The laws regulating the orthotic devices market across the globe vary from region to region. However, they all are similar in one aspect that is the quality and standards of the raw materials used and the final device. The orthotic devices industry in its nascent stage is self – regulated with no strict adherence policy. The companies tend to get their respective products certified to stay ahead in the competition. The International Society for Prosthetics & Orthotics is a governing body which has laid down the Guidelines and Regulations for training of Orthotic professionals. The BSI has implemented the Quality Management System – ISO 13485:2003. It ensures that the products are tested on various quality measures before they reach the consumers. The Bureau Veritas Certification is another benchmark for Quality Assurance. The growing demand and awareness towards orthotic devices and their advantages has propelled regulatory bodies and governments across the world to adopt and implement some policies to ensure safety and quality of the orthotic devices.
The North American market for orthotic devices is very organized and mature, and has been regulated by the regulatory authorities such as the U.S. Food and Drug Administration and Health Canada over a long time. The FDA’s Centre for Devices and Radiological Health (CDRH) regulates the entry of new devices into the market as well as monitors the safety and quality of the marketed products regularly to prevent substandard or unsafe devices from reaching the patients. The laws for approval of new orthotic devices are quite stringent in the U.S. which ensures that the approved products are safe and effective in patients. Moreover, the laws in North America also regulate the international trade of orthotic products and the imported products need to demonstrate their safety and quality before entering into the North American market. Each device is given a CE mark certification which indicates its quality. The producers of devices need to get CE approval for their devices, without which the products cannot be marketed. The region also requires the prescribing clinician to be a certified orthotists. Hence, the designing of custom-made devices can be done only by certified clinicians.
The healthcare reimbursement models of the U.S. government are also very stringent and take measures to ensure needy patients are reimbursed while avoiding Medicaid frauds. For instance, Medicare has a five-year period rule under which it replaces orthotic devices for patients only if the device is lost; irreparably damaged or the patient’s medical condition changes such that the device no longer meets the patients’ needs.
The regulation is based on whether the device qualifies as durable medical equipment prosthetics, orthotics, and supplies (collectively, DMEPOS). The Centre for Medicare & Medicaid Services established and implemented DMPEOS Quality Standards for suppliers of DMEPOS under the Medicare Modernization Act of 2003. DMEPOS suppliers must comply with the DMEPOS Quality Standards and become accredited to obtain or maintain Medicare billing privileges. CMS released a proposed rule in 2011 that addresses Off-the-shelf Orthotic devices. This rule will add physicians, treating practitioners, PTs and OTs as individuals with specialized training to provide custom fitting of orthosis. The Centre for Medicare & Medicaid Services (CMS) is charged with the implementation and oversight of the DMEPOS program. Although no set up is required for orthotic devices, the DMEPOS supplier is compelled to provide appropriate training instructions.
Foot orthotic insoles classified on the basis of sports are used by athletes for running and players during court games and others which include hockey, horse riding and many more. Most of the people have a normal running pattern as the foot pronates very less in order to absorb shocks. The rest of the running population over pronates or under pronates, meaning their foot turns too much or not enough at heel-strike. Orthotics can correct these imbalances by adjusting the angles at which the foot strikes the ground. Foot insoles can prevent and cure a problem by reducing and eliminating the stress caused by it. The manner in which a person runs depends on the anatomical structure of the foot and this helps determine the type of foot insole to be used. Use of foot insoles also benefits the athletes in maintaining the alignment of the feet and the body posture.
Court games include basketball and football. Different types of athletes experience varying forces and stresses through the feet depending upon the actions undertaken in the sport. Foot insoles help the players in making fast movements and running at a higher speed as it helps in the elevation of the flat feet.
Orthotic foot insoles are highly recommended by podiatrists and pedorthists as they assist in maintaining the health of the feet during various medical conditions such as rheumatoid arthritis, obesity and especially for diabetic patients.
Foot orthotic insoles are prescribed for the diabetic patients as they are highly prone to risk factors such as neuropathy, peripheral vascular disease, foot deformities, ulcers and many more. Foot health has a direct relation with the sugar level in the body. A very major and common complication observed amongst diabetic patients is poor blood circulation due to which proper care of the foot is of utmost importance for the diabetic patients.
Foot orthotic insoles are prescribed for the patients suffering from rheumatoid arthritis as they help in the realigning of foot deformities. Foot insoles used for the treatment of rheumatoid arthritis also help in reducing the ulcer risks and pain caused due to the high pressure areas underneath the bony prominences of the foot, specifically with respect to the metatarsal heads (MTH). According to a study (conducted in Australia) published in the ‘Journal of Biomedical Science’ in 2015, it was observed that the insole can be highly beneficial in the treatment of rheumatoid arthritis when the insole consists of a thick design and also when a uniform tissue compression pattern is observed adjacent to the metatarsal heads (MTH).
Another study published in the ‘Journal of the American Podiatric Medical Association’ in 2014, prefabricated foot insoles assist in reducing the forefoot peek plantar pressure (PPPft) which further help in decrease of pain caused in the early stage of rheumatoid arthritis (Santos D, 2014).
Plantar Fasciitis is the inflammation of plantar fascia which is the thick band of fibrous tissue that initiates from base of the toes and end in heel bone. Overstretching and over usage of this tissue results the tissue to become swollen and inflamed. The damaged inflamed tissue incurs pain and stiffness at the bottom of the foot. Plantar Fasciitis is observed as the most common foot problem. According to the American Academy of Orthopedic Surgeons, around 2 million cases of plantar fasciitis are diagnosed each year. The disorder is prevalent amongst runners, overweight people and patients of inflammatory arthritis. Foot orthotic insoles help in the reduction of strain in the fascia caused while standing. The custom and prefabricated foot orthotic insoles help in the pain reduction of patients having plantar fasciitis.
Obesity reduces flexibility of the body which leads to pain in the lower body such as the heels, arches, ankles and knees. Also, the excess pressure exerted on the feet makes it highly prone for long term foot or ankle damage and arthritis. Foot Orthotic Insoles help relieve the pain caused due to excessive pressure levied on the feet and also reduces the possibility of long term damage to the feet. Foot orthotic insoles assist in maintaining the ideal body posture and alignment of the feet which also helps in the decreasing the stress on the feet.
Metatarsalgia is a condition that results in the pain and inflammation in the metatarsal bones of the foot. The disease generally develops from excessive force or loading under the metatarsal heads. Athletes who are at high-risk of forefoot injury including track and field runners, tennis, football, baseball, rugby, soccer players and geriatric people who may develop age related atrophy, creates high risk of developing metatarsalgia. Foot orthotic insoles that are shock absorbing provide a platform for the foot and extra cushioning that deflects pressure from the bones.
Approximately xx% of adults have foot ailments, and the prevalence increases with age (Jody Riskowski, 2011). Heel spur (also known as calcaneal spur or bone spur caused by chronic plantar fasciitis, is the abnormal growth develops in the heel bone due to calcium deposits that form due to the excessive stretch of plantar fascia from the heel), pronation (inward roll of the foot at the time of walking or running), foot deformities including biunions (bony, lumpy deformity of the joint at the base of big toe), flatfeet (also known as pes planus or acquired flat foot disorder or fallen arches, refers to the condition where the normal arch of the foot does not develop completely because of loose fibrous tissues that holds the foot joints), splayed foot (the most common foot deformity in which the forefoot is broadened and the transverse bulge of the foot disappears mainly due to being overweight or wearing improper fitted shoes), pes cavus (also refers to high arch of the foot and does not flatten with weight bearing), pes planovulgus (this is the maximally pronated foot condition), Hallux vulgus (commonest forefoot deformity with a prevalence of xx% to xx%, in which the deviation of big toe also known as hallux outwardly, so that it overlaps with the second toe finger) and many other diseases that can be treated with foot orthotic insoles since they have the prime purpose of correcting, supporting or cushioning any foot deformities or disorders.
Comfort foot orthotic insoles are the final subsection orthotics when prescribed for the treatment of diabetic and rheumatoid arthritis patients. The comfort foot orthotic insoles can be further classified into slim and dress foot orthotic insoles. The subsection obtained in the end is designed for dress shoes and can be altered in shape in the form of a slim design in order to fit into narrow shoes.
The North American market for orthotic devices is very organized and mature, and has been regulated by the regulatory authorities such as the U.S. Food and Drug Administration and Health Canada over a long time. The FDA’s Centre for Devices and Radiological Health (CDRH) regulates the entry of new devices into the market as well as monitors the safety and quality of the marketed products regularly to prevent substandard or unsafe devices from reaching the patients. The laws for approval of new orthotic devices are quite stringent in the U.S. which ensures that the approved products are safe and effective in patients. Moreover, the laws in North America also regulate the international trade of orthotic products and the imported products need to demonstrate their safety and quality before entering into the North American market. Each device is given a CE mark certification which indicates its quality. The producers of devices need to get CE approval for their devices, without which the products cannot be marketed. The region also requires the prescribing clinician to be a certified orthotists. Hence, the designing of custom-made devices can be done only by certified clinicians.
The healthcare reimbursement models of the U.S. government are also very stringent and take measures to ensure needy patients are reimbursed while avoiding Medicaid frauds. For instance, Medicare has a five-year period rule under which it replaces orthotic devices for patients only if the device is lost; irreparably damaged or the patient’s medical condition changes such that the device no longer meets the patients’ needs.
The regulation is based on whether the device qualifies as durable medical equipment prosthetics, orthotics, and supplies (collectively, DMEPOS). The Centre for Medicare & Medicaid Services established and implemented DMPEOS Quality Standards for suppliers of DMEPOS under the Medicare Modernization Act of 2003. DMEPOS suppliers must comply with the DMEPOS Quality Standards and become accredited to obtain or maintain Medicare billing privileges. CMS released a proposed rule in 2011 that addresses Off-the-shelf Orthotic devices. This rule will add physicians, treating practitioners, PTs and OTs as individuals with specialized training to provide custom fitting of orthosis. The Centre for Medicare & Medicaid Services (CMS) is charged with the implementation and oversight of the DMEPOS program. Although no set up is required for orthotic devices, the DMEPOS supplier is compelled to provide appropriate training instructions.
Foot orthotic insoles classified on the basis of sports are used by athletes for running and players during court games and others which include hockey, horse riding and many more. Most of the people have a normal running pattern as the foot pronates very less in order to absorb shocks. The rest of the running population over pronates or under pronates, meaning their foot turns too much or not enough at heel-strike. Orthotics can correct these imbalances by adjusting the angles at which the foot strikes the ground. Foot insoles can prevent and cure a problem by reducing and eliminating the stress caused by it. The manner in which a person runs depends on the anatomical structure of the foot and this helps determine the type of foot insole to be used. Use of foot insoles also benefits the athletes in maintaining the alignment of the feet and the body posture.
Court games include basketball and football. Different types of athletes experience varying forces and stresses through the feet depending upon the actions undertaken in the sport. Foot insoles help the players in making fast movements and running at a higher speed as it helps in the elevation of the flat feet.
Orthotic foot insoles are highly recommended by podiatrists and pedorthists as they assist in maintaining the health of the feet during various medical conditions such as rheumatoid arthritis, obesity and especially for diabetic patients.
Foot orthotic insoles are prescribed for the diabetic patients as they are highly prone to risk factors such as neuropathy, peripheral vascular disease, foot deformities, ulcers and many more. Foot health has a direct relation with the sugar level in the body. A very major and common complication observed amongst diabetic patients is poor blood circulation due to which proper care of the foot is of utmost importance for the diabetic patients.
Foot orthotic insoles are prescribed for the patients suffering from rheumatoid arthritis as they help in the realigning of foot deformities. Foot insoles used for the treatment of rheumatoid arthritis also help in reducing the ulcer risks and pain caused due to the high pressure areas underneath the bony prominences of the foot, specifically with respect to the metatarsal heads (MTH). According to a study (conducted in Australia) published in the ‘Journal of Biomedical Science’ in 2015, it was observed that the insole can be highly beneficial in the treatment of rheumatoid arthritis when the insole consists of a thick design and also when a uniform tissue compression pattern is observed adjacent to the metatarsal heads (MTH).
Another study published in the ‘Journal of the American Podiatric Medical Association’ in 2014, prefabricated foot insoles assist in reducing the forefoot peek plantar pressure (PPPft) which further help in decrease of pain caused in the early stage of rheumatoid arthritis (Santos D, 2014).
Plantar Fasciitis is the inflammation of plantar fascia which is the thick band of fibrous tissue that initiates from base of the toes and end in heel bone. Overstretching and over usage of this tissue results the tissue to become swollen and inflamed. The damaged inflamed tissue incurs pain and stiffness at the bottom of the foot. Plantar Fasciitis is observed as the most common foot problem. According to the American Academy of Orthopedic Surgeons, around 2 million cases of plantar fasciitis are diagnosed each year. The disorder is prevalent amongst runners, overweight people and patients of inflammatory arthritis. Foot orthotic insoles help in the reduction of strain in the fascia caused while standing. The custom and prefabricated foot orthotic insoles help in the pain reduction of patients having plantar fasciitis.
Obesity reduces flexibility of the body which leads to pain in the lower body such as the heels, arches, ankles and knees. Also, the excess pressure exerted on the feet makes it highly prone for long term foot or ankle damage and arthritis. Foot Orthotic Insoles help relieve the pain caused due to excessive pressure levied on the feet and also reduces the possibility of long term damage to the feet. Foot orthotic insoles assist in maintaining the ideal body posture and alignment of the feet which also helps in the decreasing the stress on the feet.
Metatarsalgia is a condition that results in the pain and inflammation in the metatarsal bones of the foot. The disease generally develops from excessive force or loading under the metatarsal heads. Athletes who are at high-risk of forefoot injury including track and field runners, tennis, football, baseball, rugby, soccer players and geriatric people who may develop age related atrophy, creates high risk of developing metatarsalgia. Foot orthotic insoles that are shock absorbing provide a platform for the foot and extra cushioning that deflects pressure from the bones.
Approximately xx% of adults have foot ailments, and the prevalence increases with age (Jody Riskowski, 2011). Heel spur (also known as calcaneal spur or bone spur caused by chronic plantar fasciitis, is the abnormal growth develops in the heel bone due to calcium deposits that form due to the excessive stretch of plantar fascia from the heel), pronation (inward roll of the foot at the time of walking or running), foot deformities including biunions (bony, lumpy deformity of the joint at the base of big toe), flatfeet (also known as pes planus or acquired flat foot disorder or fallen arches, refers to the condition where the normal arch of the foot does not develop completely because of loose fibrous tissues that holds the foot joints), splayed foot (the most common foot deformity in which the forefoot is broadened and the transverse bulge of the foot disappears mainly due to being overweight or wearing improper fitted shoes), pes cavus (also refers to high arch of the foot and does not flatten with weight bearing), pes planovulgus (this is the maximally pronated foot condition), Hallux vulgus (commonest forefoot deformity with a prevalence of xx% to xx%, in which the deviation of big toe also known as hallux outwardly, so that it overlaps with the second toe finger) and many other diseases that can be treated with foot orthotic insoles since they have the prime purpose of correcting, supporting or cushioning any foot deformities or disorders.
Comfort foot orthotic insoles are the final subsection orthotics when prescribed for the treatment of diabetic and rheumatoid arthritis patients. The comfort foot orthotic insoles can be further classified into slim and dress foot orthotic insoles. The subsection obtained in the end is designed for dress shoes and can be altered in shape in the form of a slim design in order to fit into narrow shoes.
Table of Contents
1. MARKET OVERVIEW2. EXECUTIVE SUMMARY
3. ORTHOPEDIC DEVICES - MARKET LANDSCAPE
4. ORTHOPEDIC DEVICES MARKET-MARKET FORCES
5. ORTHOPEDIC DEVICES MARKET-STRATEGIC ANALYSIS
6. ORTHOPEDIC DEVICES MARKET- BY ANATOMY
7. ORTHOPEDIC DEVICES MARKET- BY TYPE OF DEVICES
8. ORTHOPEDIC DEVICES MARKET- GEOGRAPHIC ANALYSIS
9. MARKET ENTROPY
Methodology
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