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A defibrillator is a device that is used to restart the heart in the event of cardiac arrest. Cardiac arrest, is the sudden and usually unexpected cessation of normal heart a

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

ctivity.

Defibrillators come in two main classes or categories. The internal defibrillator and the external defibrillator. These obviously speak for themselves, one being im

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

Examples of combination products may in

lanted in the body and the other used externally.

Implanted defibrillators are about the size of a mini-cassette and are placed normally above the heart in the chest cavity.

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

They are fully automated, monitoring heart activity 24/7, and lay ready to deliver life-saving electric shocks to the heart in the event the carrier suffers sudden cardiac 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

rest.

External defibrillators on the other hand, are normally portable (these days), being used in medical facilities, emergency medical service (EMS) vehicles and, more rec

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

Combination pro

ently, in public gathering places, homes and offices.

Up until the mid 80’s defibrillators were large, somewhat cumbersome devices found only in a hospital or EMS setting. T

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

ey had to be worked manually, meaning a trained operator had first to determine if defibrillation was appropriate for the victim’s symptoms, by checking for a pulse and runni

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

ng through a laundry list of other qualifying procedures.

Due to major advances in cardio technology and electrical component miniaturization, the modern defibrillator is bu

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

a shadow of its former self. Smaller (a modern external defibrillator is about the size of a baseball mitt), fully automated and portable, these devices can now be operated

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

even by untrained hands.

The external defibrillator first monitors the patient's vital signs to determine if defibrillation is necessary, before audiovisual prompts walk the

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

rescuer through the necessary steps of the defibrillation process. These machines will even determine if CPR (cardiopulmonary resuscitation) is appropriate, and if so, guide

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

Following aspects would a

one through the entire procedure.

Relatively recently home-use defibrillators were approved by the FDA, and could be had with an accompanying prescription from a qualifying

dd to the challenges in developing combination products:

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

doctor. But recent developments in the technology have seen the FDA approve a home use defibrillator that can be purchased without a prescription. The Philips home-use AED (a

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

utomated external defibrillator) can now be bought over the counter.

Why would you need a defibrillator in your home, you might ask. Well, look at the statistics - sudden ca

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

diac arrest claims more lives in the US annually than traffic accidents, house fires, hand guns, breast cancer, prostate cancer and AIDS... combined. This could explai

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

n why the portable defibrillator seems set to become a regular “household” item in line with other preventatives like fire extinguishers, seat belts, smoke alarms, crash helm

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

Professional from academic institutions, pharmaceutical industries, health care indust

ts, etc..

Defibrillators will no doubt continue to evolve, but for now at least we have reached a welcomed milestone in their development. A place where the man in the stree

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

t can have access to a medical tool that alone may save his life.

Cardiac arrest allows its victims less than ten minutes without defibrillation before death is a foregone c

.

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

nclusion. The modern defibrillator, with its automated, audiovisual aids, has the credentials to reverse that scenario by offering immediate onsite defibrillation. Defibrilla

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

Companies that provide selfless information through particip

tion that can be administered by a family member, friend, co-worker, or even a bystander or passerby.

If you don’t yet own a defibrillator, it might be something to consider

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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