Main Subject - Business

When something fails it is human nature to blame something else. When a company implements a software system into their organisation and it doesn’t work the most common argument why this is, falls squarely at the feet o

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

f the software itself. However, one of the most avoidable reasons why a software system doesn’t work is because the people using it don’t know how it works.

In a world where we associate technology with progress, we 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

omatically assume that having a technological masterpiece in place is automatically going to produce dividends. This is not the case. Tiger Woods is not a great golfer because he uses the most expensive graphite golf cl

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

bs. In the hands of a novice, those same golf clubs will not produce the same results. Similarly, the software implemented into a company cannot be expected to just work without having a thorough understanding of how th

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

software operates. It is still incredible to see companies today, who have spent fortunes on software and then have not trained their staff in using it. In no other competitive environment would you expect to give top

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

Combination pro

f the range equipment to untrained performers and then walk away expecting results.

On one level it is understandable, with so many systems emulating the popular windows format, most software on the market today look a

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

d act very similar. It is then logical that if you are computer literate and know how to operate one system then it is possible to pick up another by trial and error. In some ways, this is possible, and if we can draw o

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 golfing analogy once again, it is possible to learn things on your own by practicing. However, the same things will result in both scenario’s, moderate success will be achieved but bad habits will be formed along t

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

e way. This may be acceptable to a novice or amateur golfer but not a professional, why then is it acceptable for a professional company?

Even when a company does implement a training regime, the most predictable cogni

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

ive reasoning attached along side any training venture is ‘cutting costs’. There are many cases where, a sales manager will have basic training in the software with the intention of passing that knowledge further to the

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

rest of the department. This chain reaction of learning is fuelled mostly by a need to cut costs in ‘wasteful’ training of the entire workforce, but also leads to insufficient and loss of knowledge. Teaching and learnin

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

Following aspects would a

g are specialist areas where subjectivity plays a strong role. One person who learns a technical or academic process learns in different ways and draws and retains information particular to his particular niche. A sales

dd to the challenges in developing combination products:

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

manager may only draw on certain points of a system that affect his own environments without passing knowledge that is useful to others.

In our education system we treat with great respect teachers and professors who a

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

e trained in teaching methods that impart knowledge to students in various ways. A student who completes a course is not suddenly qualified to teach that subject and were they to attempt it would not easily achieve the

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

ame results. Similarly, training one person to use a complicated software system with the intention of passing that knowledge on will result in the same kind of failures.

Conversely, there are occasions where the oppos

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

te is true and the whole work force is trained with the exception of the managers who may view training as a performance exercise for staff only. In such situations, the knowledge that the fully trained users are inputt

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng is lost on individuals who know little of what they are dealing with. The object of a software system is to record data and allow a company to view necessary data in manageable ways. In such a way, the software syste

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

can be compared to a central nervous system carrying information to the brain. If the brain cannot recognise or understand the information the whole process of the system is meaningless. Managers are the driving forces

.

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

of the company and as such need to know as well as anybody the best ways of utilising the tools at hand.

Companies can spend huge amounts of money investing in software that aims to improve an organisations performance

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

Companies that provide selfless information through particip

or efficiency, but what most people forget is that the investment is not in the software itself which is a tool, but in the people who are using it. Investing in the people is what will make your company more successful

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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