From Innovation to Integrity: Preventing Failures in Medical Devices

Periodically, I will be publishing material I am passionate about, specifically medical devices. Let me start by revealing my biggest fear.  

My wife and I have a family of five children, and my biggest fear is that I will not be around to see each graduate college, marry, and have children of their own, or that I may end up with a chronic disease of some kind where my children need to constantly care for my wife and me This is where medical devices come in. I have a job where I sit most of the day, so I have accumulated a number of devices to prevent any resulting chronic issues. Currently, I have a heart rate and step monitor on my iWatch, a blood pressure monitor, and blood glucose device (even though I do not have diabetes). I get regular physicals and monitor my health metrics from the devices, and as a result. I have made several lifestyle adjustments:

·       I no longer have a cup of coffee every day, as I discovered that coffee spikes my blood pressure and increases my cholesterol.

·       My way of measuring my blood glucose resulted in the discovery that I have an early morning high glucose level problem and have reduced high sugar content foods.

·       Also, seeing the impact of sitting each day on my health metrics, it motivates me to get out and exercise more.

·       I discovered that every medication prescribed comes with undetected side effects that are not visible unless you have a device to monitor. For example, antidepressants can increase heart rate, blood pressure, and blood glucose levels, which will have a significant impact on and can shorten your life span. I currently only take a daily vitamin, but I am very selective with medications my doctor recommends.

Several modern lifestyle changes contribute to the rise of chronic diseases, particularly with the rise of streaming video and other sedentary activities.

These trends promote inactivity and unhealthy habits, increasing the risk for chronic diseases. Technology and devices being created at an ever increasing rate counter this unhealthy lifestyle.

For example, on-demand services: The availability of home deliveries, from groceries to meals, reduces daily physical activity, such as walking or grocery shopping.

This increase of chronic diseases is leading to a massive demand for new medical devices driving companies to innovate and go to market quicker, which in turn is leading to more medical device failures.

This is where medical devices can help. They are among the greatest inventions ever created, revolutionizing healthcare, saving millions of lives, and enhancing the quality of life for countless individuals. Some devices can extend a person’s life by 30 – 40 years. Devices such as pacemakers, ventilators, dialysis machines, and insulin pumps allow for the management of previously life-threatening conditions. Imaging technologies like X-rays, MRIs, and CT scans have improved diagnostics, while robotic surgery and prosthetics have advanced treatments and recovery. Medical devices contribute to increased life expectancy, better disease management, and improved global healthcare.  As technology advances, medical devices continue to enable minimally invasive procedures, remote monitoring, and personalized care, improving global healthcare accessibility and overall quality of life.

Over the next few years, there are many new medical devices being developed. I am personally waiting for one device, a wearable that can track blood pressure and measure blood sugar.

There is a constant pipeline of innovation and medical device product creation. Over the next few years, we are going to see many innovative new devices for preventative care and integrated devices making healthcare more accessible for rural, remote area and aging patients without the barriers traditionally associated with healthcare access. These five device innovations are not yet available commercially but are expected to make a significant impact on patient care:

1.      Abbott Miniaturized, Self-Contained Wearable Glucose Monitor - This device is designed to be more discrete and accurate, building on Abbott’s FreeStyle Libre line. It will offer continuous glucose monitoring without frequent calibration needs.

2.      Johnson & Johnson Advanced 3D Printed Tissue-Engineered Heart Valve - This personalized heart valve uses 3D printing for precise anatomical matching, aiming to reduce complications and potentially grow with younger patients to minimize repeat surgeries.

3.      Phillips Smart Contact Lens for Early Glaucoma Detection - This device, expected around late 2025, integrates sensors for real-time intraocular pressure monitoring to enable early glaucoma detection, addressing a key need in ophthalmic diagnostics.

4.      Cnoga Medical Smart Capsule for Non-Invasive Monitoring - Cnoga’s Smart Capsule leverages optical and thermal sensors along with AI to monitor glucose, heart rate, and other biomarkers non-invasively. It’s designed for integration with smartwatches, providing a convenient, wearable solution for continuous health monitoring.

5.      Biotronik Wearable Bio-Sensor Patch for Cardiovascular Monitoring - Expected by late 2025, this patch will continuously monitor cardiac biomarkers, allowing remote tracking of cardiovascular health, potentially reducing the need for frequent clinical visits.

Many devices in R&D are new devices that are associated with preventative care, which is a huge growth area. Proper development timelines are crucial to ensure safety and efficacy, especially with the need to accelerate medical device GTM timeline.

Accelerated Medical Device Creation

With such a high impact on human life, the medical device industry is highly valuable. To compete, companies are creating new and innovative devices at an ever-accelerating rate bring devices to market quicker than ever. Also, technology has accelerated development significantly in the past few decades.

These advances have greatly increased the pace and quality of medical device innovation. In fact the medical device industry saw over 12,000 new medical devices registered with the FDA in 2020, and the global market is projected to reach $612 billion by 2025, reflecting continuous product development.

Rushing the development of a medical device can lead to significant safety concerns and other issues. These include:

1.      Inadequate Testing: Shortened timelines may result in insufficient clinical trials or real-world testing, increasing the risk of device malfunction.

2.      Regulatory Non-Compliance: Skipping steps to meet launch deadlines can lead to failure in meeting strict regulatory standards (FDA, CE marking).

3.      Product Recalls: Devices released without proper validation may cause harm, leading to costly recalls, legal actions, and damage to reputation.

With technology increasing, the need for quicker go-to-market strategies, demand increases, technological advances, and failures are increasing.

Recent Failures

Here are the reasons medical device failures have increased in 2024. In the first quarter alone, medical device recalls rose by 13.8%, despite a 51.2% drop in the number of defective units compared to the previous quarter. One reason for these failures is attributed to stricter regulatory oversight and new compliance requirements. Companies are facing challenges meeting these regulations, leading to more recalls as they struggle to ensure safety and quality. This trend highlights the growing regulatory focus on medical device safety to protect patient health. Other reason for failures include:

With failures increasing and safety an issue, I can only see regulatory oversight increasing further and having a negative impact on the timeline. Automating regulatory compliance becomes an important aspect of the device development process. Medical device failures can have a significantly impact on patients or even lead to death:

1.      Medtronic Sprint Fidelis Defibrillator Leads: A design flaw caused these defibrillator leads to fracture, leading to unnecessary shocks or device failure, affecting over 250,000 patients.

2.      DePuy ASR Hip Implants: The metal-on-metal design led to early failure, causing pain, metal poisoning, and requiring revision surgeries for over 93,000 patients.

3.      St. Jude Medical ICD and CRT-D: Premature battery depletion in these heart devices caused at least two deaths and impacted thousands of patients.

4.      Hintermann Series H3 Total Ankle Replacement: Higher-than-expected device failure rates resulted in the need for corrective procedures (FDA).

Preventing Medical Device Failures

Companies can prevent medical device failures through several key strategies:

1.      Rigorous Testing: Implement comprehensive testing protocols, including preclinical and clinical trials, to identify potential issues early.

2.      Quality Management Systems: Establish robust quality management processes that comply with regulatory standards (e.g., ISO 13485, FDA guidelines).

3.      User-Centered Design: Engage end-users in the design process to ensure usability and functionality.

4.      Continuous Monitoring: Utilize post-market surveillance to identify and address issues in real-time.

5.      Cross-Functional Collaboration: Foster communication between engineering, regulatory, and clinical teams to address challenges collaboratively.

When I speak about this topic, my advice has never changed. You need to look across the entire Medical Device Creation Lifecycle, ensuring you understand how quality can be improved through thorough testing, including the following:

 Conclusion

When discussing medical device creation, it’s vital to consider the entire lifecycle to understand how quality can be improved through thorough testing. This includes various testing phases and types, ensuring the safety and efficacy of medical devices for the betterment of patient health. The challenge is that testing is often performed to validate the product functions as expected, but defect prevention is just as important where quality, security engineering, performance engineering, and supply chain quality processes should be implemented.

Call to Action

As we continue to innovate and advance in the medical device industry, it’s imperative that stakeholders—including manufacturers, healthcare providers, and regulators—collaborate to ensure that safety remains a top priority. By investing in rigorous testing and embracing new technologies, we can create a healthier future for all, but do you have the right vendor to support bringing your medical device innovations to market?

To optimize your go-to-market, product creation, and product quality, you will need a vendor that has experience across the entire medical device product development life cycle, including security and penetration testing. This is where QA Consultants can help with experience across the entire medical device development lifecycle giving you ‘Piece of mind’ knowing that your device integrity is good.

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