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8 Challenges Affecting Medical Devices


The global medical device market is expected to reach 657.98 billion by 2028, driven by the increasing number of people suffering from chronic and life-threatening diseases. There is a significantly increasing need for medical devices in the United States which justifies this ever-growing demand.


Despite the robust growth of the medical device industry, it faces many challenges, some of which are inevitable once the pandemic is over. Our experts and various stakeholders actively participate in research initiatives and as such they have identified 8 key challenges that may be a cause for alarm with respect to the accelerated demand for medical devices.


  • 1. Uncertain Supply Chain


The pandemic of COVID 19 highlighted the need for robust supply chain systems. Some companies managed to ramp up operations to keep up with the demand and supply, ensuring that care reached patients in time. Many companies were affected by the uncertain supply chain schedule along with the price of raw materials, labour and the end product rising to sky-high levels. India saw the worst oxygen crisis. Despite global collaboration, the patients were forced to wait in order to receive optimum care and medical devices, and regretfully, this delay cost the lives of 100s of patients.


Moreover, regional lockdowns and staff shortages increased the pressure on manufacturing companies as they couldn’t cope with growing demands. Once we enter an endemic state, heavy investments and work must be directed towards establishing a well-equipped supply chain system. Effective cost control measures should be taken to reduce the prices of these medical devices and healthcare as a whole.


  • 2. Cybersecurity


As more devices become digital, security concerns have become more prevalent. Even though devices can now be easily accessed using a simple Bluetooth connection, manufacturers are now faced with the challenges of securing sensitive data. Connection points like Bluetooth, WiFi, wireless technology hubs etc are easy points for a cyber threat. These open points give access to hackers who can enter the network and expose patient data.


Regulators worldwide are implementing new stricter rules around medical device cyber security giving birth to complex innovation and manufacturing requirements. These extended regulations increase manufacturing overheads, cost and time to market. Irrespective of having innovation freedom, regulations and compliance is a must, promoting safety for end-users.


  • 3. Duplication, Imitation and Counterfeited devices


Too often, new and innovative products are only seen by the likes of counterfeiters and imitators before they are even released. This is a devastating blow to the medical device market, and these ‘copies’ are responsible for providing inferior medical care.


Original innovators spend a lifetime’s worth of fortune on developing a novel medical device. By the time regulatory requirements are met, imitators are ready to flood the market with inferior quality goods. Patients are duped by these lookalike devices and face challenges of poor healthcare facilities resulting in further illness or injury. Responsible manufacturers create the device with utmost care and compliance. Yet, these imitators fool the patients with counterfeit devices by offering a lookalike product at a cheaper cost and unproven intended purpose.


4. Regulatory Challenges


Some life science markets are heavily regulated, but there are many sectors with very light regulatory governance. The inconsistent structure and lack of global harmonisation makes it difficult for manufacturers to decide the right regulatory pathway.  This inconsistency also presents a challenge to patients and clinicians as they cannot determine what device is optimum for their healthcare. This gap further widens because of the cost associated with regulatory requirements. Exponential increase in time, cost, and effort are required to manage regulatory compliance, affecting the timely launch of medical devices. Since there are many factors associated with this process, some companies will evade regulatory requirements, which brings us to the next point:


5. Recalls and Lawsuits


When companies evade regulatory requirements, manufacturers have to face penalties and, worse, product recalls.

In this ever-evolving industry, regretfully product recalls are occurring quite frequently. Sometimes, product recalls are justified because the manufacturer might have updated certain device components and therefore the product recall is for safety measures. But recalls and lawsuits due to regulatory negligence have a significant impact on patients (sometimes, even fatal consequences) as well as the industry as a whole!


Manufacturers should consult and invest time interacting with medical practitioners and end users to ensure their demands and expectations from a product are met and clearly communicated. Regulatory compliance serves as a key to success as it helps avoid unnecessary legal implications and barriers.


6. Interdisciplinary Competition


The life science industry is seeing exponential growth in molecular drugs. Undoubtedly, DDC [Drug Device Combination] products prevail and exist in the industry, but the COVID 19 vaccine and its uptake have clearly shown the potential of molecular drugs. Since the vaccine is an example of a personalised solution, demand for medical devices might be affected within a decade. Therapies, vaccines, and other similar innovations are indicating a paradigm shift towards personalised healthcare solutions. Curing a disease at the DNA level can eliminate the need for medical devices – insulins and pumps might be part of the history yet to come.


7. Technological Advancements


Technology has spun out MedTech innovations. Integration of AI, ML and other technological advancements in the medical industry is lucrative but has an unexplored grey area. These advancements are intended for enhancing patient experience but at the same time there are factors to worry about. The latest regulations have restrictions as new MedTech innovations are yet to be tried and tested.


Manufacturers must work 100% towards innovating MedTech but should also focus on limitations, scope and safety concerns. Too much technology in healthcare can be a bane or boon 😊


8. Rising Costs


Healthcare costs are trending upwards because managing chronic diseases requires heavy deployment of medical devices. Many factors from the planning phase to the usage of medical devices contribute to this upward movement of cost.


Manufacturers are prey to increasing costs of raw materials, innovation, logistics etc., and the Patients are prey to increasing insurance, device and healthcare costs. These costs need to be adjusted to ensure economic stability in demand and supply.


The future is bright and hopeful, but all the players of the ecosystem need to collaborate and work towards eliminating these challenges. Med-Di-Dia continues to assist Innovators and MedTech companies in eliminating the challenges and supporting the innovation process, enhancing patient care experience.


Our Experts are passionately working towards industrial development by conducting a series of events, educational content and regular interaction with all stakeholders.

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8 Challenges Affecting Medical Devices