Automated storage and retrieval, secure, cloud-based monitoring, RFID based tracking, an app to check status! Is Amazon, UPS or FedEx rolling out a brand-new logistics system for fleet tracking or better still, tracking your packages?! Or is it a diabetes management system being rolled out by your primary care provider?

We are referring to TMRW’s new Digital Platform for IVF (In Vitro Fertilization) clinics and cryobanks! This transformational initiative has been featured in 2022 as #2 amongst the Top 10 of PMI’s Most Influential Projects in the Biotech Industry, and #48 amongst 50 projects overall (click to read more: TMRW Digital Platform | PMI Most Influential Projects 2022)

TMRW Lifesciences Inc., founded in 2018 and headquartered in New York, is a Life Sciences technology company that focuses on transforming the field of IVF. It has created Digital platforms that cater to both clinics and patients, to safely ensure managing and tracking specimens (embryos and eggs), using robotics and 24/7 monitoring of systems. TMRW’s customer base primarily consists of IVF clinics and cryo-banks, apart from launching its own specimen management facilities.

But first, some basics:

• IVF or In Vitro Fertilization refers to a series of procedures to help with fertility or prevent genetic problems and help with conception of a child (click to read more: Mayo Clinic— Overview of IVF). During IVF, mature eggs are retrieved and collected from ovaries, and fertilized by sperm in a lab. Then they are transferred to a uterus.
• “Cryo-banking” is an all-encompassing term for a clinic that collects and stores human tissue for later use (click to read more: What is a Cryobank?). This can include donor sperm, eggs, umbilical cord blood, stem cells, and embryos. These can be stored for multiple years until a patient is available who may use the IVF method to conceive a child.

Why does the IVF ecosystem need this transformation?
What are the typical risks which TMRW mitigates with its platform?

• The growing demand for fertility treatment has led to a large increase in frozen specimens being managed by clinics, resulting in a need for specimen management for tracking, identifying and monitoring (Mihalia, 2022)
• Eggs and embryos that are part of the IVF process are delicate and need to be handled carefully, both in storage and when retrieved and transferred to facilities for the procedure. The TMRW system leverages its CryoRobot Select, a Robotics platform to provide digital labeling and tracking, retrieval and storage of specimens, eliminating manual handling of specimens.
• Manual handling and tracking of specimens could lead to errors like the wrong specimen being used for the IVF procedure with disastrous results for the clinic including Litigation — TMRW’s software platform has features like automated workflows that also integrates with the patient’s EMR to ensure no double entry.
• Reactive systems — TMRW’s 24/7 monitoring over the cloud watches over the specimens and allows the facility to take proactive action against temperature changes, fire or other hazards in the storage area which could potentially harm the specimens.

From a Project Management perspective, for rolling out such a complex set of systems which the IVF ecosystem could leverage, a DTO (Digital Transformation Office) team would have been established. The Digital Transformation team consisting of Project Managers, Solution Architects, Quality & Regulatory Affairs and Business stakeholders at TMRW would have had to consider multiple challenges – such as re-imagining current business processes that were manual and archaic, then conceptualize and architect solutions that mitigate these challenges, conduct clinical trials to clear regulatory and compliance hurdles, and finally employ change management techniques to ensure a smooth rollout across its customer base.

Multiple Project managers leading multiple teams working in an Agile methodology would have worked closely, overseen by the DTO to ensure requirements capture, system and software design and implementation, testing and user acceptance, clinical trials and incorporating feedback in close coordination with the Quality & Regulatory teams, which would have ultimately led to FDA / other regulatory authorizations that enabled launch of the system successfully. In essence, impactful Digital transformation driven by the core tenets of project management!

References:

1. Mihaila, Sorina (2022) - Femtech World news related to FDA clearance for TMRW’s Automated platform (click FemtechWorld)

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