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Small business owners numbered over 5.5 million in 2001 and generated over one billion in annual payroll. Sam Walton was quoted as saying "There's a lot more business out there in sma

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

ll town America than I ever dreamed of." and looks like Sam was right.

During the last five years as THE small business coach in the Chicago area, I have discovered 7 mistakes

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

Examples of combination products may in

hat small business owners consistently make. These small business help tips should guide you as the small business owner, entrepreneur or executive around these pitfalls as you work to

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

dramatically improve your business results.

Work on your business not in your business

Mistake:

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

ners are so busy working in their business, they fail to work on their business and demonstrate the leadership that the business demands. In the book, It’s Not the Big that Eat th

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

Combination pro

Small, But It’s the Fast that Eat the Slow, the authors revealed that executives spent less than 15 minutes each day thinking about the future of their business because they were

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

so busy dealing with yesterday and today’s events.

Assess your business both externally and internally

Mistake: Don’t presume that you know what is going on in your b

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

siness. Take the time honestly and objectively to assess your business both externally and internally. Using an organizational assessment or survey based upon proven cr

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

teria such as Baldrige may help you to focus on the directionally correct actions.

Develop a strategic plan

Mistake: If you don’t have a plan, you are on someone else

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

’s plan. A strategic plan indicates who does what by when. Remember, hope is not a strategy.

Work your plan

Mistake: Pay for a plan and leave it on a shelf or

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

n a desk drawer. A plan’s purpose is action. Without action, the plan is useless and the dollars invested in creating the plan are wasted.

Invest in your people

Mistake:

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

Following aspects would a

/b> Spending dollars on things such as technology and not people. People make the business. They create the loyal customers or disloyal ones. Employees don’t come to work thinking h

dd to the challenges in developing combination products:

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

ow they can mess up the company. Invest in people development and watch your investment quickly multiply.

Pay yourself first
Mistake: Wearing all the hats and not pa

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

ing yourself what you are worth. Entrepreneurs wear many hats when they establish their business. As time progresses, they continue to wear these hats because money is tight and they

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

elieve that they can do things better. The end of the year approaches and the company made a profit. By paying yourself first, you will focus on what you do really well and delegate 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

hose other activities to others at a far lower rate.

Keep balance between your personal and professional lives
Mistake: You are too busy to take the time with your fa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ily or friends. By attending to your work life balance as well as your personal and professional development, you will see incredible results happen within your business.

Thes

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

7 tips will help you catapult your small business in warp time. Of course, if you like where you are now, then ignore these tips. However, can you be sure your competition will al

.

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

so ignore these tips? And what would happen, if they just implemented one tip less alone all 7?

P.S. In future articles,as the elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

com/small-business-coach.htm/">small business coach, I will provide some additional coaching advice by expanding each tip so that you and your business can reach incredible heights

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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Just Other Articles - Top 7 Tips to Avoid the Top 7 Mistakes Small Business Owners Make

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