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]]>The post ERI GROUP OPENS NEW 34,000 SF MANUFACTURING SPACE appeared first on ERI Group.
]]>ERI Group, a leader in end-to-end medical product design and development, quality assurance, regulatory affairs and contract manufacturing services, announces that it has opened a 34,000 square-foot manufacturing facility located at 5045 Robb Street in Arvada, Colorado. The new manufacturing facility will allow ERI Group to expand its contract manufacturing services and is located between the company’s current headquarters in Golden and the design studio in central Denver.
The new space will support the company’s ongoing growth and expansion of its manufacturing capabilities. Complementing the new space, ERI announces continued growth across all divisions as one of the most comprehensive medical, healthcare and wellness product development companies focusing on high-value, complex electromechanical equipment.
“Our new manufacturing facility represents not just an expansion, but a testament to our dedication to innovation, quality and customer satisfaction,” – Natasha Bond
“Our new manufacturing facility represents not just an expansion, but a testament to our dedication to innovation, quality and customer satisfaction,” says Natasha Bond, CEO of ERI Group. “Our mission is to serve medical device companies, entrepreneurs and visionaries who bring life-changing products to market and through our new expanded facility, we can meet the needs of more customers longer into their product journey.”
ERI Group’s new manufacturing facility is equipped with advanced technology and fully integrated inventory management systems. The new facility not only enhances ERI Group’s operational efficiency but also opens up substantial opportunities for future expansion.
“This new manufacturing facility will better position us to increase our capacity, expand our scope of services and volume to better meet the needs of our customers,” says John Mann, Vice President of Operations for ERI Group. “Both of our existing sites, as well as the new manufacturing facility, will operate under the same stringent quality standards, as evidenced by our ISO-13485 and ISO-9001 certifications, ensuring a smooth and planned transition of all ongoing manufacturing commitments, with consistency in staff and quality management systems across all three sites.”
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ERI Group, a leader in end-to-end medical product design and development, quality assurance, regulatory affairs and contract manufacturing services, announces that it has named Natasha Bond as Chief Executive Officer (CEO) and member of the Board of Directors and Brett Maxam as Chief Financial Officer (CFO). Bond previously served as President of the company and has been elevated to CEO.
“This is an exciting time for ERI Group. I am delighted to take the reins as CEO and to welcome Brett Maxam to our leadership team as CFO to help support our vision and to continue to help our clients achieve their goals of bringing life-changing medical and wellness products to market,” says Natasha Bond, CEO of ERI Group.
“We are one hundred percent focused on quality and delivery and that is evident in every facet of the organization – from our leadership team to our new manufacturing space.”
As part of its continued growth, ERI Group expects to occupy 34,000 square feet of additional space by year-end to expand its contract manufacturing services. The company announced in May that it had leased the new space at 5045 Robb Street in Arvada, Colorado. The expansion will increase ERI’s manufacturing capabilities and support the company’s ongoing growth as one of the most comprehensive medical, healthcare and wellness product development companies focusing on high-value, complex electromechanical equipment.
“I am very excited to be joining ERI Group at this time to help support the vision of the organization to deliver an unparalleled end-to-end suite of services to companies in the medical and healthcare sectors,” says Brett Maxam, CFO of ERI Group.
“Our commitment to quality and our expanded contract manufacturing offering will continue to set ERI Group apart and help us better meet the growing needs of our clients.”
Maxam joins ERI Group with over 20 years of experience in financial and operational leadership working with life science, professional service, SaaS, software, and manufacturing organizations of varying sizes, from high-growth startups to upper-middle market companies. Prior to ERI, Brett served as CFO for multiple private equity-backed companies and will be responsible for implementing growth strategies and focusing on overall business success at ERI Group.
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In recent years, we have observed a growing emphasis from The US FDA on proper determination of Essential Performance (EP) for medical devices submitted for clearance. We have also noted that the increased emphasis on properly identifying Essential Performance has created some conflicts and challenges for clients, (e.g. They may believe they have no EP in their device, and the during the substantive review of a 510(k), the FDA disagrees and issues an AINN, stopping the review until EP is properly addressed). Thus, our clients have occasionally asked ERI Group for help in determining their essential performance characteristics.
The FDA requires a risk-based determination of EP and further indicates that EP must be maintained throughout the product life cycle. This is important. According to Intertek1, designing your device using a risk-based model or hazard-based approach usually means that the device will be compliant with the required standards. This is the recommended approach.
This paper presents a methodical approach to determine device specific Essential Performance for a medical device. The Essential Performance analysis begins and ends with the client’s System Level Risk Analysis (RA), as those risks are generated for or from critical functions in the product specifications. It makes good sense that a detailed RA is done first, based upon intended use and indications for use of the product, prior to commencing design work. Starting the RA first is recommended. Note that the RA process may be iterative, as risks could be re-evaluated along the design flow so that, for example, an update to the Product Requirements may lead to newly discovered risks.
Essential Performance is determined from a risk-based approach to the device’s defined functions as guided by intended use and indications for use of the subject medical device. The following is a general method that ERI Group has used to define the Essential Performances of client’s medical devices.
To begin, ERI Group Regulatory team reviews the general, particular and collateral safety standards that apply to the client’s medical device in an effort to formulate initial EP. These are the most common basic safety and risk management standards to consider for electrically operated medical devices:
There are many other important documents such as but not limited to:
However, the basic methods for risk-based determination of essential performance apply to most all risk analyses methods, thus the determination of EP is similar for medical devices where you are working with biological attributes, electrical performance, or software.
Electrical Standards EP Review: IEC 60601-1:2005 (Third Edition) offers the following definition of Essential performance as:
“Performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk.”
The standard also notes that “essential performance exists when the feature or function in question is either absent or its characteristics are degraded to a point that the ME equipment is no longer suitable for its intended use.”
We conclude that General Essential Performance guidance from the standards is determined to be:
“Performance necessary to achieve freedom from unacceptable risk and ability to maintain performance in the intended use of a clinical (or critical) function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk.”
Determining Specific EP for your Medical Device: No specific EP guidance is available, as EP is uniquely determined for each medical device. We see from a review of the 60601 basic safety standards that the specific risks identified as having EP are ultimately up to the manufacturer to define. As guidance, we point out that not all performance functions listed in the Risk Analysis will be considered as EP, however, any performance function that leads to an unacceptable risk per the Risk Analysis is EP. It is noted that EP requirements for Particular and Collateral standards frequently identify specific Essential Performance within. Thus, it is important to browse the titles and document scopes of the applicable Particular and Collateral standards for specific EP considerations.
This process starts with the complete RA, and funnels down to just the few remaining risks that are not mitigated by safety, clinical, or bench testing. The remaining risks are candidates for the system EP. These include those risks that have a high enough probability of occurrence that analysis could lead to an unacceptable risk under certain conditions.
The risk item reduction to EP candidates proceeds as follows:
For all functions where loss or degradation leads to unacceptable risk Essential Performance is the performance necessary to keep the risk acceptable.
[1] Intertek Knowledge and Education Paper – Top Ten Reasons Products Fail Compliance Testing & Certification, Dec, 2022.
Connect with us to learn more about our Essential Performance expertise for medical device companies at regulatory@erigroup.com
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]]>Article For The Denver Post By Judith Kohler
A 35-year-old Colorado company that develops and manufactures medical products for clients worldwide is expanding its operation and moving into a 34,000-square-foot facility in Arvada.
ERI Group, formerly Evergreen Research, has leased the new manufacturing space and expects it to be up and running later this year. The company, whose main site is in Genesee, has doubled its workforce over the past year to about 100 employees and anticipates the staff growing to roughly 150 by the end of 2025.
“The addition of the Arvada office provides significant expansion to our manufacturing operations,” said Natasha Bond, president of ERI Group. “This is an investment to make the operations more efficient and really set the group up for success.”
The core of the company’s business involves the design and development of medical products. ERI also provides quality assurance and regulatory services.
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]]>Denver Business Journal Article by Greg Avery:
A Colorado manufacturer is more than doubling the space it leases to make complex medical devices, adding a new Arvada site to its other metro area design and production locations.
ERI Group lease 34,000 square feed of Arvada manufacturing space for an expansion beyond the company’s existing sites in Genesee and Denver.
“We’re taking ERI to the next level. We’re growing up as a business,” said Tasha Bond, the company’s president and top executive.
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]]>“The new space, located at 5045 Robb Street in Arvada, Colorado, will support the company’s ongoing growth and expansion of its manufacturing capabilities. Complementing the new space, ERI announces substantial growth across all divisions leading to two consecutive quarters of record results and a doubling of headcount in the past year.”
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]]>Golden, CO – May 11, 2023 – ERI Group, a leader in end-to-end medical product design and development, quality assurance, regulatory affairs and contract manufacturing services, announces that it has leased 34,000 square feet of space to expand its contract manufacturing services. The expansion comes as part of ERI Group’s continued growth as one of the most comprehensive medical, healthcare and wellness product development companies focusing on high-value, complex electromechanical equipment.
The new space, located at 5045 Robb Street in Arvada, Colorado, will support the company’s ongoing growth and expansion of its manufacturing capabilities. Complementing the new space, ERI announces substantial growth across all divisions leading to two consecutive quarters of record results and a doubling of headcount in the past year.
“We are very excited about our expansion and the new manufacturing space that will allow us to continue to offer an end-to-end suite of services to our clients from initial concept design through moderate volume manufacturing,” says Natasha Bond, president of ERI Group. “The additional space will help us to better meet the growing needs of our clients with the provision of high-value, low-risk domestic manufacturing of these complex products, further adding value to ERI and our local Colorado economy.”
In July of 2022, ERI Group merged with LINK Product Development to create a full-service company and expand ERI’s existing scope of services, offering industrial design and human-centric product experience, product development with depth of expertise in mechanical, electrical, software and systems engineering, quality and regulatory consulting service and specialized electromechanical manufacturing. ERI serves the medical device, diagnostic, laboratory equipment and high-value consumer wellness markets. In March of 2023, ERI Group announced an exclusive, multi-year strategic agreement with David Schnur Associates (DSA), a global supplier of outsourced technical sales and marketing services. The partnerships have helped ERI grow its customer base, expand its suite of services and extend offerings to new clients in the medical device space.
“Our new manufacturing facility will better position us to increase our capacity and help us to deliver innovative medical devices, complex electromechanical products and life-changing health and wellness advancements to the marketplace,” says John Mann, Vice President of Operations.
“This expansion couldn’t come at a better time as we continue to grow our staff and expand our scope of services and volume to meet the needs of our customers.”
About ERI Group
ERI Group brings medical innovations to life. We offer a full-service approach — from Product Design and Development, Quality Assurance and Regulatory Affairs to Contract Manufacturing. With 35 years of experience and deep technical expertise to handle the most complex projects, we partner with clients to deliver revolutionary healthcare, medical and complex electromechanical products to the market. For more information, visit www.erigroup.com.
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]]>A strategic agreement opens the company’s services to a large swath of customers.
A medical device manufacturing company based in Golden has caught the attention of a global supplier with a new agreement.
Golden-based ERI Group said it has entered into a multi-year agreement with San Francisco-based David Schnur Associates (DSA), a company that connects medical device companies to the makers of materials and components that they need.
The agreement opens ERI Group’s services, which span the process of building a medical device product from conception to manufacturing, to a large swath of customers.
“The DSA team has strong, long-term relationships with both startups and large OEMs and understands these customers’ needs well,” said ERI Group President Natasha Bond in a statement. “These existing relationships — combined with DSA’s global reach and the expertise and strength of the ERI team — will allow us to better serve our existing customers and extend our services to new clients in the medical device space.”
DSA CEO Barry Schnur said in a statement that ERI Group is an “undiscovered gem” for medical device customers, particularly because of the company’s expertise in electromechanical devices. He said DSA serves to help customers with research and development to “create and manufacture a better medical device using the right technology.”
“With in-house experts in mechanical engineering, electrical engineering, fluidics, sensors and more, ERI can take a prototype and turn it into a functional device to support clinical trials, then take it into full production,” Schnur said.
ERI Group said it is positioning itself for future growth based on exactly that fact.
The company, formerly Evergreen Research, acquired a longstanding Denver design firm last year that widened its ability to design, engineer and create product prototypes for clients.
ERI said its merger with the firm, LINK Product Development, created one of the most comprehensive development companies in the region for medical and wellness products.
With those new capabilities, the company closed out 2022 with record revenue and increased its headcount by about 30%, a spokesperson said.
The agreement with DSA focuses on “box builds” to bring electromechanical medical devices to market, according to a news release. Examples of ERI Group projects include home dialysis equipment, a battery-operated ultrasonic nebulizer and a computerized perfusion controller.
If you are a Denver Business Journal Subscriber, you can read the full article here: https://www.bizjournals.com/denver/news/2023/03/31/eri-group.html
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]]>SAN FRANCISCO, March 20, 2023 — David Schnur Associates (DSA), a global supplier of
outsourced technical sales and marketing services, recently announced an exclusive, multi-year
strategic agreement to add ERI Group (formerly Evergreen Research) to its network of partner
companies.
Based in Golden, Colo., ERI Group provides services that span the entire process of bringing a
medical innovation to market. The agreement with DSA focuses on “box builds,” bringing
electromechanical medical devices to market. Examples of ERI Group projects include home
dialysis equipment, a battery-operated ultrasonic nebulizer and a computerized perfusion
controller.
“ERI Group is an undiscovered gem that’s a perfect fit for our medical device customers,” said DSA CEO Barry Schnur. “We’re particularly excited about ERI’s multidisciplinary expertise in electromechanical devices. With in-house experts in mechanical engineering, electrical engineering, fluidics, sensors and more, ERI can take a prototype and turn it into a functional device to support clinical trials, then take it into full production.”
“We are very excited to be partnering with DSA to continue to expand our capabilities and
accelerate growth,” said Natasha Bond, president of ERI Group. “The DSA team has strong,
long-term relationships with both startups and large OEMs and understands these customers’
needs well. These existing relationships — combined with DSA’s global reach and the expertise
and strength of the ERI team — will allow us to better serve our existing customers and extend
our services to new clients in the medical device space.”
ERI Group is the latest addition to DSA’s global network of medical device component and
device manufacturing partners.
“Our partner network gives us a vast toolbox of solutions to support R&D engineers throughout the product lifecycle,” Schnur said. “We act as an extension of our customer’s team to help them accelerate R&D and create and manufacture a better medical device using the right technology.”
David Schnur Associates (DSA) is a medical device technical sales organization with 45 years of
experience consulting on the design and development of medical components and devices.
With consultancy services and a global network of material and component partners, DSA is a
single point of contact connecting customers with the best in cutting-edge materials and
custom components. For more information, visit DSA at dschnur.com.
ERI Group brings medical innovations to life. We offer a full-service approach — from Product
Design and Development, Quality Assurance and Regulatory Affairs to Contract
Manufacturing. With 35 years of experience and deep technical expertise to handle the most
complex projects, we partner with clients to deliver revolutionary healthcare, medical and
complex electromechanical products to the market. For more information, visit erigroup.com.
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