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COMPANY/ORGANIZATION

A South Florida hospital. The CEO of the hospital saw the nee

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

d to provide exceptional customer service to differentiate itself from the competit

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

Examples of combination products may in

on and avoid being acquired.

PROBLEM

The hospital was undergoing a series of chan

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

es involving personnel, organizational alignment and even an expansion of the prope

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

ty which caused disruption to the entire staff. The attitude of many of the hospita

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

Combination pro

personnel was focusing on the negative aspects of the changes and reflected on red

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

ced sensitivity towards the patients. Some ratings from the Joint Commission were b

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

low average and the public opinion about the hospital was poor.

SOLUTION

Manageme

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

t Resources Inc. (MRI):

Developed a program to meet the hospital’s needs based on

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

he input from the CEO, the Assistant VP of Planning and one Department Director Di

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

ferent programs were developed for different levels in the organization: an execu

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

Following aspects would a

tive program for doctors and administration a program for the staff a program for

dd to the challenges in developing combination products:

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

entry level personnel.

The entry level program included customized excerpts of MRI

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

s programs in:

Leadership
Customer Service
Service Recovery
Change

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

Management
Telephone Etiquette
Team Building
Personal Change

This

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

program is delivered in Spanish and occasionally in English The program was admini

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

Professional from academic institutions, pharmaceutical industries, health care indust

tered to all personnel.

RESULTS

Personnel who have attended the program show exc

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

llent results. Their attitudes show considerable improvement. The Joint Commiss

.

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

on ratings improved considerably. The hospital is among the top ten Hispanic busi

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

Companies that provide selfless information through particip

esses and one of eleven (11) hospitals who are still independently owned in Florida

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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