Subjects - Business

The art and science behind making commitments and managing expectations has always been a critical skill set for senior executives and entrepreneurs to master. In fact, understanding how to come out on the

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

right-side of the expectation curve can often be the difference between average performers and superstars. This is evidenced by the fact that the consulting industry has zeroed in on the importance of this

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

Examples of combination products may in

ssue such that it has evolved into an emerging discipline known as ”Promise Management”. In this blog post I’ll discuss the value of promise management as a discipline.

Nothing engenders confidence and cre

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

ates a trust bond like delivering on promises made and likewise few things erode confidence and credibility like commitments not kept. In a previous post entitled: “Follow Through” I discussed the importanc

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

of saying what you mean, meaning what you say and doing what you say you’ll do. The science of promise management is systematically connecting what is said with what is done. The art of promise management

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

Combination pro

is closing, or better yet, eliminating the expectation gap. Blend the art and science together and you have the framework for what is becoming the differentiating factor in performance based decisioning for

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

the twenty-first century.

Conflicts, disagreements, disputes and litigation are often born out of expectation gaps. Expectations cut both ways…Keeping what you perceive as being your end of the bargain is

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

only half of the equation as what you think only matters if it is in alignment with the understanding of the other party. We have all found ourselves in the unenviable position of assigning work product onl

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

to end-up with the deliverable falling far short of expectations while having the producer of said work product thinking they exceeded all expectations.

Expectations exist throughout the entire value chai

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 with every stakeholder needing and deserving to have their expectations managed and met. Whether it is managing customer expectations, shareholder or analyst expectations, or the inverse of employees havi

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

g to deal with the expectations of executives, it is the ability to excel at decisioning based upon managing expectations that creates high performance organizations.

Promises that are made based upon soli

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

Following aspects would a

d reasoning and underlying business logic that are consistently kept will help to create a solid brand attracting loyal customers and talented employees. The following three practices will help create an or

dd to the challenges in developing combination products:

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

anization that delivers on its commitments:

1. Collaborate early and often: Decisioning in a vacuum or without all the facts will place you in a deficit from the beginning. It is at best extremely d

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

ifficult to manage expectations and deliver on commitments made if you don’t have clear visibility as to what is wanted or needed. Before making promises or commitments collaborate with all concerned partie

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

to insure that expectations are understood.

2. Resist making verbal commitments: Most misunderstandings occur as a result of improper interpretation of oral communications. Most broken commitments

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

result from impulsive verbal promises made before all the details were sorted out. Once you have gained clarity as to the perceived need to be fulfilled place your understanding of the deliverables in writi

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

Professional from academic institutions, pharmaceutical industries, health care indust

g by outlining key business points and circulate the document for review and comments. Where possible resist formalizing agreements, proposals, or other commitments until you have alignment on key expectati

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

ons and deliverables.

3. Manages promises like projects: Build a culture that breaks down all commitments made into deliverables, benchmarks and deadlines. Allocate resources, budget and staff while

.

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

managing the commitment within a framework of measured accountability. Treating all commitments and promises as formal projects will help manage performance risk and will also create continuity of process a

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

Companies that provide selfless information through particip

nd delivery.

Performance based decisioning based upon principles of promise management will lead to a certainty of execution that should translate into one of your company’s greatest competitive advantages

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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We talk to dozens of sales and marketing candidates every month as we perform executive searches for top technology manufacturing companies in the Pacific Northwest. As we talk to these individuals there are a few things that we see that candidates can do to improve their chances as they’re out networking and interviewing for job opportunities.

I'm simply going to list these fifteen principles for complete customer service and let you draw your own conclusions regarding the following questions (these need to be answered in sequence): • Is this principle really important for my organization? • If it is important, are we actually implementing this principle consistently and thoroughly throughout the organization? • If we are implementing it, is it proving to be effective? In other words, is this principle actually working to consistently deliver complete customer service to every customer every time? • If it is not effective, what is the first thing that needs to be done to improve its effectiveness? What resources do we need to get this done? Who needs to be involved in developing and implementing this first step? When you answer these questions in the order listed, you'll quickly discover where the weak points are in your internal process chain of customer service AND what you can do quickly to strengthen or change them for immediate improvement. Here are the 15 principles . . .

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