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Digg It - Lies, Damn Lies and 99.9% Uptime
"There are three kinds of lies: lies, damn lies, and statistics."
-Benjamin Disraeli, popularized by Mark Twain
Lies, Damn Lies and 99.9% Uptime
Statistics don't lie outrigh
-Benjamin Disraeli, popularized by Mark Twain
Lies, Damn Lies and 99.9% Uptime
Statistics don't lie outrigh
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
t. They just don't tell the whole truth.
Suppose your hosting provider claims 99.9% uptime during the past month. This means all the accumulated downtime during the whole month was no more than 40 minutes. Sounds great, right?
Suppose your hosting provider claims 99.9% uptime during the past month. This means all the accumulated downtime during the whole month was no more than 40 minutes. Sounds great, right?
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
The numbers don't answer one important question: when did the downtime occur? What if you were down 40 minutes during your peak usage time on the busiest day of the week? Suddenly 99.9% of uptime doesn't sound so great. That's the whole truth often mi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ssing in uptime reports.
The All Important Monitoring Interval
Convinced you can do better than 99.9%, you search for another hosting provider. You finally settle on one that offers an additional "nine" or 99.99% upt
The All Important Monitoring Interval
Convinced you can do better than 99.9%, you search for another hosting provider. You finally settle on one that offers an additional "nine" or 99.99% upt
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
me per month. No more than 4 minutes of downtime.
Before you get too excited, let's see where that extra nine comes from by examining the concept of monitoring interval. The monitoring interval is how often your hosted server is checked to
Before you get too excited, let's see where that extra nine comes from by examining the concept of monitoring interval. The monitoring interval is how often your hosted server is checked to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
make sure everything is working A-OK. Think of it as the lines on a ruler. It's going to be pretty hard to measure down to one eighth of an inch if your ruler only has one inch lines on it.
Suppose your application is monitored every 15 min
Suppose your application is monitored every 15 min
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
utes. Now say your server is rebooted. If the monitor runs while the server is down, your server will show as down for 15 minutes, even though it only takes 3 minutes to reboot. If the monitor misses the reboot window, it won't show as being down at all
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
A provider that offers 99.99% must have a small enough monitoring interval that it can measure down to the nearest .01%. How small is that exactly? Let's break it down using the shortest month:
28 days x 24 hours/day x 60
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
minutes/hour x .0001 = 4.03 minutes
A service provider must provide a monitoring interval of no more than 4 minutes to provide a 99.99% uptime guarantee.
Finally, what of 99.999%, the so-called "five nines" of uptime? Wel
A service provider must provide a monitoring interval of no more than 4 minutes to provide a 99.99% uptime guarantee.
Finally, what of 99.999%, the so-called "five nines" of uptime? Wel
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
, we would have to monitor every .4 minutes or every 24 seconds. With the reporting period increased to a year instead of a month, it's possible to have accuracy up to five nines with a 5-minute monitoring interval. Trouble is, who wants to wait a whol
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
year for a report?
The best reporting will include a combination of daily, weekly, monthly and yearly statistics for comparison.
What Do You Mean, Down?
Now that you understand what a monitoring interva
The best reporting will include a combination of daily, weekly, monthly and yearly statistics for comparison.
What Do You Mean, Down?
Now that you understand what a monitoring interva
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
l is, this next one should be easy: what is the meaning of "down"? If your service provider is providing uptime, how do they decide when something is down? Are they simply doing a "ping" of the server? Or are they testing the application itself?
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
br>
If "up" to them means your server is running, even though your application is really "down", your uptime statistics take on a whole new meaning -- or lack of meaning.
Also, who is the one actually doing the monitoring? Ideally, you'd
Also, who is the one actually doing the monitoring? Ideally, you'd
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
like to have a third party monitoring service. That way you know your monitoring numbers are independently verified.
Availability From a Business Perspective
There is a better way. Instead of settling for the one-siz
Availability From a Business Perspective
There is a better way. Instead of settling for the one-siz
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
-fits-all approach of "nines of uptime", set your own availability goals. The key is to examine availability from a business perspective:
- What are my business-critical periods?
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
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
ow much downtime is acceptable during off hours?
What kind of monitoring interval is needed?
How do we know if the application is down?
Who is actually doing the monitoring?
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
Always make a distinction between business hours and after hours. You should have different availability requirements for each period, even if your application is used 24x7. Next, create your goal using words and whole numbers, not percentages. F
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r example:
- Zero downtime during business-critical periods.
- No more than 2 unscheduled downtime incidents per month of no more than 5 minutes per incident during after hours periods.
- 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
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 more than 1 scheduled maintenance period per month of no more than 30 minutes during after hours periods.
Monitoring interval of 5 minutes.
Monitor key aspects of the application, not the server.
Independent third-party m
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
nitoring from multiple locations.
After defining exactly what your availability goals are, you can now strive to achieve it. The difference now is that your goal is 100% achievable. That's a statistic you can count on
After defining exactly what your availability goals are, you can now strive to achieve it. The difference now is that your goal is 100% achievable. That's a statistic you can count on
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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