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It is amazing how many executives, at one point or another, feel they have made bad hiring decisions. I'm not talking about hiring an executive who has fraudulently misrepresented their career accomplishments or capabilities either. I'm talking about hiring great executives with well substantiated track record of success that simply did

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

not work out in the present role they were recruited into.

How does this happen?

It happens quite simply as a result of human nature; we like to interact with and work around people we like. This typically leads to disastrous hiring decisions based on simply looking for executives that have the same or relevant industry experience who

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

Examples of combination products may in

have held similar scope & scale of responsibilities to the role you're trying to fill with whom you enjoy talking to and as a result like being around.

What typically precedes a bad hiring decision is:

Failure to define the - specific - measurable responsibilities of a role in detail.

Failure to define the - specific - mea

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

urable business objectives the role is expected to achieve.

Failure to define the business ROI associated with achieving the - specific - measurable business objectives the role is expected to achieve.

Failure to define the - specific - executive and functional skills and abilities required to achieve each objective.

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

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Failure to interview candidates for the presence of each - specific - skill and ability by forcing them to share - specific - examples of how they have successfully achieved similar objectives, or identifying that they leveraged the same requisite skill, ability and experience to drive a different objective.

Ultimately, enj

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

Combination pro

ying dynamic, intellectually stimulating or charismatic conversation with a candidate is irrelevant to making a solid hiring decision and combining this solely with the criteria that a candidate simply possesses relevant industry experience and successful track records in similar scope & scale of responsibility roles is insufficient crite

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

ria for making a good solid hiring decision.

Why is simply possessing a relevant positive track record of - experience - in similar scope & scale of responsibility roles insufficient criteria?

From a career perspective, your experience is simply - what - you have done. What you have done says absolutely nothing about - how - you got it

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

done (work methodology combined with skills & abilities employed). Two people can produce the same outcome through completely different methods, which effectively translates into each of those individuals having - the same experience. People produce outcomes, results, and achieve objectives by leveraging their skills and abilities. Exp

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

erience simply provides a context and/or relevant common sense when leveraging your skills and abilities (i.e., it is an either you have it or you don't "check in the box").

What someone has done isn't nearly as important as how they got it done. Experience doesn't necessarily translate in a leveragable way from job to job, or from 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

tive to objective, because the value of experience is context dependant. How someone achieves objectives is highly leveragable and translatable from job to job, and from objective to objective, because the value of how they produced results (work methodology combined with skills & abilities employed) is much less context dependant.

For

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

example, if you drop an executive with the experience of successfully growing a company's revenue from $30M to $70M in 3 years, does that mean the same executive will be able to accomplish the same objective is you drop them into a similar company in a similar industry? Absolutely not. If the objective at their former company required t

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

Following aspects would a

hem to leverage their ability to be a "roll up the sleeves hands-on" executive that leads by doing, and who can work with a team of inexperienced managers (i.e., effectively micro-manage them), and the latter company requires the executive to grow revenue from $30M to $70M in 3 years by leveraging a critical ability to "get work done thro

dd to the challenges in developing combination products:

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

gh others" by delegating tactical execution responsibility to experienced managers and leading them in a hands off manner (i.e., be a leader - not a manager), then this executive is potentially at risk of falling on their face in this new role while destroying any hi-performance experienced management team they may be inheriting walking i

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

nto the role. And the fact that you enjoy dynamic, intellectually stimulating or charismatic conversation during the interview process with the executive won't change the fact you hired a great executive into the wrong role. For that matter, this only gets more difficult when the executive you are interviewing is trying to convince you

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

ow perfect they are for the role as a result of having the acquired the exact same - experience - at their previous employer.

Making great hires is difficult. It requires a lot more input and effort than most executive hiring authorities and boards are aware of. It is paradoxical to consider how much effort and energy a company will pu

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

t into assessing their needs, creating evaluation criteria, and evaluating solutions when looking to invest over $100,000 in a capital equipment or software acquisition, and yet the same company will invest only a fraction of the same time and effort into assessing their needs, creating evaluation criteria, and evaluating executive candid

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

Professional from academic institutions, pharmaceutical industries, health care indust

tes to ultimately make a much more costly investment in a mission critical executive with the hopes an entire business function will product the results/ROI that in many cases drives the success or failure of the company.

Making great hires is straight forward, but requires the willingness to invest the effort in building the basis for m

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

aking an objective hiring decision. It is critical to anchor the process in bedrock by defining the specific measurable responsibilities, and business ROI associated with achieving the specific measurable business objectives the role is expected to achieve. Once you've done this, you can define the tools you need to achieve quantified b

.

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

siness objectives by defining the specific executive and functional skills and abilities required to achieve each objective. Now you have a blueprint for success and can interview candidates for the presence of each specific skill and ability by forcing them to share specific examples of how they have successfully achieved similar object

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

Companies that provide selfless information through particip

ives, or at least identifying they leveraged the same requisite skill, ability and experience to drive a different objective.

As a result of following an objective process you dramatically increase the possibility of making a well informed mission critical executive hiring decision that propels your business in the direction you intended

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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Ever heard of FACTA? Most of us would say “No”. Have you heard that you can get a free credit report? To that we would say, “Yes”. So you have heard of FACTA. But how does that affect me?

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One thing I have always learned in business is that when your competition is going down, they usually pull something dishonest or disreputable in the process. Further those who cannot compete cheat. But what amazes me is that most of the competition out there cannot think and therefore makes poor choices and linear decisions, which gives you the edge over them. I would like to talk with you briefly about how to; Out Think Your Competition!

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