Column – Tackling Go-To-Market Challenges

The medical device industry is entering an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is published somewhere in the world. Overall, this equates to 22,000 new or updated regulations each year, a 150% increase in regulatory obligations over the past five years.

Managing this rate of change is a daunting task for life sciences organizations, especially those with global operations. Regulatory professionals cannot afford to miss changes that may require updated applications, new certifications, or additional product reviews. Moreover, to be successful in that role, we must go beyond regulatory details, apply the text to our product range, observe industry and regulatory developments, anticipate changes and take steps ahead of our competitors and regulators. You have to go ahead.

Patient safety requirements, political shifts, regulatory shifts, and definitional differences have a profound impact on the underlying market regulation and strategic planning processes in life sciences. And they remain outside the organization’s direct control. However, by deploying a connected intelligence system on a global scale, the team can weather go-to-market challenges by increasing the transparency and predictability of the complex and diverse global product registration process.

Key challenges facing global regulatory professionals

Global product launches are milestones for even the largest life sciences organizations. In addition to the business benefits of expansion, the introduction of medical devices and therapies into new markets will enable more patients to access the valuable and potentially life-saving treatments they need. .

However, we all know that a global launch presents some key challenges, including:

Intersecting influences of patient safety, politics and economicsThese three factors, alone or in combination, can have a significant impact on a country’s regulatory approach. Medical device regulations may change due to his one event such as Brexit, or ongoing trends such as a growing backlog of applications in underfunded offices. Health authorities can make life easier by approving mutual recognition agreements. You can also create a hurdle by regularly reclassifying common devices. Whatever the cause, the result is the same. Increased complexity for regulatory professionals.

Geographic differences in review processes and timelinesReceiving approval in the United States or the European Union (EU) is an important step forward, as many countries require a stable product to be launched in the country of manufacture before they can begin the registration process. That said, it is not uncommon for other countries to require additional document reviews or additional technical, toxicological and clinical activities. In Australia and Saudi Arabia, submission and review can take as little as three months for low-risk products. Also, in countries such as Brazil, Russia and China, where local product testing, toxicological testing and clinical activities are required, it takes 1-3 years after obtaining the CE mark. (And assuming all goes according to plan).

subscribe medical technology intelligence A weekly newsletter to keep you up to date with the latest news and information on medical device development and regulation.

Geographic differences for product-specific requirementsWhat is called a medical device in one country may be considered a non-medical device or drug in another. Regulations and technical standards may vary from country to country, and may also have different product-specific requirements for mechanical devices, software tools, chemical compounds, or combination products. Different standards have different product design and submission data requirements that are reviewed during product registration. This can easily turn into a product design input and data management nightmare.

Fluctuations in regulatory submissions based on many factorsRegistration pathways vary dramatically depending on whether local governments require local legal entities/nationals to act as product registered owners and/or importers. It depends on factors such as class, intended use, etc. Finally, differences in new and re-registration requirements may influence the type of submission strategy chosen.

Learn design with product registration in mind

Valid words for the above task are changeNaturally, health authorities employ registration and approval processes that make the most sense for both citizens and businesses operating within our borders. A one-size-fits-all global approach may prove impractical and unfeasible, especially given the broader political and economic factors behind national regulations.

As a result, life sciences organizations considering global product launches are challenged by the differences between product design inputs and registration submission requirements, the resources needed to meet them, and the timelines needed to meet market requirements. must be kept in mind.

Organizations can design with product registration in mind by adopting the following five steps:

define the scopeIt is important to start with the end in mind. Which countries are you targeting? What is the launch order for each country? How do I register? The sooner an organization can answer these questions, the easier it will be for regulatory teams to coordinate intersecting submission workflows for specific products.

Identify global inputs. Once the registration pathway is planned, determine the necessary registration requirements for each governing body. As previously mentioned, regulatory complex markets may have different technical, toxicological and clinical documentation needs. Identifying these inputs early in the product launch process streamlines data collection and reduces errors.

Communicate decisions transparently. Even the best of plans fail. Especially when unforeseen political upheavals or economic conditions affect governing bodies. If you need to change your regulatory submission process, the impact must be communicated quickly and clearly throughout your organization.

know the market. Regulatory teams must build relationships with customers and stakeholders in each country they plan to do business with. This includes health authorities, third-party regulatory and quality agencies acting on behalf of governments, dealers and other commercial and operational partners. Having these points of contact helps your organization know who to contact when problems arise to avoid unnecessary delays.

adjust expectations accordingly. Realize that a typical US or EU launch takes 2-3 years, and a global launch takes another 3+ years. One way to streamline this timeline is to retain submittals and other resources throughout the product lifecycle. This reduces duplication of effort and allows product design requirements from highly regulated markets to be incorporated as early as possible in the research and development phase. New product design.

The value of connected intelligence technology

While these steps may seem like a tall order, Connected Intelligence is poised to play a pivotal role in facilitating the process. Connected Intelligence brings together curated data on health authority requirements segmented by regulatory activity, product type and product risk class, with insights and expertise from subject matter experts across the organization.

Connected intelligence can drive automation of transaction processes, including submission form details. Control what you can control, such as various submission deadlines and other regulatory activities. Doing so allows regulatory professionals to focus their efforts on high-value activities across the spectrum of activity, ensuring product registration submission data is complete, accurate, and up-to-date.

Supporting regulatory professionals with clear processes and connected intelligence will ultimately enhance global product lifecycle activities. This benefits life sciences companies by reducing the risk of redoing flight registrations and increasing confidence in global product launch dates. It will also benefit our partner healthcare professionals by providing faster access to the latest medical equipment. This reduces the time patients wait for treatments that improve their results and quality of life. Ultimately, the benefit to the healthcare community is the ability to deliver safe and effective products/clinical solutions in efficient and optimized timelines.