Useful Advices - Business

If you are thinking of starting a new business, or if you are just about to take the plunge, you will know that there is a lot that you have to

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

do. But where do you start? It is a good idea to get some of the groundwork done before you start, possibly this will often mean things that y

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

Examples of combination products may in

ou hadn’t thought about, things that most people do as a reaction to circumstances rather than as a planned activity. However, in practice you

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

will almost certainly find that it is easier to set things up right at the beginning, so that systems grow with the business, rather than find

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

yourself “firefighting” later on.

Here are a few things to think about and do, before you dive straight into running your new business. Get th

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

Combination pro

e foundations right and you will be well on the way to a successful business.

This is by no means an exhaustive list, but should be enough 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

start you off.

1. Think about your goals. What are you setting out to achieve? Write them down. Did you know that only 3% of people have wri

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

ten goals? ..and did you also know that these people earn up to TEN times more than people without written goals!

2. Why are you setting up in

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

business? What do you ultimately want from your business? Write down your exit strategy. Do you want to sell eventually or pass on to your f

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

amily? Are you aiming for big profits, to create a ‘name’ or just fulfil a need that you have identified?

3. Find a good accountant, someone w

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

ho is proactive and forward thinking. (See “10 Things To Ask Your Accountant”)

4. Find a mentor. Either your accountant or other business advi

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

Following aspects would a

sor, someone in the same field who has done it already or perhaps someone from the local enterprise agency.

5. Research your market. Make sure

dd to the challenges in developing combination products:

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

there is demand, do people want what you have to sell? Also check pricing and packaging options, what would people pay, how do they

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

want it delivered and with what choices?

6. Write your Business Plan. It may sound obvious, but lots of people don’t do it. There are lots of

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

laces where you can find free help and advice, just do a search on the internet, or ask your business advisor.

7. Decide where you are going 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

o work. You have many choices – at home, in an office, in a warehouse, near to customers, out of town….. What is right for you and your busines

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

Professional from academic institutions, pharmaceutical industries, health care indust

s?

8. Make sure you know how you are going to finance your new business. Have you plans to survive the first 3-6 months whatever happens?

9.

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

Open a bank account. Keep all your business transactions separate from your personal ones. You will find it much easier to manage – your accoun

.

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

tant will like it too!

10. Read The E-Myth Revisited By Michael E Gerber. It has to be THE book for new business owners.

As I said, this is

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

Companies that provide selfless information through particip

not a comprehensive list, there are probably hundreds of other things that people might add. But this should give you a good base to start from

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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Being a 23 year old entrepreneur, I am slightly biased when I make the statement that the best time in life to start a business is before your 25th birthday. That said, I still think I make a great case for starting a business sooner than later (please note, I understand that the statements I make don't apply to EVERYONE, however I feel they apply to the overwhelming majority of people).

Leaders in businesses set the standards and the pace for their people. And sometimes it is surprising how much their people look to them to show the way. So if you are the boss, take it for granted that your behaviours are being seen, and you can use this emphatically to be a model for the character of your business. Read on to find out how...

This article lists and explains the advantages that small businesses have over their large company counterparts.

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