Main Subject - Business

There's a great little article ('Business Lifeforms') on the back

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

pages of the UK's leading management magazine, Management Today each month. It's a spoof (at least I think it is!) about some fictitious key player in a fictitious organisation. For January, it's about Ken

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

Examples of combination products may in

, who's a 'Facilities Manager'.

Now Ken has seen it all and truly worked his way up from the bottom to the top. Until, that is, a couple of years ago when new MBA-armed suits took over and decide to slash K

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

en's department (until now, running very, very smoothly under Ken's watchful eye) and Ken himself. Of course it all goes pear-shaped and the top dog has to come grovelling back to Ken, offer him loads of mo

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

ney and a big car, basically to ensure that the toilets aren't 'backing up' any more!

This is in direct contrast to Michael Gerber, in his fascinating book The E-Myth Revisited. There he talks ab

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

Combination pro

out working 'on' the business and 'in' the business, making it clear that if you do too much of the grindstone not-my-expertise stuff yourself, you lose track of what you are really good at, and what you went into

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

business for.

In a past life, I too experienced challenging outsourcing. At one time I had a great little local cleaner who I trusted (he even opened the store up for me - hmmm, that was a long time ago!).

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

He did an excellent job and was on hand for emergencies. Then a new senior director decided to consolidate and outsource, for 'economy and consistency'. It was cheap - but the service was awful. Each time I got a

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

new 'centrally sourced' cleaning company, they came with great intentions for the first 3 months and then dribbled off (with our money!) until it became unsustainable and another 'excellent contractor' came along

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

.

The moment of truth for me, was when the director for one of these contractors, came along for the first time in a brand new ?60K Merc (and it's a few years ago now). Then I knew where my money would be g

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

oing. I went through 6 contractors in 5 years, even though my hands were tied by 'Head Office' contracts!

To solve this problem? There needs to be strong leadership at the start. Very clear standards requir

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

Following aspects would a

ed from outside contractors and severe penalties (yes, stop paying them even!) for under achievement. Corporate central contracts agreed there, but implemented and managed locally, leave a lot of space for waste.<

dd to the challenges in developing combination products:

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

br>
And yes, in a small business, don't even think of doing the bookkeeping yourself as soon as you can afford not to - do what you do best, value it and get on with creating the business you love, not like str

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

uggling Sarah in the book. But, get someone who you trust and who will deliver. Chris Barrow, of Million Dollar Coaching Practice fa

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

me, suggests that the very first thing anyone going into a consulting business should do, is get a PA. And that modern day evolution, a VA (virtual assistant) has made this a real, low cost possibility for

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

many.

Moral of the story?

If you are going to outsource, especially if your business is big enough, where it's not only the fashion, but it can have economic and logistic value, take the follo

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

Professional from academic institutions, pharmaceutical industries, health care indust

wing steps:-

Find the best on the market, not the cheapest.
Set the standards yourself, and don't take theirs.
Be very clear on expectations and outcomes if standards aren't met.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
i>Keep in very business-like, however much you like/know/are related to them.
Have clear timescales for regular review.
Have a named and senior contact in the organisation for whom there will be pain

.

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

if they lose the contract.

Keep contract length manageable.

If things start going wrong tackle them early, before too much money is wasted.

If 'Head Office' agrees the contract, don't chase y

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

Companies that provide selfless information through particip

our own tail over non-delivery - get someone from there down as soon as there is a problem - you have enough to do.

Don't get involved in the problems any local operatives might have - refer them back.

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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