With the introduction of new technological reforms in the healthcare industry, loopholes like the development of second-copy medical devices and regulatory complications were bound to surface. But despite the challenges facing medical device manufacturers, the industry is making haste towards rapid advancements.

The booming medical device industry is being explored more extensively and attracting investors across the globe. With the uncertainty stemming from COVID-19, individuals feel safer possessing medical devices that they can use to monitor their health at home.

The model followed for the development of these medical devices is done in accordance with clinical practices. Then, they are passed through a series of tests to determine their performance and accuracy. This layered and extensive approach presents manufacturing challenges but ultimately contributes to the production of reliable devices built for long-term success. These high-quality devices can ultimately help healthcare professionals power remote patient monitoring models and increase telehealth service offerings.

Despite the vigorous efforts of engineers and physicians in the field, this industry inevitably foists challenges for medical device manufacturers. Let’s dive into the current state of the medical device industry, what challenges industry leaders are currently facing, and how Trapollo tackles these roadblocks.

An Insight of The Current Medical Device Industry

The medical device industry is slowly becoming one of the forerunners amongst its peers in the healthcare sector. Escalating healthcare costs, rising morbidity and mortality rates, and the onset of COVID-19 have caused investors to focus on the medical device industry more than ever. Within such growth, global medical device manufacturers are constantly working to improve their standards and make the life of healthcare providers, patients, and payers easier.

The initiation of new product developments for the medical device industry has primarily risen in the United States, Germany, and the Netherlands. Before the pandemic, glucometers, pulse oximeters, and other medical devices were relatively less in demand. That all changed with the emergence of COVID-19, as more immunocompromised patients preferred checking their vitals at home to avoid exposure to the virus. As more patients demanded at-home devices, the rate of medical device production accelerated.

Telehealth and remote patient monitoring models have also gained popularity now that immunocompromised patients are able to access quality healthcare at home. However, the medical device industry, in particular, faces massive challenges that have put it in a vulnerable position. For medical devices to further flourish and make a positive impact on the healthcare industry, these challenges must be dealt with swiftly.

5 Challenges in the Medical Device Industry

Despite positive industry growth, venturing into the medical device industry is not easy. These five challenges present a barrier to entry to the field.

Challenge #1: Regulatory Complications

Due to an imbalance of quality control, regulatory complications are a huge challenge to the medical device industry. Certain sectors of this industry are finely regulated while others receive far less attention. Moreover, not every manufacturer is told to follow the same standard or language. The lack of legal requirements allows some devices to skip the “check and balance” process.

Medical devices including glucometers, thermometers, and magnetic resonance imaging devices must adhere to a uniform set of rules that eliminates universal bias in test results. These regulations strengthen remote patient monitoring and telehealth sectors, enabling patients around the world to receive evaluations without fear of technical errors or device variation.

Achieving uniformity across device production, however, is easier said than done. A lack of industry-wide regulatory strictness has led to the development of inconsistent devices.

How Trapollo Addresses Regulatory Complications

Trapollo addresses regulatory complications by adhering to thigh standards of quality care. As providers of third-party logistics in the medical device industry, our ability to install, track, and maintain medical devices is in the palm of our hands. Trapollo’s user-friendly interface seamlessly blends our devices into your existing infrastructure.

Challenge #2: High Healthcare Costs

Access to high-quality healthcare has always been a challenge for underserved communities. Economic inflation has only further increased the gap, making it nearly impossible to keep up with certain escalating costs.

Healthcare is no stranger to these costs, becoming increasingly expensive since the rise of COVID-19. Hospitals have become overloaded with patients with every new wave of the virus, and doctors are left exhausted.

Some chronic diseases demand the use of specific medical devices for treatment. When their demand exponentially increases, these devices become scarce. In turn, there were rising fears that these devices would reach unaffordable prices.

These issues put patients in a fix. Not only do medical device solutions – such as pulse oximeters, glucometers, or ventilators – become heavy on the pockets, but they also become subject to shortages in the market. Even financial aid or insurance coverage can prove to be insufficient to cover all healthcare costs. In turn, patients with chronic conditions find themselves in a near-constant struggle to keep up with their health.

How Trapollo Addresses High Healthcare Costs

When we search for up-to-date medical devices, we keep in mind the problems both healthcare providers and patients face on the user end. Patients particularly find it hard to conform to escalating market budgets for medical-grade devices. Through these struggles, Trapollo has made a breakthrough.

We harness a flexible, low-cost device strategy that allows us to meet our clients’ budgets. Different healthcare programs demand different devices, and Trapollo possesses a highly diverse platform so we can meet the requirements and needs of vast healthcare programs. Whether your program requires a BYOD (bring-your-own-device) solution, a comprehensive kit, or a different approach, we have you covered.

Challenge #3: Cybersecurity

While technology is shaping the future of healthcare, all medical device technologies have areas of concern – including cybersecurity. Assurance of confidentiality and security is the right of every citizen, but even minor loopholes in devices can lead to the breach of sensitive information.

Smart devices are inevitably providing access points to hackers, making cyberattacks a constant threat to many healthcare institutions. A confidential data leak can expose hackers to banking, insurance, and identification details, so it’s necessary to make cybersecurity a priority.

Medical device security is no easy task, and it certainly isn’t cheap. The practice requires extensive knowledge of the industry and the integration of intricate software. These devices demand HIPAA (Health Insurance Portability and Accountability Act) compliance as well, which ensures that they follow physical, administrative, and technical safeguards.

How Trapollo Addresses Cybersecurity Concerns

Here at Trapollo, we understand the importance of security. Therefore, we have formed a successful coalition with third parties offering technology services.

Trapollo’s support team is aware of each device’s location and type, allowing us to mitigate potential risks. We personally install, track, and maintain every device that integrates with our technologies.

Our team also consistently tests and evaluates new platforms that empower us to single out robust software updates, data encryption features, and more.

Finally, the medical devices we opt for are equipped with built-in security features, ensuring that patient data is never compromised when Trapollo-powered devices are connected to Wi-Fi or other sources.

Challenge #4: Supply Chain Disruptions

Yet another challenge that arose with the onset of COVID-19 is supply chain disruption. Lockdowns and related restrictions have massively impacted the supply chain system, while uncertainty and imbalance in supply and demand have permeated a system we once thought to be robust. COVID-19 has rendered the supply chain system vulnerable, for industries both inside and outside of healthcare.

Travel restrictions imposed by different countries have also led to delays in the delivery of medical products worldwide. Escalating and sudden demands for certain medical devices have caused their costs to skyrocket. Altogether, there is a considerable gap between supply and demand in the medical device industry. Until this discrepancy is resolved, the market is forecasted to remain depressed, and the prices of medical devices are expected to inflate even higher.

How Trapollo Addresses Supply Chain Disruptions

Trapollo realized the fragility of the supply chain system as soon as it surfaced in the medical device industry. We have vowed to play our part in helping both healthcare providers and the general population navigate.

Our unique approach has led us to adopt the use of flexible logistic chains that do not rely on a sole trader. Therefore, Trapollo works with a wide variety of medical device manufacturers, each of which has an excellent reputation in the international market.

Trapollo also has a strict check and balance system on the products and materials we import. We diligently track all of our products so that we can develop cost-efficient integrations, such as the chronic disease management program, healthcare logistics & supply chain management support, and our bring-your-own-device (BYOD) solution.

Challenge #5: Counterfeit Medical Devices

One of the most complicated medical device challenges we face is tackling counterfeit products. When the demand for a certain product soars, scammers take advantage of it to produce poor-quality, counterfeit products in large amounts.

Scammers exploit and iterate IP addresses to develop copies of an original product. This copy, or dupe, is developed without any proper quality control measures or regulatory steps.

The consumer often mistakes these substandard products for authentic ones. As such, these products not only pose a potential health risk to patients, but also to revenues of original/authentic medical device manufacturers.

How Trapollo Addresses Counterfeit Medical Devices

Having served over a decade in the industry, Trapollo has become fully aware of the counterfeit trends that arise in the medical device industry. Our experience in the field has allowed us to strengthen our model and take such challenges head-on.

Our team of medical device consultants also has access to the location of every medical device. This minimizes the risk of theft and scams.

Navigate Medical Device Industry Challenges With Trapollo

Even within an industry rife with challenges, Trapollo handles medical device industry roadblocks with grace. Our experienced team has expertise across a diverse range of medical fields, patients, and populations, allowing us to recommend devices per the needs of your unique program.

Want to learn more? Click here to dive into our full suite of medical device consulting solutions.

For more than twenty years, Mia has focused her career on healthcare innovation to improve the patient experience while increasing quality and decreasing cost of care. She has managed projects and delivered solutions in a variety of consumer-driven healthcare, managed care and specialty medical management organizations. At Cox/Trapollo, Mia is especially passionate equipping consumers with the tools and solutions required to make their homes the new health hub.

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