XLOS Clinical Laboratory Digitalization:

A Strategic Investment business plan

Presenter: Satya CHILLA PhD
Content and Necessities
1. Assessing the Current State-approach

2. Implementing the Digitalization Process

3. Defining the Digitalization Strategic methodology
4. Action Team and Strategy development
5. Timelines for Infrastructure and IT Assessment

6. A tentative budget to Invest for initialisation of Project

7. Long-Term Assessment and Investment Potential

 Assessing the Current State-Approach
Understanding Laboratory Data Flows

SWOT Analysis
Data Flow Analysis
Comprehensive assessment of current Evaluating strengths, weaknesses,
data flows, processes, and tools within opportunities, and threats in the
the laboratory. current data management
processes.

Identification of Bottlenecks
Pinpointing areas of inefficiency and Perceived Complexity
redundancy that can be streamlined through
digitalization. Addressing the fear of
complexity and time
investment required to learn
new systems.
 Implementing the Digitalization Process-opportunity
OPPORTUNITY DETAILS OPPORTUNITY BACKGROUND Required tools Estimated budgets
1. through LIMS, ELN, Cloud
1. Digitization working style
• Workplace eQMS 1. 20k-100k/year licensed-cloud
2. Creating a domain server for report centralize
2. Upgrade the instruments (0,04€/GB) per region
• Documentation the results reporting status 2. Based on the accessibility of big
• Quality control 3. Quality reporting in the view of customer 3. data analytical tools data analysis tailored for
• Data Integration 4. Supply and vendor management 4. Data management multionics (reports, analysis,
Digitalization • Connectivity 5. Stockage and sample retains 5. ERP, SAP base management tables and CMC data sheets)
6. GMP or cGMP perspective
• Security
• Collaborations ▶Website update with data
I. Customer accessibility-usage protocols accessibility
▶Possible to maintain internal
II. Business visibility ▶Analysis status and timelines
servers by data management-
visibility
▶Opportunity to III. Ease of access and transparency Human resources and equipment
IV. Governance centralization ▶Big data expenses need to consider
materialization is management(internal/extern
dependent to Castle al/ cloud)
core IT being separated.
▶Culture adaptation Top to
▶Digital adaptation is Expected Benefits:
Specifics - Quick access to data down
time taking process. ▶Employe engagement
▶Clarification/ - Process optimization(occupancy,
▶Balance in work style ▶ Can be benefited through office tools
maintenance, consumables)
Information requests ▶Software for schedule
taking time - Intangible benefits management(ex: book it or
- Big view to change control google forms MS Office)
 Digital operations Strategy methodology

Strategic tasks

Operations & Digital work package DWP Network

allocations
Customer product Lifecycle Identity and
Support Management Access DC LAN Site LAN-WLAN
Work space Management

Documentation User Application Managed Scheduling

Management meeting rooms instruments Firewall Cloud Storage

Data Analytics

process Lab data

Cloud interface DATA Analytics Monitoring &
Data Data Automation
CDMS managing
Services
integrity Compliance scheduling portal
Tooling Management
software
Reporting sys(LDMS)

Equipment
management
Collaboration Universities/ DC & Cloud, On premise
Hospitals Big data agencies Owned DC
partners analytics data access Hosting DC
Security

Security compliances EU GMP annex

Collaborations ISO 17025 GDPR 21CFR Part 11
11 /ESP/USP/
 Action Team and Strategy Formation
Team Assembly (executive & Pilot Phase Implementation
strategic team)

Building an action team to define Insights from the Pilot

and execute the digitalization Sharing the valuable insights gained from the pilot
strategy. phase and how they inform the larger strategy.
Timeline Establishment(Objective Ex: Work space, instruments upgrade, automation)
based)

Taking a comprehensive approach to Agile Approach

plan data flow optimization and tool
upgrades. Discussing the benefits of an agile approach to
gradually expand the digitalization process.
Ex: eQMS, data analytics(based on instruments)
Feedback and Communication

Highlighting the necessity of a Early Adopters as Ambassadors

feedback mechanism to ensure
Leveraging early adopters to promote and support the
understanding and encourage
digital transformation within the organization.
debate.
-Trainings, process optimi., invest intangible benefits
Timelines for Infrastructure and IT Assessment

Deliverables in 13 months of initial pilot phase:

✓ Definitions of Clinical lab testing requirements
✓ Mapping of business processes and gap analysis
✓ Selection of laboratory information management system(LIMS)
✓ Executive summary of overall digitalization strategy with timeline and
milestones;
✓ Requirements and specification documents (SRS and SDS)with wireframes for
the online webplatform
✓ Proof-of-concept of the online webplatform.
 A tentative budget to Invest for initialisation of Project

Digitalization of clinical lab settings Program Budget Worksheet

DIRECT COSTS
1. Personnel (if applicable)
% Effort
dedicated to this Institutional
Description study expenses(yearly)€ TOTAL
Total FTE cost 10,00 10.000,00 € 100.000,00 €
establishment expenses(computing, cloud, network..etc) 1,00 50.000,00 € 50.000,00 €
SUBTOTAL 150.000,00 €
2. STUDY/LAB SUPPLIES - (no office supplies)

Description Unit Cost # of Units TOTAL

Automation, ELN, LIMS, Data analytics 1.500,00 100,00 € 150.000,00 €
Web platform 500,00 50,00 € 25.000,00 €
Tranings-unit per person 10,00 1.000,00 € 10.000,00 €
SUBTOTAL 185.000,00 €
3. ANALYSES & REPORTS
Description Unit Cost # of Units TOTAL
CDMS, ERP, LDMS, Audits
Consultation expenses(h)
850,00
360,00
10,00 €
250,00 €
8.500,00 €
90.000,00 €
• The initial budgets should encompass
SUBTOTAL 98.500,00 €
comprehensive expenses for addressing gaps and
4. Mapping and change control system COSTS - Use budget detail sheet
Value will transfer automatically from budget sheet
SUBTOTAL
1.000,00 €
0,00 €
1.000,00 €
mapping the process control for full or partial
DIRECT COSTS – SUBTOTAL SUBTOTAL 433.500,00 € automation
•
OVERHEAD RATE (%) SUBTOTAL 0,00 €
Based on strategic vision, knowledge collaborations
5. Pilot phase START UP FEES - (No Overhead)
Description TOTAL
can be developed which would impact marketing
Protocol Development
IRB/IEC/AEC Fee - Initial Review
5.000,00 €
0,00 €
budgets
Pharmacy setup/start up
Transport
0,00 €
5.000,00 € • Considering magnitude of company the knowledge
SUBTOTAL 10.000,00 €
6. OTHER FEES - (No Overhead) collaboration involvement can be developed for
Description Unit Cost # of Units TOTAL
Fee - Annual Review
Protocol Maintenance-status quo
3.000,00 €
0,00 €
obtaining subsidies from state governments or
Pharmacy dispensing
Advertising
0,00 €
25.000,00 €
institutional investments
Other (Specify) 0,00 €
SUBTOTAL 28.000,00 €

TOTAL BUDGET 471.500,00 €

 Long-Term Assessment and Investment Potential
Identifying Pressing Needs
Long-Term Performance Evaluation

Highlighting the long-term benefits of Focusing on departments with urgent

digitalization in improving laboratory business needs that digitalization can
performance. address.

Investment Opportunity Continuous Improvement

Presenting digitalization as a strategic Emphasizing the need for ongoing

investment opportunity for efficiency process improvement and adaptation
and competitiveness. to new technologies.

ROI Considerations

Evaluating the potential return on

investment when prioritizing
departments for digital
transformation.
Roadmap for Digital Transformation Agility
Effectiveness
Security
Efficiencies
Value

Enable New Products

Experience, and Service Innovation
Faster Time Strengthen in
to Value
process control
Continue
Sustainable and progression, Proactively innovate to improve
Reduced Risk business, culture the value proposition
• Systematic approach for continued service,
advocacy for changes and improve efficiency
• Identify optimization process, opportunities to
transform service. Develop collaborations
Future
Focus on
Benefits Proof(Pilot)
Foundation

• Transition Workplace, Equipment, Service desk, Network and Cloud Services

• Secure operations and training internal, customer services
Remove
Complexity

Time
Ongoing Services

10 Services Transition Continuous Improvement