Modular Medical Initiates Transfer of Manufacturing Operations to Phillips Medisize
Modular Medical (NASDAQ:MODD) has initiated the transfer of its pilot line manufacturing operations to Phillips Medisize's facility in Queretaro, Mexico. This move is part of the company's transition from pre-commercial production to high-volume device manufacturing for its MODD1 Insulin Delivery System. The manufacturing transfer is occurring alongside the ongoing FDA 510(k) review process for the MODD1 system.
Phillips Medisize, a Molex company, will manufacture the MODD1 system in its Queretaro clean room, while the printed circuit board assembly will be produced in its Guadalajara electronics facility. The company expects to have the manufacturing operation validated and ready for human-use production early next year. Phillips Medisize has been important in providing manufacturing expertise and leveraging its global supplier base for the MODD1 system's development.
Modular Medical (NASDAQ:MODD) ha iniziato il trasferimento delle operazioni di produzione della sua linea pilota nella struttura di Phillips Medisize a Querétaro, Messico. Questa mossa fa parte della transizione dell'azienda dalla produzione pre-commerciale a produzione di dispositivi ad alta volumetria per il suo sistema di consegna dell'insulina MODD1. Il trasferimento della produzione avviene insieme al processo di revisione FDA 510(k) per il sistema MODD1.
Phillips Medisize, una società di Molex, produrrà il sistema MODD1 nella sua sala pulita di Querétaro, mentre l'assemblaggio della scheda a circuito stampato sarà realizzato nella sua struttura elettronica a Guadalajara. L'azienda prevede di avere l'operazione di produzione validata e pronta per la produzione destinata all'uso umano all'inizio del prossimo anno. Phillips Medisize è stata fondamentale nel fornire expertise produttiva e nel sfruttare la sua rete globale di fornitori per lo sviluppo del sistema MODD1.
Modular Medical (NASDAQ:MODD) ha iniciado la transferencia de sus operaciones de fabricación de línea piloto a la instalación de Phillips Medisize en Querétaro, México. Este movimiento es parte de la transición de la empresa de la producción precomercial a la fabricación de dispositivos de alto volumen para su sistema de entrega de insulina MODD1. La transferencia de la fabricación se está llevando a cabo junto con el proceso de revisión FDA 510(k) para el sistema MODD1.
Phillips Medisize, una compañía de Molex, fabricará el sistema MODD1 en su sala limpia de Querétaro, mientras que el ensamblaje de la placa de circuito impreso se producirá en su instalación electrónica en Guadalajara. La empresa espera tener la operación de fabricación validada y lista para la producción destinada a humanos a principios del próximo año. Phillips Medisize ha sido importante en proporcionar experiencia en fabricación y aprovechar su base global de proveedores para el desarrollo del sistema MODD1.
모듈러 메디컬(NASDAQ:MODD)은 파일럿 라인 제조 작업을 이전하기 시작했습니다 이는 멕시코 케레타로에 있는 필립스 메디사이즈의 시설로 이전됩니다. 이 움직임은 MODD1 인슐린 전달 시스템을 위한 대량 장치 제조로의 전환의 일환입니다. 제조 이전은 MODD1 시스템에 대한 FDA 510(k) 검토 프로세스와 함께 진행되고 있습니다.
필립스 메디사이즈는 Molex 소속으로, MODD1 시스템을 케레타로의 클린룸에서 제조할 예정이며, 인쇄 회로 기판 조립은 과달라하라의 전자 시설에서 이루어집니다. 이 회사는 내년 초에 인간 사용을 위한 생산 준비가 완료되고 검증될 것으로 예상하고 있습니다. 필립스 메디사이즈는 MODD1 시스템 개발을 위해 제조 전문 지식을 제공하고 전 세계 공급업체 네트워크를 활용하는 데 중요한 역할을 하고 있습니다.
Modular Medical (NASDAQ:MODD) a initié le transfert de ses opérations de fabrication de ligne pilote vers l'installation de Phillips Medisize à Querétaro, au Mexique. Ce mouvement fait partie de la transition de l'entreprise de la production pré-commerciale à la fabrication de dispositifs en grande série pour son système de livraison d'insuline MODD1. Le transfert de fabrication se déroule parallèlement au processus d'examen FDA 510(k) pour le système MODD1.
Phillips Medisize, une société de Molex, fabriquera le système MODD1 dans sa salle propre à Querétaro, tandis que l'assemblage des cartes de circuit imprimé sera réalisé dans son usine électronique à Guadalajara. L'entreprise s'attend à ce que l'opération de fabrication soit validée et prête pour la production à usage humain au début de l'année prochaine. Phillips Medisize a été déterminant dans la fourniture d'expertise en fabrication et l'exploitation de sa base de fournisseurs mondiale pour le développement du système MODD1.
Modular Medical (NASDAQ:MODD) hat den Transfer seiner Pilotlinienproduktionsoperationen in die Einrichtung von Phillips Medisize in Querétaro, Mexiko, eingeleitet. Dieser Schritt ist Teil des Übergangs des Unternehmens von der vorkommerziellen Produktion zur Massenproduktion von Geräten für sein MODD1 Insulin-Abgabesystem. Der Fertigungstransfer erfolgt parallel zu dem laufenden FDA 510(k) Prüfprozess für das MODD1-System.
Phillips Medisize, ein Unternehmen von Molex, wird das MODD1-System in seinem Reinraum in Querétaro herstellen, während die Montage der Leiterplatte in seiner Elektronik-Einrichtung in Guadalajara durchgeführt wird. Das Unternehmen erwartet, dass die Fertigungsoperation zu Beginn des nächsten Jahres validiert und bereit für die Produktion zur menschlichen Anwendung sein wird. Phillips Medisize hat eine wichtige Rolle bei der Bereitstellung von Fertigungsexpertise und der Nutzung seines globalen Lieferantenstamms für die Entwicklung des MODD1-Systems gespielt.
- Transition to high-volume manufacturing capabilities
- Ongoing FDA 510(k) review process for MODD1 Insulin Delivery System
- Expected validation for human-use production early next year
- Partnership with Phillips Medisize for manufacturing expertise and global supplier access
- None.
Insights
The transfer of Modular Medical's manufacturing operations to Phillips Medisize marks a significant milestone in the company's journey towards commercialization. This move demonstrates increased production capacity and scalability, which are important for meeting potential market demand.
The choice of Mexico for manufacturing offers cost advantages while maintaining quality standards. The clean room facility in Queretaro for the MODD1 system and the high-volume electronics facility in Guadalajara indicate a strategic approach to specialized production. This setup could potentially lead to
The concurrent FDA 510(k) review process suggests the company is optimizing its timeline for market entry. If approved, having manufacturing ready by early next year positions Modular Medical for a swift market launch, potentially gaining a competitive edge in the insulin pump market.
This manufacturing transfer is a positive indicator for Modular Medical's financial outlook. By partnering with Phillips Medisize, a Molex company, MODD is leveraging an established player's expertise and infrastructure, potentially reducing capital expenditure and operational risks associated with in-house manufacturing.
The move to Mexico likely aims to optimize cost structures, which could translate to improved margins or more competitive pricing in the insulin pump market. However, investors should note that the company is still pre-revenue and the success of this strategy depends on FDA approval and subsequent market acceptance.
While specific financial figures aren't provided, this development suggests Modular Medical is preparing for scalability, which is important for potential revenue growth. Investors should monitor the FDA review outcome and initial production runs to gauge the company's ability to execute its commercialization strategy effectively.
SAN DIEGO, CA / ACCESSWIRE / August 7, 2024 / Modular Medical, Inc. (the "Company" or "Modular Medical") (NASDAQ:MODD), an insulin delivery system technology company preparing to launch the next generation of easy-to-use, prescribe and live with affordable insulin pump technology, today announced it has begun the transfer of its pilot line manufacturing operations to a Phillips Medisize manufacturing site in Queretaro, Mexico.
Phillips Medisize, a Molex company, has been an outstanding collaborator in the development of Modular Medical's platform product, supply chain and manufacturing operations, as the Company intends to transition from pre-commercial production to high-volume device manufacturing. The MODD1 Insulin Delivery System will be manufactured in the Phillips Medisize Queretaro, Mexico, facility clean room, while the printed circuit board assembly will be manufactured in Phillips Medisize's high-volume electronics facility in Guadalajara, Mexico.
The manufacturing transfer is taking place concurrently with the ongoing FDA 510(k) review process of the Company's MODD1 Insulin Delivery System. "We expect to have the manufacturing operation validated and ready for human-use production early next year," said Kevin Schmid, Chief Operating Officer, Modular Medical.
Phillips Medisize has been instrumental in providing Modular Medical with manufacturing and assembly expertise, while drawing upon its global and diversified supplier base to design and develop manufacturing capability for the MODD1 Insulin Delivery System. Conventional, two-shot, and insert injection molding, as well as other services such as packaging, electronics design and manufacturing and assembly operations, are among the capabilities provided by Phillips Medisize.
About Modular Medical
Modular Medical, Inc. (NASDAQ:MODD) is a medical device company that will launch the next generation of insulin delivery technology. Using its patented technologies, the Company seeks to eliminate the tradeoff between complexity and clinical efficacy, thereby making top quality insulin delivery both affordable and simple to learn. The Company's mission is to improve access to the highest standard of glycemic control for people with diabetes, taking it beyond "superusers" and providing diabetes care for the rest of us.
Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding MODD, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://modular-medical.com.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statements contained in this press release. These factors include, but are not limited to, Modular Medical's ability to obtain FDA clearance and foreign government approvals for its MODD1 product, market and other conditions, whether the Company can successfully develop its proprietary technologies, whether the market will accept the Company's products and services, whether the Company can successfully manufacture its products at high volumes and the impact of COVID-19, general economic, industry or political conditions in the United States or internationally as well as other risk factors and business considerations described in the Company's SEC filings, including its annual report on Form 10-K. Any forward-looking statements in this press release should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company assumes no obligation to update these forward-looking statements, except as required by law.
All trademarks mentioned herein are the property of their respective owners.
CONTACT:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com
SOURCE: Modular Medical, Inc.
View the original press release on accesswire.com
FAQ
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