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Lean enterprise and business process improvement, business optimization, cost cutting TQM, quality, Six Sigma, business reengineering and other such-like initiatives, falls within the cadre of business process management.

It forms the cradle, feeding ground and

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

impetus for making sense of, improving and capitalizing on the intricacies, dynamic elements and events that occur in our planning, conducting, practice and execution of modern business in the new economy and digital age.

It is about objectively, stepping back

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

Examples of combination products may in

diagnosing, base-lining and analyzing, then streamlining and making things more effective, changing for the better, improving, sustaining, and optimizing the processes and desired results! It attempts to objectively study, assess, measure, adapt, refine, sustai

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

and improve business processes, defying the over-reliance on at times pure speculation, past knowledge, intuition or other ‘expert’ opinion or interpretations. It gives business wings and freedom to pursue a higher calling and standard.

Core business processes

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

like budgeting and even capital expenditures, manufacturing, operations and even transactional, administrative processes from part of this coordinated undertaking and endeavor, introducing it into all areas of the business, conquering new frontiers, moving bound

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

Combination pro

ries and bars, pursuing the gold-standard of business practice (OK, or at least get a better handle on things to start with!) Measurement tools, metrics, assessments, diagnostics, performance statistics all become critical inputs for the successful execution of

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

he business enterprise.

At its truest core and in its purest form, BPM is a philosophy and practical method utilized in business practice today, to bring, enable, plan and structure for and into success. A deliberate attempt and approach or business management

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

trategy, taking proactive, co-creative, data-driven, statistical and scientific method, troubleshooting and problem-solving into the business arena, optimizing efficiencies, minimizing waste and the organizations who choose to pursue it, to new heights of perfor

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

ance excellence and positive business results, growing profit and world-class breakthrough!

Business process management is often seen as all organizational activities that deal with optimizing or adapting these processes, as changing situations and business 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

s dictate. Continuity, process design, execution and monitoring, results over time, with a forward-looking eye always on the future and opportunity, human-driven processes and even workflow systems, relational data and enterprise content management strategies an

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

solutions all find a home under this encompassing umbrella as does a lot of the quality and continuous improvement methodologies businesses choose to pursue.

The Principles of Business Process Management (BPM) and Business Process Improvement (BPI), is well kn

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

Following aspects would a

wn. Here is a brief synopsis of the premise, rationale, as well as the key elements of the strategy and approach with their implications for business:

• Changing the status quo, by placing your focus in the right places, at the right time, all the time! Outcome

dd to the challenges in developing combination products:

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

-based and focused, results-driven and oriented, BPI proposes synergizing and optimizing all steps and elements within and through processes, by focusing on the outcome itself and not as much the routine, accepted specific tasks required to get you there and get

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

ing rid of ineffciencies.

• Customer-centric, focused and driven in all acitivity and endeavor, regardless.

• Efficient, systems and process above all – not automation for example, for the sake of using technology or getting on the band wagon of another ‘fad’

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

r initiative.

• The value of frequent benchmarking and measuring, ,taking the pulse, testing the waters, direction and health of your business. Gold-standards and points of reference that are quantifiable, attainable, and realistic are at the order of the day.

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

• Roles and responsibilities, ownership and accountability for processes and outcomes.

• Process controls and regular progress checks built in, planned, executed well and responded to, including halting the process if it gets of track or it looks like failure i

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

Professional from academic institutions, pharmaceutical industries, health care indust

imminent.

• Pursuit of deliberate planning, process-standardization and commonalities and having no mere ad hoc approach to business processes anymore – it simply is NOT accepted practice, considered good enough any more to thrive, saving money and effort as a

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

new economy business!

• Immediate and consistently impelementing as well as executing with success over time, sustaining the efforts

• Utility and purpose of accurate metrics and measurements and implementing action based on them.

A final word in closing: In

.

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

ur customer-driven and empowered economy, these approaches, strategies and tools, provides us the context and means whereby we can enable enterprise capabilities and capacities, to unfold into and through business processes across applications and organizational

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

Companies that provide selfless information through particip

boundaries – pro-active, co-creative and dynamically-organic way, while doing so in planned and disciplined, data-driven, monitoring and objective fashion. Which inevitably leads to us proposing to an extent, yet another refined or even new persepctive on things

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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