The Medical Devices Market is considered as the healthcare powerhouse of the world. Over the last decade and a half, there has been a surge in demand for medical devices. According to 2021 market research, the global value of this market could reach $657.98 billion by 2028 due to an increasing geriatric population and a trend toward therapeutic and rehabilitative treatments. Medical technology in Singapore is in the forefront of the world, catalysing healthcare industry trends!
However, as promising as the runway appears to be, the medical device market faces challenges, particularly once the pandemic is over. Excerpts from recent medical device events and research throw light on seven major challenges or medtech trends confronting medical device manufacturers today, as well as how they may persist in the future as the market becomes more in demand and competitive on all fronts.
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Supply Chain Disruptions
The Covid-19 pandemic disrupted global supply chains, resulting in everything from delayed product deliveries to rising material prices. There is a huge gap between what medical device manufacturers can produce and what the market demands. The market will remain depressed until global supply chains stabilise and device manufacturers receive the materials they require. The cost of manufacturing fluctuates as the material prices are yet to recover to the pre-pandemic time.
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Rising Medical Costs
Speaking of rising costs, the already exorbitant cost of healthcare continues to rise. There is concern among those who require medical devices to treat or manage a chronic condition that these products will become unaffordable and out of reach. This is accelerated because many medical devices are not covered in conventional insurance schemes. Patients are forced to pay in full or get partial coverage of new and innovative devices. Even some financial assistance from insurance is insufficient for many people to bridge the gap between cost and need.
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Regulatory Issues
Except for the areas where it is heavily regulated, the medical device market is lightly regulated. This inconsistency makes it difficult for both patients and device manufacturers. Unregulated devices are not covered by insurance, making it difficult to get them into the hands of patients due to cost concerns. Similarly, the FDA evaluation process for new devices is lengthy, expensive, and inefficient, discouraging many startup device manufacturers from seeking approval. This gap will persist until there is a more concise and responsive approval process or a change in regulatory guidance.
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Cybersecurity Concerns
Concerns about cybersecurity are growing as more devices become digital. A simple Bluetooth-enabled device can serve as an entry point for data theft. Device manufacturers are now dealing with authorities about patient privacy and protection, which complicates and increases the cost of manufacturing smart devices. A strict cybersecurity approach can add months to the development timeline, zeros to the production cost, and headaches when seeking regulatory approval. Simply put, data security isn't optional, and it's posing problems for manufacturers.
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Imitation and Counterfeiting
We live in an era of intellectual property theft and iteration. Too often, a new and innovative product enters the market only to be met with imitators and counterfeit copies within months. For a variety of reasons, this is a devastating prospect for the medical device market. The burden of doing things correctly falls on responsible manufacturers, while counterfeiters flood the market with unproven devices. Patients may experience poor outcomes or, worse, illness or injury as a result of being duped by a skilled impersonator. To exacerbate the problem, these knockoffs are competitively priced and frequently well-packaged, further identifying them as forgeries.
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Product Recalls and Lawsuits
Recalls and lawsuits are common occurrences in a market as diverse and demanding as the medical device sector. Often, the former comes before the latter. As they continue to iterate and innovate, many manufacturers recall old models as a precautionary measure—a move that costs money but could save tens of thousands of dollars by avoiding a lawsuit. To avoid litigation, device manufacturers must establish and maintain patient and practitioner expectations. Again, a better medical device approval process would reduce tensions and protect both manufacturers and consumers.
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Interdisciplinary Competition
The world has witnessed the power of molecular drugs in the modern era with the significant milestone of a Covid-19 vaccination in approximately 12 months. This, together with incredible advances in therapies such as CRISPR and pharmacogenomics, is shifting the future of healthcare toward personalised solutions. While gene editing breakthroughs are unlikely for at least another decade, forward-thinking device manufacturers see molecular medicine as a threat. Curing a disease at the DNA level could eliminate a swath of medical devices from the market, such as insulin pumps.
Despite these so called medtech trends or challenges, the medical device market is expected to grow rapidly through 2022 and beyond. While 2021 was a critical year in the aftermath of a global pandemic that is still difficult to contain, it is also an opportunity for medical device manufacturers to establish themselves in a market that is becoming increasingly in-demand with each passing year. Medical technology scenes in Singapore are all set to face these challenges and grab the global healthcare sector.