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I recently received a most interesting phone call. When I answered the phone, I immediately recognized the name of the company as one of the most visible distributors in the construction supply industry, headquartered i

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

n a city about two hours from my office. The owner described how this seemingly invincible 75-year-old firm had very little to show for all those years except their good name. In fact, over the past five years, their 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

les had deteriorated by over one third.

The owner cited two major factors that he believed to be the cause: 1. A strong national distributor had opened in his market. 2. A near depression was looming over the communit

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

y due to the closure of a large military base.

I asked the owner to allow me to interview and test each of his key employees and also interview several customers. The owner also agreed to send me the company’s financi

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

l statements from the past five years.

The results should be a warning to every business: management apathy will kill a business.

From the psychological tests we administered, we learned that the organization was not

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

Combination pro

alanced. Inertia had set in. There was no spark, no innovation. No one was initiating change. The employees were good people with excellent product knowledge and years of experience. The problem was that they were

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

merely going through the same motions year after year, expecting different results.

The financial statements revealed that over the past five years operating expenses had steadily increased while sales and gross margin

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

had slowly declined, producing a lot of red ink. Employee interviews revealed that not one of them had a clue that the company was in trouble. Management kept profitability a secret unto itself. Everyone was working

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

ard, but no one was doing any long term thinking or planning or keeping score.

The core problem was that for years management had given raises averaging 4% to 5% regardless of performance. Gross profit didn’t keep pac

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

e, so the bottom line slowly eroded.

The salespeople had noticed that they had lost a few accounts here and there, but had spent no time on a game plan to replace them.

The operations manager realized that overtime ha

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

become a problem, but limits were never set.

The buyer was achieving around five inventory turns and thought that this was a pretty good job for a business doing almost $60 million in sales.

The customer interviews r

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

Following aspects would a

vealed that our client did have a great reputation for quality and service, but most of the customers who weren’t regular customers hadn’t seen one of this company’s sales reps in years. To make a long story short, the

dd to the challenges in developing combination products:

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

sales force was in a rut, calling on the same customers year after year. The sales force could be described as “content.”

Could a similar scenario occur in your company? By putting basic management principles in pla

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

e now, any company can avoid this kind of catastrophe. Just don’t wait until you are in serious trouble to begin.

The most profitable companies I work with have a leader at the helm. All companies have managers in pl

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

ce, but only the most progressive have placed an emphasis on leadership. While leaders are also managers, they do more than what I call directing traffic. By merely telling their people what to do, the leaders don't 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

evelope the critical thinking skills necessary to determine why their organization is not performing to high standards.

For example, if your sales force has not produced sufficient sales for your company to keep up wit

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

Professional from academic institutions, pharmaceutical industries, health care indust

the growth in your market; that is, your company is losing market share to the competition, critical thinking skills are necessary to determine why this is the case.

It is often the case that owners and managers are s

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

close to the business that they can no longer observe it objectively. They are so much a part of the “day to day” that they can’t step back and see the business analytically. If this is the case with you as an owner

.

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

or manager, it would be wise to either retain an industry consultant or invite a fellow owner or manager whom you respect to take a critical look at your business and make proactive recommendations.

Executive success i

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

Companies that provide selfless information through particip

measured by a leader’s ability to achieve an optimal level of profitability in good times and in times of slower business activity. Don’t allow management apathy to rob you and your business of the success it deserves

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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The need for wildlife officers and the successes they have had in their history.

There are hundreds of varieties of Consultants these days. We can find Consultants to take care of our diets, our physical well being, our mental well being, and pretty much anything you can imagine when it comes to business. The story below might just indicate that we take ourselves a little too seriously sometimes.

Do your employees behave toward your customers the way you would expect them to? Getting your employees aligned with your brand will empower them to make continuous improvements that will benefit your company as it strives to deliver that unique and best-in-class customer experience.

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