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Eight Principles for Purposeful Alignment

Effective teamwork requires individual members of the team to be connected by, and aligned to a common purpose, values and sense of identity. Sometimes individ

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

uals can drift away from the team as a result of the mental limitations they create about their work and role.

The following eight principles can be considered as a guide to the type of thinking and ac

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

Examples of combination products may in

ion that will serve you well in your interactions with your colleagues:

1. Success starts with clarity of purpose
Successful people, in whatever way you want to think about success, have a very s

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

rong sense of purpose. This applies as much to their life as it does to each endeavour they engage in. When thinking and acting become detached from purpose, decision-making may suffer, and this will im

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

act on you and the people you associate with.

2. Alignment transforms energy into effectiveness
Alignment here means the connection between Purpose, Identity, Values & Beliefs, Capability and Act

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

Combination pro

ion. If you put energy into actions that violate your values or your sense of identity, then you are unlikely to be effective. When all these things are aligned your energy will flow naturally and be tr

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

nsformed into effective results for you.

3. Respect is the beginning of understanding
At school and university we consolidate learning into understanding through debate and discussion; supporting

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

ur ideas, often vehemently. To truly begin understanding, it is more useful to let go of our strongly held views, and develop a respect for other people and their ideas. In this way we not only understa

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

d better, we also lay the foundation for improved learning, sharing and influencing.

4. Curiosity is the beginning of all difference
Having developed respect, we can now start to become curious.

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

Having a thirst for knowledge is one thing, but if that thirst contains prejudice or is seeking certain answers, it is unlikely to lead to behavioural change. Pure curiosity wants to discover things tha

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

are outside of our current ways of thinking about the world, and in this way we can create difference for ourselves and life becomes richer as a result.

5. Flexibility is the beginning of freedom

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

Following aspects would a

When we come across other people who have ways of thinking and acting that are different from our own, we have a choice; we can ignore the difference and keep well within our own tried and tested groov

dd to the challenges in developing combination products:

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

s; we can pretend to go along with it on the surface; or we can work with it and find ways in which it can make us a richer person. The more flexible we are to accept the world as it is and develop resp

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

ectful and subtle ways of influencing, the less we will be tied to the chains of our personal, small, perfect world.

6. Education is the key to releasing potential
To ‘educe’ is to evolve or deve

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

op potential. This implies that answers lie within. When you approach others with this principle in mind you will be recognized as someone who has conquered their ego, rather than someone who wants to 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

ll people how they have tamed the world. By developing the skills of coaching it is possible to draw the best from people whilst respecting their needs. The opposite of this is to ‘pour in’ your own ide

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

Professional from academic institutions, pharmaceutical industries, health care indust

s and attitudes like a petrol pump, but when the tank is full it can hold no more; and when the tank is empty it must return to be re-filled.

7. None of us is as smart as all of us
To push your ow

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

n ideas as ‘the best solution’ even when you are the most experienced, is to ignore the creativity and insight that comes from collective input. An idea or solution in isolation may remain an island whe

.

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

e few people want to visit.

8. Be thorough and unrelenting with issues
To notice something that is incongruent with the environment and ignore it is like finding a mine and leaving it covered up.

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

Companies that provide selfless information through particip

Sooner or later it will explode and there will be casualties. A dangerous action or a violated value has power to maim physically, mentally and emotionally. Are you going to let it pass, or deal with it

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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