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If you have ever been in the process of purchasing an electronic Quality Management System (eQMS) for your MedTech company, you know that it can be both an overwhelming and intimidating task.
Many MedTech eQMS companies claim identical value propositions regarding compliance with applicable MedTech regulations (such as 21 CFR 820, ISO 13485, ISO 14971, EU MDR/IVDR, etc.), and offering similar functionality for managing data, documents, training, quality events, etc.
Since selecting an eQMS is a significant decision that you and your company will have to live with for many years, conducting due diligence and “shopping around” to ensure that you get the best solution for your team and your needs is critical.
In a market with several providers with seemingly interchangeable offerings, the challenge emerges: how do you ensure you’re making the right selection?
Beyond the standard checklist of functionalities, what critical questions should you pose to yourself and the eQMS provider?
This blog post aims to dissect these considerations, providing you with a roadmap to bolster your decision-making process and increase the likelihood of choosing an eQMS that not only meets your current requirements but anticipates your future needs, ensuring enduring satisfaction for you and your team.
Planning for eQMS Success: Immediate Needs vs Future Growth
If you find yourself currently in the market for an eQMS, it is likely that you are grappling with challenges related to document management, data handling, and internal processes. These challenges, whether stemming from the absence of a system or the sense that your current system is inadequate or outgrown, are prevalent issues faced by both small and large MedTech companies.
While it’s crucial to address immediate pain points, it’s equally important to look into the future and what your needs are likely to be then. Collaborating with your internal team and projecting where your company will be in the coming years is essential.
This foresight ensures that the eQMS you invest in not only resolves present issues but also aligns seamlessly with your trajectory of growth and expansion. To effectively capture both current and future needs, approach your eQMS purchase by cross-functionally outlining the requirements for your business.
Begin by identifying your current needs and extending the list to accommodate future business expansions. Consider factors such as team growth, new products, product pipeline extensions, expansion into new clinical areas, scaling manufacturing, increased product distribution, expansion into global markets, and the establishment of multiple corporate sites.
Failure to adopt a long-term perspective may result in outgrowing your eQMS, impeding organizational progress and necessitating a system replacement down the line. Such a transition can pose significant challenges for your business, leading to major disruptions and potential non-compliance during the shift from the old system to the new one — an often tumultuous phase.
Therefore, seek an eQMS solution that scales alongside your organization, providing functionality for both pre-commercial activities and efficient support for commercialization and business growth.
This ensures that your chosen eQMS remains a valuable asset throughout your company’s evolution, preventing the need for a disruptive overhaul as you navigate the complexities of growth and compliance.
Streamlining eQMS Implementation: Minimizing Disruptions and Maximizing Efficiency
Implementing a new eQMS is a substantial endeavour, and the time and effort required by you and your team should not be underestimated. Whether you’re transitioning from an existing solution or introducing an eQMS for the first time, tasks such as software validation, document & data migration, and team training can become significant distractions, tying up critical resources that could be allocated to other vital aspects of your business.
To mitigate this impact, seek solutions that are pre-validated, quick to implement, and provide a user interface (UI) that is both intuitive and easy to grasp. When it comes to validation, most eQMS systems necessitate validation activities on your end, a process that, if unfamiliar, can prove overwhelming, frustrating, and time-consuming.
Despite claims of some providers offering “out-of-the-box” solutions, customers typically need to conduct a certain level of validation to ensure compliance with regulatory requirements.
Understand the validation requirements imposed on you and your team during implementation, and be aware that software updates from the provider may prompt additional validation efforts, especially if changes affect your validated state. Essentially, for a system that isn’t fully pre-validated, anticipate managing ongoing validation efforts continuously.
Ultimately, the goal is to minimize distractions for your team, enabling your business to allocate resources where they truly matter, rather than on a cumbersome and prolonged eQMS implementation that demands ongoing maintenance.
Evaluating the Stability and Reliability of Your eQMS Provider
As emphasized earlier, the commitment to an eQMS should be a forward-looking decision, considering it as the foundation for operational efficiency and a platform supporting company growth.
Therefore, the selection of an eQMS is essentially a long-term partnership with a provider that will influence your operations for years to come. Given the significance of this relationship, it’s imperative to look beyond the product during the selection process.
Equally, if not more important, is the eQMS provider’s reliability, responsiveness, and commitment to your success. Many MedTech eQMS providers, often considered startups, may have commendable software, but smaller companies inherently carry a higher risk than well-established ones.
The genuine concern that your eQMS provider might cease operations for various reasons in the future should not be disregarded. In such a scenario, not only would you be left without a system to manage your processes, but there’s also the potential loss of all your documentation and data.
This situation has the potential to not only set you back several years at best but also, at worst, lead to the termination of your company. There are various ways to assess a provider.
For publicly traded companies, scrutinizing annual and quarterly reports can offer insights. For private companies, the evaluation process might be more challenging. Checking news articles, conversing with former employees, consulting various industry stakeholders about the company’s reputation, and leveraging platforms like Glassdoor are valuable methods to gauge the provider’s health.
Additionally, request customer references — ask for a list of at least five and choose two or three to interview. Be cautious, as some eQMS providers may pay consultants or companies to speak favourably about them.
When engaging with references, inquire about their likes and dislikes regarding the software, as well as the level of service and responsiveness they experienced when encountering issues. Red flags include extravagant promises upfront and a subsequent lack of delivery in both product and service after onboarding.
Differentiated MedTech eQMS: Beyond Standard Functionalities
As explored earlier, the MedTech eQMS market has many providers presenting seemingly comparable solutions, emphasizing the need for product differentiation. Beyond the essential functionalities such as document management, change control, training, customer complaint handling etc., the focus shifts to identifying distinctive features among products.
Providers that introduce unique functionalities not only showcase innovation but also strive to deliver enhanced value to their customers. An additional critical consideration involves evaluating whether the provider outlines a clear functionality roadmap.
This scrutinizes their commitment to introducing new features and functionalities in the future. Given the ever-evolving nature of the MedTech industry, characterized by dynamic regulations and intensified global competition, the ongoing updates and improvements of your eQMS are paramount.
While certain software providers may have roots in general software development, the unique characteristics of the MedTech industry underscore the importance of providers possessing deep industry knowledge.
Individuals who have direct experience within the industry and have encountered challenges at different stages of growth are better equipped to develop a differentiated eQMS that genuinely supports your success over time. Moreover, the most reliable providers engage actively in the MedTech community, seamlessly incorporating industry best practices into their systems.
Their proactive approach ensures they stay ahead of the curve, consistently identifying and implementing new functionalities as the market evolves. Another critical aspect is pricing and the payment model. Exercise caution with contracts that involve multi-year agreements and staggered pricing.
Committing to such lengthy contracts could result in frustration if the solution proves unsatisfactory, leaving you and your team discontent for years. An alternative model, exemplified by QuickVault, involves monthly payments through a credit card, offering a customer-friendly approach that helps manage cash flow and eliminates the risk of being tied to an eQMS for an extended period.
When gauging product differentiation for optimal team support, it’s imperative to transcend mere functionality. Consider the provider’s delivery model, community, industry engagement, and the quality of support offered. Premium providers set themselves apart not only through functionality but also through various elements contributing to the overall success of your team.
Choosing an Innovative MedTech eQMS Provider
In the ever-evolving landscape of MedTech regulations and industry dynamics, the imperative for innovation is more pronounced than ever. As global competition compels MedTech companies to swiftly navigate the commercialization of new technologies, these considerations become pivotal in the selection of a MedTech eQMS.Viewing your eQMS provider as a strategic partner is paramount.
Assess how the provider plans to update and enhance software functionality over time, ensuring that it not only keeps pace with regulatory changes but also positions you with the most cutting-edge solution.
Recent instances include adaptations to the new EU MDR/IVDR and the FDA’s mandate for all 510(k) submissions to be conducted within their eSTAR program. Leading software providers, particularly in the realm of MedTech eQMS, exhibit a commitment to continuous improvement and the integration of additional functionalities.
They actively participate in communities and ecosystems, staying at the forefront of industry changes. In the context of MedTech eQMS, seek a provider acknowledged as a thought leader, demonstrating profound and extensive industry engagement through diverse channels. Crucially, the best eQMS providers prioritize customer feedback, using it as a pivotal input for ongoing enhancements.
Recognizing that your success hinges on the functionality of your eQMS, both today and as your operations expand underscores the importance of a provider that not only listens but constantly evolves to meet the evolving needs of your organization.
In Conclusion
Exploring these five key considerations for selecting a MedTech eQMS equips you with the knowledge to pose insightful questions and identify a solution that not only meets your current needs but also scales seamlessly with your growth.
It is essential to conduct thorough due diligence by engaging with multiple MedTech eQMS providers and posing challenging questions. This approach guarantees great alignment between the product and the provider, ensuring robust support for your team both in the present and as you navigate future growth.Â
Your investment in a MedTech eQMS should be a strategic partnership, and by adopting a diligent selection process, you’re better positioned for sustained success and innovation.
Axel Strombergsson, Vice President, QuickVault
