An implantable medical device is place in human body to replace the missing part of the body, to support the injured part of the body, or to change the essential function of the body. Examples include cardiac pacemakers; screws, pins and rods used to repair fractured bones, and artificial hip joints. Implants are either completely or partly inserted into the human body using surgical or medicinal procedures. Some implants are made from skin, bone or other body tissues. Others are made from materials such as metal, plastic and ceramic. Because of the difference in functionality, some implants are placed permanently while others are removed once no longer needed.

Significance

There are significant benefits of using implantable medical devices for those in need. Lives can be saved by using cardiac pacemakers, for recovering specific functionality an artificial hip is useful, orthopedic implants can help in recovering bones. Millions of people have been operated on to implant some type of medical device.

Implanted medical devices are now one of the most profitable businesses of the U.S. healthcare industry. On a yearly basis, medical device companies across the world bring in over $200 billion in revenue. In the U.S. alone, these companies generate over $85 billion a year. A large portion of that is for devices that are implanted in the human body.

About 70,000 in America who receive a cardiac pacemaker and about a million in total of the knee and hip replacements a year. It is estimated that about 7.2 million Americans have joints implants. Implantable medical devices account for a significant portion of health care spending, accounting for 30% to 80% of the payments from insurers to the hospitals. Here are the list of the most implanted medical devices in America:

1. Artificial Eye Lenses (Psuedophakos): Cataracts are a problem faced by millions of elderly Americans yearly, many of whom will require surgical replacement of their own lens with an artificial one.

2. Ear Tubes: Otitis Media, or middle ear infection, is one of the most frequently diagnosed childhood diseases with at least 80% of pre-school aged children affected. Billions of dollars are spent every year on doctor visits, medicines, and, in chronic cases, surgery.

3. Coronary Stents:  Coronary stents are small tubes, usually coated with a drug , that are placed into the arteries that supply blood to the heart. Stents are regularly implanted into patients with unstable angina (unpredictable chest pain) and recent heart attack patients whose coronary arteries have been partially blocked by atherosclerotic lesions (cholesterol).

4. Artificial Knees: As the other major, replaceable weight bearing joints in the leg, knees frequently wear down faster and in a more disabling fashion than other joints. The constant friction and shifting of weight in the joint leads to a breakdown of cartilage and bone, making knees the most frequently replaced joint in the body.

5. Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair): Bone fractures are one of the most common injuries, occurring in all age groups for a multitude of reasons. Of over one million fractures that are admitted to the hospital every year, roughly half require surgical intervention to realign and stabilize the bone, a procedure called open reduction and internal fixation.

6. Intra-Uterine Devices (IUDs): IUDs are extremely popular worldwide and are the preferred method of contraception for almost 25% of women in the rest of the developed world.

7. Spine Screws, Rods, and Artificial Discs (Spinal Fusion Hardware): Spinal fusion surgeries are performed for a variety of back problems, mainly for pain and weakness. The surgery essentially fuses two or more vertebrae with the help of hardware such as screws and rods.

8. Breast Implants:  Breast augmentation with implants is the most frequently performed plastic surgery procedure in the U.S., beating out nose jobs, eyelid surgery, and liposuction by a significant margin.

9. Heart Pacemakers:  As with ICDs, pacemakers are used to treat abnormal rhythms in the heart. While ICDs treat otherwise fatal rhythms, pacemakers are used when the heart’s internal clock is not maintaining a fast enough pace. Pacemakers override the aberrant signals in the heart by passing small jolts of electricity to multiple parts of the heart muscle, providing its own rhythm.

10. Artificial Hips: As people age and gain weight the wear and tear on their joints builds up. In particular, more than 20 million Americans suffer from degenerative osteoarthritis, which is the leading cause of chronic disability in the U.S.Hip replacement can lead to a decrease in pain and an increase in mobility in over 90% of recipients.

11. Implantable Cardioverter Defibrillators (ICDs):  Implantable cardioverter defibrillators (ICDs) are devices that monitor and treat these rhythms when they are detected by sending a large jolt of electricity to the heart, and basically pressing the reset button. Newer models can also function as pacemakers, combining two devices into one.

Market Dynamics

The medical implants market accounted for $85,389 million in 2019, and is expected to reach $147,464 million by 2027, registering a CAGR of 7.2% from 2020 to 2027.

Rise in Demands

Rise in aging population and increase in prevalence of chronic diseases are some of the major driving factors for the medical implants market. Aged people are more susceptible to chronic diseases such as cardiovascular diseases, orthopedic disorders, endovascular diseases, and dental disorders, thus being the major users of medical implants. For instance, with the increasing aging population, the demand for tooth loss is expected to grow. According to the American Academy Of Implant Dentistry (AAID), about 3 million people in the U.S. currently have dental implants, and this number is expected to grow by 500,000 annually. Likewise, the increasing prevalence of heart disorders worldwide is also the major factor fueling the implants market, reaching a value of 21.5 Billion USD in 2020.

Technology Achievements

The growth of the global medical implants market is further driven by technological advancements in medical implants. For example, Additive manufacturing (3D printing) and titanium powder have allowed the production of medical implants to be more biocompatible and fit to the body seamlessly. They will be used to greatly improve the bone implants. Some seeingly sci-fi devices, such as artificial eyeballs and Brain computer interfaces (BCIs), are no longer just imagination. They are likely to be developed and benefit human in the futre. Moreover, hike in disposable income, availability of better medical facilities, surge in number of cases with damaged limbs or organs caused by different accidents are the factors that play pivotal role in accelerating the growth of the medical implants market.

Challenges

Implantable medical devices is widely used, and various new products keep emerging in the market. However, entering this rapidly growing market has many risks.

Implantable medical devices are widely available on the market, but they lack robust regulation due to government efficiency limits, which makes them expensive and uninsured. And the market is now suffering the consequence of the Covid-19 pandemic. It crippled supply chains around the world, causing everything from delayed product deliveries to rising materials prices. Yet, demand for medical devices hasn’t fallen. The result is a huge disparity between what medical device manufacturers are able to produce. Until global supply chains settle and device manufacturers get the materials they need, the market will remain depressed.

The prices of medical implants goes high because the current already-high cost of healthcare continues to trend upward. For those who require medical devices to treat or manage a chronic condition, these products may become unaffordable and out of reach. Many medical devices exist outside traditional insurance coverage. Even some financial assistance form insurance isn’t enough to fill the gap between cost and need.

Lack of regulation is another issue of this industry. The medical device market is lightly unregulated. Unregulated devices aren’t covered by insurance, which makes getting them into the hands of patients difficult due to cost concerns. Likewise, the FDA evaluation process for new devices is lengthy, expensive and largely cumbersome, which dissuades many startup device manufacturers from seeking approval. Until there’s a more succinct and responsive approval process or a change to regulatory guidance, this gap will persist.

As more and more devices become digital, cybersecurity concerns rise. Device manufacturers now find themselves facing concerns about patient privacy and protection per HIPAA, which makes manufacturing smart devices more complex and costly. A staunch cybersecurity approach can add months to the development timeline.

Finally, the issue of piracy and patent infringement is what many manufacturers must face. Too often, a new and innovative product hits the market, only to see imitators and counterfeit examples alongside it within months. This is a devastating prospect for the medical device market, for a multitude of reasons. Responsible manufacturers bear the burden of doing things right, while counterfeiters flood the market with unproven devices. Patients can experience poor results or, worse still, illness or injury—all because they were duped by a clever lookalike. To perpetuate the problem, these knockoffs are competitively priced and often well-packaged, further mingling them as imposters. Everyone suffers at the hands of counterfeiters.

Conclusion

Implantable medical devices can save lives and significantly improve our life quality. As the growth of wealth and aging, it has become a profitable industry and is expected to have a lot of room for growth in the future. With the progress of technology, the development of medical devices is fast, and many new products are constantly manufactured and brought innovation. But at the same time, this industry also has considerable challenges, how to reduce prices, strengthen government regulation and improve safety is an important topic in the future.