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For you to get where you want to go, there are four key steps for you to take. They are not difficult, but they are vital.

Commonly known as the GROW model, the four stages are as follows:-

G stands for Goals

Being clear about whe

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

re you want to get to is absolutely critical. You MUST know where you are intending to get to, by identifying your goals and being very precise about them.

Use SMART goals - this is a useful description which is great to remember.

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

Examples of combination products may in

S - is for Specific

Be really clear about what it is you want

M - is for Measurable

There must be some sort of number of other measurable description of your goal

A – is for Actionable

You have to have some verb in the goa

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

l – you have to DO something!

R – is for Realistic

Make your goal achievable, but don’t be frightened to make it BIG!! T – is for Timebound

All of your great goals will fall by the wayside if you have no when about them – the ‘may

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

be I’ll start next week method’.

Poor Goal examples:-

To grow business revenue

To have happy employees

Great Goal examples

To build bottom line profit by 20% every year for the next three years

To have a 33% split between all re

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

Combination pro

enue streams within 2 years

You might also want to consider what ‘Purpose’ in your life there is for this goal, the more it fits what you truly want out of life, the more motivated you will be. Thus SMART(P)

R stands for Reality

B

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

e brutally honest about where you are starting from and what has held you back in the past.

Take a half hour to understand the assets and skills you bring to the business. Get really clear on your qualities - and shortfalls!

Be realistic and hon

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

est – a good way is to just list all the positive attributes you have, such as patience, perseverance and focus.

Dispel any ‘I can’ts’ right now. You can and will. Reality means just that and no untrue negative beliefs you hold about yourself.

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

O stands for Options

Here is where the fun starts, if you let it. Really let your imagination go – blank sheet of paper and 10 minutes of uninterrupted time. For organisations, this may take longer – it may involve as many of your

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

people as possible – that’s OK! You write until you can’t think of any more ideas about how to make your goal come true.

After 10 minutes, or when you dry up – take a 10 minute break – and then think of ten more – you can do it!! In this phase,

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

ou are not judging, it is very important that you don’t think of any ‘can’ts’ or even thinking of any ‘how’s’ just let the ideas flow. There are loads more idea creating things you can choose.

W stands for ‘What’ and ‘When’

Check o

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

Following aspects would a

ut the ideas from above and choose five ‘quick wins’ and five longer term projects.

Make a decision to do the five quick wins within one week, starting today (you might be surprised to find you do them all today!). Then when finished do five more

dd to the challenges in developing combination products:

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

till all are completed (mind you, once you get into the swing of it, you’ll start uncovering a lot more!).

For the longer term ideas to achieve your goals, a sense check is important first. Will action (remember the ‘A’ in SMART) on this idea, d

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

eliver the outcome you really want towards your goal – or is it a nice to do, or even off track. For either of these be ruthless and ditch the ones that are off track. Get five focused ideas in place ready for Action.

Create a timeline from your

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

goal and working back from there, decided milestones on each of your five key ideas. Use say quarterly, monthly, or weekly reviews. Be decisive and flexible as the actions will go at different speeds. In some sort of visual planner, record whe

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

e you will be with each one of your actions towards your goal at the regular reviews you have. Some people prefer to have weekly ‘action steps’ in each project – even daily.

The key is to be able to say., ‘This week (Tuesday is my best day), I wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ll visit three new potential customers, as a step towards visiting 50 this year’. Put it in your diary, Outlook or whatever as if it is an appointment with yourself. Ring-fence that time as the most important thing you are going to do and it cann

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

ot be shifted. You will need to be disciplined – if you are, it will work.

The key here is to create actionable steps in bite-sized chunks which you believe you can do.

As someone once said (with apologies to elephant lovers), ‘You can only eat

.

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

an elephant one bite at a time!’

…and finally

Remember that in life and business, you personally have the choices to make. No-one else. It is your responsibility how you act and challenge yourself. Take the responsibility and give it a go. L

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

Companies that provide selfless information through particip

ife is not a dress rehearsal – Grasp the opportunities you have today and every day.

Further reading on the GROW model (should be available from libraries)"Coaching for Performance: Growing People, Performance and Purpose", Sir John Witmore

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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