Advice You - Business

One of the most common ways of reviewing your business and determining your future s

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

trategy is to undertake an analysis of your:

• Strengths

• Weaknesses

• Opportuni

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

Examples of combination products may in

ties

• Threats

Generally an analysis of strengths and weaknesses focuses on the in

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

ernal aspects of the business and those factors that are within your direct control.

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

The opportunities and threats focus on the other hand is external to the business

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

Combination pro

nd are not within your direct control. Examples of this include areas like regulato

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

ry changes, new entrants into the market place or perhaps new ways of providing prod

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

cts and services.

STRENGTHS AND WEAKNESSES

In analysing your strengths and weaknes

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

ses consider some of the following:

• Levels of competence and skills

• Reputation

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

in the market place

• Financial resources available for new initiatives

• Technolo

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

gical expertise that you have

• Market knowledge and marketing skills

• Track reco

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

Following aspects would a

rd of developing new products or services, implementing sustainable change, developi

dd to the challenges in developing combination products:

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

g and delivering strategy

• Levels of customer satisfaction

• The range of product

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

s and services that you have

• Cost structure of the business

OPPORTUNITIES AND TH

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

EATS

When looking at the external factors, give thought to:

• Possible product or

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

service expansion

• Barriers to entry in your current or potential new markets

• C

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

Professional from academic institutions, pharmaceutical industries, health care indust

anges in the regulations that might help or hinder your business

• The impact of te

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

chnology on your business model

At the end of the day, if you are to continue to pr

.

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

sper, you need to take the time regularly to:

• Reflect

• Take action to exploit y

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

Companies that provide selfless information through particip

our strengths and opportunities

• Be ready to respond to your weaknesses and threat

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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