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Failure Mode and Effects Analysis (FMEA) or FMECA is an analysis technique which facilitates the identification of potential problems in a desig

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 or process by examining the effects of lower level failures. Recommended actions or compensating provisions are made to reduce the likelihood

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

Examples of combination products may in

of the problem occurring, and mitigate the risk, if in fact, it does occur.

The FMEA team determines, by failure mode analysis, the effect of e

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

ach failure and identifies single failure points that are critical. It may also rank each failure according to the criticality of a failure effe

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

t and its probability of occurring. FMECA is the result of two steps: 1) Failure Mode and Effects Analysis (FMEA), and 2) Criticality Analysis (

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

Combination pro

CA). Or in other words, FMECA is just FMEA with Criticality Analysis.

There are many different types of FMEA. There are Conceptual or Functiona

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 FMEAs, Design FMEAs, and Process FMEAs. Sometimes during a Design FMEA the analysis will look at a combination of functions and hardware. Some

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

imes it will include just hardware, and sometimes the analyst will take a detailed look at the system down to a piece-part level, especially whe

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

n critical functions or hardware are involved.

Why is FMEA or FMECA Important?
There are a number of reasons why this analys

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

is technique is so valuable. Here are just a few:

1) FMEA provides a basis for identifying root failure causes and developing effective

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

corrective actions.

2) The FMEA identifies reliability and safety critical components.

3) It facilitates investigation of alternatives at all

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

Following aspects would a

stages of the design or process.

4) FMEA provides a foundation for maintainability, safety, testability, and logistics analyses.

FMEA /

dd to the challenges in developing combination products:

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

FMECA Background and History
FMEA or FMECA is an offshoot of Military Procedure MIL-P-1629, titled Procedures for Performing a Fail

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

ure Mode, Effects and Criticality Analysis, dated November 9, 1949. It was originally used as a reliability technique to determine the effect of

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

system and equipment failures. Failures were classified according to their impact on mission success and personnel/equipment safety.

FMECA was

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

further developed and applied by NASA in the 1960's to improve and verify reliability of space program hardware. The procedures called out in MI

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

Professional from academic institutions, pharmaceutical industries, health care indust

L-STD-1629A are probably the most widely accepted methods throughout the military and commercial industry, although SAE J1739 is a very prevalen

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

FMEA standard used in the automotive industry.

Summary
This article just scratches the surface of FMEA. It is a valuable an

.

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

alysis technique, and has proven its worth time and time again throughout many industries. There are a number of good books and other resources

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

Companies that provide selfless information through particip

where you can find out more about FMEA. Both large and small companies will benefit as they make FMEA an integral part of their quality programs

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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