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Can one software maker do it all well? There are many software development companies in the industry that are still striving to release a single, complete, successful product of outstandi

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

ng quality and usability. With their modular approach to decision support software, ERP vendors are on the right track; because attempting to cover all of the separate functions of the mo

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

Examples of combination products may in

dules would be unthinkably large and complex--not to mention costly--for one vendor.

However, Compare SAP and Peoplesoft ERP software, if each individual module has a unique function, 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.

en each module can be a different product developed by a different vendor dedicated principally to the success of a single product.

Of course, if an ERP vendor can manage to avoid the "n

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

ot-invented-here" syndrome, it could integrate some of the best existing tools from the various niche software makers. For example, rather than writing a finite capacity scheduler from sc

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

Combination pro

ratch, an ERP vendor could purchase the rights to license a scheduling tool from an existing best-in-class tool provider, and integrate it with its other offerings. Indeed, the drive to i

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

ntegrate best-in-class software tools from different functions may be the dominant wave of the future for the ERP industry.

Another important strategic issue facing Compare SAP and Peopl

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

esoft ERP software ERP is whether the enterprise decision support market is essentially homogeneous or heterogeneous. While every company's specific problems are different, many problems

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

are variations of themes. Are the similarities strong enough to support a "mass market" approach to software? Or are the differences going to keep the manufacturing software market a wide

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

-open arena of niche specialists, systems integrators, and solutions consultants?

The point may be moot, as this issue will likely be decided by cost. Integrated packages from single ven

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

dors are going to require a major up-front investment, but buying different modules from multiple vendors will probably require a lot of effort to get them to work together, and maintenan

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

Following aspects would a

ce costs will be higher in the long term if we compare SAP and Peoplesoft ERP software. If the issue comes down to pay me now or pay me later, is it possible that these technology decisio

dd to the challenges in developing combination products:

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

ns could be decided by each company's financial situation, rather than by what the best solution is? We hope not.

For some industrial managers, ERP is the nightmare that keeps them awake

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

at nights thinking "Is the MIS department going to take over my manufacturing floor?" Much of the force pushing software makers to develop better, more useful software has been coming fr

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

om practitioners: IEs and OR types who know exactly what they need from a software package. Often these experts end up actually writing the best software, as well. However, several of the

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

ERP vendors, notably giants SAPAG and Peoplesoft come from the information systems world, and traditionally focus on the MIS piece of organizations.

For engineers who have spent months

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

Professional from academic institutions, pharmaceutical industries, health care indust

locating and purchasing software that they know and like, being forced to adopt "corporate's package" may seem like one giant step backwards. Yet, the potential strategic advantages of en

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

terprise integration are undeniable. One thing is certain: if you want to have control over the tools you are going to be using, you're going to have to utilize your engineering training

.

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

and expertise to exert positive influence on the selection process. If you sit passively on the sidelines, don't be surprised if no one hears you.

Clearly, there are more questions than

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

Companies that provide selfless information through particip

answers regarding the young ERP movement. That said, we are left with one final question: will all of this change result in ever increasing consulting bills? The answer: almost certainly.

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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