Advice You - Business

What would it take to make your business fail? What conditions could precipitate and sustain “the spiral of death”? What would complete financial collapse really look like? If your primary competitor acquired the firm, where would the

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

y strip out expenses, and what assets would they covet? These are grisly questions to consider, but sometimes we need to envision complete breakdown and failure to understand how to prevent it, and find the next level of success.

Env

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

Examples of combination products may in

sioning the failure of your organization is not a pleasant exercise, in fact it can be downright scary. In life, and in business, none of us like to think about potential failure, let alone describe it in gory detail and wallow in it.

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

Yet, in a controlled environment, it will be one of the most useful and enlightening discussions a management team will ever have. Creating a vision of failure will force management to:
· Critically understand, challenge and test

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

the assumptions that your strategy is built on. · Look at the business as an objective third party might.
· Discover remarkable clarity about weaknesses, gaps, and opportunities.
· Put traditional risk assessment into a bro

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

Combination pro

der and more useful context.
· Be truly innovative to find new sources of growth and strength.
· Learn to recognize potential warning signs of real failure, before it is too late.
· Align their thinking on key issues th

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

t usually remains unspoken.

The exercise is straightforward. We've all been through workshops, and strategic off-sites to create a vision of the future, and a strategy to get there. In its traditional form, a typical vision state

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

ent spells out where you want to be, and what the company looks like at a point in time in the future. In essence, the traditional vision statement is a snapshot of the desired future state of the company.

Rather than create a vision

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

of a desired future state, envision varying degrees of business failure, and what events, inside and outside of your control might contribute. A few pointers for success:
· Keep the session secret. The very notion can be alarming

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

and distracting to employees. Without the proper context, shareholders, customers, and competitors will draw their own conclusions.
· Keep the results secret. The output from the session is an articulation of your flaws and weakn

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

sses, and could be dangerous in the wrong hands.
· Use a consultant that is experienced with similar exercises. This exercise can get badly off-track if not handled expertly.
· Be prepared to act on what you learn. If you wo

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

Following aspects would a

't take steps to change based on the results, then don't bother with the exercise.
· Be as open and objective as possible. This is not a session for management to air their pet peeves, and bemoan everything that is bad about the

dd to the challenges in developing combination products:

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

company.
· Ensure the work is sponsored and fully supported by the CEO or division leader.

Careful preparation and follow up are as important as the session itself. After the session, you should have a solid statement of jus

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

how bad things could go wrong. Like a traditional vision statement, a vision of failure will be more useful and practical if it is strategic, but specific. Choose a planning horizon 3-5 years out to keep the discussion grounded. Make

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

sure the potential failure points are measurable, so everyone is clear. Just hope you never see those measures of failure in your business, and don't post the new vision on your website!

As with traditional strategic planning, once y

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

u have your vision of the future, you need a plan. The output of the exercise should include well defined actions with clear timelines and accountabilities for members of the management team.

There are crucial side-benefits to envisi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ning failure. After you go through this exercise your management team, you'll find that in your usual forums, negativity creeps into the conversation a lot less often. Like facing any fears, envisioning failure helps to remove some of

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

the mystery, and makes it easier to face. When negativity does surface, the team will look at it more thoughtfully, critically, and usually with less detriment to your real agenda.

Talk to anyone that has been deeply and personally i

.

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

volved in a real business failure, and they will likely tell you that things became very clear near the end. There is nothing like winding down a business after catastrophic failure to help you step back and really understand the big

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

Companies that provide selfless information through particip

icture with remarkable clarity. Like a failed marriage, it's often easier to see where things started to go off track, when it is too late to do anything about it.

This work is not for the faint of heart, but the results are powerful

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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Mothers have the same opportunity with fathers. All they have to do is to form a group focusing on the system of cooperation. Together they could come up with a better idea with a better idea on how to become productive not only as an employee of the industry, but productive and supportive mother to her family and the community as a whole.

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