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Small business owners mistakenly believe that the size of their business negates the need for strategic planning but the opposite is actually true. Its inherent size

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

is actually what makes strategic planning more important because it can be means for a small business to gradually evolve into a huge and thriving multinational cor

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

Examples of combination products may in

oration.

What Small Business Owners Need to Know about Strategic Planning
Planning is one of the five important functions of management, but it’s arguably the

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

ost important of all because it’s the first function that any manager or business owners should focus on. Planning sets the goals, mission-vision, and direction for

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

he company. Without it, the other functions may be impossible to achieve.

A business can’t, however, benefit from just any kind of planning. It must be strategic in

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

Combination pro

essence to be effective. Strategic planning is a methodical process of deciding where you want your company to be in a given time frame and what you propose to do to

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

get there.

There are different ways to let your company benefit from strategic planning so don’t worry about following the so-called rules. Whatever works for your

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

ompany is good enough.

Elements of Strategic Planning

Internal and External Assessment of Strategic Planning – A coach of a basketball team won’t be able to map ou

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

an effective play if it doesn’t know its players well, which team it will be playing against, and other related factors. The same can be said for any business manag

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

r. Before you can start working on the details of your strategic plan, you must first focus on compiling data about the external and internal environment of your com

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

any.

Outside your business, politico-legal, economic, and socio-cultural factors can affect how your business will fare in the next few years. Inside, factors such

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

Following aspects would a

s management style and the type of workforce you have can also help or hinder your company from attaining your goal.

Setting Your Company’s Goals – Small or big, th

dd to the challenges in developing combination products:

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

important thing is for your business to have goals. If you’ can be satisfied with small and short-term goals then that’s good; if you secretly desire for bigger goa

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

s then that’s even better. To know if the goals you plan to work on are indeed workable, determine if they adhere to the SMART rule – specific, measurable, attainabl

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

, realistic, and time-bound.

Rule of Majority – Of course, as owner or manager of a business, you reserve your right to approve or naysay any suggestion but as much

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

as possible, allow the rule of majority to stick. Plans can only come to fruition if everyone in the company works together and you can assure yourself of their coop

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

Professional from academic institutions, pharmaceutical industries, health care indust

ration by showing them that you care about what they think.

Devising an Action Plan – Finally, it’s time to concentrate on the nitty-gritty of your strategic plan.

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

ist down possible and specific courses of action then choose what all of you deem as most suitable. Make sure that you set a definite schedule or timetable for every

.

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

hing but give allowances for unexpected delays and concerns. Set a budget as well.

The Ever-So-Popular Plan B – Last but not the least, devise a Plan B in the event

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

Companies that provide selfless information through particip

that your first plan doesn’t work and list down indications to know when’s the right time to put Plan B to action.

Good luck on strategic planning for your business

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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Meetings are here to stay, so it makes sense to make these sessions work for you. There are eight things you can do to reach this goal.

Wise use of the e-technology options so readily available will bring investors to your door; mis-using them will slam the door in your face.

To manage is to control, handle or manipulate. To lead is to guide, influence or persuade.

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