St. Paul, Minnesota – Adhesives play a critical role in the success of a medical device, whether it’s holding the device together or adhering it to the wearer’s skin. But with so many adhesive products available, it can be a challenge for design engineers to know which one is right for their project. To help bridge this critical gap, 3M developed a Find My Adhesive product selector tool to help make medical adhesive selection a simpler process.
“Adhering medical devices can be a difficult task. Using the wrong adhesive could result in unforeseen added costs and device development delays,” said Marcello Napol, global business director in 3M’s Critical and Chronic Care Solutions Division. “Our goal with Find My Adhesive is to leverage our more than 50 years of adhesive research and development expertise to provide a useful tool to design engineers that helps streamline the adhesive selection process and improve the device’s overall probability of success. The interactive, intuitive and efficient tool can assist design engineers in an oftentimes unexpectedly challenging and critical part of the medical device design process.”
Find My Adhesive is an online resource that uses a series of project-specific questions to identify a list of the most appropriate medical adhesive suggestions. Each question is centered on an important consideration, such as the adhesive’s purpose (stick-to-skin, hold device components together or overlay / cover my device) and needs, such as wear time, the material you need to stick to and intended user, which works to narrow down the adhesives recommended for use. It’s free to use and, unlike other selection tools, does not require an account to access. If projects require extra assistance and feedback, users can contact a 3M medical adhesives expert directly through the site.
To help narrow down the right adhesive for your next medical device project, the Find My Adhesive product selector tool can be found at findmyadhesive.com.
Global orthopedic device market to reach $44B by 2022
Recent major advancements involve development of robotic-assisted smart surgery for the spine, knee, shoulder, and hip-related implants.
Cleveland, Ohio – The "Global Orthopedic Device Market 2018-2022" report has been added to Research and Markets' offering and the report indicates that the global orthopedic device market will register a revenue of more than $44 billion by 2022.
Global Orthopedic Device Market 2018-2022, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. To calculate the market size, the report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.
A large number of key orthopedic implants manufacturers are increasingly focusing on research and developmental activities, which has resulted in the introduction of innovative products and advancements in orthopedic devices. The recent major advancements involve the development of robotic-assisted smart surgery for the spine, knee, shoulder, and hip-related implants. Several specialists and surgeons are recommending the adoption of minimally invasive (MI) surgery since these surgeries are highly accurate, precise, and result in enhanced patient outputs.
One trend in the market is M&A deals. Although key players such as DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew, and Medtronicare having a significant presence in the market, they are facing tough competition from other emerging players and affecting the organic growth of these companies. Owing to these reasons players such as DePuy Synthes, Stryker, and Zimmer Biomet are changing their market strategies and focused on M&As to increase their presence in the market.
3 stages of Medical Device Single Audit Program
International auditing standards harmonize expectations, simplify auditing, and increase transparency in medical device manufacturing.
Ten years ago, the voluntary group of medical device regulators tasked with improving regulatory harmonization and convergence around the world – the International Medical Device Regulators Forum (IMDRF) – initiated preparations for a global approach to auditing and monitoring medical device manufacturing. Conceived was theMedical Device Single Audit Program (MDSAP), with the aim of improving the safety and effectiveness of medical devices globally. The stated vision is to: “Develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple jurisdictions”.1
In January 2014, an international coalition of five national regulatory agencies started a trial of the single audit program:
U.S. Food and Drug Administration (FDA)
Therapeutic Goods Administration (TGA), Australia
Agência Nacional de Vigilância Sanitária (ANVISA), Brazil
Health Canada
Ministry of Health and Labour and Welfare (MHLW), Japan
A June 2017 report revealed the outcomes of the prospective proof-of-concept criteria, confirming viability of the MDSAP2. The program is now officially active in the five participating countries, although only Canada will enforce the MDSAP as mandatory, starting Jan. 1, 2019. Presently, 11 auditing organizations (AO) have been authorized to conduct the new single regulatory audit that will satisfy relevant requirements of the different authorities. However, there are applications underway to increase this figure, so it is expected that MDSAP will eventually provide a broader choice with reduced costs.
Pathway to compliance
The IMDRF has outlined instructions3 for the planning and execution of the MDSAP audit process, including an audit sequence and instructions for auditing each process. The MDSAP is structured into seven interrelated processes:
Medical device adverse events, advisory notices reporting
Measurement, analysis, improvement
Design, development
Production, service controls
Purchasing
Audits of each of these seven processes will adhere to the following structure:
Goal
Expected results
Activities
Relation with other processes
Link with the ISO 13485 clauses
Country-specific requirements
MDSAP audits are designed to take three years and three different audits: initial, surveillance, and recertification.
Treatment of non-conformities
Non-conformities (NCs) are ranked on a scale one to five, with the first three grades classed as minor infringements, and grades four and five classed as more serious lapses. If a medical device manufacturer is audited, and their processes have one or more grade five NCs, or two or more grade four NCs, a public health threat, or fraudulent activity, then the AO must inform regulatory authorities within five days. Usually the AO will complete an unannounced visit six to nine months later to check that suitable measures have been taken to rectify the problems.
AOs provide the audit package including NCs grading to the regulatory authority within 45 days after the audit. The manufacturer then provides plans to correct each non-conformance within 15 calendar days after issue of the NC report.
Advantages, drawbacks
Although the cost of preparing the QMS for a MDSAP audit could initially be a burden, long-term financial benefits come with greater harmonization of auditing requirements and a streamlined audit process. Manufacturers also benefit from standardization and coordination within QMS and other regulatory submissions.
The benefits from the point of view of international market access should not be underestimated. Becoming compliant with the regulations of five countries brings substantial advantages in terms of facilitating trade.
Perceived challenges of the program include pressure on internal resources and the need to train internal auditors. It is true that time and resources will have to be temporarily reallocated to prepare for MDSAP, but there will be guidance available for implementation.
Conclusion
Some stakeholders have voiced concerns about MDSAP, especially when it comes to overall impact, levels of market participation, and preparation cost. However, the single audit program will significantly reduce the time and effort spent preparing for, and responding to audits and inspections from various markets, while simplified international trade is another benefit. The long-term benefits of the single action plan for compliance far outweigh the short-term challenges.
Burlington, Massachusetts – Just eight months after its initial introduction, Desktop Metal has begun shipping its metal 3D printer to early pioneer customers as part of the Studio System rollout.
Participating in Desktop Metal’s Pioneers Program, Google’s Advanced Technology and Products (ATAP) group is the first pioneer to receive the Studio printer. Among the inaugural Pioneer customers in the program, companies span other industries, such as machine shops, heavy machinery, consumer electronics, automotive, service bureaus, and government & education. Benchmark parts range from tooling, prototyping and jigs & fixtures, to end-use parts for functional applications.
“Since the launch of our Pioneers Program, we have seen really passionate engineers and world-class companies begin to develop benchmark metal 3D printed parts with the Studio System,” says Ric Fulop, CEO and co-founder of Desktop Metal. “We are extremely excited to begin shipping our Studio printer to these early pioneer customers and sales partners, including Google’s ATAP, and, over the next several months, will be working closely with each to learn more about how engineers want to use our system.”
Among Desktop Metal Pioneer customers in the USA, in addition to Google’s ATAP, include: US Navy’s Naval Surface Warfare Center Dahlgren Division; Built-Rite Tool & Die; The Technology House; Medtronic; and Lumenium LLC. Each Pioneer will begin receiving the Studio System over the coming months, with broader distribution to those who reserved the system early this year. Additionally, more than 30 USA sales partners will be receiving the Studio System to begin the process of offering product demonstrations and creating benchmark parts for interested customers.
“This marks the first time our team will be able to use metal 3D printing for rapid prototyping of our hardware parts,” said David Beardsley, manager of Google’s ATAP. “For prototyping, we have previously relied upon casting or using plastic 3D printing. Now with the Studio System, our team will experience shorter lead times, faster product development cycles and the benefits of functional prototypes in an array of metals on demand and in the lab. We look forward to exploring and developing potential applications for many of our projects.”
The Studio System, which debuted in May, is the first office-friendly metal 3D printing system for rapid prototyping and is 10 times less expensive than existing technology today. The Studio System is a complete platform, including a printer, a debinder, and a sintering furnace that, together, deliver metal 3D printed parts in an engineer’s office or on the shop floor.
Mastercam and WIDIA: Fast, simple tooling data solution
CAM users can quickly import tool assemblies from WIDIA NOVO directly into Mastercam 2018.
Tolland, Connecticut – CNC Software Inc., developers of Mastercam, have collaborated with WIDIA, the original German tungsten carbide tool developers, to provide a solution that enables CAM users to quickly import tool assemblies from WIDIA NOVO directly into Mastercam 2018.
Mastercam developers worked closely with WIDIA to let users import 3D tool assemblies directly into Mastercam, validate them, and save them in their Mastercam file and/or Tool Library. Features such as automated filtering ensure that the holders and tools that are selected can work together for the particular job. Users of Mastercam benefit from having the correct tooling for the material and for the type of machining operation, plus an accurate 3D model that can be used for visualization and collision checking, in addition to the time savings.
“We found that in the past, our customers complained of having to search through big complicated catalogs to find related parts, then having to request or build the assemblies from scratch for use in systems such as Mastercam. With the integration of WIDIA NOVO and Mastercam, customers save significant time searching for desired tools and building 3D tool assemblies that can be brought directly into Mastercam for easy use by most shops,” says Rich Taft, product owner, CNC Software Inc. “Accurate tool definitions are a critical factor in modern CAM applications. Toolpath algorithms take advantage of these definitions to provide safe and efficient motion. In addition, the models that we import from WIDIA NOVO help us to generate accurate in-process stock models that can be leveraged in subsequent operations. Customers can also make use of these models in verification and machine simulation to catch programming errors before the program ever gets to the machine tool.”
Chris Merlin, director of portfolio commericialization at WIDIA, states, “One of the promises of digitalization in manufucturing is greater precision and speed through effective use of data; this is where integration is a must. Users want their systems to work together seamlessly, via simple solutions, without extra effort on their part. By connecting Mastercam and WIDIA NOVO, users can effortlessly join cutting tool data with machining data. The 3D models, drawings, and starting parameters are easily available for validation and programming processes. All of this leads to less misapplication of tooling solutions, more optimal machining strategies, and increased productivity with better quality in the manufacturing environment.”
