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Let's start with our reminder of... "What is an improvement cycle?"

Make Continuous Improvement One Of Your Goals - As Soon As You Possibly Can (ID: 74077)

What Is An Improvement Cycle?

"Everything we do is a process, every process has a customer

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

"

The Improvement Cycle is a highly disciplined and rigorous approach to problem solving using the Plan, Do, Check, Act (PDCA) methodology developed by Dr. W. Edwards Deming.

The Improvement Cycle consists of seven steps, 3 in the Plan phase, 1 in

; 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 Do phase, 1 in the Check phase, and 2 in the Act phase.

The PDCA cycle needs to be used in a continuous manner, select your theme or project, assess the current situation, plan and implement your solutions, check the effects of your cha

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

nges, standardise on your new improved process, and plan for future improvements – the cycle continues.

---SIDEBAR---

Although a certain amount of value and benefit may be derived from implementing part of the PDCA improvement process, a far great

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

er benefit will be achieved by sticking to the process and following all 4 phases as best you can. this is especially important when involving internal and/or external team members.

Apart from getting the chance to read the main article (ID: 74077)

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

Combination pro

I hope you have also read and understood the importance of the PLAN and DO phases

"Continuous Improvement - PDCA - The PLAN Phase (ID: 76694)"
"Continuous Improvement - PDCA - The DO Phase (ID: 78506)"

- If you missed them, please t

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

ake the time to read them first, then come back.

---END SIDEBAR---

We have a PLAN and trust it

we implement the plan (DO)

we CHECK whether its working or not

if not, we fix it (ACT)

if it's workin

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

g, we standardise on improvement (ACT)

Are you ready to check your results?

What is it that makes PDCA get its results?

For me the answer to that is twofold...

As a problem solving/decision making process it is as powerful helpin

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

g individuals, groups or whole organizations minimize the risk in starting a new project or opportunity as it is in identifying root cause problems and facilitating the means by which we can fix them.

Secondly, where progress meeti

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

ngs or even plans themselves come to a standstill because of supposition, conjecture and even emotion (not to be confused with passion which is a totally different animal altogether), PDCA gives us the focus and the discipline through the CHECKIN

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

phase to analyse the data and base future decisions and actions based on that data.

Ask yourself, will I know, for definite, what the root cause of my success or lack of success actually is?

If You (and your team) developed the p

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

Following aspects would a

lan of action, if you implemented that plan, if you gathered data over the agreed period of time against each of the measures that were set, then you are now ready to check what has happened and why it has happened.

After an agreed a

dd to the challenges in developing combination products:

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

mount of time, check the data you have been gathering, what results did you achieve, are you getting the desired results?

N.B. Always check like with like, comparing your original data with new data gathered after you implemented the changes.

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

STEP 5 Study Your Results

Monitor progress as defined in your plan

- Are you following your plan? If not, why not?
- Are you gathering data against your performance measures?
- Are results being communicated effectivel

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

y?
- Is each change being documented?
- Do you know exactly why you're getting what you're getting?

Gather and analyze more data if necessary

What are your measures telling you?

Are you on track or n

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

t? Would you know?

Are you getting the results you wanted?

NOTE: Depending on the number of changes made and the number of countermeasures implemented, your results may well be mixed. Some successful, some not.

This is the

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

Professional from academic institutions, pharmaceutical industries, health care indust

basis of CONTINUOUS IMPROVEMENT. Because the PDCA model is being followed we have a number of choices we can make now. For example...

If results are positive, if the problem or issue has been fixed, or the project/opportunity has been suc

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

cessful – go forward to
Phase 4, Step 6 - ACT

Please Note... Steps 6 and 7 of the Fourth Phase of PDCA, the ACT phase, will follow shortly in the next article.

If results are not as you expected, depending on what your data analy

.

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

sis and comparisons are telling you, you may need to return to
Phase 2, Step 4 - DO. "Continuous Improvement - PDCA - The DO Phase (ID: 78506)"

However, if your analysis reveals a serious shortfall in results, you may need to return to<

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

Companies that provide selfless information through particip

br>Phase 1, Step 2 - PLAN. "Continuous Improvement - PDCA - The PLAN Phase (ID: 76694)"

TRUST THE DATA

"What we see depends mainly on what we look for."

Sir John Lubbock

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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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A business plan is an important document that cleaning companies of all sizes should take the time to prepare before signing on that first account. By sitting down to write a business plan you take the time to look at your new business in an objective and critical manner. Once completed, a business plan will give you a path to follow.

Learn from how NASA set the Space Program goals. Use this knowledge to build a sustainable business and maintain a healthy lifestyle.

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