#510 k clearance

[sigmabiomedical]

[elexes]

13 Common Mistakes to Avoid in the 510(k) Submission

If you are looking to market your cutting-edge medical device, which is low to moderate risk, in the United States you need FDA Clearance. That’s where the 510(k) submission comes into play!

[medicaldeviceconsultantinus-blog]

Medical Device FDA 510 k consulting company | Operon Strategist

What Does a FDA 510( k) Clearance mean?

Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product must meet criteria for the same intended use, have the same technology or( slightly) different technology but produces similar end results, and be safe and effective.1 Once “pre-market clearance ” is took from the FDA the device can be distributed commercially immediately.

There are important differences between “ cleared ” and “ approved ”. When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA).

In the United States, this frequently means submitting a 510( k). A 510( k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration( FDA) for “ clearance ” before you can deal your device in the U.S. In order to receive clearance from the FDA, your 510( k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device).

What Exactly is Substantial Equivalence?

Now that we know what a 510( k) is, let’s talk about the substantial equivalence standard. You ’ll recall from the intro that your 510( k) must show that the new( or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.

Operon Strategist is a leading medical device consultant providing FDA 510k Clearance process consulting to the customers to register SBU( Small Business Unit), if applicable. Take out the testing demand of the product, creation of the dossier, resolving the queries and after completion of all the conditioning, the customer receives the US FDA 510 k premarket approval. We also help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.

We helps during the process of submitting operations for class I, II, III medical devices at any stages of the product development. Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU.S and international customers. These operations include 

510( k) Premarket Notifications 

Premarket Approval Applications( PMAs) 

De Novo Request( Application) 

513( g) Requests for Classification 

Investigational Device Exemption Applications( IDEs 

Investigational New Drug Applications( INDs)

510( k) Premarket Notifications

Operon Strategist provides answers to related questions 

Which groups( Class I, II, and III) do we require an FDA 510( k)? 

How many stages consist of the 510( k) application process? 

A class I, II, and III device intended for human use, for which a Premarket Approval FDA operation( PMA) isn't needed, must submit a 510( k) to FDA unless the device is pure from 510( k) conditions of the Federal Food, Drug, and Cosmetic Act( the FD&C Act) and doesn't exceed the limitations of exemptions in.9 of the device classification regulation chapters(e.g., 21 CFR862.9, 21 CFR864.9). Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States. typically, the FDA shall be subject to a provision of 510( k), should manufacturers intend to deal the Class II Medical Devices and some needed Class I and III bias or IVDs on the US market. Apre-market 510( k) approval is also required for already approved medical devices( Predicate) if the manufacturer( s) modifies the technology or changed the intent of device operation in a way that significantly affects patient safety or device performance. 

The 510( k) is generally the most effective route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, rather of demanding to present more expansive clinical trial data. 

There are three types of 510( k) Traditional, shortened, and Special. This eBook will begin with a general overview of the 510( k) process, including its purpose and benefits. Next, we will explore the Traditional 510( k) and the sections and factors needed in depth. Finally, we will look at the Special and shortened 510( k). 

When is a 510( k) needed? 

A 510( k) is needed for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is needed for high- risk or new devices which bear a advanced position of scrutiny to be verified safe and effective. 

Complaints 

Still, the end user can file a complaint with the FDA or the manufacturer, If a FDA 510( k) cleared medical device isn't performing as intended. 

The user or client can also file a complaint with the FDA if it knows that the manufacturer or his representative or distributor is making false marketing claims or incorrectly promoting the performance of their device. This is a straightforward process to insure that medical devices on the market are being held to strict standards to make sure it's being used safely and effectively

Things to Consider

Before choosing a product with a FDA 510( k) clearance, it's important to understand what the product is claiming to do. Similar products may not perform exactly the same due to differences in technology or manufacturing. It's also important to make sure to read the indications for use to know how to use the product properly. Eventually, test data that has been transferred to the FDA should be available to the end user, frequently in a confirmation guide or test report.

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.

[biotech-news-feed]

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avicenna.AI’s CINA-CSpine tool. The post Avicenna.AI receives 510(k) clearance for CINA-CSpine tool appeared first on Medical Device Network. #BioTech #science

[ankitab]

Oral Care Market: Trends, Innovations, and Growth Forecast to 2031

The Oral Care Market is projected to reach $58.99 Billion by 2031, growing at a CAGR of 7.4% from 2024 to 2031. The market's growth is driven by the increasing prevalence of gum diseases and dental caries, rising awareness of oral health and hygiene, growing demand for dental aesthetics, increasing consumer awareness of oral care products, and the growing use of eco-friendly oral care products. Additionally, a shift towards natural and herbal oral care products and technological advancements in oral care products are expected to offer growth opportunities for market players.

Free Download sample report here: https://www.meticulousresearch.com/download-sample-report/cp_id=5927?utm_source=article&utm_medium=social&utm_campaign=product&utm_content=10-09-2024

Oral Care Market Growth Drivers

Increasing Prevalence of Gum Diseases and Dental Caries

Oral diseases are a significant health burden globally, affecting nearly 3.5 billion people. According to the Global Burden of Diseases, untreated caries in permanent teeth is the most common dental condition worldwide, particularly in developing countries, affecting 60-90% of school children and most adults. Various solutions and oral care products are available to treat dental caries. For example, in June 2023, Incisive Technologies Pty Ltd. (Australia) received U.S. FDA 510(k) clearance for the BluCheck caries detection and monitoring preventive care solution, which binds to active carious lesions and makes them visible with its blue color.

Risk factors such as smoking, poor oral hygiene, medication, age, heredity, stress, and diabetes are linked to periodontal diseases. People with diabetes are at higher risk of periodontal diseases, which can slow down the healing process, cause dry mouth, fungal infections, ulcers, and tooth decay. Increased blood glucose levels can increase sugar levels in saliva, allowing bacteria to metabolize sugar into acid, leading to tooth decay. The increasing prevalence of dental diseases and chronic conditions that degrade dental health is expected to drive the global oral care market.

Rising Consumer Awareness Regarding Oral Care Products

Oral care products help maintain oral hygiene and prevent dental caries, gum diseases, and other conditions. Poor oral health can diminish an individual's quality of life and contribute to oral diseases. Maintaining oral hygiene is crucial for disease prevention and is the responsibility of both patients and dental professionals. This hygiene can be achieved using various oral care products.

Product launches and awareness programs are increasing demand for oral care products. For instance, in February 2022, the Colgate-Palmolive Company (U.S.) launched a public health initiative to empower people to improve their oral health quotient (OQ). The company plans to commit more than USD 100 million over the next five years to address the global health crisis and incorporate oral health into broader public health strategies. Social factors also affect the selection and demand for oral care products.

In September 2023, during the World Dental Congress of the FDI World Dental Federation (Switzerland), the World Oral Health Day (WOHD) 2024-2026 campaign was launched to empower people with the tools and knowledge to prevent and control oral diseases and promote oral hygiene.

Browse in depth: https://www.meticulousresearch.com/product/oral-care-market-5927?utm_source=article&utm_medium=social&utm_campaign=product&utm_content=10-09-2024

Oral Care Market Trends

Increasing Adoption of Electric Toothbrushes

Traditionally, manual toothbrushes have been the most common type of product used to clean teeth. However, advancements in oral health products and technologies have led to increased use of electric toothbrushes. Electric, motorized, or battery-powered toothbrushes make rapid bristle motions and provide better plaque removal than manual toothbrushes. Electric toothbrushes offer several advantages, such as reliability, specialized features, ease of use, and promoting tooth and gum health, along with advancements like pressure sensors and Bluetooth connectivity.

Electric toothbrushes are also beneficial for people with physical disabilities and limited hand movement. For instance, in September 2023, CURADEN AG (Switzerland) launched Samba, an electric toothbrush with dynamic brushing motion that thoroughly removes plaque and debris. Various product launches for electric toothbrushes continue to cater to regular use. For example, in March 2022, Colgate-Palmolive India introduced sonic technology toothbrushes that provide significantly better cleaning compared to regular toothbrushes.

Introduction to Skincare-inspired Oral Care Products

Various products and devices used for skincare, such as serums, balms, and masks, are being integrated into oral care to enhance and maintain oral hygiene. Products like tooth creams and tooth masks perform functions similar to skincare creams and contain chemicals that help whiten teeth and eliminate bad breath.

From a consumer perspective, treating teeth with the same care as skin has become equally important, leading manufacturers to introduce such products. This is mainly done by using specific ingredients. The presence of collagen, niacinamide, and probiotics is increasing in markets such as China, Japan, and South Korea.

Oral Care Market Opportunity

Shift Towards Natural and Herbal Oral Care Products

With the growing manufacturing of new oral care products, consumers have become more informed about the composition of the products they use. This has led to a significant shift towards natural-composition oral care products such as toothpaste, toothbrushes, gels, pastes, mouthwashes, and mouth fresheners. Natural products are produced sustainably and environmentally friendly, without chemical ingredients.Quick buy: https://www.meticulousresearch.com/Checkout/75542967?utm_source=article &utm_medium=social&utm_campaign=product&utm_content=10-09-2024

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[tamanna31]

New Study: 2024-2030 In Vitro Diagnostics Market Trend and Forecast Report

In Vitro Diagnostics Industry Overview

The global in vitro diagnostics (IVD) market size was estimated at USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. The growth can be attributed to increasing adoption of IVD owing to a rise in the incidence of infectious and chronic diseases. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel market growth. The rising number of IVD products being launched by key players is also fueling market growth. For instance, in November 2023, ARUP Laboratories received a CE mark from EU-IVDR for AAV5 DetectCDx, a companion diagnostic to select the eligibility of severe hemophilia A-affected patients for BioMarin’s new gene therapy, Roctavian.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market

Technological advancements in terms of accuracy, portability, and cost-effectiveness are expected to be one of the high-impact rendering drivers of this market. Introduction of novel and highly accurate clinical laboratory tests is boosting the adoption of novel IVD tests worldwide. In June 2023, Toray Industries, Inc. received marketing approval from Japan’s Ministry of Health, Labour and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer. Moreover, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S. Increasing approvals of IVD tests for life-threatening diseases are expected to create new opportunities in the untapped market.

Key players in the market undertake various strategies to strengthen their position and offer their customers diverse, technologically advanced & innovative products. New product launches and partnerships are the most prominently adopted by companies to attract more customers. For instance, in March 2023, BD received 510(k) clearance for BD Vaginal Panel on the BD COR System to detect infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) formed a partnership with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for the diagnosis of cancer in Northern Ireland.

Favorable initiatives undertaken by government and non-government bodies to improve overall healthcare services are anticipated to increase market growth. In October 2023, the WHO published the Essential Diagnostics List (EDL), a comprehensive list of IVD products that helps countries make decisions regarding diagnostic tools. It provides evidence-based recommendations and ensures the accessibility of essential products for target people. Moreover, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to increase access to diagnostic tests across Africa. Such initiatives are expected to boost market growth.

A rise in the geriatric population and growth in knowledge regarding early testing have led to a surge in the number of regular check-ups, as a majority of deaths due to infections and chronic conditions occur in the population aged over 75 years. As per the Office for Budget Responsibility, UK, healthcare costs have risen exponentially, which can create economic pressure on nations with rapidly growing geriatric population. However, this expenditure is anticipated to translate positively for the IVD industry, driving market growth.

Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.

• The global point of care infectious disease testing market size was valued at USD 11.40 billion in 2023 and is projected to grow at a CAGR of 4.3% from 2024 to 2030.

• The global transplant diagnostics market size was valued at USD 5.97 billion in 2023 and is projected to grow at a CAGR of 7.3% from 2024 to 2030.

Key Companies & Market Share Insights

Some of the key players operating in the in vitro diagnostics market include F. Hoffmann-La Roche Ltd.; Abbott; Quest Diagnostics Inc.; and Danaher. Market players are adopting various strategies, such as new product launches, mergers & acquisitions, and partnerships, to strengthen their product portfolios and offer diverse technologically advanced & innovative products.

Llusern Scientific, Biocartis Group NV, ARUP Laboratories, Veracyte, and Exact Sciences Corp are some of the emerging market participants in the market. Emerging companies are actively involved in developing novel and accurate IVD testing products to improve overall health services. Moreover, these companies are collaborating with research institutes, government bodies, and global leaders to increase the range of their products in potential markets.

Key In Vitro Diagnostics (IVD) Companies

Abbott

bioMérieux SA

QuidelOrtho Corporation

Siemens Healthineers AG

Bio-Rad Laboratories, Inc.

Qiagen

Sysmex Corporation

Charles River Laboratories

Quest Diagnostics Incorporated

Agilent Technologies, Inc.

Danaher Corporation

BD

F. Hoffmann-La Roche Ltd

Recent Developments

In December 2023, ARUP Laboratories and Medicover collaborated to provide diagnostic and healthcare services in Europe. ARUP Laboratories has developed AAV5 DetectCDx in collaboration with BioMarin Pharmaceutical Inc. to select therapies for severe hemophilia A patients

In November 2023, Veracyte joined Illumina to develop molecular tests for decentralized IVD applications. Companies are focusing on the development of Prosigna breast cancer and Percepta nasal swab tests of Veracyte

In October 2023, Promega Corporation announced its plan to develop and commercialize companion diagnostics kits with GSK Plc to identify cancer patients with MSI-H solid tumors

In February 2023, Unilabs announced investing over USD 200 million in Siemens Healthineers' technology and acquiring more than 400 laboratory analyzers to strengthen its laboratory infrastructure

In February 2023, F. Hoffmann-La Roche Ltd. collaborated with Janssen Biotech Inc. to develop companion diagnostics for targeted therapies. Companion diagnostic technologies include digital pathology, NGS, PCR, immunoassays, and immunohistochemistry

Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.

[industryforecastnews]

Drug Testing Market Size To Reach USD 8.45 Billion By 2030

Drug Testing Market Growth & Trends

The global drug testing market size is expected to reach USD 8.45 billion by 2030, expanding at a CAGR of 4.8% from 2024 to 2030, according to a new report by Grand View Research, Inc.. The introduction of innovative tests, stringent regulation mandating drug testing, and growing substance abuse & addiction are some of the factors anticipated to foster market growth during the forecast period. 

Drug abuse and addiction is a global problem, affecting millions of people. As per the World Drug Report published by UNODC, in 2019, around 35.0 million people were suffering from drug use disorders globally. Such a high rate of drug abuse and substance use disorders has created a major demand for innovative tests to prevent, treat, and manage such cases. Several key players operating in this space are introducing innovative and efficient products to meet this growing demand.

For instance, in June 2019, Quidel Corporation received the U.S. FDA’s 510(k) clearance to market its fluorescence immunoassay—Quidel Triage TOX Drug Screen, 94600. This is intended for detecting the presence of metabolites or drugs in urine. Moreover, in June 2020, Cordant Health Solutions offered video-observed oral fluid drug testing to help courts & government agencies to monitor participants during the COVID-19 pandemic. This aided in combating several challenges faced by people with substance abuse disorders during the pandemic.

Continuous government initiatives and implementation of strict substance abuse testing regulations to ensure safety have derived the demand for its testing products. In July 2020, the New Zealand government introduced a new bill that provides police the power to conduct random roadside drug testing of drivers to reduce impaired driving in the country. The new bill allows usage of oral fluid tests to check drivers for substances such as cocaine, ecstasy, cannabis, opiates, methamphetamine, and benzodiazepines. Also, in February 2020, the Directorate General of Civil Aviation in India introduced extensive tests for pilots and flight crew members for psychoactive substances such as opioids & cannabis to ensure safe air travel.

Request a free sample copy or view report summary: https://www.grandviewresearch.com/industry-analysis/drug-testing-market

Drug Testing Market Report Highlights

By product type, the consumables segment dominated the market in 2023, owing to its repetitive use to conduct substance abuse screening

Based on sample type, the urine samples segment accounted for the largest revenue share in 2023, as it is the most common method of sample collection

Increased unemployment and economic crisis due to the Covid-19 pandemic has made people more susceptible to substance abuse, thus created lucrative opportunities in the market

The legalization of marijuana for medicinal as well as recreational use in several countries is anticipated to change the current scenario and may create demand for innovative testing solutions

Stringent privacy rights in some countries are likely to limit substance abuse testing at workplaces, impeding market growth

In Asia Pacific, the market is expected to witness lucrative growth over the forecast period as a result of the growing demand for substance abuse testing from emerging economies, such as China and India

Drug Testing Market Segmentation

Grand View Research has segmented the global drug testing market based on product, sample, drug, end-use, and region:

Drug Testing Product Outlook (Revenue, USD Million, 2018 - 2030)

Consumables

Instruments

Rapid Testing Devices

Services

Drug Testing Sample Outlook (Revenue, USD Million, 2018 - 2030)

Urine Samples

Oral Fluid Samples

Hair Samples

Other Samples

Drug Testing Drug Outlook (Revenue, USD Million, 2018 - 2030)

Alcohol

Cannabis/Marijuana

Cocaine

Opioids

Amphetamine & Methamphetamine

LSD

Others

Drug Testing End-use Outlook (Revenue, USD Million, 2018 - 2030)

Drug Testing Laboratories

Workplaces

Hospitals

Others

Drug Testing Regional Outlook (Revenue in USD Million, 2018 - 2030)

North America

Europe

Asia Pacific

Latin America

Middle East and Africa

Regional Insights

North America drug testing market dominated and accounted for a 39.5% share in 2023. This high share is attributable to the local presence of key global market players, such as Bio-Rad Laboratories, Laboratory Corporation of America Holdings, Thermo Fisher Scientific, F. Hoffmann-La Roche Ltd. and others. Moreover, the growth of the drug testing market in North America can majorly be attributed to the increasing incidence of abuse, stringent government regulations, and active screening programs. The governments are actively engaged in controlling the consumption of hazardous drugs to minimize the cost burden associated with it. In addition, the authorities are focusing on formulating new policies. For instance, in September 2023, San Francisco Human Services Agency (SFHSA) announced a new initiative that would need people suffering from substance use disorder who wish to gain access to county funds to enroll in treatment and services.

List of Key Players in Drug Testing Market

Quest Diagnostics Incorporated

Abbott

F. Hoffmann-La Roche Ltd.

Quidel Corporation

Thermo Fisher Scientific, Inc.

Siemens Healthcare GmbH

Bio-Rad Laboratories, Inc.

Agilent Technologies, Inc.

Laboratory Corporation of America Holdings

Clinical Reference Laboratory, Inc.

Cordant Health Solutions

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/drug-testing-market  

[markjasonstubblefield]

Understanding the Role of Sales Representatives in the Medical Device Industry with Industry Leaders including Mark Jason Stubblefield

Mark Jason Stubblefield

Understanding the Role of Sales Representatives in the Medical Device Industry with Industry Leaders including Mark Jason Stubblefield

The medical device industry in the United States is a dynamic and highly regulated sector that plays a crucial role in healthcare delivery. At the forefront of connecting innovative medical technologies with healthcare providers are sales representatives. These professionals serve as vital links between manufacturers and hospitals, clinics, and other healthcare facilities. Understanding their pivotal role and the strategies involved in selling medical devices in the USA is essential for navigating this complex field effectively.

Importance of Sales Representatives in the Medical Device Sector

Sales representatives in the medical device industry are instrumental in introducing new technologies and equipment to healthcare professionals. They provide in-depth product knowledge, demonstrations, and training, helping healthcare providers understand the benefits and applications of various devices. By establishing relationships built on trust and expertise, sales professionals like Mark Jason Stubblefield facilitate informed decision-making among healthcare providers, ensuring that the most suitable medical devices are selected to meet patient needs.

Moreover, sales representatives act as consultants, offering insights into industry trends, regulatory requirements, and competitive landscapes. Their role extends beyond sales pitches to encompass ongoing support and education, fostering long-term partnerships with healthcare facilities. This proactive approach not only enhances customer satisfaction but also contributes to the advancement of healthcare through the adoption of cutting-edge technologies.

Regulatory Landscape and Compliance Requirements

Selling medical devices in the USA entails navigating stringent regulatory frameworks set forth by the Food and Drug Administration (FDA). Sales representatives must possess a thorough understanding of FDA regulations governing device classification, premarket approval (PMA), 510(k) clearance, and Quality System Regulation (QSR). Compliance with these standards is non-negotiable and requires meticulous attention to detail throughout the sales process.

Sales representatives collaborate closely with regulatory affairs teams within their organizations to ensure that all marketing materials and product claims align with FDA guidelines. They also provide healthcare providers with transparent information regarding the regulatory status and safety profile of the devices they promote. By maintaining adherence to regulatory requirements, leaders such as Mark Jason Stubblefield uphold the integrity of the medical device industry and promote patient safety.

Targeting and Engaging Healthcare Providers

Effective sales strategies in the medical device industry hinge on identifying and engaging with key stakeholders within healthcare facilities. Sales representatives conduct thorough market research to pinpoint target audiences, including physicians, surgeons, hospital administrators, and purchasing managers. They tailor their approaches to resonate with the specific needs and challenges faced by each healthcare provider, emphasizing how their devices can enhance patient outcomes and operational efficiencies.

Building relationships through personalized interactions is paramount. Sales representatives schedule meetings, demonstrations, and educational sessions to showcase the capabilities of their devices in real-world scenarios. They leverage data-driven insights and clinical evidence to substantiate the benefits of their products, fostering confidence and buy-in among healthcare professionals. By addressing concerns and highlighting value propositions, industry leaders including Mark Jason Stubblefield facilitate informed purchasing decisions that align with the strategic goals of healthcare facilities.

Demonstrating Product Value and Clinical Efficacy

Central to the sales process is demonstrating the value and clinical efficacy of medical devices. Sales representatives leverage clinical data, case studies, and peer-reviewed publications to substantiate the performance and benefits of their products. They collaborate closely with healthcare providers to conduct trials and evaluations, gathering feedback and real-world outcomes that validate the device's effectiveness in improving patient care.

In addition to clinical evidence, sales representatives emphasize the economic benefits of their devices. They conduct cost-benefit analyses and ROI assessments to illustrate potential savings in terms of procedural efficiency, patient recovery times, and overall healthcare expenditures. By presenting a comprehensive picture of both clinical and economic advantages, sales professionals like Mark Jason Stubblefield empower healthcare providers to make informed decisions that optimize patient care delivery while maximizing operational efficiencies.

Overcoming Challenges in the Sales Process

Selling medical devices in the USA presents unique challenges, including navigating complex procurement processes and addressing budgetary constraints within healthcare organizations. Sales representatives must navigate hierarchical decision-making structures and align their proposals with the strategic priorities of healthcare facilities. They anticipate objections and proactively address concerns regarding product performance, safety, and return on investment.

Moreover, maintaining competitive edge amidst a crowded marketplace requires continuous adaptation and innovation. Sales representatives stay abreast of industry trends, competitor activities, and technological advancements to differentiate their offerings effectively. By positioning their devices as solutions that meet evolving healthcare needs and regulatory standards, sales representatives enhance their value proposition and foster enduring partnerships with healthcare providers.

Building Long-Term Relationships and Support

Successful sales in the medical device industry are not solely transactional but relational. Sales representatives prioritize building long-term relationships with healthcare providers based on trust, integrity, and ongoing support. They offer comprehensive training programs, technical support, and post-sales service to ensure seamless integration and optimal use of their devices within clinical settings.

Furthermore, sales representatives serve as advocates for customer feedback and product improvement. They relay insights gathered from healthcare providers to manufacturers, facilitating continuous innovation and enhancement of medical devices. By demonstrating commitment to customer success and satisfaction, leaders such as Mark Jason Stubblefield reinforce their role as trusted partners in advancing healthcare delivery.

Sales representatives play a pivotal role in the medical device industry by bridging the gap between manufacturers and healthcare providers in the USA. Their expertise in product knowledge, regulatory compliance, and strategic engagement is instrumental in driving adoption and utilization of innovative medical technologies. By understanding the complexities of the sales process and emphasizing value-based relationships, sales representatives contribute to the advancement of healthcare through the delivery of high-quality, patient-centered care.

[cubicdesignz]

The Future of Otho and Bone Health: Trends to Watch in 2024

Custom 3D-Printed Implants: Personalized Solutions

Enovis: Enovis completed its $846 million acquisition of LimaCorporate, adding custom 3D-printed implants to its product portfolio. This technology allows for personalized solutions, better fit, and improved patient outcomes in joint replacement surgeries. Enovis continues to expand its global footprint and make rapid inroads in the foot and ankle segment—a trend worth monitoring1.

Robotic-Assisted Surgery: Precision and Efficiency

Globus Medical: The $3.1 billion acquisition of NuVasive by Globus Medical created the second-largest player in spine, behind only Medtronic. All eyes are on the successful integration of these companies and their reportedly disparate cultures. The blending of teams will significantly impact the spine market, and so far, the signs are positive. Globus Medical’s CEO, Dan Scavilla, expressed satisfaction with the collaboration during a recent earnings call1.

Wireless Handpieces for Knee Surgery: THINK Surgical’s TMINI System

THINK Surgical received FDA 510(k) clearance for its TMINI Miniature Robotic System. This innovative platform features wireless handpieces designed to help surgeons locate bone pins and make precise cuts during knee replacement surgery. Expect further advancements in robotic-assisted joint surgeries1.

AI and Deep Learning Transforming Preoperative Planning

The convergence of Deep Learning (DL) and Generative Artificial Intelligence (AI) is reshaping preoperative planning. DL analyzes medical imaging, aiding in recognizing subtle anomalies and fractures. Generative AI predicts surgical outcomes based on patient-specific data, allowing for personalized treatment plans. Real-time decision support during surgery is another exciting application of AI1.

Digital Templating and Augmented Reality Enhancing Precision

Digital templating tools allow surgeons to plan joint replacement surgeries virtually. Augmented reality overlays 3D images onto the surgical field, aiding in precise implant placement. These technologies enhance preoperative planning and intraoperative accuracy1.

Remember, these innovations hold great promise for patients seeking better outcomes and improved quality of life. If you’d like more details or have other topics in mind, feel free to ask! 😊

[i3c-global]

FDA 510k Clearance for Medical Device and IVDs

FDA 510k - An Overview

FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective as legally marketed devices that are not subjected to PMA. Organizations planning to launch Class I, II, and III devices in the United States intended for human use must submit a 510(k) if pre-market approval is not required.

Most class 1 devices are exempt from FDA 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the FDA 510k clearance for medical devices with a ‘(k)’ number.

We offer technical and scientific assistance in identifying a suitable predicate device, regulation number, and device code, along with file drafting, e-copy conversion, and submission through the US Agent service. Few manufacturers opt for Q submission before final submission.

Role of I3CGlobal Consultants

As a prominent FDA 510k Consultants on a global scale, we have gained the trust of more than 350 plus manufacturers and specification developers. Our team consists of highly skilled subject-matter experts, assuring timely file preparation for 510(k) clearance irrespective of the manufacturer’s size or the regulatory knowledge of their internal team.

With an impressive 85% success rate, a track record of over 350+ clearances worldwide, and a history of serving more than 150+ manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.

Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete files on behalf of our clients and take full responsibility until the 510k approval is obtained.

F

DA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

Intended use,

Design,

Safety,

Adherence to standards,

Labelling,

Biological Compatibility,

Performance characteristics,

Materials used in the construction/ chemical composition,

Manufacturing Methods,

FDA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

Intended use,

Design,

Safety,

Adherence to standards,

Labelling,

Biological Compatibility,

Performance characteristics,

Materials used in the construction/ chemical composition,

Manufacturing Methods,

Get more Information : https://www.i3cglobal.com/fda-510k/

[sigmabiomedical]

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Surgical Masks Market: Post-COVID Prospects

Short-term demand for surgical masks remains unprecedented; however, growing awareness regarding their effectiveness will lead to steady sales in the long term. Our study estimates the global surgical masks market to surge at a CAGR of 10.2% during the forecast period 2022-2028. This growth is fueled by the growing awareness of healthcare-associated infections (HAI) and a rise in healthcare expenditure.

According to the World Health Organization (WHO), hundreds of millions of individuals are impacted by healthcare-associated infections (HAIs) annually, resulting in death and financial losses for healthcare systems. Furthermore, factors such as an aging population, the prevalence of chronic and long-term diseases, and increased investments in medical technology & advanced infrastructure will increase healthcare spending globally.

Why is Asia-Pacific a Promising Region in the Surgical Mask Market?

Asia-Pacific is anticipated to be the fastest-growing region in the surgical masks market. The increasing elderly population and growing healthcare infrastructure are likely to boost the demand for healthcare services. Improving hygiene and safety standards leads to increased use of surgical masks, thereby positively impacting the studied market.

Fluid/splash resistant surgical masks leads the product segment in 2021. The growth is associated with the ability of the Splash Resistant technology, which prevents the wearer from droplet infections during any surgical procedure or management of any patients prone to the transmission of the diseases.

On the other hand, India holds a significant prominence in the Asia-Pacific market. The healthcare business in the country is anticipated to expand greatly due to the growing population, increased disposable incomes, improved access to insurance, heightened health awareness, and rising spending by public and private industry participants. In addition, the growing incidence of obesity has led to an increase in chronic ailments, such as heart disease and diabetes, which necessitate various healthcare treatments and services. This is expected to contribute to the expansion of the market for surgical masks.

However, strict government regulations, coupled with the emerging use of substitutes such as N95 masks, are anticipated to hinder the growth of the surgical masks market.

Due to the COVID-19 pandemic, there was a dearth of personal protective equipment, such as surgical masks. This forced the medical staff members performing front-line activities to adopt additional face protection measures, including non-medical masks, simple cloth masks, N95/N99/FFP2/FFP3 respirators, power air-purifying respirators, and face shields/visors, etc.

Technological Integration: The Way Forward

New technology by Ascend Performance Materials is used to manufacture high-efficacy surgical masks to protect against SARS-CoV-2. This technology has shown positive results for deactivating SARS-CoV-2 and other pathogens such as staphylococcus, betacoronavirus OC43, and H1N1. However, it is still awaiting patent and FDA approval. The masks manufactured using this technology combine antiviral protection and superior physical properties meeting the requirements to qualify as Level III under ASTM F2100-19 standards.

In July 2020, Ascend Performance Materials announced the submission of a 510(k) premarket notification to the US FDA for clearance of its surgical mask that uses Acteev technology to offer protection against SARS-CoV-2. Thus, improvements in the manufacturing of reusable non-woven materials, such as antimicrobial fibers and increased comfort, will propel the expansion of the surgical masks market during the forecast period.

 

FAQs

Q1) What are the segments covered in the surgical masks market?

Product, type, material, distribution channel, and end-user are the segments covered in the surgical masks market.

Q2) Who are the key players in the surgical masks market?

The key companies studied in the surgical masks market are 3M, Mediblue Health Care Private Ltd, Cardinal Health, Kimberly-Clark Corporation, Alphaprotech, Ansell Ltd, Magnum Health and Safety Pvt Ltd, and Dupont De Nemours Inc.

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The FDA has issued 510(k) clearance for Think Surgical’s Tmini miniature robotic system to be used with Zimmer Biomet's Persona knee system. The post FDA issues 510(k) clearance for Think Surgical’s Tmini use with Persona system appeared first on Me #BioTech #science

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Comprehensive Analysis of the Global Oral Care Market: Trends and Forecasts

The Oral Care Market is projected to reach $58.99 Billion by 2031, growing at a CAGR of 7.4% from 2024 to 2031. The market's growth is driven by the increasing prevalence of gum diseases and dental caries, rising awareness of oral health and hygiene, growing demand for dental aesthetics, increasing consumer awareness of oral care products, and the growing use of eco-friendly oral care products. Additionally, a shift towards natural and herbal oral care products and technological advancements in oral care products are expected to offer growth opportunities for market players.

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Oral Care Market Growth Drivers

Increasing Prevalence of Gum Diseases and Dental Caries

Oral diseases are a significant health burden globally, affecting nearly 3.5 billion people. According to the Global Burden of Diseases, untreated caries in permanent teeth is the most common dental condition worldwide, particularly in developing countries, affecting 60-90% of school children and most adults. Various solutions and oral care products are available to treat dental caries. For example, in June 2023, Incisive Technologies Pty Ltd. (Australia) received U.S. FDA 510(k) clearance for the BluCheck caries detection and monitoring preventive care solution, which binds to active carious lesions and makes them visible with its blue color.

Risk factors such as smoking, poor oral hygiene, medication, age, heredity, stress, and diabetes are linked to periodontal diseases. People with diabetes are at higher risk of periodontal diseases, which can slow down the healing process, cause dry mouth, fungal infections, ulcers, and tooth decay. Increased blood glucose levels can increase sugar levels in saliva, allowing bacteria to metabolize sugar into acid, leading to tooth decay. The increasing prevalence of dental diseases and chronic conditions that degrade dental health is expected to drive the global oral care market.

Rising Consumer Awareness Regarding Oral Care Products

Oral care products help maintain oral hygiene and prevent dental caries, gum diseases, and other conditions. Poor oral health can diminish an individual's quality of life and contribute to oral diseases. Maintaining oral hygiene is crucial for disease prevention and is the responsibility of both patients and dental professionals. This hygiene can be achieved using various oral care products.

Product launches and awareness programs are increasing demand for oral care products. For instance, in February 2022, the Colgate-Palmolive Company (U.S.) launched a public health initiative to empower people to improve their oral health quotient (OQ). The company plans to commit more than USD 100 million over the next five years to address the global health crisis and incorporate oral health into broader public health strategies. Social factors also affect the selection and demand for oral care products.

In September 2023, during the World Dental Congress of the FDI World Dental Federation (Switzerland), the World Oral Health Day (WOHD) 2024-2026 campaign was launched to empower people with the tools and knowledge to prevent and control oral diseases and promote oral hygiene.

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Oral Care Market Trends

Increasing Adoption of Electric Toothbrushes

Traditionally, manual toothbrushes have been the most common type of product used to clean teeth. However, advancements in oral health products and technologies have led to increased use of electric toothbrushes. Electric, motorized, or battery-powered toothbrushes make rapid bristle motions and provide better plaque removal than manual toothbrushes. Electric toothbrushes offer several advantages, such as reliability, specialized features, ease of use, and promoting tooth and gum health, along with advancements like pressure sensors and Bluetooth connectivity.

Electric toothbrushes are also beneficial for people with physical disabilities and limited hand movement. For instance, in September 2023, CURADEN AG (Switzerland) launched Samba, an electric toothbrush with dynamic brushing motion that thoroughly removes plaque and debris. Various product launches for electric toothbrushes continue to cater to regular use. For example, in March 2022, Colgate-Palmolive India introduced sonic technology toothbrushes that provide significantly better cleaning compared to regular toothbrushes.

Introduction to Skincare-inspired Oral Care Products

Various products and devices used for skincare, such as serums, balms, and masks, are being integrated into oral care to enhance and maintain oral hygiene. Products like tooth creams and tooth masks perform functions similar to skincare creams and contain chemicals that help whiten teeth and eliminate bad breath.

From a consumer perspective, treating teeth with the same care as skin has become equally important, leading manufacturers to introduce such products. This is mainly done by using specific ingredients. The presence of collagen, niacinamide, and probiotics is increasing in markets such as China, Japan, and South Korea.

Oral Care Market Opportunity

Shift Towards Natural and Herbal Oral Care Products

With the growing manufacturing of new oral care products, consumers have become more informed about the composition of the products they use. This has led to a significant shift towards natural-composition oral care products such as toothpaste, toothbrushes, gels, pastes, mouthwashes, and mouth fresheners. Natural products are produced sustainably and environmentally friendly, without chemical ingredients.

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