The medical device market is rapidly becoming a powerhouse in the global healthcare industry. In the past fifteen years, the demand for medical devices in the United States has been particularly strong.Growing elderly population and trends in treatment and rehabilitation may drive the global value of this market Up to 657.98 billion by 2028, According to market research in 2021.
However, although the runway looks prolific, the medical device market still faces challenges—especially after the pandemic has passed. The following are the seven major challenges facing medical device manufacturers today, and how they can persist into the future as market demand increases and competition in various aspects becomes more and more fierce.
1. Supply chain disruption
The Covid-19 pandemic has weakened supply chains around the world, causing problems ranging from delays in product delivery to rising material prices. However, the demand for medical devices has not declined. If anything, it will rise in 2020. The result is a huge difference between the products that medical device manufacturers can produce. Until the global supply chain stabilizes and equipment manufacturers obtain the materials they need, the market will continue to be sluggish. In addition, the cost of producing many equipment may become too high before raw material prices fall back to pre-pandemic levels.
2. Rising medical costs
Speaking of rising costs, the already high cost of healthcare continues to rise. For those who need medical equipment to treat or manage chronic diseases, people worry that these products will become unaffordable and out of reach. Since many medical devices exist outside of traditional insurance coverage, this fact is even more complicated. Patients have to fight for even partial coverage of new and innovative devices-or pay for it themselves. For many people, even some form of financial assistance insurance is not enough to bridge the gap between cost and demand.
3. Regulatory challenges
The medical device market is rarely regulated—except for areas that are strictly regulated. This inconsistency ultimately makes it difficult for both patients and device manufacturers. Unregulated devices are not covered by insurance, which makes it difficult to hand them over to patients due to cost issues. Similarly, the FDA’s evaluation process for new devices is lengthy, expensive, and cumbersome, which makes many start-up device manufacturers reluctant to seek approval. This gap will persist until there is a more concise and responsive approval process or changes to regulatory guidelines.
4. Cybersecurity issues
As more and more devices become digitized, network security issues also increase. Even something as simple as a Bluetooth-enabled device can be used as an access point for data theft. Device manufacturers now find themselves facing HIPAA concerns about patient privacy and protection, which makes manufacturing smart devices more complicated and expensive. When seeking regulatory approval, a firm cybersecurity approach may extend the development timeline by several months, zero production costs and cause headaches. Simply put: Data security is not optional, it poses challenges for manufacturers.
5. Counterfeiters and imitators
We live in an era of intellectual property theft and iteration. Many times, a new and innovative product is put on the market, but within a few months you will see examples of imitators and counterfeiters. For many reasons, this is a devastating prospect for the medical device market. Responsible manufacturers bear the responsibility for doing the right thing, while counterfeiters flood the market with unproven equipment. Patients may experience terrible results, or worse, get sick or injured-all because they have been deceived by a smart look. In order to keep the problem long-term, these counterfeit products are competitively priced and are usually well packaged, further confounding them as pretenders. Everyone suffers at the hands of counterfeiters.
6. Recalls and litigation
In a diverse and demanding market like the medical device industry, recalls and lawsuits often occur. In many cases, the former preempts the latter. As they continue to iterate and innovate, many manufacturers recall old models as a preventive measure-a move that costs money, but can save more costs by avoiding litigation. Similarly, litigation is common in markets where clear medical claims may be reviewed by the FDA and customer expectations are high. Device manufacturers need to set and maintain the expectations of patients and practitioners to avoid litigation. Likewise, a better medical device approval process will ease tensions and protect producers and consumers.
7. Interdisciplinary competition
With the important milestone of Covid-19 vaccination in about 12 months, the world has seen the power of modern molecular drugs. This, combined with amazing advancements in therapies such as CRISPR and pharmacogenomics, is turning the future of healthcare to personalized solutions. Although we are unlikely to see a breakthrough in gene editing in at least a decade, forward-looking device manufacturers have seen competition from molecular medicine. Curing diseases at the DNA level can eliminate a lot of medical equipment, such as insulin pumps, from the landscape.
The market is motivated
Despite these seven unfavorable factors, the medical device market will maintain a strong momentum in 2022 and beyond. Although 2021 is a crucial year for the end of the global pandemic, it is still difficult to control, but it is also an opportunity for medical device manufacturers to gain a foothold in a market where demand is increasing year by year. Acknowledging these challenges and staying focused can help strengthen manufacturers and help them gain a foothold in a market that is prone to change.
Photo: VectorInspiration, Getty Images
