Advice You - Business

Standardize your processes! You can save time, money and prevent errors. Things you do over and over should be done the same way every time, if indeed you do the task the best way. They say vari

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

ety is the spice of life, but for healthcare processes it certainly isn’t most of the time. Consider this, if you would. Would you buy your favorite brand of soda if sometimes your 12 ounce can w

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

Examples of combination products may in

ere 3/4 of the way full and sometimes almost overflowing. Certainly not. You expect there to consistently be nearly 12 ounces every time. How would a patient behave if the results of a healthc

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 visit varied wildly? The patient would probably find a new provider. The best healthcare providers deliver a consistently good service; it helps attract new patients and keeps the old ones co

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

ming back.

Standardization helps save time. As things become routine, a process is easier to do and is done more quickly. For instance, if a primary care physician makes sure that the necessary

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

Combination pro

items for a patient visit are always in the examining room, the doctor won’t have to waste time going to look for supplies and waste time for the patient or the doctor. I recommend that primary ca

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

re physicians along with staff sit down and list the things that should always be in examination rooms and make sure someone is responsible for these items every morning before patients arrive. If

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

this is done, the doctor can save time, thereby enabling him or her to spend more quality time with the patient or see more patients.

Standardization saves money. Most doctors face rising malpra

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

ctice costs, but for one group this has not been true—anesthesiologists. According to an article in the June 21, 2005 edition of the Wall Street Journal, this group over two decades ago began im

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

plementing procedures that ensured the safety of their patients. Certain processes have been standardized across the profession so instead of one death per 5000 cases, there is now only one per 20

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

0000 to 300000 cases. Because of this, their malpractice insurance premiums plummeted.

Standardization prevents errors, as in the above illustration. Another example is drawn form a local hospit

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

Following aspects would a

al. Recently the Chief Financial Officer of the institution and I were discussing the new facility they were building. Instead of building adjacent rooms so that the bathrooms would be back to ba

dd to the challenges in developing combination products:

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

ck to save plumbing costs, each room was designed so that each room will be exactly the same with bathrooms all on the same side. Why? This will prevent errors and in the long run save money fo

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

r the hospital.

It is best if you can measure standardization. The best tool to measure standardization in statistics is variance or standard deviation. I am sure many of you have encountered th

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

is measure, but probably cannot calculate it. The best way to calculate it is either in a spreadsheet or on a calculator. For example, the standard deviation for the numbers 8, 12, 1, 4 and 5 is

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

4.18. For the group 5, 5, 5, 5, and 5 the standard deviation is 0, since there is no variety. So, when you are trying to standardize a process, see if you cannot find some significant measure t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat reflects the process and try to reduce the standard deviation as much as possible. In fact, this is the heart of Six Sigma—reduce the standard deviation as much as possible. The best manufact

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

urers and service providers often use this tool.

Once you have standardized a process and have achieved a satisfactory standard deviation, then write down the process in a manual that is a collectio

.

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

n of all best practices. This way, anyone who needs to reference how a process should be conducted can refer to the manual. Too, it is an excellent training source for new employees.

As you ca

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

Companies that provide selfless information through particip

n see in these brief illustrations, standardization or the lack of variance provides safety for patients, a savings of time for the provider and patient, and contributes to an improved bottom line.

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 You - Standardize Your Processes to Produce Best Results

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