Innovation Commerce

From Idea to Revenue:
EU Innovation Commerce Concept brings Value to Decision Makers

Failing to demonstrate the value of innovation is a top risk facing the life sciences sector. With the tremendous progress in developing solutions in pharmaceutical and medical device industry to date, demonstrating value to the relevant market decision makers at this time is difficult. Our worldwide healthcare system faces significant challenges in cost, quality and access. Instead of simply focusing on contained clinical problems, manufacturers must take a broader view to creating value. Those who adapt first will win eventually the market.

Commercial Healthcare Paradox

In too many emerging device projects, a void still exists between commercialization and R&D. Assumptions are made on the EU market analysis drafted in the Business Plan. Product development is solely driven by proof of concept with no or assumption based commercialization planning.

Today, investors are even turning down applications for early seed funding that do not document and validate the actual market size in specific EU countries targeted for the future commercial launch. Purely R&D driven innovations are looking at a foreseeable future of less funding.

Business Development Executives Survey

In 2011, an independent global survey completed by Business Development executives of the top 40 Medical Device companies worldwide (ranked by trailing 12-month revenues) revealed what they expected from start-ups that were pitching to be bought:

"In reviewing an emerging device, it is important to have the following reported but generally are not:
  • The value proposition documented for all Stakeholders
  • Actual market size calculated and validated
  • Regulatory Strategy which collects clinical and economic evidence
  • Regulatory approval…"

Innovation Commerce Concept

That said, the majority of emerging device entities still employ a more traditional approach in the EU by focusing on R&D and regulatory strategy to obtain regulatory approval, with the expectation that the regulatory approval clinical data will launch the beginning of the commercialization planning. This kind of EU regulatory strategy often lacks the orientation given by a market analysis. The reimbursement analysis is often left to wait on the sidelines until the regulatory strategy and regulatory clinical data protocols have been finalized and executed. Leaving no opportunity to capture economic data with the regulatory clinical data.

Further, no geographic market orientation is available in regards to where the EU regulatory strategy should be executed since no market analysis data is available. Too often, regulatory clinical data is collected in geographic markets that do not align with the much later developed reimbursement analysis and commercial strategy.

At Qmed Consulting, we provide emerging device entities complete Clinical Research Organization (CRO) services according to the Innovation Commerce concept. From idea to revenue, EU commercial healthcare research is used to lead the innovation process.

Every emerging device is as unique as the innovation it delivers. Therefore, the Innovation Commerce concept begins with the idea phase by determining the innovation’s unique value for its EU market decision-makers. Initial market research provides credibility to the innovation and documents its EU market potential. Further, the Innovation Commerce concept defines what clinical and economic evidence is needed to demonstrate its unique value in specific EU regions.

With every successful application of the Innovation Commerce concept, we achieve significant increases in the probability of calculating realistic sales targets and reaching them in Europe. Which ultimately leads to faster revenue growth.

Best Practices

Collaboration with a Commercial Healthcare CRO service provider has many advantages. It is critical, however, to find a good fit. To find a good fit, emerging device entities need to evaluate partners based on accepted best practices to ensure a productive and mutually beneficial outcome of proposed projects. Some of these best practices are listed below.

Excellent track record

A company with a successful track record in collaboration is a better choice than a company that does not. A careful analysis of case studies of previous engagements is one way to evaluate a CRO, specifically emphasizing project similar to those you wish to pursue. Companies with good track records will also have a good reputation in the industry, and will be actively engaged in their markets (attending tradeshows or conferences, routinely giving talks, and teaching on their know-how, for example).

Commercial Healthcare capability

Commercial Healthcare capability and a senior CRO team, supplemented by a proven budget controlling system, are all important factors when choosing a CRO. The objective of hiring a CRO with commercial healthcare capability is faster time to market—from idea through regulatory approval to revenue. It is also important to note that you should not see each other´s commercial capability or regulatory/quality/clinical team as competition, but as a resource to make the best choices to the development at hand.

Multidisciplinary expertise

Many emerging device entities, when seeking a CRO, are narrowly focused. They identify service needs, and seek a CRO that can provide them just these specific service needs. However, it has been confirmed that studying a challenge from many perspectives and through a multidisciplinary team yields the best results.

Ability to adapt

For a constructive collaboration, projects should have clear, precise, and measurable outcomes. This can be done phase-by-phase with specific milestones clearly known at finite periods of time. However, this does not mean the relationship has to be inflexible. Flexibility is important when unexpected outcomes arise. A CRO should be able to adapt to new directions as process is achieved, and should be open to revisit and rewrite objectives if the need arises.

Human element

The human aspect of collaboration is often neglected but should be an important factor when making a decision about potential CRO. Communication between individuals is key, as people need to talk to each other and not past each other. An open, honest engagement occurs when both companies are seeking the same goal and recognizing that neither company is going to succeed alone. It needs to be a true collaborative effort by all individuals in the team. Finding a CRO who has experience working with different client cultures is a plus.