DALI Medical Devices Ltd. is a medical device technology company headquartered in Yavne, Israel. Specializing in the sector of injectable drug delivery, the company operates primarily as a developer and manufacturer of safe, easy-to-use injection devices designed to improve patient adherence and safety. DALI functions as a B2B partner to the global pharmaceutical and medical device industries, providing both proprietary "off-the-shelf" technologies and customized Contract Development and Manufacturing (CDMO) services.
Founded in 2003, DALI has established itself as a specialist in Safe Auto-Needles (SANs) and auto-injectors. The company's core mission is to bridge the gap between complex biologic drug formulations and the patients who must self-administer them. By reducing needle phobia, preventing needlestick injuries, and simplifying the injection process, DALI aims to enhance the commercial viability of injectable drugs for its pharmaceutical partners.
Core Product Portfolio
DALI?s product offerings are centered around proprietary platforms that can be adapted to various primary drug containers, such as vials, cartridges, and prefilled syringes.
1. The SAN? (Safe Auto-Needle) Family
The SAN? product line is the company?s flagship portfolio. These devices are designed to combine the benefits of an auto-injector (automatic needle insertion and hidden needle) with the control of a manual syringe (user-controlled injection speed). This hybrid approach is particularly valuable for patients who experience pain during rapid injections or anxiety regarding visible needles.
SAN?-L (Luer): A disposable automatic needle device compatible with any standard ISO Luer-lock syringe. It features automatic needle insertion and passive sharps protection, making it suitable for clinical or home settings.
SAN?-P (Prefilled): Designed specifically for staked-needle prefilled syringes. It transforms a standard prefilled syringe into a safety device with auto-insertion capabilities.
SAN?-Light: A passive safety needle designed to replace standard hypodermic needles. It fits Luer-lock syringes and provides automatic shielding of the needle after use to prevent injury, without the full auto-insertion mechanism of the larger SAN units.
SAN?-DV (Drugs in Vials): A specialized unit that integrates a vial adapter. It allows for the transfer of medication from a vial to a syringe and subsequent injection using the same safe auto-needle mechanism, streamlining the process for lyophilized (freeze-dried) drugs requiring reconstitution.
2. SASY? Safety Syringe
The SASY? is a proprietary safety solution designed for glass prefilled syringes. It focuses on preventing accidental activation and ensuring full dose delivery.
* Mechanism: It features a passive safety shield that automatically covers the needle after the injection is completed.
* Reliability: The design includes a mechanism that prevents the safety shield from activating unless the full dose has been administered, ensuring patients do not accidentally lock the device before receiving their medication.
3. SYNNECT? (Smart Injection Solution)
Addressing the growing trend of Digital Health, DALI developed SYNNECT? to turn standard syringes into "smart" connected devices.
* Connectivity: The system utilizes a sensing module that attaches to standard syringes (replacing the plunger rod) to track injection data.
* Data Tracking: It records critical metrics such as injection time, date, volume delivered, and completion status.
* Integration: The data is transmitted via Bluetooth to a mobile app and cloud database, allowing healthcare providers and pharmaceutical companies to monitor patient adherence and potentially intervene if doses are missed.
Services and Capabilities
Beyond its physical products, DALI Medical Devices operates as a full-service CDMO, managing the entire lifecycle of a medical device.
Custom Design and Development
DALI works with pharmaceutical partners to customize its core platforms to meet specific drug viscosities, volumes, and user demographics.
* Human Factors Engineering: The company conducts usability studies to ensure devices meet regulatory standards for user safety and intuitive design.
* Prototyping: Rapid prototyping capabilities to test concepts before moving to mass production.
Manufacturing and Supply Chain
The company oversees the transition from design to high-volume manufacturing.
* Assembly: DALI establishes automated or semi-automated assembly lines compliant with CE and FDA standards.
* Validation: Implementation of Master Validation Plans and Quality Control (QC) processes to ensure every device meets strict medical specifications.
Regulatory Support
DALI provides the necessary technical documentation and design history files (DHF) to support its partners in obtaining regulatory approvals (such as FDA 510(k) clearance or CE Marking) for their combination products.
Strategic Partnerships
DALI frequently collaborates with other major players in the medical component space. For instance, the company has a long-standing cooperation with Elcam Medical, a world leader in disposable medical devices. Through such partnerships, DALI leverages global manufacturing footprints and distribution networks to deliver its auto-injectors and safety needles to international markets.
Please note: This information is generated by AI. For legal use, verify with company sources.
