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Ensuring the Success of Your Lab Informatics Project with the Astrix Approach™

The failure rate of Lab Informatics Projects is notoriously high. A recent survey by cloud portfolio management provider Innotas found that over half of businesses surveyed had experienced a lab informatics project failure within the previous 12 months. For any business considering a laboratory informatics project, this is not an encouraging statistic.

How does one determine that a lab informatics project has failed? There are, in fact, a number of key metrics that should be used to determine success or failure:

  • Delivered on time
  • Delivered within budget
  • Meets or exceeds requirements
  • Provides business value
  • High level of user adoption

Success in laboratory informatics projects can be particularly difficult to achieve, due to the complex processes and technologies utilized in labs, and the many different aspects of the enterprise that laboratory systems touch. Laboratory informatics projects often require significant investments of money, resources and time. A LIMS implementation, for example, can cost a company hundreds of thousands to millions of dollars, and require hundreds of labor hours to implement.

There are many reasons why laboratory informatics projects fail. Some of the most common ones include:

  • Inadequate personnel resources to meet project demands
  • Selected the wrong system for your organization
  • Lack of stakeholder (e.g., management) buy in
  • Project goals not aligned with business goals
  • Too much reliance on in-house IT (i.e., failure to obtain resources with the required skill sets)
  • Too much focus on cost at the expense of value
  • Not following a proven methodology
  • Insufficient budget allocation
  • Poor planning for future state of the business
  • Unrealistic expectations about what is to be delivered and when
  • Poor project management

In today’s highly competitive business environment, failure of a laboratory informatics project is simply not an option. Astrix Technology Group has spent the last 20+ years helping scientific organizations implement and integrate new informatics systems into the laboratory. In this article, we will discuss the Astrix Approach™ − a comprehensive and proven methodology that can help you avoid the above-mentioned reasons for project failure and ensure the success of your laboratory informatics projects.

The Astrix Approach™

One of the biggest mistakes companies make when starting an informatics project is to not do the strategic planning necessary to ensure success. The first step in any informatics project should always be a thorough workflow and business analysis.

Business Process Analysis

Laboratory informatics projects often fail because functional and strategic needs are not aligned. Instead of trying to implement a system that is based only on your current workflows, why not implement your project in a way that optimizes your business? As Intel’s CIO, Kim Stevenson, recently commented, “There are no IT projects, only business projects”.

The Astrix Team starts every laboratory informatics project off by meeting with the customer’s management team to discuss the project at a high level and understand the goals, aspirations and objectives of the desired future state (i.e., strategic needs). This is followed up with interviews of bench-level analysts in different laboratory groups (e.g., incoming materials, in-process testing, final release, QC/QA, etc.) to produce current state (AS-IS) Visio workflow diagrams.

In the next stage of the analysis, the Astrix team creates a model of the future state (TO-BE) workflows based on our experience and the customer’s strategic needs as expressed by the management team. Finally, a detailed Requirements Matrix with prioritized opportunities is detailed in a collaborative fashion utilizing the Astrix Laboratory Requirements Database™. Once the future state requirements are determined, it’s time to move on to the next stage of the process.

Enterprise Architecture and Roadmapping

For large organizations implementing complex laboratory informatics systems such as LIMS, ELNs, and scientific content management systems (SDMS), creating a fully-integrated environment can be a very complex undertaking. Integration requirements often include laboratory devices and instruments that need to be connected to laboratory systems, which are in turn connected to enterprise systems.

The Astrix Approach™ focuses on a targeted slice of the Enterprise that includes the total laboratory informatics ecosystem. A collaborative evaluation of the current state architecture is performed that details how the technology (applications, information systems, instruments, etc.)  currently fits together and supports the objectives of the business. This assessment looks at:

  • Functions & security
  • Core entity structures, user-defined entities
  • Workflow events
  • Customization/extensions
  • Reports
  • Instrument and system interfaces

Application portfolio rationalization is performed, and a future state architecture is designed, along with a strategic roadmap to deployment that is aligned with business goals. Items considered in this process may include:

  • Cloud Strategy/Deployment
  • Data Monetization
  • Big Data Strategy/Deployment
  • Internet of (Laboratory) Things Strategy/Deployment

In some cases, transitional architectures are designed to bring business value forward as opposed to waiting for payback until the vision is fully implemented.

Technology Selection

Once the enterprise architecture has been designed and a roadmap for deployment is in place, it is time to select the informatics system(s) that is the best fit for your business and technology requirements. After reviewing the finalized requirements and project budget, the Astrix Team develops a customized list of vendors for consideration utilizing the Astrix Vendor Database™ (a proprietary database of vendors offering solutions to the analytical laboratory community).

With the vendor list in hand, the Astrix Team works with the customer to develop an RFP (Request for Proposal) that is sent out to all vendors on the list. After reviewing the RFPs, the Astrix Team assists the customer with scoring the RFPs and helps guide the selection of the short list. Vendors on this short list are then invited to demonstrate their product to the customer.

The Astrix Team assists the customer in creating the demonstration scripts and score sheets, and works with the customer to evaluate each product in order to determine which one is most suitable for the customer’s business. Finally, the Astrix Team assists the customer in negotiating a contract with the selected vendor to ensure it includes the scope, budget, and assurances required (feasible implementation schedule) for the vendor to successfully implement the system.

System Development, Implementation and Integration

System Development, Implementation and Integration is the nuts and bolts of any informatics project. In this phase of the project, Astrix professionals dig into the chosen solutions and work to actualize the planned architecture in a way that satisfies user and business requirements. Key features of the Astrix Approach™ in this phase include:

  • Avoid Customizations Unless They Are Really Required – Astrix professionals work to avoid costly and time-consuming customizations by configuring the technology solution’s out-of-the-box features to meet customer requirements when possible.
  • Iterate the Implementation – The Astrix Team takes an iterative approach to system implementation, with the first iteration being the minimum viable solution to go into production with. Once this minimum solution is operational, users can provide feedback as to the pain points that they are experiencing, and then decisions can be made as to whether it makes sense from a financial and time perspective to customize the system to provide further automation.
  • Focus on Data Migration Early in the Implementation – Issues with migrating data from a legacy system into a new one can significantly increase project costs and delay timelines, especially if they occur late in the implementation process.
  • Create a System Map – For regulatory and future maintenance requirements, the Astrix team creates a detailed map of the system installed and/or the changes to the system in use (upgrades) that were made during the project – database fields created, code created or modified, integrations and interfaces, workflows configured, etc.

Computer System Validation (CSV)

Once the system is successfully installed, it must be validated to ensure it is working as expected. Validation of computer systems is required by most regulatory agencies around the world in order to confirm data accuracy and integrity in systems so that product safety and effectiveness is ensured. CSV is required when either making a change in a validated system (upgrades, patches, extensions, etc.), or configuring a new system.

Astrix professionals are experts in IT risk identification and management, and work to create CSV processes that are based on applicable regulations and guidance, best practices for the domain, and the characteristics of the system being validated.

Managed Services

Once your system is implemented and validated, it must be managed effectively to ensure a long-term value contribution to your organization. Astrix Managed Services for laboratory software and hardware removes the hassle of managing your own laboratory devices and informatics systems, allowing you to scale your business more effectively – we tailor the level of service to your needs, and you only pay for what you use. Astrix Managed Services can be especially beneficial for organizations with cloud-based systems.

Our Managed Services model is integrated into your organizational structure, responsive to your business needs and strategy, and adaptable to change. Depending on the service model implemented, Astrix will provide dedicated support processes that may include project managers and nearshore/offshore support to reduce costs. All our Managed Services include a contractual Service Level Agreement (SLA) that serves to guarantee an appropriate level of service.

Change Management

An often-overlooked key to a successful informatics project is user adoption. If users resist learning and using the new system and continue to use their paper-based processes, all the time, effort and money that went into the project was wasted. The Astrix Team has extensive experience creating user training classes that are designed to educate users on the value of the new system, as well as provide the training they need to easily incorporate the system into their workflows.

Scientific and Technical Staffing

Effective collaboration between the customer and consultant is critical to the success of any informatics project. As such, it is important that the customer assign key internal personnel with active knowledge of current systems, workflows and architecture to work with the external consultant before, during and after implementation. Unfortunately, this tends to be challenging, as these personnel typically have very demanding jobs and lack the ability to devote sufficient time to the project to ensure its success.

Unlike other companies that offer only professional services, Astrix offers a Scientific Staffing Division that is uniquely positioned to handle any internal staffing challenges that arise during a laboratory informatics project. With 32 full-time recruiters on staff and over 20 years of experience in laboratory informatics, Astrix is uniquely positioned to drive your informatics project AND help you solve any staffing challenges that may arise during the project.

Conclusion

A combination of effective project management, adequate financial and personnel resources, and a proven methodology is vital to the success of IT projects. Utilizing the Astrix Approach™ described above, the Astrix Team leverages our extensive scientific domain knowledge and technology expertise to ensure the success of your laboratory informatics project. Our accomplished consultants also have a wealth of experience across various organization types, helping to ensure that business-specific needs, along with industry and regulatory requirements, are taken into consideration on your project.

In addition, Astrix provides nearshoring options to support competitive pricing strategies for all our services. Astrix nearshoring offices provide expert informatics consulting across the full range of scientific informatics professional services described above. In addition, the Astrix nearshoring offices are located in time zones similar to the U.S. mainland, allowing our nearshoring teams to easily attend conference calls during local business hours, or travel on-site as needed to work with clients.