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80% of successful businesses have strategic plans for their organization. Even then, Strategic Plans can be less effective, even become superfluous due to two significant errors that even large corporations may make. The fir

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

st is YOU, whether you are the owner, CEO or the Executive Team. The second is doing Check Ups on the plan after it’s implementation.

The absence of YOU in the process

It doesn’t matter whether this is for a one person comp

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

Examples of combination products may in

ny or for a large corporation. It doesn’t matter which Strategic Planning model that you use for your organization. YOU must be involved in ALL three stages of the Strategic Planning process.

The 3 stages are –
1. Knowl

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

edge gathering. This is where you determine what the vision of the organization is, in other words where you want it to go. You also look at your resources and the marketplace.
2. The actual Strategic Planning process.

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

his is where you determine HOW you’re going to get where you want to go, creating your own roadmap. During the process, it will be determined what resources you may need, etc. to achieve your goals.
3. Carrying out the

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

Combination pro

trategic Plan. OK. Now you have the plan in your hands. It’s time to launch.

Most organizations don’t wish to be bothered with the 2nd stage. They hire consultants to come in, interview (stage 1), disappear and then ta-da, y

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

our consultant returns with a 400 page strategic plan that THEY created that YOU need to carry out to get the results you said you wanted. Let’s face it; you’re not going to read that 400 page report, so they may give you a 2

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

page summary and a mind numbing PowerPoint presentation for you and your team.

So is this plan accurate?
Is this plan what you want to do?
Does this plan accurately reflect optimal use of your resources?
Do

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

you fully agree with the plan and what you’re expected to do?
Are you going to effectively carry out this plan?

The answer to all of these questions is…maybe, maybe not.

So what happened?

Stage 1, the knowledge gathe

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

ing stage, you’re involved. And then when it comes time to take that knowledge and use it to make the most effective path forward for your organization, what happened? You’re not there.

So put YOU in stage 2, the actual proc

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

ss. It may be you alone. It may be a team. But when done correctly, by putting YOU in stage 2, you develop a strategic plan that is not only for more accurate in it’s detail, but since YOU created it, when it comes time for s

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

Following aspects would a

tage 3, carrying out the plan, YOU and your team have bought into where you want to go and exactly what you need to do to get there. If in a team environment, going through the process allows the team to build stronger apprec

dd to the challenges in developing combination products:

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

ation for each other’s strengths and contributions, providing improved results throughout the organization.

CHECK UPS FOR YOUR PLAN

The second gaping pitfall for any Strategic Plan is after it’s been launched. The cheering

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

crowds have moved in, the band has been paid off, the balloons and streamers have been cleaned up. Chances are you’ll start out right on target.

But think of a road trip. You need to keep your hand on the steering wheel othe

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

wise the car will veer off the road. Same with the strategic plan. What happens when you hit a road block and now you have to turn in a different direction? You need to figure out how to get back on course!

This is what happ

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

ns with the best laid strategic plan. Stuff happens. Markets change. You lose a prime contributor. There are a million things that can occur that change the course of your plan. So you have two options.

The first is to throw

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

Professional from academic institutions, pharmaceutical industries, health care indust

the plan away and give up. Proof that it doesn’t work.

The second option is to periodically do a check up on the plan. Look at your measurable goals that you have and determine where you are now. If you aren’t where you pla

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

ned on being, why not? And then look at what you need to do to get back on track, just like that road trip detour, remap what you need to do to get back on plan. By periodically checking on how your plan is doing, you can s

.

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

tay on your path to reach the vision of where you want your organization to be and you can make those corrections long before they become too big to resolve and sabotage your plan.

Thinking strategically, by being fully invo

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

Companies that provide selfless information through particip

ved in the strategic planning process and by periodically checking up on the plan’s progress, you greatly enhance the prospect of your organization successfully achieving the vision that you desired when you began the process

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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Do you have an interest in the daily activities of the stock market? Do you understand or want to understand what makes the stocks of a company rise and fall? Do you have the diligence to continuously improve yourself in one particular field even if you believe you are one of the best at what you do? Do you have the heart to help your clientele reap the most out of a transaction? If your answers to all these questions are yes, then maybe you should try looking into the building a career as a stockbroker.

The owner of the company you work for probably had reservations and fears about starting their business but instead of being paralyzed by fear they stepped out on faith facing their fears while making their dreams come true.

Planning is the management of risk ... while there are no risks involved (yet), and while it is still safe to take action ... proactive action, that is! Planning is being able to recognize friends from foe ... before going into “business battle”. Planning is the dressed rehearsal before the premiere. Here is a “behind the scene” look at what the planning process is all about.

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