Advice You - Business

How often has your organization spent months coming up with a business strategy, and paid a fortune to outside consultants for help, only to see the grand plans fizzle out over time? In most cases, attempts are made to retrofit activities performed throug

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

hout the year back to the strategy to feign adherence, until such time as it is completely abandoned. A couple of years pass and the process repeats. It’s classic fodder for the Dilbert comic strip. How does one over come this all too common occurrence?

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

Examples of combination products may in

Below are some tips on how to approach a strategy and execute it successfully.

Developing Strategies and Goals

Keep it Simple and Make It Quick - If it takes 6 months to come up with a strategy, there’s a problem. Either it is not a prior

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

ity, or you are getting too carried away. Set a goal to have the planning completed in one month. After all, this is serious business right? It’s crucial to the success of your organization, so timely completion is very important. The strategy should n

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

t be complicated. It should be easily understood by all stakeholders.

Make It a Priority - In order to complete this type of activity quickly, upper management must make it a priority to design and implement the plans. There can be no excuses for

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

Combination pro

not completing it. Being “busy” is not an excuse. There must be full preparation and participation in meetings. Realistic deadlines are set and honored. Those who don’t play along must be held accountable.

Look to the Inside - Resist the urge

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

to call on the consultants. Your people don’t have time, right? Problem is, it will take as much of their time to meet with the consultants as it would to come up with the plan on their own. You also want the expert opinion. In most cases, though, your

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

personnel know what needs to be done. They just need the opportunity to put their ideas forward. This gives them a vested interest in succeeding, and does not allow the outside consulting firm to be made the scapegoat. All too often consultants tell you

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

what you already know anyway, or they set you up with the trendy strategy of the day. If you’ve really lost your way, outside consultants might be the answer. In most cases, though, the money is better spent on implementation of the plan.

Walk the T

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

lk – If a strategic initiative is contradictory, you’ll need to eliminate it. For example, if one of your tasks to grow your business is to establish an employee referral program, you need to make sure that the workers like their jobs. If they don’t

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

they won’t be very willing to recommend the organization to others. Spend time addressing the morale problem prior to executing the referral program.

Communicate Early and Often – Explain to all stakeholders the reason for re-setting strategy. B

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

Following aspects would a

e honest. Nothing turns employees off more than hidden agendas: “Oh, a new strategy. How many people will be laid off this time?” Explain the importance. Lay out the expectations with time frames, etc. Explain why it is important for everyone to part

dd to the challenges in developing combination products:

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

cipate and let them know what their roles will be. Follow up frequently with updates.

Set Realistic Goals – Set realistic and measurable goals for each strategy. Again, don’t get carried away.

Developing Initiatives/Tactics and Delivering
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
>

Ask the Employees - Once the strategy is set, let the employees help with the initiatives and the actions that support them. This gives them a sense of ownership. They are the closest to the ground so they know what will make the clients happy;
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
make themselves more productive, etc.

Again, Keep it Simple – One of the main reasons implementation fails is that the plans are unrealistic. There are so many things to get done. Many efforts start, but none complete. To avoid this, pick just o
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
e initiative. How do you choose? Don’t pick one that is most easily measured, or that is easiest to achieve. Rather, pick the one that will have the most positive impact on the organization. If a project will take months to complete, break it into meas
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
urable phases that take no longer than one month to finish.

Put a Plan in Place and Execute with a Vengeance – Put a plan in place for the one initiative and complete it by the stated due date come hell or high water. Once completed, pick one or t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o more and repeat. This process of taking little bites builds up a sense of accomplishment and success, and gradually major progress is made toward the achievement of the strategy.

Communicate, Communicate, Communicate – Review the plan in team me
.

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
etings. Send out e-mail updates. This indicates the importance of the projects and highlights progress and success.

Stay involved Big Shots - Upper management must remain involved. They can’t bail out after the strategy is set. They must be act
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
vely engaged throughout.

It’s a lot of effort to come up with a good strategy. It’s an even larger effort to implement a plan to achieve it. By following the above suggestions, you will be well on your way toward achieving a successful strategic program

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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Advice You - Strategic Planning Done Right: Tips to Develop Strategies and Deliver Results

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