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This year, too many valued healthcare products will not make it to market.
A thorough understanding of global market complexity and the issues at stake can help you avoid the pitfalls that keep you from transforming your ideas into revenue. That’s what Innovation Commerce is all about.
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Hospitals value Qmed
 
Did you know that in 2013 Qmed completed 18% of all new CA submissions and 8% of all new EC submissions (specifically medical device, not including amendments)? Our gratitude goes out to all the investigators, study coordinators and hospital staff that directly request our services for Competent Authority (CA) submissions, Ethics Committee (EC) submissions, monitoring, data management, bio-statistical analysis and project management services for Investigator Initiated studies and company sponsored clinical trials. Qmed Consulting continues to grow because of your personal referrals.
Here's what's keeping you from your revenues
 
After having received regulatory approval, company Y decided to change the mode of the delivery system for their clinically proven device. This decision was the cause that no revenue was obtained until the new mode of delivery system would be modified, tested and obtained again regulatory approval.

Thanks to Innovation Commerce, commercial healthcare experts at Qmed researched the actual market potential for the device, validated and documented an immediate market to sell the device with its originally approved mode of delivery system, even though reimbursement has yet to be granted. By implementing this commercial strategy, company Y will now obtain substantial revenue before the new delivery system is approved for market.

Looking back, had the company Y adopted Innovation Commerce standards from the beginning, the commercial healthcare expert review of the design concept would have led to discussions on how to obtain reimbursement in both the acute and post-acute settings by modifying the design concept to accommodate both setting. Eliminating the time and cost to repeat testing and regulatory approval.
Avoiding the accidental auto-goal
Company O received an unfortunate delay in their reimbursement submission in France when they learned that reimbursement for their device would not be granted in France due to lack of French-patient evidence data.

In this case, initial market research done by the commercial healthcare expert would have determined that France was one of the EU countries in their first tier for sales. This information would have led the Regulatory, Clinical and Reimbursement Strategies. That is, the reimbursement expert would have informed the regulatory and clinical team that French reimbursement requires that French-patient clinical and initial economic data be included in the French reimbursement application.

The reimbursement expert would have informed the regulatory and clinical team as to what kind of clinical and initial economic evidence is needed for each of the EU countries chosen in the first and second tier of the commercial plan. Further, the regulatory and clinical team would have understood why the reimbursement expert needs both clinical and economic evidence directly upon receiving the regulatory approval, because it is required in the reimbursement application - which is submitted upon receiving regulatory approval.

Also the marketing and sales team would need the clinical and economic evidence collected during the clinical study so that they are able to use this data to sell the device while waiting for reimbursement.
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We can help you
To learn how Qmed's Innovation Commerce team can help you obtain better market access and faster revenues for your product, contact us today for a free, no-obligation consultation.
 
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Happy Holidays!
From all of us at Qmed, we would like to wish you and your loved ones a very happy holiday season and our best wishes for the New Year!
From idea to revenue, Qmed is your partner for medical device clinical research.
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Qmed Consulting ApS.
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