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There’s no getting away from it, design and development projects are a nightmare to manage successfully, particularly the development of software. Nonethele

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

ss, in these days of customers requiring ever increasing functionality and ever more sophisticated technology, they are sometimes necessary.

Your company al

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

Examples of combination products may in

ost certainly has procedures in place such as Make or Buy (do you design/build the item yourselves or do you sub-contract) and Design to Cost (you’ve estimat

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

d how much it will cost, now make sure that it doesn’t run over budget. The Make/Buy procedure should have been used when compiling the bid and the advantag

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

s and disadvantages in terms of capability, price, programme and risk between procuring from internal or external sources analysed. The availability of requ

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

Combination pro

red technology should have been ascertained.

The Design to Cost process should also have been part of the programme from its inception through the bidding s

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

age but it too should be reviewed at this stage. If a significant cost/risk reduction can be achieved by changing your approach, it may well pay dividends i

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

the end.

There are a number of things to consider in respect to design. Firstly, you don’t have to design from scratch. It may be that there are two piec

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

s of electronics out there already which will do the job that your project wants and all they need is a piece of software or hardware to make them talk to ea

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

h other. That is far preferable to designing the whole piece of kit from square one and far less risky. Make sure that your engineering fraternity know thi

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

. Bear in mind that, since you compiled your bid and did the initial technical assessment, technology may have moved on and something which didn’t exist t

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

Following aspects would a

hen may well be on the market now. It’s worth a little time and effort to review your design decision and confirm that it’s still a valid one.

Rule number

dd to the challenges in developing combination products:

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

ne for the Project Manager is that he must never forget that engineers are just that. They love to tinker and play, they love to solve technical problems an

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

they will almost certainly be unaware of how long it’s taking or how much it’s costing. As the Project Manager, you will have to keep a firm eye on what th

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

y’re doing as even your Technical Lead may get carried away with the excitement of an emerging new technology.

If you really must design hardware, or heaven

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

forbid, software, make sure that plenty of checks and tests are built into your plan along the way. It’s very easy to fall behind time on a design and deve

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

Professional from academic institutions, pharmaceutical industries, health care indust

opment job.

Another important point is to liaise with your customer all along the way. There’s no point finishing a stunningly clever design only to have y

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

ur customer tell you that he forgot to say way back that your electronic gizmo needs to be operational in temperatures of 100 degrees Centigrade.

In a nutsh

.

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

ll, don’t reinvent the wheel, keep things as simple as possible and get customer approval as you go along. Above all, as the Project Manager, the ultimate r

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

Companies that provide selfless information through particip

sponsibility is yours, so don’t sit back and just let the techies get on with it - manage them. This should ensure the smooth running of your design project

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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