Advice You - Business

Decisions - especially ones made in rapidly changing, uncertain business environments - demand a balance of intuition and logic. Malcolm Gladwell in his book Blink referred to it as thin slicing... the art and science of thinking witho

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

ut thinking.

In also demands a level of attunement and trust in your inner voice that calls for a pretty high level of self-awareness. Without that the signals come and go and you are left standing still.

Why bother? It is too easy for soft skills to

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

Examples of combination products may in

be dismissed as too much woo-woo. Judgment of that nature indicates that the dots just are just not being connected.

In decision-making and in ethics, self-awareness is the foundation for seeing the context with the widest and clearest lens possible, t

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

he underlying forces impacting direction, the web of people who are affected, and the dynamic in its entirety. For someone with a high level of awareness, the map is before them at all times.

Areas of power and turf overlaps are clear and recognized al

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

ng with what is driving the division. Reality has a sharper and clearer focus. The invisible forces that drive temptation no longer escape detection. You know when you are leading yourself into temptation and you know there are alternatives to choose fr

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

Combination pro

om. You are not immune to making mistakes; you know why you made them. This is learning that can be applied and it is much less painful than repeating the same mistakes over and over again.

Ethical breaches demonstrated by Enron, WorldCom are bigger, m

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

ore complex examples of the same kind of behaviour seen when CEO's or executives deceive boards on uncomfortable truths. In The Five Temptations of a CEO Patrick Lencioni named "the desire to protect the status of career, the desire to be popul

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

ar, the need to achieve certainty - make correct decisions, the desire for harmony and the desire for invulnerability" as the pit traps for executive success. You will note that every single one of them is also a pit trap for ethical breaches.

Clearly

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

here is more to resolving the situation than just becoming more aware. Systems, procedures and totally outmoded business models hold a part of the responsibility. Obviously these can not be addressed until they are seen, noticed and the connection to re

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

sults has been made.

Personally and professionally, it starts with awareness. Awareness is the information-gathering stage, and it typically begins when you notice something is seriously wrong with the picture-either within you or in the environment. O

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

nce you notice, you simultaneously open a window to question and understand. Questions reveal understanding and understanding brings clarity. Clarity is looking through the window defogged by assumption, desire, or need.

In gray zones, the advantage of

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

Following aspects would a

being aware is even more magnified. Shades of gray can often have ethical and moral implications that you really want to know about. Not knowing about them can put you in the headlines or in jail. Without awareness, without being able to see what put y

dd to the challenges in developing combination products:

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

u close to the delicate line, you cannot see the line; much less know when you are standing on it.

So what gets in the way of this clear-seeing awareness? The following:

Ego: The need to feel separate from others. Your entire self-identity is

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

based on who you are in relation to others.

Misuse of Power: The desire to use the power of your position to serve yourself.

Righteousness: The need to be right all the time; rigidity.

Judgment: Too much judgment makes learnin

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

g a risk-taking venture, and vulnerability a personal-safety issue rather than a springboard for strength.

Unconsciousness: Walking around in a fog, being unaware of what is going on around you.

Closed-mindedness: Not being receptive t

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

o information that informs who you are in that moment-and not wanting to know. Dr. Charles Ehin in an article in Baseline named seven indicators signalling when an executive is out of touch. All of them source back to self-awareness.

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

Professional from academic institutions, pharmaceutical industries, health care indust

he indicators include being clear on the personal lenses and filters used to navigate life, reliance on tried and true principles that ignore the current reality, the degree to which you rely on doing what has worked before without noticing it is not an

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

ymore, and the inability to be aware of when change has happened. You can not change what you can not see.

Most of the indicators named, refer to the personal and professional need for validation from outside of themselves, rather than an intrinsic sen

.

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

se of security, identity and emotional self-knowledge.

Simple steps help shift self-awareness to higher levels. Asking yourself or noticing:

Where do I need to have control? Why?
What situations bring out an unexpected reaction from m

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

Companies that provide selfless information through particip

e? What is at the source of that reaction?

Did I say that out loud? Where did that come from?

As you gain clarity, you will see when the cultural or social context is driving your personal integrity or whether you are holding the wheel

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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