The traditional ‘best of breed’ approach to departmental systems in Life Sciences is losing popularity. That’s as a more comprehensive ‘platform’ approach enables greater flexibility, adaptability, and interoperability including data sharing. But change can feel onerous so it’s important to develop a strategy that’s both future proof and non-disruptive to your organization. fme’s professional services team can help you strike the right balance.

All organizations are striving to be more agile, productive, and cost-efficient, and none more so than those in the Life Sciences industry where the pressure to adapt and change is constant. And as long as individual business functions, such as Regulatory, Clinical, Quality, and Safety, continue to operate in silos using their own systems, data and document formats to fulfil their respective business processes, costs and complexity will increase rather than diminish.

Challenging the status quo can feel daunting, but Life Sciences organizations have limited choice about this. For many years, the ‘best of breed’ approach to deploying technology promised organizations optimal functionality as well as protection from single-vendor point of failure. But as data exchange and flow between teams and external parties (such as Regulatory agencies and outsourced partners) has grown in strategic importance, the pressing priorities now are platform and data standardization, simplification, and unification. A single, holistic platform approach is also ultimately easier and more cost-efficient to run and manage.

That’s not to say that any one software vendor has 100% of the functionality a Life Sciences company needs. The leading platform players, with a well-established end-to-end business capability, probably get close to ~90% while supporting the integration of peripheral elements such as submission publishing or specific IDMP components to provide full coverage.

This offers companies something to aim for, even if they do this incrementally via a phased approach.

Triggers for change: M&As,  persistent pain points, new regulations

The best roadmaps for digital transformation allow for steady, manageable progress toward a simpler and more flexible future, while delivering (relatively) easy wins along the way.

There are many triggers that can initiate a technology change.

• A company merger inspires a more modern IT solution stack
• The incoming company in an acquisition has a mature business application platform and business process
• New industry regulations compel function-specific changes that are too onerous to apply

When these opportunities present themselves, the important thing is not to make another siloed decision, but to work toward a more modern, harmonized, and agile future state.

For instance, if Regulatory demands are becoming overwhelming, platform-based transformation could start here – applied initially to registrations (core data about licensed products), and archived submissions (aligned to that data). A next phase can then progress to content authoring, review, and approval process management.

Once Regulatory processes have been migrated to a modern cloud platform, companies can look to prepare Clinical, Quality, and Safety data and business processes for migration to the same core platform. Then each can access and add to the same core/master data set – enabling a unified platform.

One of the powerful benefits of tackling platform-based system modernization incrementally is that it presents the chance to bring people along on the journey. Teams have to opportunity to learn what works and what doesn’t, and refine features, processes, and capabilities along the way.

To ensure that any new system- and data-based decisions move the company in the right direction, and reap maximum returns, it’s important to be methodical in setting and following a strong overarching platform strategy.

We recommend:

• Establish the right mindset and gain leadership commitment and buy-in to a long-term platform-based technology and data management strategy.
• Start with a thorough ‘Phase 0’ assessment and gap analysis across the interlinked lines of business (Regulatory, Clinical, Quality, and Safety) to establish what’s possible and the level of work and investment that will be needed. This process could take 6+ months, depending on the size and complexity of the organization and its portfolio, and the current level of digital maturity.
• Bring in the right talent, both externally in terms of vendor and systems integrator/IT services support, and internally so that there are subject matter experts on the client side. These SMEs are essential to work with external providers to help confirm an appropriate roadmap and determine the investment in time and skills that will be needed on both sides to ensure success.

Benefits of a platform roadmap

A strategic platform roadmap will provide substantial guidance and benefits over time. With the support of an established modern, cloud-based platform, business functions will start to behave like well-oiled machines, optimized in their process management and ability to re-use the latest data on demand. Because cloud-based platforms are updated frequently, teams will be ahead of and less reactive to changes such as Regulatory updates as these continue to occur in the interests of patient safety and enhanced patient experiences.

The same goes for scope to add new functionality and incorporate the latest technology advances. A recent example is the emerging capability of AI solutions at they become more accessible, relevant to, and proven in Life Sciences processes.

Additionally, phased approach to modernization, as part of a longer-term single-platform strategy and roadmap, means that the business will encounter minimal disruption. There is an opportunity to socialize, mature and optimize new functionality so that it works well for everyone. Crucially, no new and costly legacy dead-ends will be created.

How fme can help

fme’s team of Life Science experts can support the entire end-to-end digital transformation experience. This starts with providing deep Life Sciences industry-specific business and IT deployment experience and best practice guidance to help shape the right long-term platform strategy via our Business Consulting team. We then provide full technical implementation, integration, and comprehensive migration services supported by a rich toolkit of solutions accelerators that are exclusive to fme.

We are a client-focused provider dedicated to your success. We partner with all of the major Life Sciences platform solution providers, so we are able to provide recommendations and services that meet the unique needs of your company with the most effective solution, and work in partnership with your own IT team.

Once the new platform is live, we also provide an intense ‘Hypercare’ package combining full business, technical and administrative support, as well as appropriate change management and training. Finally, we provide exceptional post-implementation managed services with fme PlatformAssist™ to maintain your environment through application updates, process improvement and daily support.

To learn more about our full range of services, and to discuss your specific requirements, contact us today. We’d love to help you establish your long-term roadmap to technology and business success.

Related Links

• fme Life Sciences Overview
• ECM Platform Services for Life Sciences
• fme Vendor and Solution Partners
• fme Life Sciences Posts

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.