Advice You - Business

Every company needs a sound and robust business model that scales as life changes. Many small businesses start with a business plan based on guesses. Th

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

en as life rolls on, there is never time to update it to reflect your evolving situation. When your accountant nags you, you just feel bad. And your ban

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

Examples of combination products may in

manager makes a new business plan a condition for any money discussions so you rush into guessing again.

Be succinct and clear

In my experienc

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

e, a well-written Business Plan will earn you money! For small businesses, it can be two sides of A4 – in fact the briefer the better. Four quest

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

ons need to honest answers:

Do you tell a clear story in simple business terms?
Do you show where extra investment (of

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

Combination pro

money or effort) will lead to increased returns?

Do you show where unique value is added for your customers?

Do you explore h

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

w you expect to maintain your competitive edge even as your market changes?

Stay flexible and client-centred

You need to consi

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

der Scale, Scope and Structure, aligning them with your long term Mission and current Business Plan.

Your mission is simply 'Wh

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

are you running the business?' State your clientele, the needs you satisfy with products/ services and your unique approach. A strap line of 15 wor

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

ds is ideal.

Your scale describes your team – whether you employ them, associate with them or do sub-contracting.

Your scope outlines th

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

clients you want to work for and your key products and services.

Your structure defines how you sell to clients, the experience and skills need

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

Following aspects would a

ed for purchasing, production and delivery and how you manage your cash flow. Being small, you are unlikely to have departments but you will have indivi

dd to the challenges in developing combination products:

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

uals following processes within a team.

Please remember that organising your firm is an exercise in frustration. (Sorry I am not joking!):

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

Time and market events overtake even the best organisation - so design in flexibility ready for when you need it.

Unintended conseq

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

ences grow with time – so keep watching for the unexpected. Set up triggers to flag possible issues, agree who monitors each flag and make the mo

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

st interested person responsible for fixes.

Make/ buy decisions always trade-off costs against co-ordination – so monitor how your suppliers a

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

Professional from academic institutions, pharmaceutical industries, health care indust

d associates effect ‘internal’ costs of quality control, communication and re-work. Be prepared with a ‘plan B’ and re-take these decisions at le

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

ast once a year to keep people on their toes.

Understand the balance points in your business. But only re-organise once in three years – even

.

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

small changes take several months to work through a business.

Look for results

If you will accept advice, you should pencil

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

Companies that provide selfless information through particip

comments on your Business Plan monthly and re-write it yearly. As you keep your business plan focused on the needs of your clients, you will thrive

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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Advice You - Profitable Business Planning: How Do You Organise Your Small Business For Profit

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