Cases - Business

Corporations have many constituents. But they seem to play to only one audience – the investment community or Wall Street. Any business is made up of workers, supervisors, managers and executives. They also have customers, suppliers and in many cases dea

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

lers or distributors. They have facilities in cities, towns and communities. Some have factories and others have only offices. But the fact is that all corporations touch the world they operate in beyond the narrow confines of where they raise money thro

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

Examples of combination products may in

ugh investors – or Wall Street. So why do almost all corporations decisions revolve around how Wall Street will react? Are there alternatives?

What is the problem?

Most corporations can track performance to a “gnat’s eyelash” but do not spend time under

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

standing downturns. Is the problem the product? Is the problem competition and if so why? Is it the economy? Is it a problem with marketing? There can be many reasons for a down week, month, quarter or year for any company or for any industry. The key

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

is to analyze why and to look at the long term. A week, a month or even a quarter or small in the scheme of long term business success – except to Wall Street. Analysis is required to understand the problems and to understand the trends before any action

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

Combination pro

s taken.

What is the answer?

The first answer for any downturn in a business or corporation always seems to be to cut. To cut deep. And to cut fast. There are alternatives to cutting. What do customers want? Why are they not buying? What would they buy?

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

Is the price right? Is the marketing communications effective? Is the sales and distribution addressing the customer? Is the product too much or too little? Rather than cutting, perhaps the answer is investing. Investing in new products. Investing in mo

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

re research and development. Investing in more and difference sales and distribution channels. Investing in customer service to delight the customers. Sometimes when the instinct is to cut, the best thing is to invest and to invest for the short and the l

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

ong term growth of the business.

Where to start?

The analysis is done. The investing has been done. And the performance is still poor. Who is accountable? Is it the worker on the factory floor? Is it the salesman? Is it the customer service represent

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

ative? In all likelihood these people did not make the decisions – good or bad – that got the corporation to where it is now. Also in all likelihood these people have the lowest pay and benefit costs of anyone in the corporation. The also product the produ

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

t, touch the customers and drive the revenue. Does it make sense to “shoot” them? No! The cuts must always start at the top. Before one worker or supervisor or even manager is laid off, corporate executives must reduce their compensation and benefits. T

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

Following aspects would a

hey must do it in a material way. Without exceptions. They also need to hold themselves accountable. If they have not produced the results they had committed to – they should resign – sans any “golden parachutes”. Failure should not be rewarded. What a

dd to the challenges in developing combination products:

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

horrible example golden parachutes are for businesses or any organizations – rewarding failure! No the top executives must cut back, reduce their ranks and hold themselves accountable first before a single lay-off takes place.

Where to end?

Who and what

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

touches the customer? The product? Customer service? Sales and distribution representatives and account executives? Anything that touches the customer – product or sales or service should be the last thing to be cut or the last place to perform lay-off

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

s. Yes, this flies in the face of conventional wisdom to cut at the bottom first. But the bottom of a triangle is the widest part. And the widest part has the broadest and most impacting effect on customers. The goal must be to delight customers profita

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

ly. Anything else is short-sighted. Corporations should not cut across the board but rather cut at the top and work their way down and eliminate staff functions before touching areas like product and sales and customer service. Less top-heavy organizatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns with leaner chains of command and top executives closer to the workers in both face time and compensation are huge steps toward improving corporations which are currently out of control in terms of their worship of Wall Street.

Lay-offs have grown to be

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

a fact of life for those who work for corporations. Often times they are a knee-jerk reaction to short term financial results. They are announced less to improve performance and more to send a signal to the investment community – Wall Street. Corporatio

.

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

ns should be slower to lay-offs by taking the time to analyze what the problem is and how to best address it for the long term. If and when there are no alternatives to lay-offs – they should begin with pay and benefit cuts plus force reductions – without

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

Companies that provide selfless information through particip

golden parachutes – at the very top of a corporation. If corporations focused as much on their customers, their profitability and their employees as they did on Wall Street, companies and communities would be the winners in both the long and the short term

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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