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CEO…Boy that title sounds good doesn’t it? OK, so you founded the company but does that mean you should also be the CEO? Did you bestow the title upon yourself simply because you had the authority to do so, or are you the right person for the job? Perhaps you were the r

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

ight person for the job initially, but has the company outgrown your management ability? Can you, or should you, as the founder attempt to grow with the company? What does a CEO really do anyway? In today’s blog post I’ll assess what it takes to be an effective CEO and

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

Examples of combination products may in

you can decide for yourself if you have what it takes to get the job done.

Sure, it’s your business, your idea, your net worth at risk and certainly nobody else will work as hard as you will, but is this really the right way to evaluate who should be the chief executiv

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

e? The answer is no it’s not…however this is often times exactly how the decision is made. While entrepreneurs are clearly talented innovators and visionaries, most don’t have prior experience as a CEO.

Over the years I have come across many self-appointed CEOs that ca

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

n’t read a balance sheet, don’t understand capital formation or financial engineering, have poor communication skills, have never built a sales force, authored a business plan or lack any number of other requisite operational abilities. I’m not suggesting that all entre

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

Combination pro

preneurs are incapable of being chief executives, but I am suggesting that you stop and make an honest assessment of whether you are doing the job because you’re the most qualified or just because you don’t know what you don’t know…

Before I start breaking this down le

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 me disclaim that a post of this nature works off generalizations and stereotypes, and that there are clearly exceptions to every rule. I have known many entrepreneurs that are exceptional CEO’s, but I have known many more that don’t measure-up and shouldn’t be fulfill

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

ing the role of CEO. I’m not making any judgments or pointing any fingers, but readers of this post will know which camp they fall into.

It is the nature of the beast that most entrepreneurs are a disruptive force within a company. A VC friend of mine refers to most en

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

trepreneurs as practicing “seagull management” in that they fly in, flap their wings, crap all over everything and fly back out…Many entrepreneurs desire to have input on everything yet don’t want anything to do with the details and don’t possess the skill sets to add v

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

alue to the initiatives they want to control. This type of behavior is proof certain that the entrepreneur is not being effective at leading, team building, delegation, leveraging process and a variety of other best practices for CEOs.

Let’s begin by determining what i

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

t is that a CEO does…First and foremost it is the CEO’s job to provide leadership based upon a clearly articulated vision and a well defined strategy. Priority number two is team building and talent management. One of the main keys to generating organizational leverage

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

Following aspects would a

is for chief executives to know when, where and why to deploy (or redeploy) talent and resources. It has been my experience that it is much easier to recruit talent or acquire resources than it is to properly deploy talent and allocate resources.

Jack Welch the former

dd to the challenges in developing combination products:

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

head of GE built a reputation as one of the great chief executives of this era. When asked how he transformed a lack-luster, institutional, global corporate giant into a dynamic culture focused on innovation and growth, Welch responded by saying; “My job is to put the b

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

est people on the biggest opportunities and the best allocation of dollars in the right places. That’s about it. Transfer ideas and allocate resources and get out of the way.” Welch clearly not only understood the concept of organizational leverage through proper deploy

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

ment of talent and resources…He mastered it.

I’ve heard it said that the role of a leader is to create and manage good followers. While there is an element of truth in that statement if this is what you aspire to as a leader it constitutes a complete underutilization 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

f leadership responsibility. I believe great leaders will mentor and coach subordinates for the purpose of identifying and developing other great leaders.

To achieve maximum success I believe it is incumbent upon an entrepreneur to take an honest inventory of his/her s

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

Professional from academic institutions, pharmaceutical industries, health care indust

kill sets and competencies, and contrast them with the needs of the enterprise as it relates to what is best needed to efficiently and effectively lead the company forward. If your skill sets are best suited for business development, product development, finance or othe

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

r areas you may want to consider playing to your strengths by taking a senior position in the area of your subject matter expertise and hiring the best chief executive you can find to lead the company.

Surrendering the chief executive role doesn’t mean that you must gi

.

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

ve-up financial control or lose the ability to have input on decisioning, but it does mean that you’ll have to trust in, collaborate with and delegate to someone who has the necessary domain expertise to get the job done.

For those not willing to bring in professional

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

Companies that provide selfless information through particip

executive talent I would strongly advise that you at least hire a CEO coach to help develop your executive skills and advise you in areas outside of your competency. At the end of the day the choice of who occupies the chief executive role is yours to make…choose wisely

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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Have you ever met a fairly smart person and then watch their activities in business and just wanted to puke? It certainly gives entrepreneurship a bad name. Indeed, it makes me sick to my stomach. Why do they stoop so low? Well it appears that they do it because it works and that there is a sucker born every minute and rather than having a little integrity and ethics they simply get down to the lowest common denominator and take people’s money.

The best resource for a free sample sales letter or sales letter templates is in your own mail box nearly every day. Create a swipe file from these, and use them as a model of success.

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