FEATURED EDITORIAL

GettyImages-637482390 The 2 Things Investors Want To See In Your Medtech — & How To Show Them

The host of the MedTech Gurus podcast recaps two recent episodes and shares the two things that his guests agreed that investors want to see before they will loosen their purse strings for your new medtech product. The article also describes how to make your pitch to those investors.

  • Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.

  • Medical device manufacturers are well positioned to capitalize on the opportunity of developing wearable devices. However, to deliver devices useful for clinicians and patients, wearable technologies must advance further. This article describes three areas for manufacturers to focus on for success in the market.

  • Despite a substantial reduction in the number of inspections that the FDA conducted in FY 2021, the 483s that the agency issued are still very important for the medical device industry to take note of. What were the top 3 citations, and how do the rest of the top 10 compare? This author shares all the data, as well as the 4 priority takeaways.

INDUSTRY INSIGHTS

  • Small Regulatory Steps For AI In SaMD

    Recently released guiding principles for good machine learning practice in medical devices and other regulatory documents, are giving medical device companies an indication of what regulations might look like.

Medtech Manufacturing: From Disruption To Evolution

Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.

3 Ways To Rethink Regulatory Change In Personalized Medicine

The landscape for the regulation of personalized medicine continues to evolve as the innovation in personalized medicine increases. Here are a few ways that companies in personalized medicine can approach regulatory as opportunities instead of obstacles.

Life Sciences Start-Ups: What You Need to Know About Phase Appropriate Quality Requirements

This article discusses implementation of a phase-appropriate QMS and the importance of starting early in the product development life cycle, the disadvantages of using a manual paper-based QMS in the early phases and advantages to your company by using a digital QMS.

7 Steps To Ensure CAPA Success

Product development in the life sciences is a multimillion-dollar process. With this level of money on the line, good corrective action/preventive action (CAPA) processes are essential. In this blog we give a general overview of the seven steps companies need to take to successfully complete and document CAPA.

SOLUTIONS

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

MasterControl's supplier management solution automates supplier management processes and ensures supplier quality and compliance.

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

FEATURED SUPPLIERS

The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.

For the biopharmaceuticals industry, Sartorius offers a comprehensive, globally unique program of products and services, ranging from the discovery of active pharmaceutical ingredients to process engineering, from scale-up and production to compliance with regulatory steps.

MED DEVICE ONLINE CONTENT COLLECTIONS

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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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