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Flat feet, also known as fallen arches, is a condition that occurs when the arch in the foot collapses. The collapse of the arch causes the entire sole of the foot to come into complet

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

e contact, or almost in complete contact, with the floor. As a result, people with flat feet are unable to tread normally and are forced to alter their steps.

What causes flat feet?

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

- Genetics - In most cases, (approximately 20-30% of the population) flat feet is genetic and both feet are affected. Those born with naturally flat feet usually have a malformed joint

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

or two or more bones may have merged together that caused the feet to become stiff and flat.

- Injury that causes stiffness and distorts the foot joints such as a ruptured tendon

- A

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rthritis

- Illness – Diseases that affect the nervous system or muscles (I.E. spian bifida, cerebral palsy, muscular dystrophy) can cause flat feet because muscles become week and stif

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

, and can no longer function effectively together.

- Natural aging process

- Pregnancy – Sometimes pregnant women develop flat feet from the temporary changes caused by an increase in

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

elastin in their body.

Usually, flat feet is a permanent condition.

What symptoms can occur from having flat feet? People with flat feet are at a higher risk of developing foot prob

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ems because they suffer from over-pronation. Over-pronation is when the feet roll excessively inward due to the stress overload placed on the ligaments and tendons of the ankle. This

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

weakens the ankle and inside portion of the foot causing it to turn inward. Over-pronation can lead to painful symptoms including -

Bunions – A deformity of the big toe that occurs wh

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

n the joint becomes misaligned and protrude outward.

Calluses – When the big toe loses flexibility, calluses usually occur under the sole of the foot near the second toe where stress i

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s being placed.

Hammer toes – When the angle of the big toe increases inward, it begins to slide under the second toe. As a result, the metatarsal bone rises up and causes a hammer to

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e to form.

Plantar fasciitis and heel spurs – The Achilles tendon becomes shorter and pulls up on the heel of a person with flat feet, causing the arch to flatten and the foot to becom

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

longer. Thus, the plantar fascia (tight band of muscle under the foot arch) becomes abnormally stretched, which can lead to pain in the heel bone (plantar fasciitis) and heel spurs.

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Low back pain – This usually occurs due to strain on the sciatic nerve. This nerve links the lower back to the foot via the leg. The strain is typically caused by repeated shock from

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

unning and over-pronation.

Finding relief from symptoms – There are different methods for treating flat feet, such as –

- Stretching exercises – Engage in exercises (2 – 3 times daily

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

) that focus on the arch of your foot and Achilles’ tendons (IE. rolling your foot back and forth over a rolling pin or foot gymnastics). This will help increase flexibility and reduce

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

the stress and pain felt by these areas.

- Lose weight – If you are overweight, losing weight helps to provide relief for your feet.

- Wear supportive shoes – Keep an eye on the stabi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

lity of your footwear. Don’t wear shoes that are worn, tight, or tilt inwards. These shoes only increase your risk of injury and pain. Also, use orthotic insoles for your shoes to pr

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

vide your foot with better support.

- See a professional – If you suffer from chronic discomfort or pain, seek the attention of a foot specialist such as a podiatrist or orthopedist.

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

They can help provide you with proper shoes and orthotics that are custom made for your foot. They can also recommend exercises and even surgery if it is in the patient’s best interest

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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