costs associated with emergency replacements or redesigns.
4. Inventory control: Strategic bulk or last time buys of critical components to avoid shortages.
5. Regulatory compliance: Ensure planned changes comply with stringent regulatory standards.
6. Supplier collaboration: Foster stronger relationships with suppliers for better insights and planning.

Sustaining Engineering

A device’s lifespan is, on average, 5 – 20 years. However, that lifespan can be cut short if there isn’t a plan to manage component obsolescence risks. Applying sustaining engineering practices to a device’s ongoing maintenance and life cycle management can lower instances of obsolescence in medical devices.

Sustaining engineering involves ongoing activities that ensure devices remain functional, compliant, and effective throughout their life cycle, specifically addressing the challenges posed by component obsolescence.

These practices include:

• Proactive obsolescence monitoring: Continuously track the availability and life cycle status of critical components to anticipate obsolescence issues before they impact device functionality.
• Redesign and requalification: Develop redesigns and requalifications for devices well in advance of component obsolescence. This process includes rigorous testing and validation to ensure new components meet all safety and regulatory standards.
• Strategic inventory management: Build and maintain strategic inventories of critical components that are prone to obsolescence. This stockpiling helps mitigate immediate impacts and provides time to plan for long-term solutions.
• Supplier partnerships: Establish strong relationships with component suppliers to gain insights into their production plans and receive early warnings about potential obsolescence, allowing for proactive planning and response.
• Comprehensive documentation: Keeping thorough documentation of all components, including their specifications, alternatives, and regulatory compliance, to facilitate easier transitions when obsolescence occurs.

Outsourcing sustaining engineering services allows OEMs to focus on new product development while ensuring that existing products receive the necessary updates and support.

This approach helps medical device companies manage the complex and resource-intensive process of addressing component obsolescence, ensuring that their devices remain reliable, safe, and compliant over time.

Supply Chain Management

The supply chain crisis during the COVID-19 pandemic revealed how healthcare systems can be severely disrupted by component shortages and logistical challenges.

Proactively managing the supply chain by diversifying suppliers, securing long-term agreements, and continuously monitoring component availability is crucial to mitigate electronic component obsolescence risks.

To effectively manage supply chains and safeguard against component obsolescence, consider the following strategies:

• Multiple suppliers: Source critical components from multiple suppliers, ideally from different regions, to mitigate the risk of a single supplier’s discontinuation or regional supply chain disruptions. This diversification ensures a more resilient supply chain.
• Long-term agreements: Establish long-term agreements with suppliers to secure a continuous supply of essential components. These agreements can include clauses for early notifications of any discontinuations, allowing manufacturers to plan and adapt accordingly.
• Supply chain monitoring: Implement continuous monitoring of the supply chain to track component availability and potential risks. Utilizing advanced analytics and supply chain management tools can help in identifying early signs of obsolescence or supply disruptions.
• Strategic inventory management: Maintain strategic inventories of critical components to buffer against sudden shortages. This approach can involve stocking up on components that have a higher risk of obsolescence or are crucial to device functionality.
• Supplier collaboration: Foster strong relationships with suppliers to enhance communication and collaboration. Regular meetings and transparent communication channels can help in anticipating and addressing potential obsolescence issues before they become critical.

Manage Electronic Medical Device Obsolescence with Vantage MedTech

Bringing a medical device to market is an enormous success often reflecting years of work and financial investments. However, once in service, ensuring that device stays in service requires ongoing vigilance and proactive management of potential obsolescence issues.

Partnering with the qualified team at Vantage MedTech can help. With decades of experience in medical device development, compliance, and risk management, we know the importance of ensuring devices remain in service.

We’ve brought over 1,600 medical devices to market and have what it takes to make sure they avoid becoming obsolete as long as possible.

Contact us today to learn more about how to manage your device’s obsolescence risks.

It’s hard to recall a time when software wasn’t standard in electronic medical devices. Creating safe, issue-free software is a critical aspect when developing new devices. As such, it’s no surprise that medical device software testing is vital to a device’s eventual development success and sustainability.

Software testing is more involved for medical device software than in other industries. In comparison to other industries, the consequences of a software glitch or bug is greater for medical devices. As such, testing software in a medical device requires a thorough, rigorous, and exhaustive approach.

These stakes, and accompanying compliance regulations, require stricter, more thorough practices when performing testing on medical device software that can be challenging to manage.

Testing medical device software is deeply complex and must comply with more regulations than most other industries require for their software. A strong knowledge of the medical industry—as well as best practices for software testing is necessary to ensure a medical device is safe for use.

What you’ll find in this article:

• What is medical device software testing?
• The importance of testing software for medical devices.
• Challenges of medical device software testing
• How to manage medical device software challenges effectively

What is Medical Device Software Testing?

Medical device software testing is the process of evaluating and validating software used in medical devices to ensure it functions correctly, safely, and effectively. This testing is critical because any malfunction or defect in the software can directly impact patient health and safety.

Software testing for a medical device is different from software testing practices for non-medical devices; developers need a different approach when testing software for use in the medical industry.

Key differences between standard software testing practices and ones for testing software in a medical device often are:

• Patient safety: The primary focus of medical device software testing is to ensure patient safety. This necessitates more thorough and extensive testing compared to standard software to identify and mitigate potential risks.
• Regulatory compliance: Medical device software must comply with strict regulatory standards such as FDA guidelines, ISO 13485, and IEC 62304.
• Validation and verification: Medical device software testing involves both verification (ensuring the product meets design specifications) and validation (ensuring the product meets user needs and intended use).
• Clinical environment testing: Medical device software often requires testing in real-world clinical settings or simulated environments to ensure it performs correctly under actual usage conditions.
• Risk management: Comprehensive risk management strategies are required to identify, assess, and mitigate potential risks throughout the software development lifecycle.
• Traceability: In medical device software testing, every requirement, test case, and defect must be traceable back to specific regulatory and design requirements. This ensures complete accountability and compliance.
• Usability testing: Medical device software must undergo usability testing to ensure it is safe and effective for healthcare professionals and patients.

The Importance of Testing Software for Medical Devices

Testing software for use in medical devices is a more involved and nuanced process than for other types of software. As mentioned earlier, medical device software is inherently risky due to its direct impact on patient health, stringent regulatory requirements, and the complexity of integrating with medical devices.

For instance, if an issue in the software of an insulin pump occurred, disrupting its ability to accurately monitor its user’s insulin and glucose levels, serious health concerns could quickly develop. With over 350,000 insulin pumps in use in the US, the potential impact of software failures on patient health is significant, highlighting the critical need for rigorous testing.

Here’s why medical device software testing is important.

Patient Safety

Any malfunction or bug can lead to incorrect diagnoses or treatment, potentially causing harm to patients.

Thoroughness in software testing ensures medical devices can be reliable in critical situations, such as the continuous operation of a ventilator pump or pacemaker monitoring. This reduces the risk of device failure during use, which we know can have severe consequences for patient health and safety.

Regulatory Compliance

Regulatory compliance is crucial for medical device software to be legally marketed and used. The rigorous software testing measures are in place to protect patient safety as well as meet established standards and regulatory requirements, avoiding costly recalls, and reducing the risk of data breaches and legal issues.

Key aspects of regulatory compliance of medical device software testing include:

• Standards adherence: Ensuring alignment with ISO 13485, IEC 62304, and FDA guidelines.
• Certification: Facilitating the certification process for market approval.
• Documentation: Providing thorough documentation to demonstrate compliance during audits.

Device Performance

Medical device software testing ensures that the software operates efficiently and effectively, aligns with the device’s intended use, and that it performs all intended tasks without glitches. This leads to more reliable and accurate medical devices, crucial for patient care.

Furthermore, thorough testing improves the user experience for healthcare professionals and patients. By identifying and resolving potential issues early, testing ensures that medical devices are intuitive and easy to use, ultimately supporting better healthcare delivery and outcomes.

Challenges of Medical Device Software Testing

Medical device software testing comes with unique challenges that can significantly impact the successful development of a medical device and its FDA approval. Common software testing challenges that medical device manufacturers often face include:

Meeting Compliance Requirements

Software in medical devices is required to meet the safety, security, and quality control regulations found in a number of regulatory bodies. Compliance requirements will depend on the type of software being tested, the class of the medical device it’s developed for, safety parameters, and the region the device will be used in.

Examples of regulations medical device software may be tested against include:

• IEC 62304
• ISO 13485
• IEC 60601
• ISO 14971

Lengthy Product Development Times

On average, 3 – 7 years is how long it takes to bring a new medical device to market. The extensive time required to meet all testing requirements can significantly slow down time to market launches.

Each phase, from regulatory compliance to real-time performance testing, demands thorough attention to detail and exhaustive documentation.

This prolonged testing period, while essential for ensuring safety and efficacy, can delay product launches and increase a device’s development costs. Balancing thorough testing with efficient time management is a key challenge for medical device manufacturers.

Interoperability

Ensuring interoperability is a significant challenge in medical device software testing. A medical device’s software must seamlessly integrate with various other medical systems and devices, such as:

• Electronic Health Records (EHR) systems
• Hospital information systems
• Diagnostic equipment
• Other therapeutic devices

Achieving this often involves using different communication protocols and data formats, all of which need thorough, rigorous testing processes to confirm their compatibility and functionality across diverse platforms.

Hardware Integrations

Electronic medical devices must physically interact with the patients they serve and care for, software alone cannot create these effects. As such, software for medical devices must integrate with a device’s physical components with great precision.

The software must interact flawlessly with sensors, processors, and other electronic components to ensure accurate and reliable performance of the device. Any discrepancies can lead to malfunctions, compromising patient safety.

Rigorous testing is required to verify that the software can handle various hardware configurations and operating conditions.

Cybersecurity Risk Management

Testing software for cybersecurity and risk management is particularly challenging in medical device software due to the personal nature of the data it will handle, the compliance requirements they must adhere to, and the ever-evolving cybersecurity threat landscape.

Key challenges facing software testing teams of medical device software:

• FDA approval: Medical device software must meet the unique risk management compliance requirements outlined in the FDA’s Cybersecurity in Medical Devices document.
• Long-term security management. Regular testing is required to ensure a device’s software is safe from new or persistent threats and that potential threats can be easily identified and resolved before a device’s vulnerability can be exploited.

How to Manage Medical Device Software Testing Effectively: Partner with Vantage MedTech

Navigating medical device software testing is a daunting, albeit necessary, part of the medical device testing and development process.

When ensuring a device’s software is secure, safe for patients, and meets all necessary compliance requirements, there is no room for compromise. However, it’s not a simple process and requires time, attention to detail, and a strong knowledge foundation.

How do we know? At Vantage MedTech, we help large OEMs and start up companies manage their medical device software testing needs with ease. We help our clients to overcome:

Compliance Complexities

With Vantage MedTech, companies can access our extensive regulatory expertise, ensuring software testing practices meet necessary standards such as ISO 13485, IEC 62304, and others required by the FDA.

Lengthy Development Times

Our proprietary AdvantagePlatforms® significantly reduce development timelines by up to 60%, without compromising on quality or compliance needs. These customizable, pre-existing platform systems accelerate every medical device’s software testing process, ensuring faster time-to-market.

Hardware and Software Optimization Hurdles

Create precise alignment between a device’s software and hardware with help from our expert engineering team. We ensure flawless integrations between software and hardware components and provide rigorous testing to verify software performance and reliable device functionality.

Cybersecurity Risks

Your innovations are invaluable and deserve to be shielded from cyber threats. That’s where we come in. Our tailored medical device security solutions are designed to safeguard medical innovations.

We start off by developing the correct cybersecurity risk documentation – the first time – so your device stays compliant and secure in today’s healthcare environment.

Contact us to learn more about how we can ease your medical device development journey.

Medical device development and cybersecurity are crucially linked. Internet of Things (IoT)-enabled devices for diagnostics and patient care are on the rise, as are cyber attacks seeking to leverage their security vulnerabilities. To ensure medical devices don’t create risk for their users, medical device cybersecurity risk management needs to be carefully considered at every stage of their lifecycle.

This is because medical devices contain, or provide access to, incredibly valuable personal information hackers are looking to exploit. The value of a medical record on the black market is anywhere from $100 to $1000.

In response to the growing attacks leveraging medical devices, regulatory bodies require manufacturers to implement cybersecurity risk management processes at every stage of a device’s lifecycle.

In this article, we’ll look at the importance of cybersecurity risk management for medical devices and how risk is managed at every stage of a device’s lifecycle.

The Importance of Cybersecurity Risk Management in Medical Devices

Cyber risk management is the process used by organizations and governments to identify, categorize, assess, and manage cyber risks. For medical devices, this process involves identifying potential security vulnerabilities that could impact the safety and effectiveness of the devices, as well as the people and organizations that use them.

These risks are real—82% of healthcare organizations have experienced a cyberattack due to medical device (IoT) vulnerabilities. The impact of cyber incidents involving medical devices are costly to hospitals, health organizations, and pose serious, life-threatening risks to patients.

Security vulnerabilities in medical devices are understandably complex, as risk can be introduced at each stage of a devices life cycle leading to serious, harmful events. IBM’s 2023 Cost of a Data Breach report indicates that healthcare is the top target for online criminals and tends to last 231 days before discovery.

As a result, there are strict risk assessment and management processes OEMs, users, and stakeholders must adhere to ensure a device is as low risk as possible at every stage of its life.

Regulatory bodies and standards that address cybersecurity risk assessment in medical devices include:

• U.S. Food and Drug Administration (FDA)
• ISO 14971
• IEC 62304
• ANSI

Note: This is not a comprehensive list of regulations. Devices must meet security risk requirements depending on the region it will be used in, its medical class, the functions they are designed to perform, and other factors.

[dynamic_cta id=”27055″ title=”Simplify Compliance with Global Regulations” desc=”Tap into exceptional regulatory and clinical consulting services.” btn_text=”Learn More” btn_url=”/manufacturing/regulatory-manufacturing/”]

Cybersecurity Risk Management Throughout a Device’s Lifecycle

To effectively manage medical device cybersecurity risks, comprehensive security measures and risk assessments must be integrated at every stage of a medical device’s lifecycle. Not only does this safeguard its users against risk, it increases its ability to meet FDA approval—the average FDA approval rating for medical devices is just 45%.

Measures must be taken during design and development, production, deployment, post-market, and when decommissioning a medical device.

Design and Development Phase

During this stage, a risk assessment is tailored to ensure devices are built using secure software and firmware, threat vector identification, and to instill the appropriate traceability measures.

Two components central to attaining these goals are the Secure Product Development Framework (SPDF) and Software Bill of Materials (SBOM)

Secure Product Development Framework (SPDF)

Incorporating a Secure Product Development Framework (SPDF) in device development helps OEMs ensure that security is a fundamental part of the design and development process.

SPDF is crucial to achieve FDA requirements that a device is “secure by design” and includes threat modeling, security architecture, and cybersecurity-specific testing.

Software Bill of Materials (SBOM)

Traceability and a clear outline of all open source and third party components used in a device’s codebase is crucial to the long-term security of a medical device. This helps in managing and mitigating vulnerabilities that could be introduced through these components, regardless of its age, and is also a requirement of the FDA.

Production Phase

Risk assessments in the production phase of a medical device address cybersecurity risks within the supply chain, manufacturing processes, and in the implementation of security measures within the device itself. These are to ensure medical devices are resilient against cybersecurity threats, such as this event reported by LivaNova in late 2023.

The FDA’s document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, last updated in September 2023, provides guidance on how to approach cybersecurity risks medical device cybersecurity risk assessments during the production phase of a cyber device.

It addresses security within:

• Manufacturing processes of a medical device
• Supply chain risks and traceability
• Secure coding practices
• Regular security audits during manufacturing

Deployment Phase

Once deployed, a medical device becomes exposed to security vulnerabilities and threats resulting from network integrations, IAM misconfigurations, physical damage and theft, interoperability problems, and more.

Managing cybersecurity risks during deployment involves ensuring that proper network and data system configurations are established, connected communication pathways are secure, as well as establishing regular security assessments and testing schedules to evaluate and monitor security risks to be used during post-market surveillance.

Key medical device cybersecurity risk management practices during the deployment stage include:

1. Network security: Ensure secure integration with hospital networks through firewalls, encryption, and intrusion detection systems.
2. Proper configuration: Create secure information and access management processes, disable unnecessary services.
3. Interoperability testing: Ensure security measures aren’t reduced or compromised when a device is integrated with other systems including other devices, communication systems, and databases.
4. Physical security: Install devices in secure environments with tamper-evident seals and access controls.
5. Continuous monitoring: Implement systems to continuously monitor and respond to security incidents.
6. Regular updates: Perform regular updates of software and security patches.

Post-Market Surveillance

After deployment, ongoing monitoring and management of cybersecurity risks are crucial to ensure the continued safety and effectiveness of medical devices. Cybersecurity threats evolve, and new vulnerabilities can emerge over time, necessitating a robust post-market surveillance strategy.

Post-market medical device cybersecurity risk assessments are established based on the following:

• FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices
• ISO 14971:2019 Medical Devices – Application of Risk Management

Decommissioning Phase

At the end of a medical device’s life, any sensitive, protected, and health data must be securely erased before disposal or refurbishment. This is to prevent data from being accessed by unauthorized users or exploited by cybercriminals.

Media sanitization of medical devices should be done in accordance with NIST SP 800-88 Rev. 1 guidelines.

Manage Medical Device Cybersecurity Risks from the Ground Up

Since the integration of the internet and software into medical devices, development of these innovative and essential tools has changed drastically. Addressing safety concerns is no longer just about ensuring devices are safe for patient use, researchers must now create devices that are safe for physical and digital use.

Navigating these new foundations is complex; and not incorporating risk assessment processes at an early stage can lead to project failure.

At Vantage MedTech we can provide a way forward. We are an ISO 13485-certified company and our product development services incorporate cybersecurity consulting that can help ensure your Class I, II, or III device is as safe as possible—and meets every security regulatory requirement—from inception to decommissioning.

Visit us today to learn more.

Medical device software is a rapidly evolving field. The United States currently leads in this sector, producing 45% of medical device software tools, followed by Germany and South Korea. Regardless of your location, grasping the principles of medical device software engineering is essential for any manufacturing company looking to capitalize on this opportunity.

This blog will equip you with essential knowledge about the medical device software engineering process. You will discover the various roles involved in software development and some best practices to ensure success.

What’s The Difference Between Medical Device Software vs. Healthcare Software?

Medical device software specifically refers to software integrated into medical devices. Examples include software in MRI machines or insulin pumps. Healthcare software typically encompasses a broader range of applications used in the healthcare industry. It includes electronic health records (EHRs), telemedicine platforms, and healthcare analytics tools.

Healthcare software engineering focuses on developing these systems to improve patient care and operational efficiency in healthcare facilities. Unlike medical device software, healthcare software often interfaces with a range of medical and administrative systems but is not always embedded in a physical device.

The scope of this article is focused specifically on medical device software engineering, not general software engineering in healthcare. You may need to seek additional sources if you are interested in learning more about software development in healthcare beyond medical devices.

Different Types of Software for Medical Devices

There are several different types of software used in medical devices. This is because devices have different needs and different software applications are required to cater to these needs. Each software type brings a unique set of functionalities to medical devices, enhancing their precision and effectiveness.

Here are examples of the types of software seen in the medical device industry.

Who is Involved in Medical Device Software Engineering?

Medical device software engineering is a collaborative process that brings together professionals with diverse skills and expertise.

Key players include:

• Software Engineers: Develop and program the software. They ensure the software meets specific functional and regulatory requirements for medical devices.
• Quality Assurance (QA) Testers: Test the software to ensure it is free of bugs and meets quality standards. They play a crucial role in ensuring the software’s reliability and safety.
• Regulatory Affairs Specialists: Ensure the software complies with all relevant healthcare regulations and standards. They navigate the complex regulatory landscape to maintain legal compliance.
• Project Managers: Oversee the development process. They coordinate the efforts of the team, manage timelines, and ensure the project stays on track.
• Clinical Engineers: Provide clinical expertise. They help to align the software’s functionality with medical needs and user requirements.
• UI/UX Designers: Design the software interface. They focus on making the software user-friendly and intuitive for healthcare professionals.
• Cybersecurity Experts: Protect the software from cyber threats. Their role is crucial in safeguarding sensitive patient data and ensuring the integrity of the software.
• Biomedical Engineers: Bridge the gap between technology and medicine. They contribute to the design and implementation of software in medical devices.

What Programming Language is Used in Medical Devices?

C, C++, Java, Python, and JavaScript are widely used in medical device software development. However, you may or may not need people on your team who know all of the above. Your predominant language(s) largely depends on what kind of software you’re developing.

C and C++ are often used for real-time medical applications like pacemakers and monitoring systems. They allow for precise control over device functions and memory management, critical for devices that require high reliability and accuracy.

Java is popular for networked applications and devices that require a high level of security. Its platform-independent nature makes it suitable for software solutions that need to operate across various systems and devices.

Python is particularly useful for any software that involves data analysis and machine learning. It’s a good choice for software that involves complex data processing, like imaging analysis and predictive analytics in diagnostic devices.

JavaScript is generally more for user interfaces. It allows developers to create intuitive and engaging interfaces for end users.

Medical Device Software Development Best Practices

Prioritize Risk Management

Risk management involves analyzing how software failures could impact patient safety and device functionality. Implement strategies to mitigate these risks, ensuring the safety and reliability of the software. Regular risk assessments throughout the project keep safety as a top priority.

Follow a Structured Software Development Life Cycle (SDLC)

Adhering to a structured software development life cycle ensures that each phase of development is executed methodically. This approach allows for thorough testing and review at each stage. By following a well-defined SDLC, you can catch and rectify errors early.

Utilize & Improve Existing Software Where Possible

Leverage existing software components when possible. This practice not only saves time but also reduces the likelihood of introducing new errors. When using existing software, ensure it aligns with the current software requirements and perform necessary modifications.

Incorporate Regular Testing

Implement regular testing throughout the software development process. This includes unit testing, integration testing, and system testing. Regular testing helps identify and fix issues early, ensuring the software performs as intended.

Ensure Continuous Documentation

Maintain detailed documentation throughout the development process. This includes recording software requirements, design choices, testing procedures, and changes made. Continuous documentation is essential for regulatory compliance and aids in future software maintenance or upgrades.

Seek Professional Guidance Implementing These Best Practices & More

Whether you’re new to software development or have a long-term, full-time development team, you can always benefit from the expert advice of manufacturing professionals.The right partner can show you how to properly implement engineering best practices or show you new innovations in the field.

Vantage MedTech is glad to be your medical device software engineering partner. Our team will guide you from start to finish and help ensure that your software-powered device meets market approval. We’re familiar with several global compliance standards, so we can help you get your device to market on an international stage.

Contact us today.