Useful Advices - Business

My husband and I were enjoying our dinner meal one evening while discussing various plans and ideas. I was sharing that I wanted to submit articles and ads to a huge number of ezin

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

es to market my eProgram in a big way, and I wanted his help to make this happen. His response stopped me in my tracks, "Can your systems handle the increased demand?"

I know that

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

Examples of combination products may in

my online systems and processes are capable of handling significant transaction volumes daily - but there are still a couple manual processes that are not as smooth as they could

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

be and at times they may not create the very best experience. With the current demand, I can tolerate these manual processes and easily get by, but the additional demand that I exp

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

ect from my marketing efforts will make these tolerations intolerable very quickly. If I had moved forward without changing and extending my systems first, I would have risked some

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

Combination pro

very important things - my new customers' loyalty and my sanity!

It seems like I am frequently in this push-pull situation. The need to establish the right system setup conflicts

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

with going after the opportunities. With my strategic sense, I can see several steps ahead. I often get really excited about those steps and I'm eager jump ahead before it's time.

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

I see this as a challenge for both large and small businesses alike. I believe the successful ones plan their operations and implement the correct systems to properly manage the

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

increased demand loads. The key is to take strategic steady steps forward - you need to learn to walk before you run. All businesses need a solid foundation or platform of business

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

operations so they are able to easily handle increased business needs and growth while serving the customers well. This is fundamental. Otherwise, the business owner may easily be

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

come overwhelmed.

The Top Ten Qualities that Allow Business Operations to Grow Easily:

1. Scalable - Operations are scalable, easily handling exponential, sudden demand.

2. Desi

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

Following aspects would a

gned to create great customer experiences (while meeting business needs) - Operations provide a consistent, repeatable level of service that caters to the customer each and every t

dd to the challenges in developing combination products:

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

ime.

3. Flow through - Efficient operations allow all transactions to flow through the business effortlessly, with minimal manual effort or intervention where manual effort only o

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

ccurring when it makes good strategic sense.

4. Professional looking - Operations help you present a professional face to the customer at all times.

5. Simple - The processes are

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

simple and straightforward for both you and your customers. They are simple to use, simple to maintain and simple to execute. Everything is done quickly and efficiently.

6. Teste

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

d - Operational processes are tested and produce repeated successful results.

7. Backed up - Operational systems are always backed up and the back up is also backed up.

8. Docume

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

Professional from academic institutions, pharmaceutical industries, health care indust

nted - All processes are documented, including customers' experiences as well as team members' roles and objectives.

9. Understood - The whole team knows and understands the opera

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

ting procedures and suggests ongoing improvements.

10. Improved Upon - Improvements are proactively discovered through the conscientious observation of the customer's experiences

.

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

as well as though direct customer feedback. Adjustments to improve the customer's experience are incorporated quickly and with easily.

I believe that these ten qualities can be ap

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

Companies that provide selfless information through particip

plied to any operation - at work or at home. Examples at home include, but are not limited to, meal preparation, house maintenance and bill paying.

Copyright 2004 Donna P. Lendzyk

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 - The Top Ten Qualities that Allow Business Operations to Grow Easily

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