Main Subject - Business

In the US it is mandatory for medical professionals to keep an accurate medical record of all aspects of a patient. The medical professionals gather the data related to the patient in audio format b

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

y using a dictaphone or voice recorder. The details of the patient are then transcribed in text form. This process of transforming dictation of physicians and other healthcare professionals from au

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

Examples of combination products may in

io format to written text is known as Medical Transcription (MT). This written text may be stored as printed and/or electronic data. The preferred means of data storage are electronic medical recor

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

ds, which allows medical professionals the ability to access information, regardless of the geographical location.

Medical transcription is an ancient process. In olden times, Vaidyas (medical prac

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

itioners) in India used the services of their disciples to record the process of treatment in text form. It was a fully manual process. It has evolved now to digital form and speech recognition tec

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

Combination pro

nology. The person who undertakes the process of transforming (transcribing) medical data from audio to text is known as Medical Transcriptionist and to a lesser extent, a Medical Transcriber.

Medi

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

cal Transcriptionists are essential in all hospitals. They document patients' healthcare information for their permanent medical records. Physicians or other healthcare providers dictate this infor

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

ation to them through the use of hi-tech tape recorders. Medical transcriptionists are highly sought after and when they become certified, they have invaluable knowledge that provides a lifetime of

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

job options. Its possible now for the medical transcriptionists to work from home using the internet. The digital recordings of a doctor's notes are downloaded from a central source and transcripti

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

nists transcribe them on computers in their own homes. They can then be uploaded back after completion of the transcription.

Completion of a 1 year certificate course or a 2 years associate's progr

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

m is usually required to work as a medical transcriptionist. It is increasingly becoming a highly-paid career, though not without its share of difficulties. Long sitting hours often lead to back pa

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

Following aspects would a

in, eye strain and headaches in addition to the stress of concentration needed to provide accurate transcription. The accuracy in medical transcription is of paramount importance as the future treat

dd to the challenges in developing combination products:

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

ent strategy of the patient is decided based upon this data in text form. The poor quality of some of the audio files further adds to the woes of the transcriptionist. However, people are still flo

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

cking to this career due to the high levels of salary.

The process of transcription is usually outsourced overseas. South-East Asian countries are the main beneficiaries of these outsourcing jobs.

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

The primary reason for outsourcing to these countries is the low cost and availability of educated personnel. One other aspect is the time factor. And the winner in this aspect is India. There is

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

pproximately a 12 hour time gap between the US and India (more than one time zone is followed in the US). A medical professional can gather data from his patients all day long. He can then upload d

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

Professional from academic institutions, pharmaceutical industries, health care indust

ata at the end of the day to India where it is early morning.

The data can then be transcribed during the day in India. The transcribed files in text format can then be uploaded back to US at the e

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

d of the day, where it is early morning. Thus the gathering of data being done in US, while night time in India, can be transcribed in India, while night time in the US, which creates an ideal cycle

.

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

, beneficial to personnel both in the US as well as in India. It is a win-win for both. The medicos don't lose a single day and the transcription firms in India can work during the day. All this c

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

Companies that provide selfless information through particip

n be easily achieved due to the time factor. In this way the time factor plays the role of a catalyst in furthering of trade relations the two countries and both the countries are mutually benefited

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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