fme AG
fme SRL
From continuous diabetes monitors to wearable blood pressure gauges, smart hearing aids and Wearable Cardioverter Defibrillators (WCDs), academic spinoffs and medical technology startups are devising a whole host of intelligent aids to keep patients safe and improve their quality of life. But getting products to market and developing a robust exit plan relies on responsible teams being ahead of regulatory demands.
The market for smart medical consumer devices, already worth tens of billions of dollars annually, is growing and evolving sharply. These devices, also known as “wearable health tech” or “medtech devices”, are products designed to monitor and manage various aspects of an individual’s health and wellness. This includes fitness trackers, smartwatches with health monitoring features, connected scales, blood pressure monitors, glucose monitors, and more.
The rising popularity of such products is the result of a number of converging developments. First, people are becoming more conscious of their health and are seeking ways to monitor and manage it themselves – they see the potential to use technology to keep themselves well. Continued growth in fitness tracking and wellness monitoring has driven the demand for devices that can provide real-time data on activity levels, sleep quality, heart rate, and more.
At the same time, huge advances in smart digital capabilities (including connected sensors), and easier access to advanced data capture and AI-enabled analytics (e.g. cloud-connected devices), have finally made these devices technologically possible. Many wearable health devices are designed to sync with smartphones, so users can track their health data conveniently and receive personalized insights.
But all of this smart technology needs to be reliably enabled, and regulated to ensure patient safety.
Regulatory Requirements for Medtech Innovation Companies
Many of the latest medtech innovations are coming out of academia, young biotechs or incubation hubs. For these creative, science-led teams, it can be quite a leap to progress from having a promising idea for a new wearable device and coordinating its manufacture to bringing a compliant product to market, to preparing a viable business entity for sale.
When most of the strategic focus is on the innovation, and on the potential impact on patient outcomes and quality of life, it can be easy to overlook the systematic rigor and data housekeeping that will set the venture in good stead and smooth the new device’s path through licensing approvals and/or due diligence as part of an exit plan.
Starting off on the right foot is always advisable. It’s vital to ensure that initial “make-do” practices don’t have to be unraveled later in favor of something more robust, consistent, and compliant with the demands of regulatory bodies in current and future markets.
Put another way, it is never too early to adopt established industry best practice. This includes implementing an appropriate regulatory information management (RIM) system or platform that can keep the right records of product detail, in a format that is compatible with the requirements of health authorities.
Collecting data and structuring it correctly is a critical first step. Providing meaningful insights to users is important too, which means having access to appropriate algorithms and software that can analyze the collected data and present it in a way that is comprehensible and actionable. Other challenges for manufacturers include differentiation in a growing market that is attracting a lot of attention. The sooner developers can bring their products to market, the greater their chance of securing commercial advantage.
Addressing these market preparation challenges requires a multi-disciplinary approach. This will need to combine expertise in medical technology/electronics, the optimal user experience, regulatory affairs, appropriate software selection, and compliant data capture and management.
How fme Can Help
As a Life Sciences data and technology service specialist and business consultancy, fme is ideally positioned to help smart medical devices developers ready their propositions for market; or for sale to an investor or commercial entity.
From initial strategic consultancy, regulatory advice, and business transformation services, to help selecting the right RIM platform provider and preparing and organizing the right data, we provide the full range of guidance and implementation expertise to smooth the path to market.
We also help master the complexity between Hardware (Devices), Electrotonic (Sensors) and Software which is typical for smart devices (see Prof., Porter: How smart connected products are transforming competition) especially in the context of validation.
We can advise on and provide tailored services around:
- Individual regulations in target markets
- Required system capabilities
- Data scoping, structuring, migration, and analytics
- Standard operating procedures
- Systems validation/quality management
Because we know the Life Sciences industry so well, and what’s needed to foster the right data delivery and data practices, we’ll help you maximize the payback on your product innovation and associated investment. fme can also support the necessary Sales Transformation, as selling Smart Medical Devices is different than selling just Smart Devices.
Crucially, we are vendor independent which means we’ll provide technology and data recommendations that fit the exact needs of your organization.
To discuss your specific needs with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.