3D modeling & 3D ANIMATION of a heart transport device
Situation: A medtech startup with a state-of-the-art heart transport system (for use in association with transplants) needed a 3D model/video demonstrating the device.
Task: JANA Life Sciences was tasked to complete this 3D Modeling effort within 8 business days working from basic photos of the prototype and rudimentary SolidWorks elements.
Action: From graphic artwork to 3D modeling and associated renderings, we performed all the work in house. We even weighed in on the overall look and feel of the product and designed the associated carrying case from scratch.
Result: The CEO and team members couldn’t have been more pleased with the outcome!
The VP.S ENCORE® Device, with patents pending, has received a Breakthrough Device Designation from the FDA. The VP.S ENCORE® is a device that can be modified to eventually extend the preservation of other organs and vascularized tissue. Future uses include the use of ex vivo therapies, and ideally provide a foundation for organ banking. The VP.S ENCORE® device has not yet been approved by the FDA. https://www.vascularperfusion.solutions/
JOB BREAKDOWN SHEETS (JBS)
Situation: A global life science conglomerate needed to improve its training of factory workers responsible for producing both medical supplies and a series of pharmaceuticals, including major CNS and oncology drugs.
Task: JANA Life Sciences was tasked to develop JBSs associated with over 200 training curricula while conforming to Training Within Industry (TWI) methodology.
Action: JANA team members were trained in TWI, and then shadowed operators and supervisors over several months. SOPs and Master Batch Records were reviewed together with other source data. Using state of the art image capture for video and photographs, the JANA team used the Training Within Industry (TWI) methodology for the JBSs. In the process of producing this procedural documentation meant to facilitate and accelerate training, SOPs and Batch Records were reviewed.
Result: The project entailed producing well over 1,000 pages of ‘technical’ documentation in all, broken into ‘digestible pieces’ associated with over 200 processes. JBSs were developed to the specifications and style guide of the company. The JBSs will facilitate and accelerate training, in part because of the visual components (i.e., video and photographs).
Multi-Media Technician Training
Situation: A medtech division of a global conglomerate sought support in bringing their in-house training programs to the ‘next level’. With a state-of-the-art robotic radiotherapy surgical system, they aspired for a training program leveraging multi-media while incorporating aspects related to augmented reality.
Task: JANA Life Sciences was tasked to conceptualize, develop and present a program centered on the repair of their ‘workhorse’ system. This involved writing the storyboard and script as well as developing 3D models (working from their primary model) and associated renderings. In addition, JANA orchestrated and conducted video and photo shoots and did extensive animation work for the project.
Action: Within 6 weeks we completed the entire effort and developed a mixed media training program associated with helping technicians identify and replace a motor within the robotic surgical system.
Result: The leadership lauded the effort.
Instructions FOR Use (IFU)
Situation: JANA Life Sciences collaborated with a pioneering medical technology company to develop comprehensive documentation for their state-of-the-art protein analysis machine. The project involved creating two comprehensive manuals: a Hardware Manual and a Software Manual, leveraging Structured Data Development to enhance documentation efficiency and user experience.
Task: JANA Life Sciences was tasked to develop high-quality documentation to enhance user satisfaction and drive product adoption. JANA produced both manuals in alignment with industry standards, such as S1000D and DITA, while ensuring compliance and best practices.
Action: JANA Life Sciences employed a structured approach to documentation development, involving the creation of comprehensive manuals that provided clear and concise instructions for the hardware and software components of the protein analysis machine. Their Structured Data Development capabilities ensured that the documentation was organized, easily accessible, and searchable, enhancing the overall user experience. The analysis revealed that the documentation developed by JANA Life Sciences was effective in supporting the successful adoption of the protein analysis machine. The manuals provided users with clear and concise instructions, enhancing the overall user experience. The use of advanced tools and technologies in Technical Authoring & Illustrating ensured that the content was both informative and visually engaging.
Result: The partnership between JANA Life Sciences and the medical technology company resulted in the development of comprehensive documentation that supported the successful adoption of the protein analysis machine.
Laboratory Information Management System (LIMS) Validation
Situation: A biotech conglomerate (with 7 subsidiaries) custom designed and developed a LIMS integrated with several databases, a series of instruments, a software program, a reporting engine, a customer order-entry portal and numerous peripherals. They needed the entire ‘ecosystem’ validated and a User Manual produced in 8 weeks.
Task: JANA Life Sciences was tasked to develop the entire validation plan (IQ, OQ, PQ) and qualification data sheets for the core system as well as that related to connected databases, instrumentation, peripherals and reporting. In addition, we were tasked with creating a User Manual.
Action: Within 8 weeks we completed the highly complex validation effort and developed a comprehensive User Manual (~150 pages) for five different functions (Lab Tech, Lab Mgr, QA, Customer Operations, SuperUser).
Result: The Vice President of the company lauded the effort, which enabled the system to Go Live as projected.
Website Development – Full Stack (i.e., Front & Back End)
Situation: A life sciences organization came to JANA with a WordPress website that required a significant overhaul in part because a handful of different developers worked on it over 15+ years. The overall look and feel of the website was severely outdated and the navigation system was in disarray. The website contained multiple databases, and the corresponding information had not been entered in a uniform manner.
Task: JANA was tasked to revamp the website, and in the process rationalize the associated code and information, which included over 17,000 articles, 3,629 studies, and approximately 2,500 images and videos.
Action: Over a five-month period JANA’s team compiled and analyzed its Google analytics, surveyed its user base, interviewed key stakeholders, assessed ‘competitive’ sites, and developed personas and mood boards together with Figma wireframes. JANA also managed and created graphics and images used in the website.The JANA Team even helped with branding and messaging throughout.
Result: The website was completely re-coded and re-built from the ground up, and a myriad of elements were streamlined while search & SEO were greatly enhanced. The resultant website is not only more clean, modern and intuitive for users, but also easier for administrators to manage.
enhancing operational efficiency through CAPA Mitigation
Situation: A leading life science company faced operational challenges in their manufacturing environment, distribution process and warehousing operations. The company’s operational challenges were driven by a combination of factors, including inadequate processes and procedures.
Task: JANA Life Sciences, a trusted partner in providing Technical Data Services and Data Management Consulting Services, offered Corrective and Preventive Action (CAPA) mitigation services to address these issues. The project involved conducting thorough root cause analyses, proposing effective mitigation plans, and reviewing source data, which included Investigation Reports, PR attachments, SOPs and Work Instructions, to ensure compliance with regulatory requirements.
Action: JANA employed a structured approach to CAPA mitigation, involving root cause analyses, mitigation planning, and review of source data. recorded all findings and conclusions in a standard template covering 5 key areas (Initiation, Data Collection, Impact Investigation, Root Cause Analysis, CAPA Information) provided by the customer.
Result: The result of the work performed identified constraints, resulted in processes being clarified and/or refined, and helped establish clear goals for improved product quality and operational efficiency.
data/Content Strategy & Content management
Situation: A mid-sized pharmaceutical company recognized the need for a more robust content strategy and structured data development framework to streamline their operations and ensure compliance with industry standards.
Task: JANA Life Sciences was asked to create a clinical “playbook” to enable the company to readily understand their study portfolio and to see the connections between their studies, vendors and systems.
Action: JANA employed a structured data approach to address the client’s challenges. We conducted extensive interviews with key stakeholders and reviewed numerous data sources to distill the necessary information. We created a comprehensive ‘master data sheet’ and developed business process maps to clarify the connections between studies, vendors, and systems, thereby enhancing their Technical Documentation Management. The analysis revealed that the company’s existing data management practices were fragmented and inefficient. The implementation of a structured data management system, coupled with an in-depth data analysis, enabled the company to improve their operational efficiency, reduce costs, and drive business growth.
Result: The outcome was a significant improvement in the company’s technical documentation management capabilities and its ability to manage their clinical projects, related vendors, and systems through optimized Content Strategy and Process Optimization.