Advice You - Business

The words "change" and "improve," are easy to misuse. Since change is essential to improve, it can be a common mistake to assume that change equals improvement. However, just because

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

something changed, doesn't necessary mean it improved. This shadowed truth can transform the best ideas for a positive step forward, into a devastating step back.

But fear not! You

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

Examples of combination products may in

can avoid the danger of change by adding these tools to your project development arsenal.

So Much to Do… So Little Time

Before you do anything, it is essential to ask yoursel

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

f one simple question, "What should I do?"

Make sure to allow enough time to answer this question. Allow enough time to prioritize outstanding issues when making your decision. To a

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

rrive at an educated answer, you need to ask a series of additional questions: "Is there something more important to do?" "Is someone else already working on it?" "Am I the best person

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

Combination pro

to make the change?" and most importantly "Where are the opportunities for improvement?"

Take the time to explore your current environment. Inspiration can fool us into believing ou

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

r most recent idea is the most important. By taking a step back to view the big picture, you can be more confident that you're making effective use of your time.

Know Your Destina

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

How many times have you made an important trip, such as a vacation, without a final destination? Unless you are someone who enjoys adventure and the mysteries of the unknown

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

; rarely, if ever.

Then why would you make a change without knowing what you want the change to be? Taking a little time in the beginning of your efforts to set goals and milestones

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

will save you much more time later by eliminating rework and unnecessary waste. It will also ensure you're even headed in the right direction all together.

Tell Somebody!

Aft

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

r you have decided what you need to do and how to do it, the most important thing to remember to communicate! Schedule a meeting, dial an extension, or at the very least send an email

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

Following aspects would a

. Whatever you do, make sure to share your ideas with the right people. Not only does this keep everyone on the same page, but also opens the door to further discussion and brainstor

dd to the challenges in developing combination products:

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

ming that can take your idea places you never imagined.

Define "Improvement" with Numbers

Ever seen an advertisement that makes claims similar to this one, "Our new formula is

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

33% better than the leading competitor's." Now imagine if the advertisement said, "Our new formula is a lot better than the leading competitor's."

Which is the stronger ad?

Though

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

obvious, we often use ambiguous measurements such as, "a lot better" instead of powerful alternatives that use hard numbers, "33% better".

If you can't express "improvement" with numb

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

ers, you are opening yourself up to two big problems:

Playing for the Wrong Team

The first, and worst, is the possibility of worsening the problem. When I redesigne

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

Professional from academic institutions, pharmaceutical industries, health care indust

d the website for a company I work for, the primary goal was to increase the number of leads we receive each day. If we had made the change without a measure for daily lead production

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

, how would we know if the change was for better or worse?

Robbing Yourself

Just like the formula that is "a lot better", your accomplishment, if not measured in nu

.

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

mbers, can rob you of the all the recognition your achievement deserves. Does your new car go fast, or does it go from 0 to 60 in 4.6 seconds?

Everyday we should strive

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

Companies that provide selfless information through particip

to, not simply change, but IMPROVE what we do. Just remember that change, no matter how well intended, can be dangerous. Just because you're moving, doesn't mean your moving forward

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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