Advice Pool - Health and Fitness

I recently watched a program on television about people who are deaf and consider them

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

selves in what they call a deaf community. To them their deaf community is considered

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

Examples of combination products may in

ore of a culture than what we most consider the deaf - a disability.

Now enter a devi

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

ce that ends deafness and is causing, get this, anger in the deaf community. Instead o

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

being happy about such a device the deaf community is applaud by it. The device we ar

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

Combination pro

referring to is called the cochlear device or also referred to as the bionic ear.

Th

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

e cochlear device is an implant that goes inside the head of a person without hearing.

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

The implant inside the head connects to the brain's hearing function. An external unit

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

attaches to the outside of the head by use of a magnet and feeds sound to the brain.

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

The cochlear device does not itself guarantee that the deaf person will function as we

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

l as a person who does not have the disability but it has very encouraging results. Mu

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

Following aspects would a

h speech training is needed and generally this device is only encouraged for young chi

dd to the challenges in developing combination products:

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

ldren who can learn at a better rate than adults.

Here is where I think the deaf comm

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

nity is concerned. Since it really is only encouraged for very young children they are

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

in fear of losing their relationship with their children. They may feel they are uncom

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

fortable outside of the deaf community and are uncomfortable with their children being

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

Professional from academic institutions, pharmaceutical industries, health care indust

outside of it. I have a hard time figuring if this is an act of love or selfishness.

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

o I came to the conclusion that this bionic ear device is probably going to be more su

.

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

ited to children who have hearing parents. The training process would be easier for th

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

Companies that provide selfless information through particip

m since they are not falling back on their sign language usage with their deaf parents

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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