Advice You - Business

As a career coach, workers reveal their souls to me. Not just clients, where the relationship requires and benefits from, deep personal exploration -- but complete strangers sen

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

d me emails, almost daily, about their work experience, their frustrations and dreams. Always, they ask, “What shall I do?”

More often than not, they tell me that they’ve been

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

Examples of combination products may in

working on a career shift for a long time – a year, or longer. And it’s clear that they have made little to no progress on their path.

Granted, career change does take a long 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.

ime…and people learn and grow in different ways. But to have worked for a year or two, and be no further ahead in terms of clarity suggests that, despite the yearning, career ch

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

nge may not be an important priority after all. In fact, I’m reminded of a framework put forth some years ago by coaching industry great (now-deceased), Thomas Leonard.

Thomas

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

Combination pro

drew the distinction between “wanting” and “being ready”. He described a scenario that we can all relate to personally, or because we know someone who fits the bill: many peopl

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 want -- a healthier body, or a new career, or to be a well-known author -- but few are ready to roll up their sleeves and do the work necessary to reach their goals. “Wanters

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

live in hope”, he explained. “The adrenalin rush comes from the dream, not the reality of their lives.”

Sad, but true. And while career change can be a cat’s cradle of variabl

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

s that provide near-endless excuses for non-achievement, all of the variables can be managed. For example, I encourage workers to ‘keep their day job’ to alleviate the financial

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

pressure that causes them to pick ‘any old job’.

I provide many approaches to managing fear.

I guide workers through the change process, step-by-step.

I provide a supportive

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

environment…and nudge clients gently forward.

But the variable that must be managed initially, and by the seeker alone, is the readiness factor – a willingness to take the bull

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

Following aspects would a

by the horns. Career change doesn’t happen in a vacuum. It requires action: soul-searching, testing and planning -- to name a few of the steps. And, it requires objective fee

dd to the challenges in developing combination products:

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

back from a mentor, friend or coach who is market-savvy and wise to the ways of career change.

Finally, it requires consistent focus. Under the best of circumstances, career ch

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

ange takes one to three years. Without consistent focus, it will simply fall through the cracks of your busy life.

For those who desire change, here’s how you can tell if you a

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

re living in hope:

1. You have talked about it for a long, long time – without measurable progress.

2. You’ve done a bit of soul-searching, but your ‘clues’ are too few, and pr

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

obably not specific enough.

3. You’ve done the soul-searching and refuse to pare down and prioritize the many interests you have.

4. You’ve read a book or two, but kept the pro

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

Professional from academic institutions, pharmaceutical industries, health care indust

ess in your head. You’re not “in play” – researching, testing, getting coached.

5. You dabble. Your quest for career change goes in fits and starts and generally takes a back

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

seat to other circumstances in your life.

Those who have completed the career change journey successfully know that, despite the challenges, it is the most rewarding outcome ima

.

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

ginable. For those, who are willing to do what it takes, let this be your wake-up call to action.

For those who are not willing to do the work, what’s my advice? Stop living i

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

Companies that provide selfless information through particip

n hope. Let go of the angst, the guilt, the frustration, for you are only chipping away at your sense of self. Find another dream that you can embrace fully and march out after

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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