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The last ten years of medical advance has promised again and again the ability for physicians to remotely examine and even treat their patients. Federal government states and univ

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

ersities have spent that millions of dollars in the development of examination stations and “robots” to provide stereo two-way voice communication, stereoscopic video and even remo

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

Examples of combination products may in

te stethoscope capability to patient bedsides in remote hospital communities. This new science of telemedicine has brought advances to hospital and emergency room based medicine f

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

r those remote communities.

But what about the average consumer? The coming pandemic looms ominously on the horizon. But this ominous shadow may actually be a new dawn for telem

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

edicine.

The SARS outbreak in Toronto and Singapore proved that quarantine does not work but that “Social Distancing” does. The message in Toronto was clear and simple. “Don’t g

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

Combination pro

to hospitals and healthcare institutions unless you want to catch SARS. That’s where the SARS is.” In Toronto it worked. The SARS epidemic fizzled out after only a few short we

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

eks of social distancing.

But in the United States, emergency rooms, hospitals and urgent care centers are the destination for the treatment of after-hours illnesses and sudden on

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

sets of the flu. Pandemic flu will strike like a blitzkrieg across the world. People will fall ill in a matter of hours not days. Doctors’ offices will be overflowing with the s

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

ck and those who are afraid that they will become sick. The default will be the urgent care centers emergency rooms and hospitals of the nation. This is where the disease will be

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

concentrated and like with SARS in Toronto this is where it will be most likely that you will become ill.

Here’s where telemedicine has the advantage, if somebody, anybody can pr

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

duce a telemedicine technology solution within a reasonable price range for the average consumer to buy. What would be needed would be a high resolution web camera and a simple ha

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

Following aspects would a

ndheld stethoscope-like device that could produce high fidelity sound in real time. A web based portal for physicians would also be needed. The examination would need to be compl

dd to the challenges in developing combination products:

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

etable in real time.

Imagine a simple device with a webcam and a modified microphone similar to that already found on electronic stethoscopes used by physicians coupled with an el

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

ctronic blood pressure cuff. Now imagine this device providing information in real time to the physician a rudimentary medical examination, a kind of “telemedicine triage.” With th

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

is consumer priced equipment, an examination could be performed and basic healthcare decisions such as the need for home healthcare nursing, antiviral medication prescriptions, or

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

imple chicken soup could be made. This “telemedicine triage” would ensure that only the sickest of the sick would go to the hospital guaranteeing that the spread of the disease wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

s decreased because fewer people would be sent home from the hospital not sick, but now contaminated.

Of course Medicare, Medicaid and other healthcare insurances would have to be

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

gin to actually pay physicians to perform telemedicine services. While the codes exist reimbursement is slow and difficult. Telemedicine takes more time than a regular examinatio

.

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

and time does have a value.

Will anybody step up to the plate? That depends on demand for “telemedicine triage” by the public, the demand for a consumer telemedicine product and

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

Companies that provide selfless information through particip

, unfortunately, the ability of physicians to get paid for what they do. On the other hand, the cost if telemedicine triage does not become is that the future pandemic will rage on

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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