Subjects - Business

Approach to Change

How is your change initiative going? Are managers and employees singing from the same hymn sheet or are you seeing constant bickering and recriminations? Are positive resul

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

ts emerging for all to see or is your organization’s performance going backwards? Is your program meeting targets and deadlines or is money and time being continually sucked into a black hole?

Whether you are

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

Examples of combination products may in

implementing a new local accounting system in your department or your organization is embarking on a comprehensive culture change program, it makes sense to take a breath and review how you are traveling. Here

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

is a quick eighteen-point checklist that you can use on your current change project. You can either answer the questions on your own, or better still, get your team in to discuss the answers as a group.

The

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

ollowing questions are based on the CHANGE Approach © to managing change in organizations. This approach recognizes that a disciplined process is required for leading and managing change, from

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

Combination pro

the initial good idea to eventual institutionalization of the new way of working. These six phases of the change process are:

Create tension
Articulate why change needs to

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

happen and why it needs to happen within the planned timeframe.

↓
Harness support
Get on board the key decision-makers, resource holders and those with the potential to su

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

bvert the change process.

↓
Articulate goals
Define in specific and measurable terms the desired organizational outcomes.

↓
Nominate roles

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

br> Assign responsibility to specific individuals for the various tasks and outcomes.

↓
Grow capability
Build organizational systems and people competencies necessary for

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

affecting the change.

↓
Entrench changes
Institutionalize the change to make it “the way we do things around here”.

The checklist questions act as a quick

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

diagnostic by surveying the critical activities in each phase. Neglect in one or more areas will likely result in the change program suffering.

The Checklist

Cre

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

Following aspects would a

ate tension

Is there a clear and compelling reason for adopting this change program?
Is the objective data needed to convince the skeptics available?
Do people feel the urgency to

dd to the challenges in developing combination products:

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

hange? Harness support

Do we know what are the motivators for each stakeholder group?
Does the senior executive team support this change?
Are all stak

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

eholders engaged in the change process? Articulate goals

Do stakeholders take ownership of the vision and goals?
Are people involved in devolving the goals to l

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

wer levels of the organization?

Are performance measurement and reporting systems set up?

Nominate roles

Are change management and new operational accountabilit

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

ies clear?

Are the right people selected for the right roles?

Are project management principles and methods being used?

Grow capability

Is the trainin

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

Professional from academic institutions, pharmaceutical industries, health care indust

plan sufficiently scoped and adequately resourced?

Are teams being developed and supported for high performance?

Is support in place ensuring transfer of training to the workplace?

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

/ul> Entrench changes

Are performance results reported and successes celebrated?
Are remuneration, rewards and recruitment systems aligned with the change objectives?

.

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

Do managers and supervisors lead by example?

How does your program measure up? If you get your team together, the actual answers are not the most important thing. The resulting discussion amon

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

Companies that provide selfless information through particip

gst the group should highlight where you will need to direct your future efforts. You will get the most benefit from this checklist if you check progress with your team and review the checklist every few weeks

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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