No matter how hard you try to manufacture a safe, efficacious, and quality product, it is not going to generate the revenues you anticipated unless it can be properly reimbursed. Here are some quick Dos and Don’ts of the reimbursement process. (Some details have been modified to protect company privacy.)

1. www.mediclever.com
UK: Mediclever Ltd.
27 Old Gloucester St.,
London WC1N 3AX
E-mail: uk@mediclever.com
Phone: +44.208.099.7435
Israel: Mediclever Ltd.
6 Te’ena St.,
Modiin 71799
E-mail: il@mediclever.com
Phone: +972.50.837.1711
Reimbursement DOs and DON’Ts
No matter how hard you try to manufacture a safe, efficacious, and quality product, it
is not going to generate the revenues you anticipated unless it can be properly
reimbursed. Here are some quick Dos and Don’ts of the reimbursement process.
(Some details have been modified to protect company privacy.)
1. Do – Develop your reimbursement strategy early.
Don’t – Delay developing your reimbursement strategy until just before your
product launch.
Real life examples:
Example #1: Company A developed a 4-sensor product that competed with other
available 6-sensor products. This product was clinically better and less
expensive than its competitors. The company invited Mediclever to check
whether they could utilize existing reimbursement mechanisms in France. A
short assessment revealed available codes, a positive coverage policy, and
payment rates that exceeded the company’s expectations. However, the
wording in the identified existing codes specifically indicated 6 sensors!
Redesigning the product at that stage was too difficult, and the company was left
out of the French market.
Example #2: Company B developed and launched a product in the US market.
Unfortunately, the pressure settings employed by their product deviated from the
allowable range specified under existing reimbursement mechanisms. The CEO
asked Mediclever to provide them with a ‘reimbursable’ specification. The
company is currently redesigning their product according to this spec.
Remember: Your reimbursement strategy could affect your product design.
2. Do – Consider reimbursement factors when selecting the most appropriate
application to start with.
Don’t – Choose your “killer app” only on the basis of R&D, regulatory
criteria, or marketing.
Real life example: Company C developed a platform that could be used for a few
applications. The company invited Mediclever to develop and implement its
reimbursement strategy, while its pivotal trial, focused on Application I, was
underway. Mediclever’s assessment discovered that if the company proceeded
with the current Application I, the likelihood for reimbursement was low and might
only be granted in five to ten years at a considerable investment. On the other
hand, if the company used the same device for Application II, immediately upon
receipt of the CE mark, the device would be reimbursed at a lucrative rate.
Obviously, the company realized that by continuing with Application I, the
company would probably not survive to reach profitability. Consequently, the
company abandoned Application I and is currently selling its product, under
existing reimbursement mechanisms, for Application II.

2. Reimbursement DOs and DON’Ts Page 2/3
UK: 27 Old Gloucester St., London WC1N 3AX
uk@mediclever.com +44.208.099.7435
Israel: 6 Te’ena St., Modiin 71799
il@mediclever.com 050.837.1711
Remember: Your reimbursement strategy could affect the first application of your
product.
3. Do – Leverage your clinical trial(s) to gather reimbursement related data.
Don’t – Focus only on the regulatory aspects.
Real life example: Company D developed outstanding clinical data for their
product and invited Mediclever to help them develop specific reimbursement
mechanisms for it. All Payers that Mediclever approached were impressed by the
developed clinical ‘evidence’, but wanted the company to also present data
regarding a few economic aspects. Since these economic aspects were not
observed during the company’s previous clinical trial, the company had to perform
a new trial to gather the requested data. Had the company thought about its
reimbursement strategy prior to initiating the clinical trials, those economic aspects
could have been easily integrated into their previous trials making the investment
in a new trial, and the delay in the sale of their product, redundant.
4. Do – Develop your regulatory and reimbursement strategies in parallel.
Don’t – Think that since regulatory clearance comes before obtaining
reimbursement that this is a serial process.
Real life example: Company E asked Mediclever to start working on its
reimbursement strategy after applying for, and receiving, the regulatory clearance.
Unfortunately, the wording that was used in the application substantially
decreased the likelihood of reimbursement. Consequently, the company re-
applied for the regulatory clearance, this time, with a modified indication for use.
Needless to say, this delayed the launch of the product resulting in substantial loss
to the company.
Remember: Short regulatory path ≠ optimal reimbursement.
These real-life examples can help you avoid these common mistakes, reduce costs,
and reach the market sooner.
To verify the existence of relevant reimbursement mechanisms for your product in
the US or any European country, to develop and implement an appropriate
reimbursement strategy and for any additional questions, please contact:
Amir Inbar, CEO
Mediclever Ltd.
www.mediclever.com
amir@mediclever.com
About the Author:
Amir Inbar founded Mediclever, which provides a cost-effective solution to
manufacturers of medical technology products interested in obtaining
reimbursement for their products in the US and Europe.

3. Reimbursement DOs and DON’Ts Page 3/3
UK: 27 Old Gloucester St., London WC1N 3AX
uk@mediclever.com +44.208.099.7435
Israel: 6 Te’ena St., Modiin 71799
il@mediclever.com 050.837.1711
As an expert reimbursement consultant Amir has consulted for organizations
ranging from incubator startups to large, publicly traded companies, resulting
in reimbursement for their products in the US and across various European
markets.