Joanna Jackson
Senior consultant, Regulatory Affairs
Julia Selmani
Senior consultant, Regulatory Affairs
Many businesses aim to expand and diversify their medical device markets to generate additional revenue while spreading risk. Despite the global regulatory environment for medical devices being diverse and complex, opportunities for expansion exist. However, if managed incorrectly, this expansion can lead to costly administrative activities with little or no return on investment.
So, what is the best way to optimize market expansion to secure revenue, both now and in the long term?
There are three key elements to defining a business case that will hold up over time:
• What is the market potential?
• What are the upfront costs of registering the device?
• What are the ongoing costs related to regulatory maintenance?
Below, we will review the main points to consider for each of these elements, giving extra attention to the third element, as it is often neglected.
Considering the customer base is important, even for unregulated markets without existing product registration requirements. This is due to the trend of implementing regulations. Many markets that previously accepted FDA approval or a CE mark have implemented their own approval processes. While FDA and CE certifications often facilitate a smoother and quicker approval process, they no longer guarantee approval.
Conducting solid market research is a crucial part of the business case:
• How large is the potential customer base?
– Have you considered competitor medical devices and competing technologies.
• Is reimbursement possible?
• How stable are the market and its economy?
– Can you rely on the order estimates and currency value?
Even with an excellent dossier prepared for CE Mark or FDA approval, you may face significant additional requirements. Some countries, such as Russia and China, have their own country-specific standards. These typically require in-country type testing. The classification of your device is also key, as it determines many associated certification costs.
Examine if any of the following are required and find out the specific associated costs:
• Device classification
– Registration fees
– Product certification
– Local quality certification (i.e., an ISO 13485 Certificate is not sufficient)
– Type testing requirements (including in-country requirements)
– Resources (internal/external work hours)
• Requirements for a local representative
• Translations and country-specific labelling requirements (note that some countries require more than one language)
This aspect is often neglected in business cases. Including this element in your calculations will significantly reduce the risk of incurring long-term costs not matched by product sales.
• Change notifications/submissions
• Product renewals
• Quality certification renewals
• Monitoring to stay compliant.
– Requirements may change over time.
• Costs related to import/export requirements.
• Service/Repair requirements (when applicable)
Markets differ in how sensitive they are to changes and how burdensome the change process can be. Product and quality certification renewals also vary in complexity and frequency. It is important to know, not only how demanding the process is but also how often it is required.
Monitoring to stay compliant applies to both regulated and unregulated countries. Many countries have implemented their own approval process in the past 5-10 years where previously there were no regulations or an acceptance of FDA approval or the CE Mark.
Costs related to import/export requirements vary, so potential tariffs/customs duties related to existing trade agreements should be considered when estimating long-term marketing costs.
Service and repair obligations, regulated by law or tender agreements, detail how many years of service/maintenance must be provided after the last device is placed on the market. The national law in some countries stipulates a service/repair requirement of 10 years.
To optimise market expansion and secure revenue:
• Ensure there is an adequate and stable customer base for your product.
• Consider all costs associated with getting the device registered.
• Estimate the costs associated with keeping the device on the market.
Entering new markets should be based on strategic business decisions supported by strong market research conducted by the company and industry-based advisors.
We at Key2Compliance are a diverse team of medical device specialists who can translate your business case into concrete actions, including a Regulatory Strategy.
