The past quarter century has witnessed a remarkable expansion of the medical devices industry.
It’s driven by the rapid gains in science and engineering. Breakthroughs in the miniaturization of key electronic components have allowed small devices to be packed with functionality that was impossible just a few years ago.
Furthermore, fundamental biomedical, clinical, and bioengineering research aided by raw science and mathematics has made more innovative types of medical devices possible.
Along with the advent of a burgeoning number of medical devices has come an all-new level for the regulatory system.
Government oversight groups –- the FDA in the case of the United States –- are responsible for reviewing and approving all pharmaceuticals and medical devices that “reach inside” the human body to effect positive outcomes.
The amount of bureaucracy and paperwork associated with the regulatory and approval process is staggering. The process itself is monumentally complicated. It’s a situation that prompted a new category of software designed to navigate and streamline the process, called RIMS software.
RIMS stands for Regulatory Information Management Systems. This software tool is focused on handling the regulatory process and requirements to achieve official approval to sell a medical device product on the global market.
Note that RIMS is used for other newly developed medical products as well, such as biologics and pharmaceuticals.
RIMS software is used to:
a. Manage regulatory production data and handle product dossiers.
b. Assist with the preparation of product submission/regulation forms.
c. Manage the overall submission process that leads to approval by regulatory agencies.
Keep in mind that med-tech firms market their products globally. Meeting the complex and bureaucratic process of the American FDA is just one hurdle. New products must also meet the complicated and often significantly different regulatory requirements of dozens of other nations.
It’s not uncommon for a medical device to be used in more than 100 to 150 different countries, all with their own specific compliance and regulation process.
International authorities recognized this challenge which led to an effort to “harmonize” the regulatory compliance issue in a way that could be uniform across national boundaries.
This effort was the mission of the ICH — the International Council for Harmonization of Technical Requirements for Human Use medical devices and pharmaceuticals.
While this was a leap forward for med-tech firms, the regulatory situation and approval process remains overly complicated by its very nature, harmonization efforts notwithstanding.
For example, out of the ICH effort came what is known as the CTD – the Common Technical Document, but it is complex itself. The CTD consists of five modules. Four of these CTD modules are standardized across all international agencies, but one module varies by country or even geography within a country.
Again, this points to how important it is to have a powerful tool — RIMS software -– to navigate and streamline all the “must-do paperwork.”
Just a few examples of the functions RIMS software perform include:
a. Identifying the specific product information needed by international regulatory agencies.
b. Collects information into dossiers.
c. Manages the dossier to account for variations in requirements across all global agencies.
d. Automatically creates client submission forms/documents.
e. Provides highly transparent oversight of the origin and lifecycle of submissions.
f. Adjusts to the size and complexity of the candidate med-tech provider.
g. Creates and tracks submission documents across appropriate gateways.
h. Manages changes and revisions.
And much more.
Just as medical device technology is a rapidly evolving sector, the regulatory side has grown along with it to bring all-new challenges. The burden of compliance has never been greater and shows an upward arc of momentum.
It’s not just the approval and compliance process itself. Med-tech firms are realizing new costs associated with planning, anticipating new regulations, defending the execution of their product and marketing strategies, forecasting outlays and efficiencies, and much more.
There is the potential for violations to consider. That may come with fines or sanctions. All medical/pharmaceutical firms face unparalleled risks in terms of lawsuits associated with patient outcomes.
RIMS software is at once a superb proactive tool in getting to the finish line of the approval process and a hedge against the potential problems or errors made along the way.
Getting compliance right is critical. Delays for approval can be extremely costly and potential regulatory failure could be deadly. Making sure that this process is streamlined and compliance measures are met is essential.