Advice You - Business

Decisions are the coin of the realm in business. Every success, every mishap, every opportunity seized or missed is the result of a decision that someone made or

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

failed to make. At many companies, decisions routinely get stuck inside the organization like loose change. But it's more than loose change that's at stake, of c

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

Examples of combination products may in

ourse; it's the performance of the entire organization. Never mind what industry you're in, how big and well known your company may be, or how clever your strateg

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

y is. If you can't make the right decisions quickly and effectively, and execute those decisions consistently, your business will lose ground.

Indeed, making goo

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

decisions and making them happen quickly are the hallmarks of high-performing organizations. When we surveyed executives at 350 global companies about their orga

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

Combination pro

nizational effectiveness, only 15% said that they have an organization that helps the business outperform competitors. What sets those top performers apart is the

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

quality, speed, and execution of their decision making. The most effective organizations score well on the major strategic decisions – which markets to enter or

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

exit, which businesses to buy or sell, where to allocate capital and talent. But they truly shine when it comes to the critical operating decisions requiring cons

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

stency and speed – how to drive product innovation, the best way to position brands, how to manage channel partners.

Even in companies respected for their decisiv

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

eness, however, there can be ambiguity over who is accountable for which decisions. As a result, the entire decision-making process can stall, usually at one of f

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

our bottlenecks: global versus local, center versus business unit, function versus function, and inside versus outside partners.

The first of these bottlenecks,

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

Following aspects would a

global versus local decision making, can occur in nearly every major business process and function. Decisions about brand building and product development frequen

dd to the challenges in developing combination products:

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

ly get snared here; when companies wrestle over how much authority local businesses should have to tailor products for their markets. Marketing is another classic

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

global versus local issue – should local markets have the power to determine pricing and advertising?

The second bottleneck, center versus business unit decision

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

making, tend to afflict parent companies and their subsidiaries. Business units are on the front line, close to the customer; the center sees the big picture, se

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

ts broad goals, and keeps the organization focused on winning. Where should the decision-making power lie? Should a major capital investment, for example, depend

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

Professional from academic institutions, pharmaceutical industries, health care indust

on the approval of the business unit that will own it, or should headquarters make the final call?

Function versus function decision making is perhaps the most co

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

mmon bottleneck. Every manufacturer, for instance, faces a balancing act between product development and marketing during the design of a new product. Who should

.

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

decide what? Cross-functional decisions too often result in ineffective compromise solutions, which frequently need to be revisited because the right people were

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

Companies that provide selfless information through particip

not involved at the outset.

"Who Has the D?", Paul Rogers and Marcia Blenko, Harvard Business Review, January 2006. Visit CJPS-Enterprises for more information

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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Advice You - Business Strategy – How Clear Decision Roles Enhance Organizational Performance

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