Useful Advices - Business

When I ask audience members at my seminars and speeches “What is your biggest strategic planning problem right now?”, I inevitably hear the response “Implementati

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

on”. Without question, this is on of the biggest issues for any company trying to accomplish anything at a strategic level – execution seems to inevitably fall s

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

Examples of combination products may in

hort of our stated intentions. As one CEO put it, “We say we will do something, and get excited about it, but a month later, it’s forgotten as we move on to the

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

ext thing”. This is perhaps true even when attempting to implement non-strategic objectives – but it’s far worse with the strategic ones. Why? Because nothing

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

is more postponable than a strategic objective – until it’s too late to even think strategically. In addition, strategic objectives are much more likely to intro

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

Combination pro

duce powerful changes in your organization, and so they meet with far greater resistance than more operationally oriented objectives.

You can enhance your effect

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

veness at strategy implementation by the things you choose to do in your strategic planning process. There are three key areas where you can do this: 1. Implem

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

entation Planning, 2. Resource Allocation and 3. Implementation Monitoring. The approach we take to these three areas is quite different from the norm in strat

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

egic planning, and it yields superior results. According to Robert Half Associates, most companies achieve about 30% of the objectives they set for themselves in

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

a process like strategic planning. Using Simplified Strategic Planning, you should be able to achieve an average that is closer to 80%. It is the unusual way we

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

handle the three key implementation management steps that makes the difference.

First, in implementation planning, it is important to set objectives well. This

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

Following aspects would a

means using the SMART approach – objective must be specific, measurable, achievable, results stated in a timely way. In addition, you should make sure you set a

dd to the challenges in developing combination products:

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

reasonable number of objectives. We find many companies improve their execution effectiveness simply by limited the objectives they set in strategic planning. S

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

econdly, you need to write a good, clear action plan that is useful for directing and tracking the implementation of your objectives. The approach illustrated in

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

the Simplified Strategic Planning seminar and book is a robust way to assure this.

In resource allocation, we find that most organizations already pay a great d

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

al of attention to the money required for effective implementation. This is the first resource you should look at. Money is important, but it is usually less im

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

Professional from academic institutions, pharmaceutical industries, health care indust

portant in strategy implementation that time. Ironically, few companies devote even half as much attention to time as they devote to money.

Finally, monitoring

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

of strategy implementation is vital, even if it is sometimes difficult. This implies two important things. First, you must write your action plans to be monitor

.

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

ble – which means the steps should be stated as clear, finite actions which are clearly completed at some point, and also that each step needs a clearly stated st

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

Companies that provide selfless information through particip

art and completion date.

Assure that your team follows the recommendations in all three of these areas and you will find your execution will improve dramatically

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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Useful Advices - Execution and Executability

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