Useful Advices - Business

Senior Management must practise what they preach. The desire to implement lean m

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

ust be evident from the top of the organisation.

Select a charismatic project l

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

Examples of combination products may in

eader capable of binding together teams from a cross functional environment.

Se

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

lect an implementation team (3-5 people) to work with the project leader. Make s

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

re they are from different departments and are enthusiastic about lean.

Train t

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

Combination pro

he implementation team in the various lean tools and techniques.

Select the mos

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

t appropriate techniques for you company and then a prioritise their implementat

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

ion. Do not make the mistake if thinking you have to introduce as many as you ca

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

.

Brief the workforce. You must make sure you address the following issues:

a.

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

Why you are implementing lean?
b. How will it affect them?
c. What is

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

required of them?

Select a pilot area and a pilot project. I would suggest you

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

Following aspects would a

start with a lean tool which is fairly easy to introduce and will bear immediat

dd to the challenges in developing combination products:

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

results, something like 5S.

Run with the project in the pilot area for 2-3 mon

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

ths and learn from your mistakes before you gradually roll the project out to ot

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

her areas.

Once the first project is well underway in the business start to col

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

lect data for your second project. Start to involve the staff from the area wher

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

Professional from academic institutions, pharmaceutical industries, health care indust

the second project will be introduced to get their thoughts, concerns and ideas

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

.

Repeat the above steps as appropriate to introduce further lean tools & techn

.

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

iques.

For further information contact:

Paul Wilson

Axis Electronics Ltd

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

Companies that provide selfless information through particip

target="_new" href="http://www.aster-training.co.uk">www.aster-training.co.uk

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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Useful Advices - How to Implement Lean Manufacturing

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