Main Subject - Business

Many years’ experience has resulted in the development of two standard planning documents, the Product Marketing Strategy (PMS) and the Marketing Communications Plan (MCP). When properly completed, these docum

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

ents - in particular the PMS - will be of great value not only within the organization but also for informing and impressing potential investors, lenders, joint venture partners, agents, distributors, etc.

Th

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

Examples of combination products may in

e function of the PMS is to help the person responsible for marketing the product or service to produce a written specification of the task to be done, in a standard and logical format. Some of the statem

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

ents in the PMS may seem self-evident, but remember that you will have been living with this project for some time and what may be obvious to you may not be so obvious to others. The purpose of a PMS is to exp

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

lain clearly to everyone who reads it what the company's objective is and what its strategy is to reach this objective. As such, the completed document is company confidential information. You should note that

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

Combination pro

the PMS requires answers to be given from the customer's viewpoint, not only yours.

You may think this too is obvious, but some years ago an exercise was conducted with the top international management of 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

Scandinavian hi-tech company. After a long discussion of their new product, the people involved were divided into two and put into separate rooms. One group was asked to make a list of what the company was sel

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

ling; the other group a list of what their customers were buying. Each list had ten points, and to be worthwhile everybody had to play it for real. They were very shocked when the lists had only two points in

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

common, and a valuable lesson was learnt.

A properly completed PMS fully documents everything one needs to know in order to undertake a product launch, marketing and sales campaign, and post-sales support.

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

The second document, the Marketing Communications Plan (MCP), must be ignored until the PMS is complete, approved and signed off. The purpose of the MCP is to define (and cost) all the different marketing comm

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

unications activities required to implement that aspect of the PMS. To avoid confusion, the various types of activity are divided into categories - advertising, PR, etc - which are defined in the document. No

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

Following aspects would a

t every category may be relevant to every product or service.

The MCP cannot by definition be worked on until the PMS is complete; after all, if you don't know what you are trying to achieve and why, you cann

dd to the challenges in developing combination products:

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

ot possibly say what is required to do it. The MCP has another advantage in that it defines each individual item and activity and puts a cost to each one, resulting in a total MC budget. If the result is too h

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

igh, then rather than just saying 'cut 10%', you go through the MCP and choose to manage without specific items. You can decide not to produce an ad, or run it fewer times, reduce a brochure from 12 pages to 8

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

, print a datasheet in black-and-white instead of colour, and so on. In each case you know how much you are going to save, and what you will have to make do without in order to achieve this saving.

In general

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

, the PMS should be reviewed after a year, and updated if and as required. Then a new MCP is produced to give next year’s MC budget, and so on each year. This is not a one-off exercise, to be forgotten once it

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

Professional from academic institutions, pharmaceutical industries, health care indust

has been done. This system of PMS+MCP really does work; several clients have found it most valuable in making them think through in detail exactly what they are trying to achieve and how, and then putting thi

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

s down on paper so everybody involved is not only playing in the same match, but on the same side. Nobody can come afterwards and say they didn't understand what they should have done.

The MCP similarly provi

.

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

des a specification of exactly what MC support the sales force will get, where and when, so they can plan how best to make full use of it. A well-thought-out MCP, professionally executed, can provide a good re

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

Companies that provide selfless information through particip

turn on the investment, since it can improve the productivity of the sales force by reducing the number of sales calls required, and the time taken, to win an order and reduce the demand for post-sales support

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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For many small medium sized businesses, cash flow has received and will continue to receive the highest possible attention. Why? Simply the cash flow is the lifeblood of the business, and without a sustained positive cash flow the business may stagnate and eventually fail.

Have you watched key business goals suffer as you missed deadline after deadline? Often such problems arise because we don't hold ourselves truly accountable. When teams don't execute effectively because of lack of accountability, the company fails to generate results.

How well do you truly understand the people you have working with you in your business? Why would you want to know? They show up, do what you tell them, take their pay and go home. It’s as simple as that. Or is it? In fact, is there a trick you are missing?

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