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Jack Welch, former chief executive of General Electric Corp., said “Good business leaders create a vision, articulate the vision, passionately own the vision, and relentlessly drive it to completion.” Why do so many new

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

business ventures start with such enthusiasm for a new idea, only to be stopped dead in their tracks a short while later? It may be convenient to assume the product or service is simply not a good match for the market.

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

Examples of combination products may in

That assumption would most likely prove to be just plain wrong.

You had a great idea for a new product or service and you started selling it to anyone you could find that would buy. Your business took off and one by

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

one you picked up a decent customer list. You thought you were successful in chasing your dream. Then after a couple of years you find yourself stalled. After all these months, you seem to have hit a wall.

No matter h

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

ow hard you work, you can’t seem to break through. How do you make this business grow? What happened? Many new business owners reach this stalled position believing they need to control every aspect of every activity

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

Combination pro

n their company. Over-controlling everything severely restricts any sense of empowerment from the team whom they depend on to execute.

Start with your attitude and the habits you adopt along the way. Adjust your attit

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

ude to separate you from your business vision, or dream. You [personally] are not your dream. You must become the steward of your business vision. You can then develop a more objective and balanced perspective on the

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

real potential for your business. That will help you assess the resources and expertise you need to make it happen.

If you keep tying yourself to the dream, you will constantly create limitations on what you are willin

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

g, or believe you are able, to do to pursue the dream. You will probably over-control it and constrain it from growing. Worse yet, the vision may overwhelm you as it expands in scope and size.

Develop a clear and obje

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

ctive vision for your business before you begin the strategic planning process. This work is essential and perhaps the most important work that you, as leader of the business, can do. With a clear vision, or statement

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

bout the future you want your business to create, you can confidently begin planning. Establish long term goals. Gain the commitment of key people inside and outside of your business. Plan the activities and deliverable

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

Following aspects would a

s and milestones needed to accomplish the plan. Estimate the revenues, costs, resources, time, and capital needed to accomplish your vision.

The planning process includes short term plans for the next 90 to 120 days tha

dd to the challenges in developing combination products:

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

t lead progress toward the long term. Having a clear vision allows each of these initiatives and the people you depend on to develop and execute plan to appropriately align with a common purpose. Following these steps

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

will dramatically reduce the complexity of your vision and clarifies for you how it can be accomplished. Better yet, it greatly increases the potential for you to achieve success.

Use the mantra, “big plans; little ste

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

ps” as a constant reminder of the need to stay focused and committed to your vision. At the same time, stay equally focused and committed to the planning process required to achieve it. Redo your vision and strategic p

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

anning process each year. Constantly adjust your business as market and competitive forces change. You and your team will be able to make sure every little step takes you just a little closer to the reality of your vis

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion.

You may succeed at directing and delegating the work required to accomplish your vision. However, the real key to successful execution comes from the words Jack Welch used, “… passionately own the vision, and rele

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

ntlessly drive it to completion.” Your employees and other team members will assess and frequently emulate your behavior, regardless of what you say.

Clearly communicate your vision for your company frequently and as d

.

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

irectly as possible to all team members. They will only commit to your vision and pursue it with a passion of their own if they see this passion and commitment in you first. Do not delegate this assignment and do not un

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

Companies that provide selfless information through particip

derestimate its importance. Take the big plans; little steps approach, and stay relentlessly focused on controlling the focus on your vision. Then you and your entire team can drive your vision to successful completion

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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