Webinars

Managing Medical Device Design Transfer and Validation

07.22.21

See the process through the eyes of a fully-integrated medical device contract manufacturer.

At Lincotek Medical, we are able to support our customers and their patients in every aspect of a medical device launch. Join us on 22nd July, when we’ll be revealing more about our approach and our integrated quality management system.

The session will be the first in a series of webinars designed to provide an insight into the support we give to customers in the orthopaedic market.

You’ll learn about our service, which takes you all the way from design to final launch, encompasses design controls, regulatory approvals and design verification and validation. We’ll then focus on design transfer to additive, as well as casting, coating, machining, finishing, cleaning/passivation and post-market surveillance.

The July webinar will provide an overview of:

·     Lincotek Medical and our offering

·     Our integrated quality management system

·     Our design controls and regulatory pathway process

·     Our design transfer and process controls

·     Our post-market maintenance and charge control process

Hear from our experts at first hand and take away a real understanding of the latest thinking in device design transfer and validation.

Speakers Include:

Shibu Korula
Senior Director, Regulatory Affairs and Quality Assurance
Lincotek Medical

Steve Brown
Associate Director, Regulatory Affairs and Quality Assurance
Lincotek Medical

Domenico Grieco
Director, Quality Assurance
Lincotek Medical

Global Trends in Medtech: OEMs and the Supply Chain

February 23 - 25, 2021

MPO Webinar Series: Global Trends in Medtech: OEMs and the Supply Chain
February 23 – 25, 2021

Speaker: Anthony S. Freeman, President, A.S. Freeman Advisors LLC

February 23 - 2:00 PM ET
Session 1—The OEM Landscape and Business Drivers

Objectives of the Presentation and Sources of Information
How Big Is the Market? What’s the Growth Rate?
Where is the Growth (or Decline) Coming From?
The Impact of Covid
Evolving Business Models—Growth of Service/Product Pairings
New Settings For Medicine – Devices outside the Hospital/Doctors Office
Rise of Non-Medical Companies in Medical Devices
Four Most Significant Product Trends

February 24 - 2:00 PM ET
Session 2—A Consolidating Supply Chain? A Tiering Supply Chain? Both?

How Big Is the Supply Chain? What’s the Growth Rate?
The Rise of the Mega Contract Manufacturer
The Evolving Role of the Traditional and Smaller Suppliers
New Opportunities for All Suppliers
Warning Signs in the Supply Chain—Will You Be Shifted Away from the OEM?
LCC Strategies vs. Automation in Developed Countries
Other Than Price, What Will Matter to OEMs?

February 25 - 2:00 PM ET
Session 3—Panel Discussion of Medtech’s Global Trends

The final portion of this three-part series will feature a panel of industry representatives discussing topics and points made during the first two sessions. Moderated by Tony Freeman, this candid conversation will look at factors impacting OEMs as well as the supply chain. The audience will be encouraged to pose questions to the panel as they look ahead to what to expect in 2021 and beyond.

Moderator:
Anthony S. Freeman, President, A.S. Freeman Advisors LLC

Panelists:
J. Mark King, Operating Partner, Vance Street
Paul Orlando, Vice President of External Operations, OLYMPUS SURGICAL TECHNOLOGIES AMERICA
Randal Ours, Director of Medical Device Procurement, Bayer
William Pratt, VP Operations and Director of Creative Design, Kinamed Inc.

From Powder to Serial Additive Production

02.18.21

NOW AVAILABLE ON-DEMAND

With our 15 years of experience, we can help take you from powder to ready-to-use part – then help you manage the complete supply chain.

While purchasing additive manufacturing (AM) equipment has its financial burden and commitments, scaling up and moving into the critical area of volume serial production is a real challenge.

This webinar will focus on helping Orthopedic OEMs decide if they want to embark on this journey of AM as a serial high-volume operator, or if it would be better to outsource the endeavor. Additionally, it will give OEMs pointers on assessing the capabilities and knowledge base of a Contract Manufacturer and determine if they would be comfortable considering their implants.

So, the machineshave been installed, what next?

There is the issue of the validation of the machines, bearing in mind that the FDA wants you to address a lot of questions as laid out in the Guidance Document.
What about CAD files and the need for support structures? Every extra layer adds to time on the build later, as well as extra time spent on support removal.
Perhaps the most overlooked part of AM is stress relief and the required heat treatment (HT), including HIP (Hot Isostatic Pressing). The validation of the HT and/or HIP process is essential and running a HT process around the clock has its own challenges stemming from the vacuum systems involved. If it goes wrong, entire batches go to scrap, as the chemistry of the final device is outside the acceptable range.
Another aspect of the operation that is sometimes neglected is the fact all AM machines are different, even if they are from the same vendor. It is fundamental to know what aspects of these machines must be tuned and how in order that the output results in statistically equivalent parts.
Patient Specific implant manufacturing via AM, in a well-oiled AM production facility, is particularly complex. These parts take priority over other regular parts. They are one-offs, a surgery date has likely been fixed, so this unique part must be made flawlessly with no chance of revision.
Finally, the AM process input and process monitoring generates a lot of data, allowing serial AM producers to go from a reactive company to a data-driven predictive operator.

Lincotek has championed innovation in additive manufacturing solutions since 2006 and our medical division - an organization fully dedicated to orthopedic implants manufacturing – was the pioneer. Today, we guarantee a complete service through our unique serial production expertise in the field of global additive manufacturing.

We boast more than 25 AM machines; we produced over 110,000 implants in 2020; and we have manufacturing sites in Europe and the US, while we actively work to set up a site in Asia in the near future.

Our experience of 15+ years offers many lessons on scaling up – and this webinar discusses a few salient points to consider. Be sure to secure your seat, register now.

Speaker:
Stefano Rappo
R&D Project Manager - Additive Manufacturing, Lincotek Medical

Early Reimbursement & Market Access Planning: It’s Not Optional

06.11.20

NOW AVAILABLE ON-DEMAND

This webinar will cover the importance of early reimbursement and market access planning.

Key topics will include:

Overview of reimbursement fundamentals
Commercialization and reimbursement pathways for new and novel therapies
Establishing reimbursement and market access is an evidence based process
What it takes to build a successful U.S. reimbursement and market access strategy
Common mistakes and how to avoid them

The AM Particulate Problem: A More Efficient Means of Removing Residual Powder

10.10.19

NOW AVAILABLE ON-DEMAND

One of the main issues related to the generation of highly intricate, porous structures produced by additive manufacturing (AM) techniques involves the proper removal of trapped residual powder. The orthopedic community is well aware the in vivo release of such fine metal powder, post implantation, will result in third-body wear, osteolysis, and tissue necrosis. Since the most common cleaning methods are limited in their ability to remove and quantify the trapped powder, Eurocoating has developed an alternative. XClean® is a proprietary technique that allows for fast and complete removal of semi-sintered or loosely attached metal powder by means of a mechanical agitation without damaging the part. This webinar will highlight the benefits of this process and explain why it’s a much more effective and efficient protocol.

Speaker:
Mukesh Kumar, Ph.D.
Global Technology Director, Lincotek Medical