And there are more challenges realted to the laboratory space:
Paper-based lab systems and/or disconnected systems are still predominant and make sharing and leveraging existing knowledge difficult
Working on a global scale with products developed, manufactured and tested all over the world adds extra complexity to collaboration and exchange of data and methods
Tech Transfer between different domains is key for real digital transformation but it is hindered by a lack of integration and difficult collaboration
Increased competition from generics as well as the significant discounts of 27 to 49% on the list price of drugs demanded by the governments are driving margins down and require budget cuts in all areas. This means that although laboratory operations are expected to deliver more results quicker with less resources they need to reduce costs.
Only 2 of every 10 marketed drugs produce revenues that meet or exceed development costs. This demands streamlining operations related to the R&D processes which includes the lab.
Compliance pressure from all agencies like the FDA are increasing which requires more non-value added steps also in the laboratory not only in the execution but also the documentation of the tests performed. Data integrity must be proven.
The lab very often is considered as a bottleneck. Research scientists are waiting for results on product characteristsics, development needs the results on methods and specifications, manufacturing is waiting for the testing results of raw mterails to be used int he prodcution process as well as the certificate of analysis for final product release. But processes are often manual, disconnected and require time consuming and costly review steps.
So what are the sources of of these challenges in the laboratory space?
A lack of integration will always lead to manual steps in the processes which lead to a high likelihood of errors. Many different applications are also difficult to configure and cumbersome to maintain.
When processes, methods and data are not standardized collaboration becomes more difficult and past knowledge impossible to access. A lack of standardization always means high efforts for compliance.
Due to the heterogenity of instruments and methods in the lab, analysts have to deal with a plethora of different data formats that cannot easily be shared and leveraged.
A challenge is also the accessibility of the data. When data is locked away in various systems and applications that are unable to communicate with each other, access to those data becomes impossible. And scientists cannot re-use the data for further analysis, learning from past experiences and for knowledge-driven decision making.
With many different systems and applications in place the likelihood of overlapping capabilities is high. This is unnecessary and adds to high costs. It will also create frustration for the users that cannot work in a straight forward way.
The next generation is incrementally better but not game changing
We can use tablets to enforce the correct procedure is followed,
Instruments can be connected to eliminate transcription and enforce compliance
Barcode scanners can be used to record materials and there associated expiry information
This Enforced compliance is good from a compliance standpoint but this requires conscious actions that take time away from the science.
The technology for the physical devices is progressing rapidly enabling futuristic lab capabilities.
Identification has progress from handwritten labels, to 1D barcodes to QR codes to RFID all the way to Near field communication
Biometric ID has progressed from fingerprints to retinal scanning, to Biorhythmic Bluetooth bracelets
Additional “gadgets” provide the ability to virtually merge physical and metadata seamlessly on an augmented display. Over the years, augmented displays have progressed from science fiction to Google Glass type devices.
Enabling the Lab of the future – or should I say the Labrador of the future?
Motion control started in gaming with the gyroscopic WII controller, progressing to leap motion all the way to the Kinects style sensor with servo tracking and video sensing of the motion.
“method under glass” with integrated direct data capture to database