Advice You - Business

As a manager and leader, problem solving is a core part of your role. In a few instances you nee

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

d to solve the problem immediately, for example, when the fire alarm is ringing. In the vast maj

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

Examples of combination products may in

ority of cases you can however take a more structured approach.

So what are the key steps in eff

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

ective problem solving?

Clearly Identify the Problem

While this might seem like stating the obv

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

ous, managers can fall into the trap of starting to leap into action before they have got clarity

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

Combination pro

on what the problem is.

To avoid this take time to get clear and write down the problem.

Estab

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

lish the Facts

Getting a clear understanding of the facts is essential. This is particularly im

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

ortant when dealing with a staffing problem such as a breakdown in a relationship between colleag

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

ues. In these situations everyone will want to give you their views some of which might be factu

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

al or some which might be personal opinions. It is the facts that matter.

Identify Potential So

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

utions

The key at this stage is to identify possible solutions. Brainstorming or mind maps are

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

Following aspects would a

two excellent tools to use for identifying potential solutions. Adopt an anything is possible ap

dd to the challenges in developing combination products:

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

proach to the process and don’t start eliminating things at this stage.

Review and Refine Potent

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

ial Solutions

Go through all of the potential solutions and eliminate those that are clearly not

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

workable in this situation. Carry on this process until you have a short list of 3-5 solutions.

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

Weigh up the benefits and drawbacks of the 3-5 solutions.

Select a Solution

Decide on what sol

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

Professional from academic institutions, pharmaceutical industries, health care indust

ution you are going to adopt in this particular case.

Implement Solution

Once you have decided

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

n your solution put it into action as quickly as you can.

Review

Set up an appointment to revie

.

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

w success and identify learning points.

At the end of the day, problems will always arise that n

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

Companies that provide selfless information through particip

eed to be addressed. Make sure that you stand out from the crowd when it comes to problem solving

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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