Biotex Inc

Before we say HELLO to 2025, Biotex would like to acknowledge and celebrate the partnerships we built, the milestones we accomplished, and the innovations we cultivated as ONE TEAM in 2024. Here's to a healthy and prosperous 2025. Happy New Year, everyone! #biotex #makingadifference #hello2025 #happynewyear

As we take a break to celebrate this joyful time with our friends and families, Biotex wishes you and your loved ones a festive and meaningful season. Happy Holidays from all of us at Biotex! #biotex #makingadifference #happyholidays 

Biotex wishes you and your family a Happy Thanksgiving! #makingadifference #biotex #medicaldevices #innovation #medicalsolutions #thanksgiving2024

The success of your clinical investigation requires more than basic monitoring. It demands a deep understanding of study design objectives, recruitment strategies, the specific challenges the study may encounter, continuous support for evolving regulatory requirements, and approaches to improve the quality of your data. At Biotex, we're committed to offering more than what some typical CRO services provide their clients. Biotex CRO+ goes above and beyond, offering a collaborative and committed partnership to ensure the highest standards of efficiency and quality in any clinical research we help our clients with. Here’s what John Uiters, CEO of Medwave Clinical Research B.B., says about their experience working side by side with our team during a clinical investigation: "Medwave is an imaging CRO dedicated to neuro-oncology research with expertise in implementing advanced imaging biomarkers in tumor response evaluations to discriminate between true progression and radionecrosis/post-treatment effects. It is a true pleasure to work with Britnee, supporting the set-up of the first-in-human phase-I study in Germany. We greatly appreciated working with a CRO that has the knowledge and experience to translate a complex clinical study into a pragmatic approach to get the study started. This positive attitude, combined with the friendly cooperation, makes working with Biotex an experience to repeat." - John Uiters, CEO, Medwave Clinical Research B.V. Entrust your clinical investigation to Biotex CRO+. Our dedicated team of experts understands, values, and implements the highest standards in preparing accurate clinical documents, monitoring, and auditing for seamless regulatory approval. Together, we can be part of your successful journey to bring your product to the market sooner. For more details or questions, please contact our CRO at clinical@biotexmedical.com or visit https://lnkd.in/gnwTetfA today! #cro #clinicalresearchorganization #clinicalresearchteam #clinicalresearch #clinicalinvestigations #clinicalservices #clnicalsupport #cromanager #clinicalresearchassociates #clinicaldocuments #regulatoryapproval #medicaldevices #croexperts #monitoring #auditing #biotex #makingadifference

According to scientific journals, foreign bodies, such as lint and fiber, can cause severe complications inside the patient's body during complex endovascular procedures. Likewise, undetected lint from wet towels and gauze trapped in the guidewires can easily travel inside the patient's body, which can cause problems, including embolization and stroke.   Wire Watch aims to address these problems.   Wire Watch uses a lint-free high-friction foam for secure wire storage and comes with a lint-free wipe, allowing you to clean or wet the wires safely. Wire Watch also adheres securely to the patient drape, allowing techs and operators to secure the wires to prevent contamination and avoid potentially severe complications caused by lint exposure.   That’s the Wire Watch advantage over makeshift guidewire storage techniques as a common practice in complex endovascular procedures. Right now, you can schedule your FREE WIRE WATCH TRIAL AND DEMO. That means you’ll have the opportunity to experience how Wire Watch offers an innovative guidewire management solution during complex endovascular procedures to help you achieve a significant difference in your guidewire management system. Contact our National Sales Director, Victor Vozzo, at victor.vozzo@biotexmedical.com for details. You can also visit https://lnkd.in/gNbRScZM for more info.   #endovascular #endovascularprocedures #technologists #endovascularsurgeons #vascularsurgery #interventionalradiology #interventionalcardiology #peripheralprocedures #guidewires #betterguidewires #guidewiremanagement #guidewiresolutions #guidewirestorage #medicaldevices #wirewatch #zeroguidewirereplacements #biotex #makingadifference 

Mechanical engineering plays a critical role in the development of medical devices, blending principles of physics, material science, and engineering design to create technologies that improve patient care. Mechanical engineers in this field design and optimize devices like surgical tools, implants, diagnostic and therapeutic machines, and combination medical device drug delivery systems. At Biotex, our mechanical engineering expertise includes: ·       Part and Assembly Specifications ·       Design for Manufacturing ·       Enclosure Design ·       Packaging Design ·       Reliability Engineering ·       Engineering Analysis and Simulation ·       Surface Modeling ·       Rapid Prototyping To further accelerate development, we have built an extensive library of proven mechanical design solutions and components. By leveraging these libraries, refined through decades of real-world applications, we help our clients avoid reinventing the wheel, reducing design cycles and accelerating time-to-market without compromising quality or innovation. Partner with us to bring your medical device ideas to life, from design to deployment! Explore our expertise and services by visiting www.biotexmedical.com. To schedule a call, please reach out to our Business Development Manager, Ginger R., at ginger.rigby@biotexmedical.com. #novelmedicaldevices #medicaldevices #medicalsolutions #productdevelopment #ISO13485 #MedTech #mechanicalengineering #mechanicalengineers #packagingdesign #prototyping #rapidprototyping #surfacemodeling #engineeringanalysis #engineeringsimulation #reliabilityengineering #partandassemblyspecificationsenclosure #biotex #makingadifference

Let's review your HIPAA knowledge, which is critical in clinical studies and other aspects of healthcare. Since LinkedIn only allows four options, please feel free to add what you think should or should not be included on the list in the comments section. Happy Friday!

Wire drops happen more frequently during complex endovascular procedures. They are inevitable, resulting in additional costs due to prolonged procedure time and wire replacements. If you’re a tech, surgeon, or hospital administrator, you must be frustrated when wire drops and damages occur during procedures. But, no worries. Our innovative and effective wire management solution, Wire Watch, has been proven to make ZERO WIRE REPLACEMENTS possible. Last year, a study was conducted at Good Samaritan Hospital in Cincinnati, OH, to evaluate the financial impact of wire replacements during complex endovascular procedures. In less than three months, 21 wire replacements were recorded, resulting in almost $6,000 in added cost. Over the next four months, Wire Watch was utilized in 28 complex endovascular procedures, which resulted in ZERO WIRE REPLACEMENTS. That’s the Wire Watch advantage. Wire Watch offers an innovative guidewire management solution during complex endovascular procedures that you, too, can utilize to see a significant difference in your guidewire management system. Right now, you can schedule your FREE WIRE WATCH TRIAL AND DEMO. Contact our National Sales Director, Victor Vozzo, today by sending him a message at victor.vozzo@biotexmedical.com. You can also visit https://lnkd.in/gNbRScZM for more info. #endovascular #endovascularprocedures #technologists #endovascularsurgeons #vascularsurgery #interventionalradiology #interventionalcardiology #peripheralprocedures #guidewires #betterguidewires #guidewiremanagement #guidewiresolutions #guidewirestorage #medicaldevices #wirewatch #zeroguidewirereplacements #biotex #makingadifference

Design controls are a set of processes used in medical device development to ensure products meet regulatory requirements, function safely, and achieve high-quality standards. They provide a clear framework for designing, testing, and documenting each stage of the development process. They are also essential for delivering safe, effective medical devices that improve patient outcomes while maintaining regulatory integrity. By implementing systematic procedures, from risk management and usability evaluation to  verification and validation, design controls help guide the development process, minimize errors, provide traceability from concept to commercialization, and ensure compliance with FDA or ISO regulations. At Biotex, we prioritize quality and regulatory compliance in every step of medical device development. By rigorously adhering to design controls, we ensure that our products not only meet but exceed industry standards. These are key aspects of our Product Development process: ·       Market Research and Needs Assessment ·       Concept Development ·       Regulatory Strategy ·       Feasibility Studies ·       Risk Management (hazard analysis, mitigation planning, benefit/risk assessment) ·       Design Verification and Validation ·       Manufacturing Process Development and Validation ·       Clinical Testing ·       Regulatory Submission and Approval ·       Transfer to Production Partner with us to bring your medical device ideas to life, from design to deployment! Visit www.biotexmedical.com to explore our expertise and services. To schedule a call, please reach out to our Business Development Manager, Ginger R., at ginger.rigby@biotexmedical.com. #novelmedicaldevices #medicaldevices #medicalsolutions #productdevelopment #ISO13485 #MedTech #designcontrols #biotex #makingadifference

Did you know the FDA recently issued three ASCA guidance documents?   On September 20, the FDA issued the draft ASCA guidance documents as part of the transition from a pilot to a permanent program.   The FDA ASCA Program aims to enhance the FDA's confidence in medical device testing, promote consistency in the premarket review process, and enhance regulatory efficiency and international harmonization.   There is now an entire clause in the draft guidance outlining the FDA’s emphasis on collaboration between test laboratories and device manufacturers whenever possible, particularly when developing IEC 60601 test plans for Basic Safety and Essential Performance.   A proper test plan adequately defines essential performance and acceptance criteria. Defining essential performance is the manufacturer’s responsibility as the expert for their medical device and its intended use.   If you find yourself asking, “What is essential performance?” or “Does my medical device have essential performance?” we have an exclusive resource available for those who sign up for our email list. We’ll help answer those questions and more!   Contact us today at criterion@biotexmedical.com or visit us at https://lnkd.in/ggU7YqTH if you have questions or want to speak with our team! Here's the link to the FDA's draft ASCA guidance documents: https://lnkd.in/geBaRVHp #FDA #ASCA #FDAASCA #medicaldevices #medicaldevicetesting #testingservices #testinglabs #thirdpartylabs #fdacompliance #regulatory #criterion #biotex #makingadifference