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All business continuity analysis should be risk based, and risk prioritised to deal with the important business risks first. This means that any risks to your business

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

need to be identified, examined and dealt with. There are 4 options for dealing with each risk:

1. Reduce the risk. Reducing the risk falls into 2 categories – reduc

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

Examples of combination products may in

ng the likelihood of the problem occurring and reducing the impact of the problem if it does happen. A simple example is that by having a fire alarm you are reducing th

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

e likelihood of a fire spreading unseen and by installing a sprinkler system you are reducing the impact of fire.

Reducing the risk is often referred to as mitigation.

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

For example, data backups are a form of mitigation. They reduce the impact if a problem occurs which affects the primary data source. Any mitigating actions require test

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

Combination pro

ing to provide assurance they work when required.

2. Transfer the risk. This is an interesting option which may be seen as a get-out, but which is a perfectly valid 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

ing to do. By transferring a risk it becomes someone else’s problem and you therefore have the risk covered. We are not talking about blaming someone else, or even tra

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

nsferring the risk to someone else in the company.

For example, there could be a risk that office space will not be available in the case of a disaster in the main loca

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

ion. Therefore the risk can be transferred to a third party company which organises office space for disaster recovery and keeps offices available for companies who nee

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

d such a recovery service.

3. Accept the risk. By accepting the risk of a potential problem you are at least aware of its existence and can plan for it happening. If

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

it is a risk that would have no impact for an acceptable period of time it should still be noted but you may decide to take no action until it occurs.

Almost by definit

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

Following aspects would a

ion, accepting a risk is also reducing the impact of the risk as you are aware of the potential problem and can write it into your business continuity plan.

4. Ignore

dd to the challenges in developing combination products:

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

he risk. This option should never be selected. There is never a reason for ignoring a risk once it has been identified. A risk can be accepted (acknowledged) but must

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

never be ignored.

Once the actions for each risk have been identified, then anything put in place to help cope with a risk needs testing. However, many companies eith

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

r test nothing at all or try testing every facet of a business continuity plan. Both methods are doomed to failure. The answer is to adopt a risk based testing approac

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

h from two perspectives: the business continuity plan is fit for purpose and it will work when invoked.

A health check (testing the plan is fit for purpose) needs to be

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

Professional from academic institutions, pharmaceutical industries, health care indust

performed by someone other than the authors of the business continuity plan. Ideally it’s performed by an independent third party that specialises in testing business co

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

ntinuity plans, but it could be a disinterested party from another part of the company. Independence is essential here for an objective assessment.

Testing the plan wil

.

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

work when invoked, must be viewed in a business context and the elements of the plan prioritised so that the risks with the most business impact and likelihood are test

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

Companies that provide selfless information through particip

ed first. This approach and the techniques to perform business continuity testing in a cost effective manner are the subject of other articles.

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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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Is it possible to use advertising to create a trend? Can we use advertising to start a social movement? Can advertising be used to get the ball rolling and change the way our society works? Advertising to create a trend is possible and it is done more often than you think.

No matter how wonderful your product appears, no one will buy it if the purchase is a hassle. Sure, the product itself may be great, but if the means of having it aren't, a person won't risk it. Customers will buy your product ONLY if they see that the benefits of having it in their life will outweigh the risks in buying it.

Whatever your product or service, define a business model that separates you from your head to head competition. Do not play the price game. Lowest price is almost always a temporary benefit, someone will come along that can produce cheaper, faster, better. Your goal should be the offer of a benefit that the customer will value, desire and not find immediately available. Then back up the benefit with superior service and the promise of continued new cutting edge innovation. Innovate or die!

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