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Penetration Testing is the art of using known "Hacker" techniques to identify potentia

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

l attack vectors both internally and externally in computer networks. Quite often, com

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

Examples of combination products may in

panies overlook the need for this type of testing when performing scheduled security a

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

sessments. This may be caused by fear of service disruption of just a lack of knowledg

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

e on the subject. Also, Penetration testing should not be confused with a vulnerabilit

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

Combination pro

assessment or audit. Penetration Testing uses manual and automated techniques to vali

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

date vulnerabilities. When done correctly, this eliminates false-positives and ensure

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

s that internal IT admin spend time correcting issues that actually exist.

At PacketF

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

cus, we recommend that our clients use a mixture of internal security assessments and

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

external penetration tests. Internally, this will help identify policy and procedures

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

hat need development. Externally, this will identify potential attack vectors that may

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

Following aspects would a

be used to gain access to your internal network or sensitive data.

When looking for

dd to the challenges in developing combination products:

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

a 3rd party security company to perform these services there are several questions tha

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

need to be asked.

What methodology do you use?

What experience do your testers have

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

?

What certifications do your testers have?

Is your reports based on Nessus or do yo

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

perform real analysis?

How many pen-tests have you done?

What type of vulnerabiliti

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

Professional from academic institutions, pharmaceutical industries, health care indust

es do you usually find?

What tools do you use?

The questions above should give you a

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

good example if the firm has a solid methodology such as the ISECOM testing standard.

.

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

Most importantly, security tests should NOT be a Nessus or other commercial tool repor

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

Companies that provide selfless information through particip

t with the Logos changed. The report should clearly define Business and Technical risk

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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