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Surviving a crisis, more often than not, provides a chance for a total turn-around and a new direction for your business. But managing a crisis is not an easy task as it entails a lot of things to

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

be done on multiple fronts for sure-fire results, albeit in a very short period.

“Companies, whether big or small, are judged more by what they do wrong than what they do right,” claims Cindy Rail

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

Examples of combination products may in

ng, a PR consultant from California. Your business is going to suffer if the situation at hand is not properly handled. Crisis management means immediately blocking the holes in the dam which if le

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

ft unattended, even though for a short time, would cause major damage.

Common Causes Of Crises In Start-Ups

Awareness of causes which could lead to unmanageable crises beforehand could help avoid

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

the onset of one. But missing the signals will land you in troubles every time. The common causes for crises in start-ups are listed here.

1. Lack Of Planning And Failure To Follow One: Although s

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

Combination pro

mall businesses are supported by the SBA and other agencies, many lack a proper contingency plan. Broadly speaking, many contingency plans do not make provisions for impending disaster. What is wor

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

e, anticipated risk profiles are not in place from the beginning.

2. Lack Of Financial Discipline: Most start-up small business owners use their business and personal bank accounts interchangeably

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

. Procrastinating on the part of receivables and payables increases your interest burden, which pushes your business towards a crisis.

3. Unforeseen Problems: Sudden cancellation of order/s or dec

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

ine in product demand for unforeseen reasons (also a failure to plan for this).

4. Obsolescence And Irrelevance: Your product loses relevance because of obsolescence of technology or due to the ar

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

rival of a replacement. This includes loss of relevance due to market erosion, as in the case of outsourcing to third world countries.

5. Acts Of God And Changes In Laws: Hurricanes, earthquakes,

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

ires, floods and war can wreak havoc on your business, as can changes in laws which don’t favor your current line of business.

Tiding over the Crisis

Let’s take a couple of representative cases o

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

Following aspects would a

f crises to examine how the businesses can survive through them.

Crisis due to fire hazard:
1. Make sure there is no loss of life
2. Report the fire and any associated losses to your cr

dd to the challenges in developing combination products:

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

ditors, clients, insurance company and banks
3. Get losses estimated; if necessary, get help from professionals
4. Evaluate the possibility of early commencement of operations and if po

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

ssible, begin operations even if on a small scale or in a makeshift/temporary office.
5. Try to reschedule credit repayment and delivery of goods or services by explaining your situation to yo

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

r creditors and clients. It is very important to preserve your credit rating if at all possible.
6. Take the advice of your attorney. Explore any government grant possibilities.
7. Plan a

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

head and stick to the plan in every respect.

All Other Crises:

Finance side:
1. Negotiate with creditors, banks and clients professionally to reschedule repayment so that your business cred

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

Professional from academic institutions, pharmaceutical industries, health care indust

t rating is not harmed
2. Try to refinance your loans, try second mortgaging or using a collateral loan. Go for a long repayment term if the loss was huge.
3. Try unsecured loans (they ha

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

ve high interest rates, of course) as the likelihood of collateral requirements is less as you would have attached them to the first loan.

Production side:
4. Ask your staff to stand by you d

.

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

ring the time of crisis. Motivate and take them into confidence.
5. Analyze what went wrong. You don’t want to face bankruptcy or risk your good credit. Be brave and don’t waver if you have to

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

Companies that provide selfless information through particip

make the difficult decision to reduce staff
6. Make short term and long term plans and abide by them
7. Try and regain your creditors’ confidence and don’t change suppliers at this stage

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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