Main Subject - Business

For professionals not involved in sales or front line service delivery it can sometimes feel like what you are doing is not add

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

ing value or your value is not recognised.

So how can you start to build credibility and really demonstrate the value you deli

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

Examples of combination products may in

ver to your organisation?

Get Clear On What You Are Here To Do

It might seem like a really obvious question but:

• What are

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

you here to do?

• Are you only interested in your area of expertise, say Finance, HR or Law?

• How interested are you in othe

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

r areas of the business?

• Do you want to train executives and managers on how to be more knowledgeable in your areas of exper

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

Combination pro

tise?

• What impact do you want to make?

Get Clear On The Benefits You Deliver

One of the key questions others outside of pr

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

ofessional support services function might ask is:

How is the business getting benefit from the significant amount of investme

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

nt in the professional support functions?

Could you list 10 benefits that your function will bring to the business? Within th

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

e 10 is there at least one benefit that is so compelling that managers will be eager to work with you?

Find Out What Your Clie

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

nts Want

When was the last time that you did some structured research to find out what your clients want? Being clear about w

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

hat they want allows you to respond to their needs and add value.

Create A Vision For Your Function

In his book The 7 Habits

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

Following aspects would a

of Highly Effective People, one of the habits Stephen Covey promotes is to Begin With The End In Mind. At a basic level this m

dd to the challenges in developing combination products:

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

eans what outcomes do you want. Develop and Implement an Action Plan To Take You Forward

Now that you are clear what you ar

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

e here to do, the difference you want to make, know what your clients want and the outcomes you want to achieve you can start t

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

hinking about how to create it. Document it in action plan with clearly defined deliverables.

Review, Refine and Adapt Your P

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

lan

Even with the best of intentions, you are not likely to get it 100% right immediately. Set up a process for getting feedb

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

Professional from academic institutions, pharmaceutical industries, health care indust

ack from the business on the changes you are making and the impact that they are having. Use the feedback process to adjust an

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

d revise your plans so that the whole focus is on continuous improvement.

Professional support functions have a tremendous amo

.

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

unt to offer businesses but will encounter resistance. Continuing to build the credibility of your function can transform func

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

Companies that provide selfless information through particip

tions from technically great specialists to essential business advisors who make outstanding contributions to business success.

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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