Joint Verification and Validation (V&V)
Michael Segev I 19.03.2023
Design Verification and Validation (V&V) are independent procedures that are utilized in conjunction to ensure that a product meets its specification requirements and fulfills its intended purpose.
Design Verification ensures that a product meets the design specification. In the development phase, verification procedures include performing special tests, models, analysis, or simulating product performances.
Design Validation ensures that the product meets the intended use in the field (Hospitals, Medical centers, etc.). Design Validation involves human factor engineering studies, clinical experiments, or literature review.
Essential steps in product development process for V&V:
Process Validation demonstrates with a high degree of assurance that the process can create products that can be consistently manufactured while meeting predetermined specifications within stated parameters. Process Validation will include IQ, OQ, and PQ to qualify the production process.
Design V&V and Process Validation stage, as part of the Product development stage
As an OEM manufacturer, Elcam performs the Design Verification and Process Validation. Elcam carries out Design Validation when developing a new product that involves a change in the intended use. This process includes coordinating with the customer, depending on whether the new product is a combination product, part of a customer’s product, or the final product.
Joint V&V Program
Verification and validation during the implementation or transfer of components and products from development to production can be particularly challenging in terms of time and effort, especially for companies dealing with resource constraints, meeting regulatory requirements and maintaining their core capabilities.
A mutual V&V Integration program that includes inputs and cooperation of both the component manufacturer and the medical device company, will alleviate the workload of the medical device provider. This program can significantly accelerate the approval process and time to market of the end product, in addition to saving significant resources for the medical provider.
It is believed, backed by extensive experience and evidence, that adopting a collaborative model of mutual V&V for introducing a new component (e.g., stopcock, luer connector, drip chamber) into a medical device or medical set, will result in better process efficiency, eventually translating into cost and time savings for both sides. This will facilitate collaboration which creates synergic value, minimizes variability in the process, and meets critical quality requirements with the least amount of time, resources, and costs used.
The Joint V&V service program provided by Elcam serves to streamline the V&V process of integrating a new component into a medical device or a set. This service focuses on building a single mutual V&V plan instead of two separate plans to utilize resources most efficiently.
Joint V&V Program includes the following package, or partial package, as required specifically in each case:
In conclusion, Elcam’s joint V&V service is a uniquely managed V&V process that enables the medical device manufacturer to save crucial time and money when approving a new product or replacing medical components in combination with customers’ products.
In addition, utilizing this service can aid in obtaining regulatory approval for the product. Therefore, it is advisable to consider utilizing and enhancing the V&V service when selecting components and suppliers. The value you get is the peace of mind that comes from having greater transparency and assurance in the V&V processes and quality standards.
Chief Technology Officer, Elcam Medical
Environmental, Social, and Governance Responsibility
Hadas Bibi Eizenberg I 17.08.2022
Environmental, Social and Governance (ESG) responsibility is a framework by which organizations demonstrate integrity regarding social, environmental, ethical, and economic issues. It is a way to take action to support the vision, mission, and values of an organization, rather than relegating it solely to a written statement.
ESG is not a side issue, or a hassle to be quickly disposed of. Rather, it is a strategic approach which suggests that organizations voluntarily include social, environmental, and ethical considerations in their decision-making process in order to ensure long-term success.
ESG is constantly growing and evolving as an increasing number of countries as well as global and local organizations decide to take action to ensure a better world. There is increasing recognition that in order to have a good life, we all need to take care of one other, especially as the pressure on limited environmental resources becomes increasingly challenging. Since we have only one planet, our actions today impact us all tomorrow.
Elcam Medical is committed to ESG responsibility. We believe it is not a goal, but a long-term journey where improvement comes by diligence and perseverance; it is the way that our organization operates in the world and as a way of life.
In 2022, Elcam Medical received a silver medal from EcoVadis and reached the 78th percentile in our industry sector.
EcoVadis is a global business Sustainability Ratings company, well known in the medical industry. EcoVadis operates an evidence-based online platform, providing sustainability ratings and allowing companies to assess the ESG performance of their global suppliers. The EcoVadis Rating covers a broad range of non-financial management systems including environmental, labor & human rights as well as ethical and sustainable procurement. Each company is rated on the material issues as they pertain to their company’s size, location, and industry.
Elcam is committed to maintaining good corporate citizenship by actions related to different aspects of ESG:
Social responsibility in Elcam means promoting diversity and inclusion in the workforce and providing equal non-discriminatory working opportunities. Our employees come from 33 countries across the world and from 5 main religions and ethnicities (Jews, Christians, Muslims, Circassians and Druze). In our Israeli facilities alone, we employ workers from 72 different communities from all around the northern part of Israel. We currently have 47.5% women employees and 37.5% women in managerial roles.
Social responsibility also means being involved and taking an active part in promoting social issues in our communities and especially creating role models for future generations. We do so in a variety of ways, such as donations to local hospitals and establishments in need in Modena, Italy during the COVID19 pandemic, or investing in one of the high schools near our Israeli facility, where together, we’re building an innovation lab for research and promoting technological education through different activities. Our Italian facility is one of the founding members of the ITS FOUNDATION — New Technologies of Life, which carries out free two-year and post-diploma courses to train senior technicians in the fields of design, production and quality assurance of the biomedical sector, bringing highly specialized skills and innovation capacity to companies.
Environmental responsibility in Elcam comes in many ways — recycling plastics and cartons, maximizing efforts in order to save energy by adopting innovative technologies, and employing natural gas and solar energy as environmentally-friendly energy generation for self-consumption in our facilities. We also encourage our employees to be more environmentally friendly through recycling, reducing use of plastics, sustainable mobility and more.
Governing responsibility means being obligated to high standards of Ethical and Business Conduct. Elcam operates both internally and externally in a fair and non-exploitive manner, according to the laws and regulations in all the countries we operate in. Our managers and employees abide by a comprehensive set of internal procedures and guidelines which are consistent with our commitment to acting with integrity in all that we do. As part of Elcam’s ongoing improvement processes, we are currently refining our code of conduct. Furthermore, in order to promote the ESG concept among our suppliers and help them do better for their stake holders, we also ask our major suppliers to acknowledge our code of conduct for suppliers.
Elcam believes that through our ESG responsibilities, we can enhance collaboration with colleagues, strengthen relationships with customers, partners and society, and create added value.
Elcam’s Ecovadis Silver Medal
Hadas Bibi Eizenberg,
ESG Leader, Elcam Medical
Amir Bohadana I 14.07.2021
Customizing products to fit different needs of various applications and usage is a basic requirement of most manufacturing companies and in particular medical device manufacturers.
Medical device companies are consistently searching to develop new solutions for improved procedures and more effective patient treatment. The innovation of new solutions often requires customized devices and components which in many cases are small however essential part of the whole new product development.
Some manufacturers use in-house customization capabilities while others outsource projects to companies that have expertise in specific product lines, especially when it comes to smaller components and devices. To make it feasible for a company to invest such efforts in a specific component or a production line, it must be a company that focuses on a relative niche product line.
When it comes to medical product customization being able to customize products is good, but to truly be a significant partner in developing new systems, one needs to be familiar with the clinical area, have vast experience and internal knowledge in product customizations.
Furthermore, product customization processes require significant documentation in order to receive regulatory approval. In the medical device field this requirement is trifold – as each change requires regulatory approval and documentations according to ISO standards, biocompatibility, shipping tests and more.
Elcam Medical is a world class producer of disposable medical devices and accessories for the OEM market, and a provider of innovative solutions for specialized flow control needs.
Being an OEM company, the capability to customize our products to fit new developments is one of our most important assets.
Elcam’s focus on disposable components for OEM, enables us to invest a lot of efforts in this line which led us to having the broadest portfolio of stopcocks, manifolds and connectors for IV and drug delivery, with more than 1000 SKUs for the stopcocks line alone.
Elcam does not work as a subcontractor. We treat our customers as partners and share our extensive knowledge in product development and our long-standing clinical know-how gained in over 40 years of experience. The Elcam teams know how to recognize market needs and recommend solutions, making us a significant partner in the development process.
Furthermore, as a true OEM company, Elcam’s quality assurance and regulatory affairs department provides customers with comprehensive regulatory support including all the required documentation.
Chief Sales Officer, Elcam Medical
Volume 15, Number 4
Growth is one of Elcam’s values and it means for us being bold and innovative in new products, services and solutions. Elcam is invested in product innovation with more than 20 new ideas reviewed annually and over 7000 manhours devoted to screening new projects. We innovate together with our customers and partners in an effort to provide real solutions to real problems.
Understanding the needs and requirements for safe and effective medical care requires the expertise of healthcare professionals, clinicians as well as clinical specialists of medical device companies. Elcam uses its close cooperation with OEM customers, key clinicians and inventors to explore the medical market on an ongoing basis in order to stay up-to-date and committed to the medical market evolving needs and trends. Explore our review and development processes
Elcam strives to enhance patients’ and medical teams’ safety. The two following examples show how our innovation is rooted in the unmet needs of the medical fields we operate in
The potential for Environmental Stress Cracking (ESC) is a well-known concern when plastics are used in medical device components. The use of lipids and other aggressive solutions can initiate microcracks in the polymer and compromise the material’s mechanical integrity. Adverse events such as medication discontinuation, blood loss, air and bacteria ingress, as well as exposure of clinicians to hazardous drugs and bodily fluids, are all potentially dangerous events that may result from ESC and need to be prevented as much as possible by safety guidelines and smart products. One way to decrease the incidence of ESC is to use more resilient raw materials as did Elcam with its SafeT™ product line.
Elcam Medical’s Tritan™ integrated SafeT™ Stopcocks and Connectors provide safer treatment through enhanced lipid and chemical resistance.
Tritan™ is a new-generation copolyester that has been shown in bench-top testing to be resistant to a large spectrum of medical fluids such as oncology drugs, lipids, drug carrier solvents, and nutrition.
The SafeT™ stopcocks have been tested and proven to be resistant to 10 different drugs including lipid and other aggressive substances and IPA (isopropyl alcohol).
Luer connector misconnections are under-recognized, but common and potentially dangerous events. The objective of the ISO 80369 Standards is to prevent these adverse events and improve patients’ safety. The ISO 80369-6:2016 Standard, is part of the 80369 series and affects devices for neuraxial applications such as epidural devices, pain medication pumps and their administration sets, regional anesthesia catheters and needles. Elcam has taken a proactive approach to the implementation of the new ISO 80369 standard regulations and currently has products that comply with the different parts of the standard (-3, -6, -7). Our Neuraxial (NRFit) products are compliant with the new ISO 80369-6 standard. They include the NRFit stopcocks and both male and female ISO 80369-6 connectors. The connectors are also available with clear Tritan™ material from Eastman, providing further advantages of improved lipid resistance and the benefits of not containing BPA.
Tomer Gil, of Elcam Business Development and Marketing team is relocating to our US office in Hackensack, New Jersey. Tomer has been with Elcam since 1993, first as an engineer in R&D department and during the last 15 years as a Marketing Director. Tomer will continue to fulfil all his former tasks from the US and will also take charge of US business development activities. Join us in wishing him a smooth transition and much success in his new role
Last year LyondellBasell announced the discontinuation within 2023 of its polypropylene material Purell HP 371-P.
Over 400 codes from Elcam Italy’s product portfolio are involved. Elcam Medical started and almost completed a replacement program, with the Borealis polypropylene Bormed RF830MO. For some product families, like Caps and Clamps, Elcam will offer further alternative with the new LyondellBasell polypropylene Purell HP 373-P.
The replacement of the materials will take place throughout 2023.
Elcam strongly recommends our customers who use our products made of Purell HP 371-P to anticipate this changeover at earliest possible. This may enable us to offer the same components made of alternative equivalent polypropylene materials.
Igal (Guli) Kohn, CEO and General Manager
Palm Springs, California
The Westin Copley Place, Boston
Hall 8a Booth E28
Hall B1 Booth H003
Volume 15, Number 3
Elcam has recently received the MedAccred accreditation for plastic injection molding processes for its Israeli sites, and has become the first company in Israel to be awarded this accreditation.
MedAccred is an industry managed, consensus-driven approach for ensuring critical manufacturing process quality throughout the medical device supply chain. In today’s world of global manufacturing, the supply chain is multi-tiered and geographically remote, making oversight challenging and costly. To prevent output deficiencies, critical processes and products must be validated during manufacturing to prove that they are fit for purpose, satisfy customers’ and regulatory requirements and reduce overall risk. The MedAccred accreditation is unique because it is industry driven and managed. Its subscribers are the top tier medical device companies such as Bausch Health, Baxter, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker. These companies fund and manage MedAccred, determine audit criteria, have full access to audit findings, and determine who is granted accreditation.
Israel Dembus, Elcam’s Chief Quality & Regulatory officer shared: “Elcam decided to obtain the MedAcrred accreditation based on our understanding that this accreditation is a growing trend in improving the medical device industry quality standards, which will help us better serve our customers and partners. The accreditation validates that we maintain the highest quality standards for our products and ultimately helps assure patient safety.”
Elcam intends to continue the accreditation process and to receive accreditation for all applicable production processes in all worldwide sites during the next 2 years.
Elcam Medical was recently awarded a Silver Business Sustainability Rating by Ecovadis.
EcoVadis provides holistic sustainability ratings service of companies. The EcoVadis Rating covers a broad range of non-financial management systems including environmental, labor & human rights, ethics and sustainable procurement impacts. Each company is rated on the material issues as they pertain to their company’s size, location and industry. These evidence-based assessments are refined into easy-to-read scorecards, providing zero to one hundred (0-100) scores, and medals (bronze, silver, gold & platinum), when applicable. Additionally, the scorecards provide guidance on strengths and improvement areas, which the rated companies may use to focus their sustainability efforts and develop corrective action plans to improve their sustainability performance.
Hadas Eisenberg, Elcam’s Sustainability officer explained: “Elcam chose to be rated by Ecovadis as part of our belief in the importance of ESG (environmental, social and governance) and sustainability as well as our approach to maintain and keep improving high level customer experience.
We are proud to share the recent silver rating we received from Ecovadis. Elcam scored in the 78th percentile of all companies in our industry that were rated by Ecovadis and we aim to continue and improve our score over the next years”.
In a recent article (February 2022) of the APSF (Anesthesia Patient Safety Foundation) Newsletter, Dr. Elliot S. Greene wrote about ‘Challenges and Solutions for Reducing Infection Risks When Accessing Vascular Catheters’ and discussed the contamination and infection risks when using disinfected DNCCs (Disinfectable Needleless Closed Connector) and OLS (Open Lumen Stopcocks). In his notes he wrote: “The current literature supports that disinfected DNCCs should be used instead of OLSs based on the following premises: the documented overall lower contamination and infection risks of disinfected DNCCs compared to OLSs and the recent SHEA recommendations that “stopcocks used for injecting drugs should ideally be closed with needleless injection ports.” To reduce infection-related patient risk, vascular catheters used for medication or fluid administration, or blood withdrawal, should be routinely accessed via either disinfected DNCCs or via disinfected DNCC-stopcocks. Compliance with disinfection is essential. For DNCC-stopcocks, the DNCC should preferably be bonded to the stopcock injection lumen to eliminate removal and bypassing the DNCC. Current studies support that blood samples from arterial tubing sets be obtained via disinfected DNCC-stopcocks instead of OLSs. Manufacturers should supply IV and arterial transducer tubing sets with DNCC-stopcocks instead of OLSs and there should be DNCC-stopcocks made available as single packaged items.”
Elcam’s Closed swabbable Stopcock and Marvelous™ Stopcocks are both DNCC stopcocks that present many advantages to both clinicians and patients for helping reduce infection risks.
The Closed Swabbble Stopcocks are DNCCs as described by Dr. Green – Stopcocks integrated with a swabbable luer activated valve (i.e, disinfectable needleless closed connector) allowing for maintenance of a fully closed system through the entire use of the stopcock, as well as eliminating needle stick injuries when using a stopcock. This integration also reduces the stopcock’s residual volume in comparison to standard stopcock with attached LAV cap.
As for the Marvelous™ stopcock– this unique product carries more advantages as in addition to being closed & swabbable it also has a proprietary flow channel feature specifically designed for IV administration and pressure monitoring applications, allowing to continuously flush drugs and blood residuals, without the need to expose the system to the open air, assuring minimal residual volume and further reducing infection risks.
It looks like the Covid – 19 is moving away and Elcam is very happy to be able to return to in- person meetings.
Over the past 2 years many of us have spent a lot of time apart, away from our normal lives. For Elcam, our business model has always been relationship-driven, but the pandemic largely put a halt to in-person customer meetings. Just like our customers, how we are able to meet has changed dramatically since the beginning of Covid-19.
In some cases, the shift wasn’t a totally bad thing. We’ve all learned how to use Zoom, Teams, Webex and other communication tools, and once everyone got comfortable with the technology, it was beneficial being able to meet with customers virtually. Now as we are beginning to see the end of the pandemic, we are all trying to understand what meetings are supposed to look like in a post-pandemic world. What will the new normal look like for businesses like ours that used to count on face-to-face interaction as a core part of how we work?
It’s likely we will not completely return to pre-pandemic modes of conducting business – the conveniences of modern technology are just too great to abandon entirely. On the other hand, we do not expect our business to stay strictly virtual. We expect a hybrid approach to communicating with our customers, taking what we’ve learned during the last 2 years and applying it to our future business practices.
We at Elcam are always looking for a return to personalized service and we are looking forward to getting back to seeing our customers face to face. As your situation changes, please contact your Elcam representative to schedule a meeting and we hope to see you face-to-face in the near future.
31 August – 2 September
Hall 1 Booth 2H003
Prevention of Intravenous Bacterial Injection from Health Care Provider Hands: The Importance of Catheter Design and Handling
Elcam is investing 2.85 millionִ$ in DiagnosTear Ltd. for development and manufacturing of an innovative Dry-Eye diagnostic test – TeaRx™ for Dry Eye disease
Elcam is investing 1.5 millionִ$ in Serrenno Medical for development and manufacturing of a unique urine output monitoring device, the Sentinel™.
Volume 15, Number 2
Elcam products can be customized according to customers specific needs, offering the company’s expertise, world class equipment, and production capacity for custom made products for you. Our customization capabilities are broad and include unmatched configurations, dimensions, flow rates, colors, variety of high-performance materials and more.
Elcam Medical is committed to understanding your unique requirements, applying our 40 years of experience and advanced manufacturing capabilities to every project, in order to design, develop and manufacture comprehensive solutions for your customers need.
Michael Segev, Elcam’s Chief Technology officer, shared: “When it comes to customization, we combine your idea with our in-depth product knowledge and expertise. Our Design and Development Engineering team through its vast experience, creativity and application of up-to-date engineering tools, is qualified to give the best advice and support in cost-effective designs, raw materials, product features and specifications, while the Process Engineering team transforms prototypes into manufacturable, cost-effective, validated devices, as well as developing and adjusting specially designed production lines”.
Over the last 5 years Elcam has developed 150 customized products. The company’s renowned stopcocks that are now available with tube assembly in a variety of dimensions as well as the low-profile disposable pressure transducers (DPT), constitute just a few examples of Elcam’s capabilities to provide tailor made adjustments.
As part of Elcam’s continuous efforts to expand product range to best answer customers’ needs, Elcam is now offering its standard and Marvelous™ stopcocks with a variety of extension tube lines as cost effective sub-assemblies.
Elcam offers the widest variety of tube fitments for bonding, off the shelf or tailor made, that together with Elcam’s highly automated processes ensure consistent production of high-quality products.
Available customization options include different tube lengths and Stopcock configurations, male luer lock connectors and optional connector covers including Elcam’s unique Safe2 Rotator™ connector as another optional customization
The new low-profile DPT that is gradually replacing Elcam’s prior DPT was designed per request from the market to be more suitable for applications that do not require the use of a flush-device. The low profile is more elegant, intuitive and easy to use. The new low-profile transducer offers many customization options including different luer configurations as female or male luers, tube sockets or bonded stopcocks, as well as variety of connector types and also optional logo engraving or printing. The DPT continues to present all the benefits of the older version:
Ease of use
Full visibility of the flow path
Easy and safe priming and debubling
Improved luer locks – utilizing Elcam’s “ramp lock” patent for excellent connectivity
Reliability & Safety
Elcam’s High quality standards
The DPT is suitable for any pressure monitoring applications for which Flush Device is not required
Elcam sales department has recently made some organizational changes in an effort to better serve our customers’ needs. The Sales department under the Management of Amir Bohadana has been divided into 3 groups: Product management – Stopcocks & Manifolds (Catalina Gutman), Patient Monitoring and Interventional (Gal Halperin) and Elcam IV &Dialysis Components (Gianluca Mariotti); Territory management (US- David Landspurg, Europe – Gianluca Dispenza, Asia, LATAM, ME & Africa – Alon Gamliel) with corresponding specific local account managers; and of course, our dedicated Customer Service teams in all territories.
We would like to introduce our new team members:
Gal Halperin is Elcam’s new Patient Monitoring & Interventional Procedures Product Manager. Gal has a BA in economics and statistics and MA in Business administration. Gal has joined Elcam 4 years ago as a cost accountant and is familiar with Elcam’s products and customers. He is a member of Baram and has deep roots in Elcam as his parents and even grandparents are veterans of Elcam. Gal shared: “I’m very excited about my new position. I love a good challenge and I look forward to deepen my knowledge and learn the clinical background of the products. I believe that this knowledge and good relations are key factors for Elcam’s and our customers’ success”.
Alon Gamliel is the new territory manager for Asia, Middle East & Latin America. Alon has 20 years’ experience in the international market and 15 years in the medical market. His latest positions were at Medispec and at Schultz Medical in England as a commercial manager for about 5 years. He has a B.Sc. in Electrical engineering. Alon says: “I believe that Hard work can divert falcons in flight. Working at Elcam is a dream come true, of challenges throughout the company, working with professionals, who feel that everyone is an integral part of the company as a whole.”
In November 2021, EMI welcomed Abe Santrich to the team in the role of Logistics Customer Service Coordinator. Abe’s background is in Logistic and Import Management and his skills and abilities will be a major contributing factor in continuing the exceptional customer service and support our customers expect. Abe stated: “I am grateful to be given the opportunity to be part of this team and be able to enhance my experience by working together with each team member.”
Saar Maoz is our new Customer Service for the USA and Latin America territories. He joined Elcam after working at Apple Inc (London) as a customer service team leader and in the last 3 years as the Deputy CEO of Israel AIDS Task force, where he was responsible for both human resources and advocacy on a governmental level. Saar moved to Baram in 2020. Saar tells us: “I believe in people and that getting communication flowing is the way to create success in abundance. I would love to see Elcam continue to grow and be a safe sustainable environment that promotes diversity and inclusion”.
Einav Gutman joined the Customer Service team in Israel a year and half ago after previous roles in agriculture, studying economics and management, and working as an accountant in Baram’s Agricultural industry. Einav is a proud father of 3 teenagers. He loves sports and manages Braam’s Sports department. Einav shared: “I had the great opportunity to join Elcam’s team. I look forward to continue working with Elcam customers, to provide the best solutions to their needs”.
Like every year we have sent you the Elcam’s annual customer satisfaction survey in December and have recently finished summarizing its results.
We would like to thank all of you that took the time to answer the questions and help us with Elcam’s consistent efforts to improve its services.
Despite the obvious difficulties dealing with the ongoing pandemic and its continued impact on the global logistics crisis as well as raw material shortages and price increases, Elcam is excited to share the feedback received from the 2021 customer satisfaction survey that shows a high level of satisfaction from Elcam services and products quality in general, and from the reliability of supplies specifically.
The Net Promoter Score (NPS score) measured annually representing the customers loyalty levels (a positive score is considered good, and an NPS of +50 excellent), further improved in 2021 and received the best score we had seen so far. Amir Bohadana, Executive Sales Director, elaborated: 2021 was one of the most challenging years for keeping our services at high level in light of the world logistics crisis. We were happy to see from the survey results that our efforts have been successful. We are aware that this crisis is not behind us yet and that we will need to try even harder to keep ranking above 50 in the following years as well”.
Igal (Guli) Kohn, CEO and General Manager
Anaheim, California, USA
Volume 16, Number 4
The Elcam Devices product line represents Elcam’s commitment to the OEM market and our obligation to remain innovative and current in providing differentiating solutions for safe and effective flow control needs.
This sub-brand includes 3 main sections of our product lines – Patient Monitoring, Medication Delivery, and Interventional Procedures. Each of these sections includes dedicated devices that were developed to create solutions to real flow control problems with an emphasis on patients’ and care givers’ safety.
The New A-Tap™ for orthopedic procedures, the Y-Click for interventional cardiology procedures, and the Safeport™ manifold for anesthesia and ICU applications are all part of this brand and are excellent examples.
Elcam Medical designed the new an innovative A-Tap™ to facilitate intra-articular injections. This medical solution optimizes injection procedures, focusing on reducing procedure time, enhancing accuracy, and minimizing needle movement.
The A-Tap™ enhances treatment precision and efficacy with by confirming needle tip position with aspiration, which supports best practice recommendations. Enabling two procedures with one needlestick and minimizing needle movement, it can greatly improve both practitioners’ and patients’ treatment experience.
The A-Tap is now CE approved and 510(k) cleared and available for sale
Cathlab procedures require working areas with minimum bleeding. Elcam’s Y-Click connector was designed in collaboration with interventional experts with this need in mind – to provide a hemostatic solution for percutaneous transluminal coronary angioplasty (PTCA) procedures and other diagnostic and interventional applications.
Its most unique advantages – three working positions, self-closing mechanism and one-handed operation, make the Y-Click connector an easy-to-use hemostatic device that improves physicians’ performances
Induction of anesthesia during operation is involved with enormous responsibility and requires multiple skills and focus. Elcam’s SafePort™ is a unique function manifold with patented dual flow option innovative side-port valves that can simplify the anesthesiologists’ work during procedures.
The SafePort is now available with a new improved design in which the handles are injected using 2C molding technology, guaranteeing improved accuracy and reliability.
SafePort™ is also available as a closed system with integrated Swabbable Luer Activated Valves, for minimizing leakages and exposure to air and contamination
Digital transformation is all around us affecting many facets of life and business. Elcam is navigating these changes with an ongoing commitment to advancing through digital transformation, aiming to enhance work efficiency, simplify procedures, and boost our competitive edge, all driven by technology.
These are some of the steps Elcam will continue to vigorously promote to achieve this goal:
With these ongoing steps Elcam aims to create an organizational climate that will provide our employees with an advanced and interesting work environment that fosters personal and organizational growth.
13 – 16 November
Hall 8a Booth E28
Volume 16, Number 3
Elcam Accessories is Elcam Medical’s brand for sourcing your everyday needs of accessories for medical fluid control applications, such as Infusion Therapy and blood lines for Dialysis.
Elcam Accessories end to end customer experience includes clinical, engineering, manufacturing, QA, regulatory and logistics support. This support allows seamless integration of our components into your products, providing peace of mind when sourcing medical products.
The comprehensive Elcam Accessories product portfolio, provides our customers one source for all their needs in the area of disposable medical flow control.
Whether an injection site, a male luer lock connector, an IV filter or tube assembly, our Infusion Therapy Accessories are a perfect fit for your customer’s sets.
The Elcam Dialysis Accessories offer a wide variety of options, providing our customers with solutions for their bloodline products, whether customized or standard.
Elcam believes that Accessories are not merely components, we believe that they are a crucial part of the set and as such their development and production are managed with Elcam’s meticulous high quality standards.
The New NeedleFree connector (NIP ®), the recently added tube assembly capabilities, EU regulation updates and raw material changes are all part of this activity and serve as excellent examples.
As a medical device company, Elcam is well aware of the risks involved in IV Therapy and understands the importance of minimizing them. The newly developed NIP® – a needle-free alternative that reduces the chances of device-associated infections and accidental needle stick injuries, is part of Elcam’s efforts to improve the safety of care.
Elcam’s needle-free stand-alone connector can help reduce line contamination and enhances patient and caregiver safety. With a swabbable Luer-activated valve that maintains a fully closed connection throughout use, the NIP® is a safer, more reliable option for patients and caregivers. Plus, with confirmed bacterial barrier protection for 11 days – including seven days with lipid solutions – the NIP® is an ideal solution for ICU needs.
As part of Elcam’s continuous efforts to expand product range to best answer stopcocks needs, Elcam is offering its stopcocks with a variety of extension tube lines as cost effective sub-assemblies.
Elcam’s Stopcock with extension Tube line delivers the ultimate convenience and efficiency while maintaining the top-quality standards customers have come to expect. And with Elcam’s wide range of stopcocks and tubes, you can customize your setup to fit your specific needs
Elcam offers the widest variety of tube fitments for bonding, or oversizing, off the shelf or tailor made and also offers its professional support in building and tweaking your bonding process.
Many of Elcam components that are manufactured in Italy are made from PVC plastic and may include substances that act as plasticizers and stabilizers. The new European Regulation 2017/745 for Medical Devices includes new requirements for limiting the usage of Hazardous substances such as DEHP and DOTE and to inform users when their content is more than 0.1% in weight of the device.
The limitation and restriction of using hazardous substances in medical device has been an increasing trend and main focus for regulatory authorities over the last few years in alignment with the MDR implementation. It is a critical aspect of the regulation that medical manufacturers should consider in the coming years including during the transitional period that recently has been extended per Amendment Regulation 2023/607 until December 2028, at the latest.
What is Elcam doing about it? – Getting ready!
Any part number (P/N) ordered from Elcam that ends in “NDL” means that the product is DEHP-free PVC and part numbers that end in “DOL” represent both DEHP-free and DOTE-free PVC. Elcam currently offers these options for drip chambers, connectors, pillows, luers and other components, and is currently molding and validating more components.
Please inquire with your customer service representative for additional information.
As shared in one of Elcam’s previous newsletters, during 2022 LyondellBasell announced the discontinuation within 2023 of its polypropylene material Purell HP 371-P.
As Over 400 codes from Elcam Italy’s product portfolio include this raw material,Elcam Medical Italy has devoted many resources to the great project of replacing Polypropylene grade which is going to be discontinued.
Elcam confirms that the project is ongoing and the company is keeping its commitment to its customers : a large number of components made with the new Polypropylene Bormed RF830MO are already available and distributed, Elcam plans to complete the switch over by the end of 2023, and has already granted coverage of material for the excess demand from our customers.
Please contact your local customer service representative for further information
Booth B1- H003
September 9 – 12
Volume 16, Number 2
Elcam Medical is a world leader in OEM stopcocks, offering the widest range of Stopcocks and Manifolds for all fluid control related applications. Elcam Stopcocks™ is our sub brand enhancing our leadership in this field and over 40 years of experience and expertise in developing and manufacturing medical disposable stopcocks. Professionals in the area of medical devices know that when searching for a stopcock – a critical component of the final product – they need a supplier who can offer best fit to all varieties and applications, a product that will work flawlessly at all times and, most importantly, uncompromising regulatory, quality, engineering and customer support to come with it. Elcam’s leadership in stopcocks ensures the benefits professionals value so much: broadest portfolio, innovation, seamless integration, highest quality standards and all-around support.
Elcam believes in continuous enhancements of product features and Elcam’s Stopcock Road Map is a great example of this promise. This program was established 15 years ago in order to continue and develop advanced stopcock designs that better serve the needs of our customers, increase treatment safety while keeping handling and use easy and simple for care givers.
The Marvelous™, Closed and Safe2 Rotator™ stopcocks are part of the products that were developed under this this program and serve as excellent examples of this activity.
Marvelous™ is the first minimal residual volume luer-activated stopcock designed to save time and increase safety with two main features: self-flushing and closed & swabbable luer-activated valve (LAV).
The Marvelous two main features both contribute to patient and caregiver safety and workflow improvement:
The LAV serves as a bacterial barrier, allowing access to the line without opening it and producing a closed system and needle-free injection site.
The fluid flow around the handle creates a unique “circumferential channel” that reaches the entire internal volume of the valve. Whether a drug or blood, the internal volume is constantly flushed by the in-line flow providing greater protection against blood clotting, bacterial colonization and residual drugs related complications.
Furthermore, the Marvelous improves work flow, saves precious time and reduces costs
A Closed Stopcock, integrated with a Swabbable Luer Activated Valve, allowing for maintenance of a fully closed system through the entire use of the stopcock, as well as a needle free work environment. Elcam’s Closed stopcock enhances patient safety by providing full barrier protection against microbial and air ingress, thereby reducing the risks of infections and air embolism. This stopcock also improves caregiver safety by preventing needle stick injuries and avoiding drug and blood spills. It improves workflow by replacing the need to add a cap or LAV on a stopcock and eliminates the need for additional adaptors or cannulas
Elcam’s Safe2 Rotator™(S2R) Stopcock with the spinning lock feature provides a small yet significant contribution to the efforts of keeping medical teams and patients safe. It was designed to ensure secured connection along the entire treatment so critical to safe and effective IV therapy. The S2R Stopcock features a 360º rotational flexibility that can prevent accidental disconnections, reduce tube kinks and twists in the tubing set, facilitate convenient approach to injection and sampling ports, prevent leakage due to over-tightening and more
Shivani Shivkumar is our new Customer Service for Europe.
Shivani joined our team 4 months ago. She is originally from India and relocated to Israel at the end of 2020 to build her family in Baram.
Shivani has a Bachelor degree in Science as well as in Communication and Marketing, and she previously worked as a business development manager for an advertising agency in India.
Shivani told us: “I am in admiration of working in an environment that functions as a community, I want to bring in my people skills and calmness to build a harmonious relationship with Elcam’s clientele. I’m really happy to be able to contribute to Elcam’s growth”
Jessica Miller joined our US team 2 months ago as a Customer Service Specialist. Her background is in office administration, customer service, inventory and purchasing with over 30 years’ experience and her last position was Service Administrator at Winter Scale & Equipment.
Jessica shared: “I look forward to growing in my position with my skills and experience and being a part of Elcam’s continued growth and success. I am excited to have joined such a great and amazing team at Elcam”
Like every year we have sent you Elcam’s annual customer satisfaction survey in December and have recently finished summarizing its results.
We would like to thank all of you that took the time to answer the questions and help us with Elcam’s consistent efforts to improve its services.
This year we received lower results than in previous years in terms of responsiveness time and on time delivery for both long lead-time and not meeting delivery dates. Elcam is well aware of this situation which is mainly related to major changes and peaks in demand as well as to the worldwide logistic crisis.
On the other hand, Elcam continues to score very high in terms of product quality and our customers continue to appreciate Elcam’s quality regardless their satisfactions in other aspects of our services.
Our Net Promoter Score (NPS score) measured annually representing the customers loyalty levels (a positive score is considered good, and an NPS of +50 excellent), respectively decreased in 2022 to 50% but is still in the positive range.
Amir Bohadana, Executive Sales Director, elaborated: “Your important feedback together with the challenges we faced during 2022, have increased our motivation to take the necessary actions to keep our services at top level. This need was acknowledged by Elcam’s management and became one of our main topics in the 2023 plan”.
Volume 16, Number 1
Over the past few years, it has become evident that medical device companies are looking for ways to expedite approval processes of new designs. A highly effective process for Joint Validation & Verification (V&V) activities is a customized service offered by Elcam in order to meet this need and remove the burden from the medical device provider. The process complies with ISO 13845 standard requirements.
It is well known that when a medical device manufacturer sources certain critical components from a supplier, the component must comply with specifications and be validated for a certain application. This validation is a documented guarantee that a product can be manufactured reliably and repeatedly to satisfy a predetermined level of quality.
Many companies invest meticulous efforts and valuable time in product or component acceptance activities. The traditional V&V approach in sourcing a new or substitute component is usually done in series of stages on both sides – component manufacturer and OEM.
A mutual V&V program will reduce the work load of the medical device provider. This service that is offered by Elcam can significantly accelerate the approval process and time to market of the end product in addition to saving the provider a significant amount of resources.
Elcam strives to enhance patients’ and medical teams’ safety and treatment experience. Following you will find two excellent examples of new and improved products that were designed with these intentions in mind.
The new and innovative A-Tap™ by Elcam was designed to facilitate intra-articular injections by allowing aspiration and injection to be done with the same device, thereby reducing the number of steps for practitioners and improving the patient treatment experience.
“A-Tap™ makes a cumbersome procedure easier for both the practitioner and the patient” says Dr. Michael Wilmink, MD, Orthopedic Surgeons
By allowing aspiration and injection to be carried out with the same device, the A-Tap™ cuts down the number of steps for practitioners and reduces procedure time.
Enabling two procedures with one needlestick and minimizing needle movement, this new device can greatly improve the patients’ treatment experience.
Furthermore, the A-Tap™ enhances treatment accuracy and efficacy with the confirmation of needle tip position by aspiration, which supports best practice recommendations (ACSM’s Sports Medicine: A Comprehensive Review 2012 I Francis G. O’Connor I pg.126).
The SafePort™ is an improved function manifold with patented dual flow option innovative side-port valves designed to improve safety in anesthesia and ICU applications. The two flow options are controlled by a simple 900 turn of the handle: Accessible for two-way free flow or one way pressure activation.
The SafePort is now available with a new improved design in which the handles are injected using a new technology of 2C molding which guarantees improved accuracy and reliability.
As with the previous design , the new SafePort™ is also available as a closed system with integrated Swabbable Luer Activated Valves, for minimizing leakages and exposure to air and contamination
Tomer Gil has replaced David Landspurg as General Manager of Elcam Medical Inc. Tomer has been part of the Elcam team for 20 years and recently relocated to the US to empower the US business development activities, a role which he will continue to uphold, together with managing our US office in Hackensack New Jersy. Join us in wishing him a lot of success in his new position.
Yolanda Roman has joined the Elcam Medical Inc. team in New Jersey on July 2022 in the role of Customer Service Specialist. Her background is in Customer Service, Management and Purchasing with over 30 years of experience.
Yolanda told us: “I am excited to have been given this opportunity to work here at Elcam with a very gifted and welcoming team. I look forward to growing in the position and bringing my skill set from my years of experience in Customer Service”.
Hall 7.2 Booth F71
Volume 15, Number 1
Elcam’s core values are Care, Consistency, Quality and Growth. Each quarterly newsletter during 2021 focuses on one company value and shows how it is implemented and expressed within the organization. The chosen value for this newsletter is CARE.
CARE has been one of Elcam’s core values for many years spanning our entire operation and state of mind, from patient care to caring for one another, care is at the heart of everything we do. It is working as one team, regardless of where we are in the world. It means respecting all people and celebrating a diverse workforce where everyone is treated fairly and honestly. It is caring for the society and environment in which we live in – for our communities, our planet, and for future generations.
In this newsletter we will focus on how the value of caring is expressed in Elcam’s activities.
At Elcam we believe that sustainability is no longer a buzz word but a way of living and caring for all that surrounds us. Igal Kohn, CEO Shared: “We are committed to maintaining good corporate citizenship with a holistic attitude that provides balance between providing the best clinical outcomes for patients and caregivers, and maintaining a positive impact on all areas comprising Elcam, including workforce, environment, economics and community.”
Social responsibility for us means to promote diversity and inclusion between our employees who represent many minority groups and to provide equal non-discriminating working opportunities regardless of origin, sex or age. Through our environmental responsible actions Elcam aims to reduce its environmental footprint in order to leave a healthier planet for future generations. These actions include recycling, energy preservation, environmentally friendly energy generation using trigeneration and solar energy. Being a business responsible company is part of our environmental, social and governance (ESG) responsibilities, and Elcam is obligated to high standards of ethics and business conduct, operating both internally and externally in a fair and non-exploitive manner. Elcam is also committed to rules and regulations concerning cybersecurity and Data protection.
Elcam is always striving to gain new capabilities in all facets of the organization in order to provide better service to our customers. In the last few years, one of Elcam’s main endeavors has been to gain new capabilities in assembly technologies introducing modern and more sophisticated assembly machines.
For example, the new tube assembly machine in Elcam Medical Italy (EMIT) that assembles stopcocks manufactured in Elcam Israel with tubes and components manufactured in EMIT. Gianluca Menghi, General Manager EMIT, elaborated: “With this new machine, we aim to design and develop new sets according to the different needs and requirements of our customers. It is very versatile allowing assembly of both straight and coiled extension lines, with different types of connectors, activating or disactivating stations, when necessary for a specific product design. The machine performs 100% flow test to assure that no obstruction is present. Moreover, the machine includes many control systems that verify during the process if parts were correctly assembled while each station is able to scrap a faulty product through a ramp”.
Another great example is two new assembly machines that are currently being added to the transducer line in Elcam Israel all in an effort to improve production time and capacity as well as diversify our product offering. One machine will combine the work of 2 separate older version machines including lase drilling, and also carry out flow tests. The second will perform fully automatic soldering, 100% in-production tests to assure electrical and leakage conditions, and will have much higher production rate.
The new Elcam website that was recently launched, was developed for easier and simpler navigation with several drop-down menus that enable the viewers to quickly reach their point of interest. No efforts were spared to improve the site’s user interface, as part of Elcam’s philosophy of providing the best customer experience. In the new website you can find our products as well as our advantages in terms of company mission, partnering, corporate responsibility, global presence and more.
At Elcam Medical, customer service is paramount and we pride ourselves on meeting our customer’s needs. It’s no secret that the pandemic and the current global logistics crisis has disrupted all of our businesses in some way or the other. Globally, there continues to be massive delays due to container availability, sea shipping and port backlog, reduction in available air cargo routes and limited trucks & container chassis. That coupled with limitations in human resource such as port workers, truck drivers and warehouse personnel add up to a very significant challenge.
Amir Bohadana, Chief Sales Officer, specified: ” With no near-term end to this crisis in sight, Elcam is working internally, working with suppliers and working with our customers to minimize impact as best possible through a variety of methods: workers vaccinations, expedited deliveries as best possible, automation in warehouse facilities, additional warehouses and safety stocks of both products and raw materials, as well as exploring new potential alternate sources of raw material supply”.
Anaheim, California, USA