Digg It - Business

Step 1

Get the proper level of Six Sigma expertise at the executive level of the company. If the top leaders don’t understand the advanced six sigma principles, the company has no shot to at

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

tain total quality. This will probably require a hefty budget, entailing the hiring of several high-priced consultants for long periods of time. The consultants need to observe and gather data about

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

Examples of combination products may in

the companies operations, and show the executives how to interpret the data.

Step 2

Get the staff involved. The ones in the trenches are the most knowledgeable about the day-to-day operatio

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

s, and the day to day’s are where most costs are spent. This means getting people like the shop foreman, the line supervisor, and the office manager involved in the training. Not only do they need t

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

understand the thinking behind six sigma, but they also need to buy into the benefits. Since they’re the ones carrying out the orders and directing the vast majority of employees, if the trench-lev

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

Combination pro

el staff isn’t aligned with management, the company is sunk.

Step 3

Measure the data - quantify the number of defects per unit. This applies not only to manufacturing, but to services as we

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

l. It’s easier to measure defects on an assembly line. You just divide the number of defective units by total output (that’s really simplified, but you get the point). Services are more vague.

This

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

is why it is vital to get input from your customers. Ask them how things are going from their perspective. Is there anything they would like to see you improve on that would make their experience mo

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

e favorable? You’re looking to increase overall quality. Nobody knows your faults better than your customers.

Everything must be measured and quantified into actual numerical data. How long does it

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

take the average customer order to ship? What percentage of customers is satisfied with your performance? What is the average employee break time? How long does it take the customer service departm

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

nt to answer the phone? Once enough data is gathered to answer questions like these, the six sigma process and the path to quality improvement can begin.

Step 4

Now you must analyze all of

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

Following aspects would a

he data that has been collected so far and identify the difference between perfection and your current operating efficiency level. The goal is to constantly close the gap between the two. Again, a

dd to the challenges in developing combination products:

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

stated in Step 2, staff buy-in is extremely important. If management does not show a link between "total quality improvement" and "workplace improvement," then all the data collection will go to w

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

aste. The staff will not willingly take the extra steps (which often require harder, more detailed work) if they are not being rewarded. Some companies use bonuses to provide incentive, other comp

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

nies offer prizes for attaining goals or add employee perks based on improvement levels.

Step 5

Now is the time for improvement. Changes in procedure and operations should have been in pla

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

e, and more data should be collected to gauge the level of overall quality improvement. Either the hired consultants or an internal team of Six Sigma Black Belts should supervise the data collectio

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Again, this step will be expensive. Gathering the vast amount of data needed to accurately assess performance takes a great deal of time, resources, and capital. But without proper data and mea

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

surement, you will never know if the changes are working or not.

Step 6

After improvement begins, the constant chore of ongoing control must be monitored. Unforeseen variables will arise.

.

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

Employees may turn over, competitors might introduce new products, your facility may undergo changes, and many other things could happen which will impact the overall quality of your business. Top

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

Companies that provide selfless information through particip

evel Black Belts need to be constantly analyzing data to gauge the impact of any future changes, spot possible trends, and formulate actions to keep on the path of consistent and eternal improvement

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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