Main Subject - Business

"What do you mean you need to push back the launch date?" Says the CEO. Says the CFO. Says the user community. CTOs, CIOs, and all officers who oversee major development proj

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

ects have had to deliver the dreaded message. But a deadline for the sake of a deadline is a dangerous pitfall that can consume an entire project and stymie it to the point

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

Examples of combination products may in

hat it never launches. Over the years I've come up with six simple rules that help deadlines become more meaningful, while keeping the developers, the user community, the CF

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

O and the CEO all satisfied.

1. Always have minor version control throughout development. Group functional requirements into minor versions so that core functionality is prio

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

itized and so that the entire development team is generally active on the same minor version.

2. Always target minor version releases every 2 to 4 weeks.

3. Always begin tes

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

Combination pro

ing immediately once each minor version is complete.

4. Always prioritize bug-fixing to the highest level upon the completion of any testing.

5. Never allow a problematic fu

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

nctional enhancement to be a showstopper. Negotiate with the user community and the CFO or CEO for a delay in, or removal of, the delivery of that functionality.

6. Alway

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

launch the product on time - as long as the most recent fully completed minor version is functionally equivalent or better than the current production system. Launch it, no

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

matter how far you are from 100% complete.

So I want you to launch an incomplete application? Let's just call it "functionally challenged". This is what I call the 70% solutio

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

n. The deadline doesn't move and the developers deliver a fully tested, bug-fixed version on time and within budget. This gives management the opportunity to evaluate furt

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

er investments into application functionality while reaping the benefits of any developments to date.

Don't blame the developers. It's more likely a project runs over budget

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

Following aspects would a

and over deadline because of optimistic cost planning or scope creep than poor developer skills. Following these rules ensures delivery of the best product the development t

dd to the challenges in developing combination products:

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

eam can achieve within a set budget or period of time. Even in an environment where scope creep becomes a factor, escalating requirements can be scheduled into minor version

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

so they never hold back the launch of the "functionally challenged" application.

Testing? Who needs testing? So you didn't follow the six rules, you're past the code freeze

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

date, and you're supposed to be in final testing but there are still more things to implement. The user community and the CEO want to know if you'll be able to launch on tim

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

e regardless. That's when it hits you— if only we could "streamline" the testing phase we could still make it. Very bad idea. The cost of backing out due to insufficient t

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

Professional from academic institutions, pharmaceutical industries, health care indust

sting can cost more than the project itself. Recently I witnessed a botched implementation of a customer service application that almost cost the company in question its thr

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

e largest clients—and millions of dollars.

Work your mediation magic. Application development managers have to be part negotiator and part magician. They need to keep all si

.

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

des happy, even if product expectations and budget restrictions are in conflict. No one really wants the 70% solution, but everyone can live with it. And when no one's 100%

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

Companies that provide selfless information through particip

appy, you know you're probably doing it right.

Read more in Case in Point: "The Thursday Rule"

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Make a lot of money fast, make a lot of money fast from th ground up, dedication, knowledge is power

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Main Subject - The 70% Solution: Practical Testing and Version Control

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