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Design for Six Sigma (DFSS) is the application of Six Sigma principles to the design of products and their manufacturing and support processes. Whereas Six Sigma by definition focuses on the production phase of a product, DFSS focuses o

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

n research, design, and development phases. DFSS combines many of the tools that are used to improve existing products or services and integrates the voice of the customer and simulation methods to predict new process and product perfor

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

Examples of combination products may in

mance.

DFSS can be compared to DMAIC (Design, Measure, Analyze, Improve, Control) and often the acronym DMADV (Define, Measure, Analyze, Design, Verify) is used to describe the strategy of DFSS. The precise phases or steps of a DFSS me

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

thodology are not universally defined. Most organizations will implement DFSS to suit their business, industry, and culture. DFSS methodology, instead of the DMAIC methodology, should be used when:

* A product or process is not in exis

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

tence at your company and one needs to be developed

* The existing product or process exists and has been optimized (using either DMAIC or not) and still doesn't meet the level of customer specification or six sigma level

DFSS is a wa

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

Combination pro

y to implement the Six Sigma methodology as early in the product or service life cycle as possible. It is a strategy toward extraordinary ROI by designing to meet customer needs and process capability. DFSS can produce the same order of

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

magnitude in financial benefits as DMAIC. But it also greatly helps an organization innovate, exceed customer expectations, and become a market leader.

DFSS is the Six Sigma approach to product design—namely, designing products that a

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

e resistant to variation in the manufacturing process. Using DFSS means designing quality into the product from the start. You are preventing wasteful variation before it happens, thus being able to identify and correct problems early w

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

hen the solution costs are less. A successful DFSS implementation requires the same ingredients as any other Six Sigma project: a significant commitment and leadership from the top, planning that identifies and establishes measurable pr

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

ogram goals and timeline, and the training and involvement of everyone.

Planning for DFSS requires collecting the necessary information that will allow for error free production of defect-free products and processes that satisfy the cu

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

stomer profitably. DFSS attempts to predict how the designs under consideration will behave and to correct for variation prior to it occurring. That means understanding the real needs of your customers and translating those needs into v

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

Following aspects would a

ital technical characteristics of the product and ultimately into critical to quality (CTQ) characteristics of the product and process. You can then use design of experiments (DOE) to develop a robust design that optimizes efficiency an

dd to the challenges in developing combination products:

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

d reduces defects.

Valid and reliable metrics to monitor the progress of the project are established early in the project, during the Measure phase if using DMADV. Key inputs are prioritized to establish a short list to study in more d

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

etail. With a prioritized list of inputs in hand, the DFSS team will determine the potential ways the process could go wrong and take preemptive action to mitigate or prevent those failures. Through analysis, the DFSS team can determine

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

the causes of the problem that needs improvement and how to eliminate the gap between existing performance and the desired level of performance. This involves discovering why defects are generated by identifying the key variables that a

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

re most likely to create process variation. Failure Mode and Effect Analysis (FMEA) and Anticipatory Failure Determination (AFD) can be used for both the design of the product and the design of the process.

DFSS provides a structured w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ay to constructively use the information learned from these analyses. Armed with real data produced by the DFSS process, you can develop competent manufacturing processes and choose processes that are capable of meeting the design requi

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

rements. Further analysis can verify and validate that the product design will meet the quality targets. This can be accomplished through peer reviews, design reviews, simulation and analysis, qualification testing, or production valida

.

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

tion testing.

The benefits of DFSS are more difficult to quantify and are more long-term. It can take over six months after the launch of the new product before you will begin to see the true measure of the project improvements. Howeve

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

Companies that provide selfless information through particip

r, the eventual return on investment can be profound. This is especially true when the organization can use the DFSS project as a template for fundamental changes in the way it develops new products and processes across the organization

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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So many lawyers want to run the law, play jury, policeman, regulator and judge in the franchising industry. What is amazing about this is that they have already hijacked the law to serve their will and pocket book in such a self-serving way that it seems unfortunate indeed.

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