Advice Pool - Business

All small to mid-sized company owners want to know where their dollar is being spent when it comes to computer technology in thei

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

r organization. The challenge is for them to get the information they need to make the right purchasing decisions. ‘Tell me in En

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

Examples of combination products may in

lish why you think we need this technology in our company?’ That question goes through every company owner’s mind and mouth. Gett

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

ing the answer that makes sense to them is another story. How can the people in charge of your company understand what the value

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

s of specific technology if their computer support people cannot articulate why it is so important?

This guide will assist every

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

Combination pro

company owner in understanding how to communicate with your technical consultant so technical recommendations are applied, unders

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

tood and the full potential of technology is realized throughout the company. After all, your technical consultant wants you to a

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

preciate what they do. And you will not be able to appreciate it until you understand how it effectively applies to you.

Company

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

Objectives- Understanding your company objectives is not a one way street. This information cannot be kept with upper management.

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

Share it with your technical consultant. “Give a man a fish and you feed him for a day. Teach a man to fish and you feed him for

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

a lifetime.”

Big picture- Your technical consultant must understand how the company functions as a whole. They must understand t

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

Following aspects would a

e duties of the different departments. How else will the company be able to apply technology to the business’s everyday processes

dd to the challenges in developing combination products:

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

if those processes are never articulated?

Changing with the times- Just because a technical consultant has worked in an environ

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

ent for ‘a couple years’ does not automatically mean they are aware of changes to the intricacies of the company’s business funct

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

ons. Just like technology, business strategies change. It’s important to consistently keep them in the know when these changes oc

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

cur at the business level.

A picture is worth a thousand words- Tell you’re technical consultant to chart out why they recommend

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

Professional from academic institutions, pharmaceutical industries, health care indust

a specific technology. Managers love colors and charts. After all, a picture is worth a thousand words, right?

Define; Measure;

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

nalyze; Improve; Control. As long as every project is measurably articulated in the following order, upper management will have n

.

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

o issues understanding what is being recommended and how to proceed in the future. None of the steps above should be skipped. Thi

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

Companies that provide selfless information through particip

is very important. The clearer the projects are defined quantitatively, the easier it will be to control processes going forward

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 Pool - 5 Surefire Ways to Bring Your Business Objectives Full Circle with Technology

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