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Businesses operate in circumstances which are caused as a result of macro- and micro-economic factors. Macro-economi

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

c factors are due to myriad forces such as political stability and unforeseen natural calamities upon which business

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

Examples of combination products may in

s have little or no control. For instance, businesses have little control over oil price hikes caused as a result of

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

war in certain parts of the world.

Micro economic forces are those which act upon the industry or firm. Businesses

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

may react by seeking and allocating internal resources to prompt a strategy to solve them. In most cases, a business

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

Combination pro

may not have the resource as the firm itself runs with optimal resources. Management consultants pitch in for such s

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

tuations with their valuable expertise and resources. They have resources according to the industry and function. Pu

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

rchasing consultants have expertise in the areas of supply chain management of different industries.

In most of the

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

organizations, purchasing reports to operations. Hence most of the management consultants who have operations expert

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

se consulted on problems related to purchasing. Purchasing consultancy evolved from the need for IT in purchasing fu

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

ction and the transition from tactical to strategic function. As IT was integrated into the business functions, firm

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

Following aspects would a

s needed to know the level of automation and the different systems available in the market.

Globalization and compe

dd to the challenges in developing combination products:

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

ition forced the purchasing from a transition role to a strategic role: from cutting costs to managing suppliers, fr

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

m confrontational behavior to collaborative. This necessitated strategies to engage the suppliers, evaluate them bas

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

ed on the new criteria, and help firms formulate strategies to go global.

Manufacturing firms spend more than half

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

f their operating costs on materials and parts. Hence most of the consultants focus on manufacturing industries. For

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

Professional from academic institutions, pharmaceutical industries, health care indust

instance, the automobile industry with many tiers of suppliers for parts and modular supplies presented great scope

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

for cost reduction and supplier involvement in new product development. They provide consultancy in contract managem

.

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

nt, ecommerce strategies.

The cost of consulting prohibits small and medium enterprises to hire consultants. There

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

Companies that provide selfless information through particip

re online services to post the problem so that consultants are pulled to the firms, thereby eliminating search costs

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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