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 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.
Igal (Guli) Kohn, CEO and General Manager
31 August – 2 September
Hall 1 Booth 2H003
Palm Springs, California
The Westin Copley Place, Boston
Prevention of Intravenous Bacterial Injection from Health Care Provider Hands: The Importance of Catheter Design and Handling
Over the past few years, it has become evident that medical device companies are looking for ways to expedite approval processes of new designs. The development of a new customized service, a highly effective process for Joint Validation & Verification activities is a service offered by Elcam in order to meet this need and remove the burden from the medical device provider.
“Employing Elcam’s Validation & Verification (V&V) testing services not only helped the project move along more expediently, but it allowed our internal resources to be utilized more efficiently. Elcam was professional and comprehensive with all the required testing. We will certainly take advantage of Elcam’s V & V services for future partnership opportunities”.
R&D Manager, BBraun Melsungen
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™.
Elcam continues to operate at full capacity and in compliance with the instructions of the health authorities in the countries of operations. Currently we do not foresee any disruption to our operation.
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 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