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Numerous studies, articles and books have remarked recently on a key governance gap for many technology companies’ boards of directors. Attention to this issue arises from survey results that show only about

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

14% of technologies focused companies have well developed global technology intelligence scanning practices. What expectations and fiduciary assessment practices should be instituted in the boardroom to asses

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

Examples of combination products may in

how well management can explain the company’s product development strategy in terms of the ever changing global technologies landscape and the competition?

These 7 questions represent the strategic question

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

s mentioned in recent publications that should be asked of CEO’s.

1 - Do we have a complete view of what our technology stacks are? Does our picture of the technology stacks include potential disruptive as w

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

ll as sustaining options? Does management have a clear and up-to-date understanding of the technology innovation landscapes for all of the layers of our technology stacks?

2 - What is the sense of urgency r

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

Combination pro

egarding the opportunities and risks that exist in our technology stack? Is there consensus among company stakeholders about the strategic priorities of the technologies in these stacks in terms of the curren

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

competitiveness of the company’s technology portfolio and strategic innovation roadmap? What compelling visual tools are used to ensure people “see it and believe it,” regarding urgency and impact?

3 - What

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

is our on-going process for technology innovation intelligence gathering, and how do we ensure that we are getting the most reliable information? If the service or data is being outsourced, how do we ensure

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

hat the analysis is tuned to our company’s specific strategies, rather than being generically common data that any competitors in this marketplace can also view and act upon?

4 - Are we able to involve our k

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

ey domain experts in the technology innovation discovery and analysis process early enough in the process for them to spot truly innovative, “out-of-the-box” ideas that no one else would perceive? What proces

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

and tools are in place to ensure that whoever in the company that might contribute to the discovery of viable insights is kept in the loop early on when creative ideas can still have time to be considered. O

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

Following aspects would a

tsiders can’t generate some of the insightful business ideas that can “connect” in the minds of people who are living and breathing a business daily – are we involving the right internal people in the process

dd to the challenges in developing combination products:

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

?

5 - How effective are we at finding potential technology partners and assessing the true synergistic value of their technology? Do we have a way to do thorough homework on potential partners’ technologies

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

apabilities before approaching them? Are we able to surprise them with how much we know about their capabilities and intents, so we can quickly get to the real truths? Can we easily prove to them with hard da

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

ta the profit-making synergistic technologies fits of our proposed partnering ideas?

6 - Do we have a clear picture of what real intellectual property barriers in a technology area look like? Do we have buil

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

into the process the analysis and visualizations that can give us the confidence to know why and when to say no? Especially before we decide on our strategic direction of new initiatives, and begin to invest

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

Professional from academic institutions, pharmaceutical industries, health care indust

and develop or acquire technology? Alternatively, can we easily drill down deep into the data that proves a winning idea’s technology risk proposition?

7 - Who in our organization fully understands our tech

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

ology landscape and can present our technology innovation strategic plan in a way that everyone can understand it? How deep is our bench? Is everyone visualizing the company’s future from the same playbook? C

.

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

ould each and every one of the key managers in R&D, or Business Development, or Marketing, or Partnering “pinch hit” for the CEO on this subject? Could they each make a strategic level technology landscape pr

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

Companies that provide selfless information through particip

sentation to the Board in terms that the Board would understand?

Most importantly a final question, if we can’t do this all now, can we get most of these answers in time for the next board meeting in 8 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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