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The Marketing Plan section of the business plan demonstrates how a company will penetrate the market with its products and services. The Marketing Plan should include “the four

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

P’s” – Product, Promotions, Price, and Place.

Products and/or Services

The first “P” stands for Product, but includes all products and services that the company offers. This s

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

Examples of combination products may in

ection of the business plan should detail all the features of the products and services, how they work, their unique/proprietary attributes, etc. For products that are patented

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

nd/or technical in nature, drawings and backup materials should be presented in the Appendix.

Most growing companies offer certain products and services today but expect to off

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

er more in the future. It is important to mention both current and future products/services here, but to focus primarily on the short-to-intermediate term horizon.

Promotions

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

Combination pro

Promotions include each of the activities that induce a customer to buy the company’s products and services. Promotional activities could include advertising, public relations (

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

R), free samples, discounts, direct mail, telemarketing, partnerships, etc.

This section of the business plan discusses which promotions will be used and how they will be used.

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

For instance, if partnerships will be used to secure new customers, the plan must explain which companies are partners, how they will be able to provide new customers, how the

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

partnership will work (from operational/ financial standpoints), etc.

This section must be as specific as possible, particularly as it relates to discussing future promotions.

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

o say that a company is going to generate PR in trade magazines is simply too vague. Rather, the plan must explain the type of article/feature that may be written about the firm

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

and why, which specific trade journals that will be targeted and/or the projected publication dates.

In discussing how the company will promote itself, it is important to disc

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

Following aspects would a

uss how the company will position itself. This positioning statement details the attributes that customers will assign to the company, its products and services. The choice of p

dd to the challenges in developing combination products:

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

omotional activities must support this positioning. For example, discounts might not be consistent with a desire to be considered an upscale brand.

Price

This section of the p

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

lan should detail the price point(s) at which the company’s products and services will be sold. If the products/ services are sold as bundles, these should be detailed in this s

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

ection. Rationale for the pricing should be given when applicable (e.g., why the company has chosen an initiation fee plus monthly membership fees versus a one-time lifetime mem

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

ership fee).

Place

The final “P” refers to “Place” or “Distribution” and explains how a company’s products and/or services will be delivered to customers. This section is cruc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ial because if customers cannot access products and services, they cannot purchase them.

This section is especially critical for high-growth, capital-constrained companies. Att

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

aining profit-effective distribution channels is often the most vexing challenge for these businesses. Examples of distribution methods include retail locations, website, distri

.

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

utors, wholesalers, direct mail catalogs, etc.

Many companies have multiple distribution methods to deliver their products and services to customers and each should be detailed

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

Companies that provide selfless information through particip

here.

Detailing the “the four P’s” in the marketing plan is critical in proving to investors that your company will be able to efficiently and effectively penetrate its market

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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