Overview of Universal Safe Magnetic Validation Study (LS Adaptive Hana Fasteners™)

Project title: Universal Safe Magnetic Validation Study (LS Adaptive Hana Fasteners™), covering polyphase coded magnetic technology in hospital patient gowns and recovery wear.

Summary: This study generates the empirical evidence and technical documentation needed to demonstrate that LS Adaptive’s patented Hana Fasteners, the magnetic closures that restore one-handed, independent dressing, do not produce hazardous magnetic fields for patients with cardiac implantable electronic devices (CIEDs). It combines computational finite element analysis (FEA) with NIST-traceable bench testing to characterize the unique field profile of polyphase edge-magnetized magnets and to establish safe separation distances.

Research focus: Applied electromagnetics and magnetic-safety characterization. This includes 3D magnetic flux density mapping, distance and angular field attenuation, and measurement uncertainty quantification (GUM, k=2). The work culminates in a technical file, a risk assessment, and Instructions for Use suitable for hospital procurement and biomedical-engineering review. The study involves no human subjects.

Target population: People with limited dexterity, including stroke survivors and people with arthritis, Parkinson’s, MS, spinal cord injury, limb difference, or age-related decline, who depend on adaptive apparel. The study is especially relevant to the subset who have cardiac implants and are currently excluded by the lack of magnetic-safety documentation. Validation removes a key barrier to deploying adaptive gowns and recovery wear across hospitals and rehabilitation settings.

Our Ask

We are seeking support to fund and advance the Universal Safe Magnetic Validation Study, an independent technical validation of LS Adaptive’s patented Hana Fasteners™ (polyphase edge-magnetized coded magnets). The study will document that these fasteners are safe for patients with cardiac implants (pacemakers and ICDs) when used in hospital gowns and recovery wear. Northeastern University has agreed to perform the study under Prof. Nian X. Sun. Our primary ask is research funding of approximately $105,000 (range $85,000 to $140,000), directed to Northeastern University, to cover FEA model validation, NIST-traceable bench testing, risk assessment, and hospital-ready safety and IFU documentation. We also welcome introductions to aligned funders, healthcare systems, and clinical partners who can help bring validated adaptive apparel into patient care.

Institution & Principal Investigator

Performing institution: Northeastern University, College of Engineering, Department of Electrical and Computer Engineering (Boston, MA). The work will be carried out in the laboratories of Prof. Sun: the W.M. Keck Laboratory for Integrated Ferroics and the Advanced Materials and Microsystems Laboratory.

Principal Investigator: Prof. Nian X. Sun, COE Distinguished Professor of Electrical and Computer Engineering. Prof. Sun’s research program focuses on magnetic and magnetoelectric materials, devices, and sensing, which is directly relevant to characterizing polyphase edge-magnetized fields. He will lead independent validation of LS Adaptive’s computational models and direct the bench testing, supported by a graduate researcher in his program.

Sponsor and applicant: LS Adaptive, LLC (Charlotte, NC), the technology originator. Any funds raised will be directed to Northeastern University. LS Adaptive’s Co-Founder and COO, Scott Craycraft, a named inventor on magnetic-technology patents, serves as the company’s technical liaison to the research team.

Research Capital Needs & Timeline

Capital required: approximately $105,000 (point estimate), with a planning range of $85,000 (low) to $140,000 (high). The range depends mainly on whether initial bench results require a design iteration and whether third-party accredited certification is required for hospital procurement. All funds are directed to Northeastern University.

Budget priorities (point estimates, per the attached study budget estimate):
1. FEA modeling labor and software: about $31,000
2. Lab equipment and setup: about $11,000
3. Bench testing labor: about $15,000
4. Fastener test samples: about $4,000
5. Risk assessment, labeling, and IFU development: about $19,000
6. Design iteration and third-party certification contingency: about $15,000
7. Institutional overhead: about $5,000
8. Miscellaneous (project management, travel, QA, and contingency): about $4,000
These line items total approximately $105,000.

Anticipated timeline: approximately 6 to 8 months. The study is carried out by a graduate researcher under Prof. Sun’s direction, so the schedule reflects an academic research cadence across the four phases (computational FEA modeling, empirical bench testing, risk assessment, and design optimization and labeling), with allowance for ramp-up and a design iteration if one is needed.

Research Status & Prior Funding

Current stage: Designed and ready to launch upon funding. The detailed protocol, the test matrix (Tests A to D), the deliverables, and the budget are complete and attached. The performing institution and principal investigator are confirmed: Northeastern University and Prof. Nian X. Sun have agreed to conduct the study. The underlying Hana Fasteners™ technology is production-ready, with representative samples available for testing, and three provisional U.S. patents are filed (a fourth is in development). The study involves no human subjects, so no IRB approval is required.

Prior funding: No prior funding has been received for this validation study specifically. This is the first funding sought to execute it. LS Adaptive has been bootstrapped to date, funded by founder capital plus a non-dilutive NC IDEA Micro grant, with no institutional or venture investment.

Research Team & Collaboration

Key team:
– Prof. Nian X. Sun: Principal Investigator, Northeastern University (Department of Electrical and Computer Engineering). Leads FEA model validation and bench testing. Magnetics and magnetoelectrics expert, and Director of the W.M. Keck Laboratory for Integrated Ferroics and the Advanced Materials and Microsystems Laboratory.
– Graduate researcher (Prof. Sun’s program): executes the computational modeling and bench measurements.
– Scott Craycraft: LS Adaptive Co-Founder and COO, technical liaison, and a named inventor on magnetic-technology patents (22+ years in engineering and manufacturing; MBA, UC Irvine).
– Emily Gerhardstein: LS Adaptive Co-Founder and CEO, leading product, clinical context, and dissemination.

Collaborating institutions and partners: Northeastern University is the performing institution (Prof. Sun’s laboratory). LS Adaptive also maintains healthcare and academic relationships that inform clinical context and downstream hospital deployment, including Atrium Health and Carolinas Rehabilitation, Ortho Carolina, and adaptive-design collaborations with the University of Alabama and UNC Greensboro.

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FOR DONOR ADVISED FUND & WIRE INSTRUCTIONS PLEASE REACH OUT TO: pkent@disabledlifefoundation.org

disAbled Life Foundation (Montcalm Social Enterprise) is a fiscally sponsored program of Legacy Global Programs, a 501(c)3 organization, EIN: 20-8099462

FOR DONOR ADVISED FUND & WIRE INSTRUCTIONS PLEASE REACH OUT TO: pkent@disabledlifefoundation.org

disAbled Life Foundation (Montcalm Social Enterprise) is a fiscally sponsored program of Legacy Global Programs, a 501(c)3 organization, EIN: 20-8099462

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