Technical
advances and innovation in design within the medical devices industry have
prompted regulatory authorities to update the laws governing various aspects of
the development, manufacturing, design and approval of such products. Further,
it is imperative that various stages of medical device development and
production are closely monitored and regulated in order to avoid serious and /
or life-threatening consequences. In this regard, several regulatory agencies
and organizations across the globe have established standard operating
protocols, regarding the sale and use of these devices. Reimbursement
is another integral aspect to the successful sale and distribution of medical
devices. Similar to regulatory compliance, healthcare authorities require
continued clinical and economic data collection, such as observational studies
and cost benefit / use analyses, as well as dissemination of the information
collected in deciding reimbursement for medical devices. Presently, almost
every country has its own regulatory authority, which issues guidelines to
regulate the development, distribution and reimbursement of medical devices. Such government-sponsored initiatives
also oversee licensing, registration, manufacturing, marketing and labeling of
medical devices within their respective jurisdictions. Therefore, it is crucial
for a developer to understand and comply to the evolving regulatory environment
in order to successfully market its offerings.
General Regulatory and Reimbursement
Guidelines for Medical Devices
The introduction of a
new medical product in the market involves extensive medical communication,
reimbursement, and continued compliance with regulatory requirements. These are
critical elements of the business planning process and therefore, each area
requires early planning. Significant amount of time and effort is required to
obtain approval from a regulatory body, however, clearance alone does not
guarantee a revenue stream. Majority of the payers and providers now require stakeholders
to demonstrate both clinical and economic value of their new products owing to
the fact that lack of appropriate strategies to understand the economics of the
healthcare marketplace can relegate a potentially successful, innovative
technology to commercial failure. Thus, preparations should begin early in the
product development process; development of a comprehensive strategic regulatory
and reimbursement plan can help stakeholders to identify economically
attractive indications and market opportunities.[1],
[2]
Table 5.1 provides the general guidelines for market authorization and
reimbursement of medical devices.
Table 5.1 General Guidelines for Market
Authorization and Reimbursement for Medical Devices
S. No. |
General Guidelines |
Description |
1 |
Identify and train Key Opinion Leaders (KOLs) |
KOLs are usually physicians or clinical investigators similar to a
medical advisory board. Keeping such individuals informed about the product
and making them familiar with the use or applicability of the product helps
build a strong roadmap for facilitating reimbursements and / or obtaining
other regulatory requirements. |
2 |
Collect and organize data to demonstrate profitability / clinical
value to payers |
In case of both government and private payers, the decision-making
process is governed by evidence-based medicinal standards. In addition to
that, insurers opt for a cost-effectiveness analysis (CEA) to gauge the
financial aspects of a particular product. It has been established that
clinical trials, though important; may not necessarily evaluate the economic
aspects required to prove the product’s cost-effectiveness. Hence, it is
extremely important to focus on providing evidence for both cost-effectiveness
and clinical efficacy. |
3 |
Focus on publications to communicate clinical information |
Insurers constantly seek reliable information and therefore, are known
to value data published in reputable, peer-reviewed journals. In order to
address this aspect of publicising, it is important to build an effective
publication strategy. Some of the important points to be considered while
building such a strategy are: § § § |
4 |
Relationships with specialty medical societies[3] |
Specialty medical societies, such as the ones listed by the American
Medical Association (AMA), have a strong influence in the reimbursement
process and therefore, working closely with an appropriate medical society
can help build support and trust potential buyers. |
Source: https://www.nature.com/bioent/2003/030601/full/bioent738.html,
https://www.rcri-inc.com/developing-effective-reimbursement-strategy-build-will-come/
It is worth
highlighting that in order to ensure the robustness of design and manufacturing
processes, as well as product quality, several industrial standards have been
established that need to be followed by stakeholders involved in the
manufacturing process of products (including medical devices). Further, these
industrial standards play an essential role to protect the product
conformations and harmonize the respective national / international regulatory
requirements. There are several management standards, which are applicable to medical
device manufacturing. The most prominent standards have been listed below:[4]
§
§
§
§
§
There have
been some modifications in the industrial standards that is likely to impact
the medical
device manufacturing in coming years. These changes have been highlighted
below:
§
§
[1] Source: https://www.nature.com/bioent/2003/030601/full/bioent738.html
[2] Source:
https://www.rcri-inc.com/developing-effective-reimbursement-strategy-build-will-come/
[3] Specialty medical societies influence the
coding and payment processes and also present the financial interests of their
constituents to organizations, such as Centers for Medicare and Medicaid
Services (CMS) and AMA. For a list of specialty medical societies and links to
their websites, please refer to AMA's web page
[4] Source: https://www.nqa.com/en-us/certification/sectors/medical-devices-services
[5] Source:
https://certification-experts.com/deadline-implementation-iso-134852016-quality-management-system/
[6] Source: https://www.emergobyul.com/blog/2018/11/iso-14155-third-edition-preview-role-risk-management-clinical-investigations