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In Strategic Planning, there are many analytical tools like PEST, 5-forces of competitions, SWOT etc to assist in the development of a good strategy. How detail these analysis

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

are used depends on the complexity and competitive position of the business. A business environmental scanning is able to provide leaders to assess the future competitiveness o

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

Examples of combination products may in

f the business and thus it own business development. Assuming all these are done well, the next challenge for leaders is to implement these strategies effectively such that it

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

yields the desired results.

Effective communication is the starting point to the implementation of the strategies. Without such communication, companies are not able to implem

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

ent these strategies effectively in a cohesive manner. So, the objective of communication in Strategic Deployment is to attain Total Alignment of understanding of performance e

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

Combination pro

pectations, key result areas and Key at company level as well as at operation level.

I came across companies who did the communication by merely sending out emails or pass aro

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

und a budget report to key personnel. and hope they will pass down the information accordingly. While this mode of communication is most time effect, they do not ensure informa

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

tion are really pass down to the next level as complete as it should be. Another minor point about this mode is that there is no indication or feedback the budget details are w

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

ell accepted (willingly).

Alternatively, many companies conduct a "Budget Roll-Out" sessions with key personnel on a more elaborated manner. It was held in workshop style type

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

of session involves a lot of discussion and further details of actions plans to the strategies are developed. Templates are used to guide leaders to conduct this type of sessi

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

n. Graphical examples of these templates are available at http://www.tqmcasestudies.com/sc_cat2rev1.htm

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

Following aspects would a

During these sessions, balanced Scorecard and Strategy Map are used to develop Key Performance Indicators that are complement each other and well aligned to the company l

dd to the challenges in developing combination products:

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

evel objectives.

On the soft side, there are plenty of opportunities for participants in the session sot cross share their ideas and opinion about the budget, strategies and a

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

ction plans. All these happenings are eventually created better understanding of the budget and hence obtain better buy-in from key personnel who are responsible to execute the

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

strategies.

In summary, to ensure a effective Strategic Planning, its detail implementation plan must be incorporate as part of the Strategic Planning Process. Next task is t

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

monitor and track the action performance of the actions.

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Disclaimer: This article is writte

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

Professional from academic institutions, pharmaceutical industries, health care indust

n by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it has no intention to conflict w

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

ith experts in similar topic. The author holds no responsibility for the use of this article in any way.

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.

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

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

Companies that provide selfless information through particip

rticle. Please ensure that the URL in the resource box remain active and it is linked to the author's website.

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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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A great Business Coach can help a business owner or manager make significant advances in their business in a relatively short period of time. All Business Coaches are not the same! This article will highlight a few key questions that you should ask your prospective coach before your hire them!

How many times have you heard or seen advertising for a graphic design company that states they do branding? If you think branding is a logo, letterhead or a web design with all the same look, and colours, then its true….they can “do branding”.

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