• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » How to leverage a supplier partner for change validation

How to leverage a supplier partner for change validation

June 10, 2022 By Sponsored Content

By By Dan Aicher, CEO, EmbedTek, LLC

Supply chain disruptions are forcing an inordinate amount of change to critical components of medical devices. The burden placed on medical device OEMs to validate these changes distracts engineering, quality, and operations teams from more strategic activities. Reacting to an unpredictable supply chain endangers new development as well as ongoing production.

Seeking partnerships with supplier organizations that have the resources, organizational discipline, and structure to help execute change validation can be part of the answer. A third-party resource, especially one already familiar with the product and OEM’s processes, would be able reduce the burden on the OEM’s internal departments giving them the opportunity to focus on more strategic projects. Following are questions to keep in mind when determining which suppliers can step up to the task.

    1. Is the supplier well-versed in quality management system (QMS) protocols and are they accustomed to the documentation and traceability that is required with every change?

      A supplier’s quality credentials are a result of integrated design and manufacturing processes, as part of a seamless value stream, delivering consistent and quality products to their customers and end users.

      EmbedTek, a manufacturer and supplier of embedded computers and integrated displays, currently holds certificates of registration for ISO 9001:2015 and ISO 13485:2016. We are also registered with the U.S. Food and Drug Administration as a Contract Manufacturer of Medical Devices. EmbedTek provides extensive support during the introduction of new systems for medical device OEMs. This has only expanded given recent demands on customers.

    2. Is the supplier experienced in validation testing? And do they know your product well enough to perform the level of testing required?

      Trusting a supplier partner with change validation doesn’t happen overnight. Ask them to outline the breadth of their capabilities, share examples of how they have conducted validation procedures before, and compare how they propose running a validation on your product with how your internal team would approach it.

      In one recent circumstance at EmbedTek, an embedded computing/visualization system required a significant update due to the end of life of a high-performance GPU and increased use of AI. We collaborated with the customer – a neurological surgery device manufacturer – to develop the test scope and expected output of the process to validate the new system.

      This included electromagnetic interference (EMI), electrostatic discharge (ESD), shock and vibration, thermal, performance, functionality (including regression testing of earlier revisions), and output verification. Scripted tests and sample output of earlier testing was provided to EmbedTek so that we could perform the testing in compliance with the medical device OEM’s quality system and, when complete, it flowed smoothly through their system.

    3. Does the supplier have the capacity to take this on permanently?

      Providing support in a supply chain and QMS pinch is certainly a life saver. But once an OEM and supplier partner are coordinated with change validation, why stop? When production becomes more predictable, OEMs should consider using this relationship to their advantage for the long run.

      In the scenario above, EmbedTek performed the testing and provided the output, while the medical device OEM focused on work only they could do. This was possible because of the close partnership that existed before the more extensive need developed due to the supply chain disruption and its impact on the medical device OEM’s resources. The validation was a success and will now be the new operating method going forward. In addition to much needed help during this current environment, EmbedTek now knows considerably more about the intricacies of the OEM’s device, which allows for better communication and collaboration in the future.

Whether required now or not, having supplier partners that are able to pivot in the current environment – or unknown situations to come – makes for a stronger supply chain and a more competitive company.

Sponsored content by EmbedTek

Filed Under: Sponsored Content Tagged With: EmbedTek

In case you missed it

  • They said it at DeviceTalks Boston
  • Elucid raises $27M for heart disease diagnosis software
  • Summer health technology program brings diverse group of interns to Silicon Valley
  • BioSig expects to raise $3.5M from public offering
  • Haemonetics completes move to new Pennsylvania manufacturing facility
  • Vivera adds two industry veterans to its technology advisory board
  • Abbott Fund grants $750k to education, health equity program
  • Another Medtronic HVAD recall is serious
  • Endologix reports positive results from percutaneous bypass trial
  • NorthStar Medical names new president and chief operating officer
  • Vektor Medical names Rob Krummen as CEO
  • Baxter’s Volara lung therapy system recall is Class I
  • BD voluntarily recalls intraosseous products
  • Bioventus restructures $315M CartiHeal acquisition
  • Intrommune extends scope of Phase 1 trial for peanut-allergy-treating toothpaste
  • How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
  • Hamilton Medical warns on some ventilators

RSS From Medical Design & Outsourcing

  • They said it at DeviceTalks Boston
    Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event. And make sure to save the date — and save your seat… […]
  • Summer health technology program brings diverse group of interns to Silicon Valley
    Diversity by Doing HealthTech (DxD) is holding a Summer Innovation and Exploration Series for college student interns from underrepresented groups. The series is on its second day today at Fogarty Innovation and Stanford Byers Center for Biodesign — the two organizations that jointly formed and support DxD. The event debuted last year in an online… […]
  • Clippard releases new series of isolation valves
    Clippard (Cincinnati) has Its Clippard NIV Series media isolation valve — a solenoid-operated device using a flexible diaphragm to isolate the actuation mechanism from the fluid path. Media isolation valves find everyday use in a wide variety of applications. Think uses that require precise, repeatable dispensing of media for analytical instrumentation. Clippard says media isolation… […]
  • Another Medtronic HVAD recall is serious
    A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this… […]
  • How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
    SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff… […]
  • How Avail Medsystems seeks to create a connected OR experience
    Much like a normal Starbucks-goer expects the coffee to taste a certain way at any location, Daniel Hawkins wants that type of experience in the operating room. Hawkins is the CEO of Avail Medsystems, a company developing telemedicine equipment that can connect surgeons, interventional specialists and medical device sales reps. Hawkins and the team at Avail… […]
  • How to leverage technology to drive diversity in clinical studies
    Convenience was the driver, and the traditional clinical trial model had to evolve when it came to a colorectal cancer screening study. The clinical study had 35,000 patients across the U.S. Chuanbo Xu, Freenome Cancer doesn’t discriminate. It’s the second-leading cause of death in the U.S. Early detection is key in treating — and even… […]
  • Medical device licensing pitfalls to avoid
    Prevent costly disputes caused by these common mistakes in patent license agreements. Marcelo Barros, Kathleen Daley, Brian Kacedon and Matthew Ritter, Finnegan Licensing and other technology transfer agreements can be critical for medical device companies that invest significantly into new technology R&D and seek and obtain intellectual property protection for those investments. But if these agreements… […]
  • Tolerance stack-up: Insight into the inner workings of high-density microelectronic medical devices
    Tolerance stack-up is a defining design concept to ensure new products are built efficiently and effectively.  Darren Gilmer, Intricon At a time when the future of micro-miniature medical devices seems unlimited, one fundamental reality remains firmly in place — the sizes and shapes of human anatomy. From blood vessels to ear canals, respiratory passages to… […]
  • Deburring and finishing for beautiful, functional medical devices
    The latest automated cutting tools help medical device manufacturers meet strict specs and high demand. Dave Sawicki, Xebec Increasing demand and advances in technology are driving growth in the medical device industry. Chronic diseases are more prevalent, and the aging population is larger, contributing to the demand for highly regulated Class III medical devices such… […]
  • FDA seeking innovations to move beyond heater-cooler device problems
    The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices. According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm… […]

Primary Sidebar

DeviceTalks Weekly

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS