The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over the last five years.
Managing this rate of change is a tall task for any life science organization, and it’s especially daunting for entities operating globally. Regulatory professionals can’t afford to miss changes that may require updated applications, new certifications or additional product reviews. What’s more, to succeed in their roles, they need to look beyond the fine print of regulations to apply the text to their company’s product ranges, observe industry and regulator trends, and anticipate changes to stay a step ahead of the competitors and regulators alike.
Patient safety requirements, political changes, regulatory variations and differing definitions have a strong impact on underlying market regulations and strategic planning processes in life sciences. And they remain largely outside of an organization’s direct control. However, by deploying connected intelligence systems at a global scale, teams can navigate go-to-market challenges by increasing the transparency and predictability of the complex and divergent global product registration processes.
Key Challenges Global Regulatory Professionals Face
Global product launches are a milestone for even the largest life science organizations. In addition to the business benefits of expansion, introducing medical devices and therapies to new markets ensures that more patients can access the valuable and potentially life-saving treatments they need.
It’s no secret, though, that global launches present several significant challenges, including:
The intersecting influence of patient safety, politics, and economics. Alone or in combination, these three factors can heavily influence an individual country’s regulatory approach. Medical device regulations can change because of a single event, such as Brexit, or an ongoing trend, such as a growing backlog of applications in an underfunded office. Health authorities can make life easier by endorsing mutual recognition agreements, or they can create hurdles by routinely reclassifying common devices. Whatever the cause, the effect is the same: Increased complexity for regulatory professionals.
Geographic variation in review processes and timelines. Receiving approval in the U.S. or the European Union (EU) is an important step forward, as many countries require a stable product launch in the country of manufacture before their registration process can start. That said, it’s not unusual for other countries to require additional documentation reviews or additional technical, toxicological and clinical activities. These timelines rarely match; submission and review can take as little as three months in Australia or Saudi Arabia for lower risk products, and one to three years post CE mark in countries such as Brazil, Russia and China where local product testing, toxicological testing and clinical activities may be required (and assuming all goes to plan).
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Geographic variation in product-specific requirements. What one country calls a medical device could be considered a non-medical device or a pharmaceutical by another country. Regulatory and technical standards can vary from one country to another and there may be variations in product-specific requirements when it comes to mechanical devices, software tools, chemical compounds, or combination products as well. With varying standards comes varying product design and submission data requirements that are reviewed during product registration. This can all too easily turn into a product design input and data management nightmare.
Regulatory submission variation based on numerous factors. Registration pathways vary dramatically depending on whether a local government requires a local legal entity/national to act as the product registration holder and/or importer. Likewise, submission processes vary based on factors such as product type, risk class, and intended use. Finally, the variation in requirements of a new registration versus a re-registration can affect the type of submission strategy that is chosen.
Learning to Design with Product Registration in Mind
The operative word in the challenges described above is variation. Health authorities have understandably adopted registration and approval processes that make the most sense for both their citizens and the companies operating within their borders. A one-size-fits-all, worldwide approach would likely be impractical and unfeasible particularly when the broader political and economic drivers behind country regulations are considered.
As a result, any life science organization considering a global product launch needs to be mindful of variations in product design inputs and registration submission requirements, the resources necessary to meet them and the timelines required to meet market requirements.
Embracing the five following steps will ensure that an organization is designing with product registration in mind.
Define scope. It’s important to begin with the end in mind. What countries are you targeting? What is the launch sequence in each country? What is the registration pathway? The sooner an organization can answer these questions, the easier it is for regulatory teams to orchestrate the intersecting submission workflows for a given product.
Identify global inputs. Once registration pathways are mapped out, it’s time to determine the necessary registration requirements for each governing body. As noted above, technical, toxicological and clinical documentation needs are likely to vary in high regulatory complexity markets. Identifying these inputs early in the product launch process will streamline data collection and reduce errors.
Communicate decisions transparently. Even the best-laid plans will go awry—especially if unanticipated political upheavals or economic conditions impact governing bodies. When regulatory submission processes have to change, impact must be quickly and clearly communicated throughout the organization.
Know the market. Regulatory teams should develop relationships with customers and stakeholders in each country they plan to do business. This includes health authorities and third party regulatory and quality agencies acting on behalf of the government, along with dealers and other commercial and operational partners. With these contacts in place, organizations know who to contact when issues arise to avoid unnecessary delays.
Adjust expectations accordingly. Recognize that a typical launch in the U.S. or EU will take two or three years, with another three years or more needed for a global launch. One way to streamline this timeline is to retain submission documentation and other resources throughout the product lifecycle—which cuts down on duplicative efforts—and build in product design requirements from the high regulatory complexity markets as early as possible in the research and development phase of a new product design.
The Value of Connected Intelligence Technology
Taking these steps may seem like a tall order, but connected intelligence is poised to play a pivotal role in easing the process. Connected intelligence brings together curated data about health authority requirements, segmented by regulatory activity, product type, and product risk class, as well as insights and expertise from subject matter experts throughout the organization.
Connected intelligence makes it possible to drive automation in transactional processes, such as the minute details of submission forms; and control the controllables, such as the wide array of submission deadlines and other regulatory activity. By doing so, regulatory professionals can focus their efforts on high-value activities across their range of activities and ensure that product registration submission data is complete, accurate, and up to date.
Supporting regulatory professionals with clear processes and connected intelligence ultimately enhances global product lifecycle activities. This benefits life science organizations by reducing the risk of having to re-work inflight registrations and bringing increased confidence to global product launch dates. It also benefits the healthcare practitioners they partner with, by providing faster access to the latest medical devices. In turn, this ensures that patients spend less time waiting for treatments that improve outcomes and quality of life. Ultimately, the benefit to the healthcare community is the provision of safe and effective products/clinical solutions in an efficient and optimized timeline.