Main Subject - Business

Do you know the NUMBER ONE reason that new or existing product initiatives fail?

Management falls in love with their product. They believe

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

they have an excellent product and often act in reliance on the assumed fact the product is great. Don't make this mistake!!! Follow the

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

Examples of combination products may in

teps below to ensure your success.

Product Development/Research

Step 1: Conduct research to see if the product is a good one (not excelle

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

nt).

Step 2: Make any required changes to improve the product.

[If the product fails, then stop here.]

Product Marketing

Step 3: Assume

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

that the product is "terrible" and the management has “inventoritis”.

Inventoritis n. Any of a group of disorders usually characterized by

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

Combination pro

withdrawal from reality, illogical patterns of thinking, paranoia, delusions and hallucinations accompanied in many cases by a portfolio co

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

ntaining granted patent applications and other forms of intellectual property including trade secrets. Inventoritis is associated with depr

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

ssed or non-existent product sales and defects in marketing programs and is caused by excessive reliance on the assumed idea that one’s pro

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

duct or idea is an excellent one.

Step 4: Assess financial capability to support product-marketing initiatives.

Step 5: Create an invento

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

y of all the tangible and intangible assets available to the company.

Step 6: Understand the value proposition, target market, goals and e

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

vironment.

Step 7: Clarify timeline, plan, target market needs, priorities and objectives.

Step 8: Examine all processes within the compa

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

Following aspects would a

ny (operations, financial and internal / external marketing).

Step 9: Make all required improvements to the internal processes.

Step 10:

dd to the challenges in developing combination products:

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

mprove the marketing materials.

Step 11: Design an external marketing strategy and process. (considerations below)

Positioning - competit

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

ive strategy, differentiation, brand and pricing strategy Selecting - distribution channels, marketing vehicles and service providers

Ste

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

12: Finding the Leverage Point (Strategic Leveraging) by analyzing networks, trends, technology and alliances.

Strategic Leveraging is a

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

roprietary process developed by Atomica Creative and involves the following 5 steps:

1. determining the opportunities for improvement from

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

Professional from academic institutions, pharmaceutical industries, health care indust

the status quo.
2. evaluating strategic improvement opportunities.
3. creating a strategy centered around a Leverage Point (LP).

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

br> 4. establishing a position.
5. executing the strategy using sufficient leverage and force to drive the process to completion.

Te

.

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

am

Step 13: Get the right people into the right places at the right time.

Execution and Review

Step 14: Leverage all the appropriate tan

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

Companies that provide selfless information through particip

ible and intangible assets and execute on the strategy and process.

Step 15: Review the process and make any necessary changes.

Good Luck

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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