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While I’m not prone to stereotyping, it has been my experience that there are generally two types of people: those that don’t know what they don’t know and those that do, in fact, know what they don’t kn

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

ow. All other things being equal the difference between the two groups boils down to experience and discernment.

Those people who don’t know what they don’t know typically tend to be either younger prof

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

Examples of combination products may in

ssionals beginning their careers who have a lack of experience, or older professionals who have not gained wisdom and maturity as they have progressed along their career path.

The Early Stage Profession

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

al:
On the positive side of the equation young, inexperienced and energetic professionals sometimes accomplish great things because they don’t have the experience to know what they are not supposed

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

o be able to accomplish and as a result sometimes appear to achieve the impossible. However more often than not young professionals operating outside of experience and/or educational boundaries are met w

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

Combination pro

th failure and frustration by having what appear to be great ideas eventually unwound by unforeseen factors that only were unforeseen to them do to their inexperience or lack of discernment.

The failure

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

s and setbacks of the early stage professional can be healthy learning experiences that lead to professional maturation so long as learning actually takes place and mistakes of naivet? don’t become patte

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

ns for future disruption. It is essential that young professionals gain an understanding of where their skill sets and competencies begin and end. Once the boundaries of knowledge are understood then def

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

nitive steps can be taken to create a plan for personal and professional growth. The decision can be made to ignore weakness by design by playing to your strengths or you can choose to improve weak areas

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

by closing the gap between where you are and where you want or need to be.

The Tenured Professional:
Regrettably it takes more than time on the job to reach true professional maturity. I have pers

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

nally witnessed people 20+ years into their careers that have reached executive level positions and they still don’t know what they don’t know. It is all too common for these types of people to operate i

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

Following aspects would a

a vacuum by believing that their experience alone is a cure-all for any issue or problem.

How many times have we all observed an experienced person with subject matter expertise in one area try to driv

dd to the challenges in developing combination products:

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

e an initiative or an agenda in another area only to fail miserably because they didn’t know what they didn’t know? Let’s look at this issue another way…how many times have you seen an older and more exp

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

rienced person fail to solve a problem that a younger and less experienced person solved with seemingly little effort? While experience is a valuable commodity, in and of itself and to the exclusion of o

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

her traits and characteristics, the sole reliance on experience can be a barrier to professional growth and maturity.

That being said, I have never been a believer in the adage “you can’t teach an old 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

og new tricks.” In fact quite to the contrary, I believe anyone (yes I mean anyone) can change given one prerequisite; the desire to do so…However in that vein I feel just a strongly that change cannot b

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

Professional from academic institutions, pharmaceutical industries, health care indust

forced upon someone who does not recognize the need for change, or even worse, recognizes the need but has no desire for change.

Whether young or old, experienced or inexperienced, the best way to appr

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

ach personal and professional development is to always stay in the learning zone. When you think you have all the answers is when you are headed straight for the proverbial brick wall. Always seek out pe

.

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

ople who know more than you do and actively learn from them. Find a mentor or coach who can dispassionately point out your shortcomings and help you chart a path to progress. Most things in life happen a

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

Companies that provide selfless information through particip

a result of choices we make and you can make the choice to gain an understanding of what it is that you don’t know and determine what you want to do with that information. It’s your choice…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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