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Whether you’re just starting out or already in business, it’s important that you set goals for yourself and your business. And once you know how to avoid these common mistakes, these simple princi

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

ples can be applied to any other area of your life:

MISTAKE - Not Setting a Deadline

It's a well known fact that when we give ourselves deadlines for our goals, we are much more likely to achiev

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

Examples of combination products may in

e them. Somehow, knowing that there is a timeframe involved focuses our efforts and even when we do very little differently, our success is faster.

MISTAKE - Phrasing Your Goal as a Negative

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.

important that you frame your outcome in a positive way. Swap a negative goal like “I want to get rid of my debts from training and start earning” to “by 30th January, I will be earning ____”.

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

Alternatively, if you know how many clients or customers you will need for such an income, “by 30th January, I will have 20 regular clients/customers each week.”

MISTAKE - Not Considering the Var

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

Combination pro

ables

You need to work out how much of your goal you control. Using the example above, you may think “I can’t possibly get 20 clients or customers on my own because it depends on the market…” Thi

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

s is fine. Once you know that the market is an important factor, you can tailor your approach to be better prepared.

What do you have control over?

MISTAKE - Not Being Clear on What You Want to

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

Achieve

Are you clear about what you want to happen? The clearer you can be, the more motivated you will feel and everything will be easier. What will change when you have 20 regular clients/cust

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

mers each week? Picture your diary filled with appointments. How does that feel?

Too hectic? Do you want to readjust your figure or reschedule your available working hours? Once you’re happy that

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

your goal is clear and that you want to put your energy into making it a reality, fill in the details.

MISTAKE - Not Thinking About the Impact on Other People

How will reaching your goal affect

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

your friends, family, community and the planet?

Ruth wanted a busy business and was doing lots of marketing with no success. When we examined what business would actually mean for her, we realise

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

Following aspects would a

d why. Beth worked from the home she shared with her partner so he had to make himself scarce a lot. This exercise made Beth realise how much she hated putting him out.

MISTAKE - Not Having Clear

dd to the challenges in developing combination products:

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

Goalposts

Often, we get so lost chasing a dream we forget to assess our progress. How will you know when you have reached your goal? What will success look and feel like?

There’s no point worki

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

g all out if you don’t appreciate it once you get there. The most successful and happy people set themselves measurable goals. Using the same example of getting 20 regular clients/customers by 30t

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

h January, you might decide that this will involve building up slowly. If you currently have 10 clients/customers, you will want to double it. If you’re new to your business, you’ll probably want

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 build up from a lower number than that.

MISTAKE - Not Having a Map

Again, by breaking your overall goal into smaller steps, you will illustrate the old saying: “A journey of a thousand miles b

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

Professional from academic institutions, pharmaceutical industries, health care indust

egins with a single step”

If you were apprehensive about driving from London to Cornwall for the first time, you’d break it into stages. Your first leg of the journey might take you to Reading wh

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

ere you might stop to refuel, then a second leg to Exeter where you could stop off for lunch. The final leg would take you to your holiday destination. Or this may be too much driving and you woul

.

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

decide to break the journey into smaller steps.

Give yourself credit for each step you take.

MISTAKE - Not Identifying Your Support Systems

Don’t underestimate the support you have or could ga

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

Companies that provide selfless information through particip

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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