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There is an old adage that says if you want to be successful you should start with the end in mind. In other words, it is a good idea to have a goal. This is especially true when it comes to managing a system's p

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

erformance. The purpose of this article is to explain how using a benchmark is one simple way to get started in managing the performance of your system.

Obviously, the reason for having a goal is to create a clear

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

Examples of combination products may in

view of where we want to be. As it relates to system performance, this would mean having a way to see what good performance looks like. This is where it gets tricky. The first thing to understand is that there

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

are no strict rules which distinguish good performance from bad performance. It is often all about perception. If you don't believe this, just ask someone who uses a web-based email system, "How well did it perfor

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

today?" Depending on whom you ask, their likely response would be that it was “slow", "bad", or "the usual". Seldom does a person respond with the actual number of seconds it took for them to log on and retrieve

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

Combination pro

their email. Without consciously keeping track, a person can tell whether the experience was acceptable. For the person who was most disgruntled perhaps there was not a problem with the speed of the system, but

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

rather a pop-up ad got in their way while trying to get their emails. People's perceptions make the assessment of a system’s performance a difficult task. The way around this is to obtain a benchmark of your syst

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

m's performance which can be used in the process of developing system performance goals.

In daily life we use benchmarks, or points of reference, to manage perceptions. Imagine traveling along the highway at 70 M

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

PH and unexpectedly, you come upon a small town where there is no speed limit posted. Somewhat perplexed, you know that you should drive slow, so you reduce your speed to what you feel is safe. Suddenly, you are

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

being pulled over and the officer tells you that you are going too fast. You ask the officer what is the speed limit and his reply is “slow”. From your perspective, you had been going 70 MPH and then you were go

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

ng 35 MPH, which you feel was a significant slowing. But the officer explains that he had just come from an accident where a car going 25 MPH had hit a pedestrian. In real life, most places in which you drive do

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

Following aspects would a

have speed limit signs posted in order to avoid these types of perception issues. However, for the people who use and manage systems without benchmarks which define acceptable system performance, conflicts of perc

dd to the challenges in developing combination products:

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

eption are a regular occurrence.

In the case of your system’s performance, it is likely that there are no “posted” response times for your system. In order to manage perception, it is necessary to create a benchm

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

ark of good system performance. Document everything you can about the system during the times when the system is heavily used and there are no reports of a performance problem. When you capture a profile of metri

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

s which represent a known state of the system, you are essentially benchmarking your system's performance. This would include taking note of the available system metrics, such as the CPU, memory, and disk utilizat

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

ion. Even using a simple stop watch to measure the time it takes to complete a transaction is a good way to way to capture a response time benchmark. If available, get the application metrics such as the transact

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion throughput or the number of con-current active users. This information can be used to identify if there is abnormal usage of the system which could be responsible for a performance problem. If you acquire the

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

e metrics when the system is known to be performing well, this information will be your system's benchmark of good performance.

Benchmarking is the first step in managing the performance of a system. When the sys

.

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

tem’s performance is reported to be unacceptable, you will now have metrics that were taken at a point in time when the performance was known to be good. Compare the metrics obtained during the time of the reporte

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

Companies that provide selfless information through particip

d poor performance to the benchmark metrics when the system was known to be performing acceptably. Identifying the differences will likely provide a good place start troubleshooting your system's performance issue

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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