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 blockbuster oncologic.
Task: JANA Life Sciences was tasked to develop JBSs associated with over 200 training curricula while conforming to Training Within Industry (TWI) methodolgy.
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: A medical technology company designed and developed a state-of-the-art protein analysis machine using laser technology. They needed instructions associated with the use of both the hardware and the software.
Task: JANA Life Sciences was tasked to develop two separate User Manuals, one for the Hardware and the other for the Software.
Action: Within approximately 14 weeks, new pages were developed, existing pages were revised, images were incorporated or revised, and tables were developed to the specifications and style guide of the company.
Result: The project entailed approximately 250 pages of documentation in all.
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 pgs.) 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-architected 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.
CAPA MITIGATION
Situation: A Fortune 50 life science company needed support in addressing a series of issues associated with their manufacturing environment, distribution process and warehousing operations.
Task: JANA Life Sciences was tasked to describe the problems, assess their known impact, conduct a root cause analysis (using 2 approaches: 5 Whys; Machine, Method, Material, Manpower & Environment), and to propose mitigation/action plans. In addition, JANA reviewed source data that included Investigation Reports, PR attachments, SOPs and Work Instructions.
Action: JANA 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 will help improve product quality, study efficiency, and operational efficiency.
DATA MANAGEMENT (CLINICAL)
Situation: A mid-sized pharmaceutical company needed to understand and then clearly convey across their ranks information related to their clinical studies, including the associated vendors, key contacts, processes, and systems.
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: We distilled information from dozens of interviews and over a hundred data sources that included Word, Excel, PowerPoint and Visio documents into a single Excel workbook with a ‘master data sheet’. We developed and refined dozens of business process maps, and much more.
Result: Members of the company for the first time had a clear and comprehensive view of their clinical projects as well as related vendors and systems (and data flows), which will support regulatory requirements and enable their IT group to better architect information solutions within the company and with their collaborators.