A new white paper from RQM+, the leading regulatory, quality, and clinical consulting firm, provides clarity on the clinical evidence required to comply with the EU In Vitro Diagnostic Regulation (IVDR), and spotlights synergies between EU and US requirements.

It is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment requirements also increase. This new rigorous risk-based classification means that an estimated 84% of IVDs now fall under Notified Body (NB) scrutiny compared to the mere 7% under the directive.

To ensure that IVDR compliance is as efficient as possible, manufacturers must check whether they can leverage existing clinical evidence from IVD submissions to the US Food and Drug Administration. If a company sells diagnostic products that are 510(K) cleared in the USA, then they may have a head start. It is likely they have already obtained a significant proportion of the supporting testing and performance data that is required to comply with some of the IVDR requirements.

This new white paper from RQM+ provides advice on how to identify synergies, as well as a table that clearly presents areas where these synergies may be found. This is an addition to a detailed summary of clinical evidence requirements under the IVDR, including a checklist of questions to assess whether scientific validity, analytical performance and clinical performance have been sufficiently addressed in their Performance Evaluation Report (PER).

Carlos Galamba, vice president, IVD Intelligence and Innovation, says, “The EU Commission’s recent proposal could mean a sigh of relief for some IVD manufacturers with existing directive products on the market. If approved, it would not change the date of application, but it would allow for a progressive roll-out to the IVDR based on device classification, with a shorter timeframe for higher risk devices.

However, there is no room for complacency. Notified Bodies will not engage with companies unless their technical documentation, including performance data is complete. I cannot stress enough how important it is for IVD manufacturers to review whether they have enough clinical evidence, to give themselves enough time to take remedial action. We hope that this new paper will help manufacturers to plan efficiently for compliance, by making full use of what is already available.”

Download the RQM+ white paper, ‘Performance Data and EU IVDR: Improving operational efficiencies through compliance’, here.

CEA-Leti, a CEA microelectronics research institute, will introduce a smart, integrated multi-sensor system for knee implants at CES 2022 that can help surgeons more accurately position the implant, dramatically reduce risk of follow-up surgery, and enhance rehabilitation.

Called FollowKnee, the patented system integrates a deformation sensor, a pH sensor, a temperature sensor, and an accelerometer in a titanium tibial baseplate.

A more accurate implant fitting is achieved via the deformation sensor and accelerometer that guide the surgeon during the operation. In a world’s-first application connecting a pH sensor with living tissue, the system’s pH and temperature sensors detect infection early, while the deformation sensor and accelerometer also trigger an alert if they detect mechanical problems, such as loosening of the implant. Those two devices also enhance rehabilitation by helping physiotherapists adapt therapy for knee-implant recipients.

At Eureka Park booth #60655, Jan. 5-8, 2022, CEA-Leti will demonstrate the sensors, electronics, and a reader integrated in a clear acrylic column representing a leg fitted with a complete knee prosthesis. A tablet displays data collected by the sensors.

Developed with CEA-Leti’s deep expertise in sensor and integration technologies, the system also includes the first low-power deformation sensor in a biocompatible system with highly compact electronics powered via inductive coupling.

"Accuracy is vital in knee-implant surgery,” said Dr. Eric Stindel, an orthopedic surgeon at Brest Hospital, France, and a member of the project team. “By integrating the deformation sensor and the accelerometer, this innovative architecture gives both the surgeon and the patient peace of mind for a successful operation and follow-up.”

The technology can be adapted for hip and shoulder replacements.

The Center for Orthopedic & Neurosurgical Care & Research in the U.S. estimates knee-implants will increase by 673% by 2030, or 3.5 million operations.

FollowKnee is a project financed by the French ANR program, and brings together 13 partners.

Small and mid-sized medical equipment manufacturers and resellers face plenty of challenges, not the least of which is how to differentiate from competitors. If you are a manufacturer or reseller looking for a key area where you can create an important distinction, add real value, and drive sales, look at customer financing.

A customer of a small or mid-sized enterprise could simply go to a large bank and work with its existing program and offerings. But manufacturers and resellers that want to stand out to their customers should consider the following four ways to differentiate themselves with customized customer financing programs.

1. Serve as business advisors: You can always simply offer customers a standard financing program. Or you can seek higher-level advisory services designed to help you and your customers on a one-to-one level. Work with a financing company that is experienced in the medical equipment sector and looks to learn business models, financial positions and goals – yours and your customers’. This will result in the development of customer financing programs that go a step beyond the norm.
   A trusted financing company whose representatives prioritize getting to know your business as well as your customers’ business can provide sound input and help that go past base customer financing. Some savvy financing companies will even help with sales training, educating on how to incorporate financing into the sale. They may even accompany reps to trade shows or customer meetings to truly become part of your team A good financing company will offer input on how to incorporate financing options into sales strategy for a new piece of equipment, a review of the pros and cons of a lease versus loan, or other – all with an eye on what’s best for your customers’ goals and your sales success.
2. Provide flexibility in financing to customers: Many small and mid-sized manufacturers and resellers will only offer customers a one-size-fits-all financing program. Some large banks, for example, may have just a couple of programs and look to compete solely on rates. However, manufacturers and resellers can differentiate themselves with the ability to handle a variety of transactions: large-volume, small-volume, different structures – perhaps even setting up a subscription model. Working with a financing company that has the resources and expertise to develop customized programs can be a game-changer
3. Speed financing: A financing company that has significant resources as well as an entrepreneurial mindset can lead with agility and speed in setting up programs, credit decisioning, document processing and fast payment (think 24-48 hours, versus end of the month). If your customers are able to acquire their equipment easily, and if you are getting paid quickly, you should be able to focus your energy on strategy, sales and moving inventory.
4. Offer white-label financing programs: Also known as private-label financing, white-label financing takes place when a third party offers funding to your customers under your company name. The financing company handles the entire financing process from start to finish, working as an extension of your company. The financing company will brand itself with your company name and logo, or develop a coordinating identity. A sophisticated financing company will train personnel in your business. Those individuals will identify themselves to customers as an extension of your company, and treat your customers as the valuable assets they are.

Your customers benefit from a seamless, simple process. You simplify operations by dealing with just one contractor, you add value to your brand, and you build credibility among your customers.

Small and mid-sized medical equipment manufacturers and resellers can distinguish themselves in the market, and to their customers, with smart and creative approaches to financing. Flexible, customized programs streamline your operations and ease the path for your customers to acquire your products.

James Teal is president and COO, Vendor Services, Mitsubishi HC Capital America, a provider of customized financing solutions that meet a variety of needs for the manufacturing industry.

Finishing and superfinishing, lapping, honing, and vibratory grinding: an impressive range of manufacturing processes can be used to create a final surface finish. The proverbial finishing touch influences the functional behavior of workpieces and components, yielding unique characteristics and competitive advantages. GrindingHub, a trade fair for grinding technology, will be held in Stuttgart May 17-20, 2022, and will provide a platform for finishing and superfinishing.

Companies looking for specialists to help them move into superfinishing
It took Uli Lars Bögelein “less than ten seconds” to make up his mind to exhibit at GrindingHub. The entire industry is certain to benefit from the trade show, says the managing director of Stähli Läpp-Technik GmbH, based near Stuttgart. Founded over 40 years ago as a sales company for flat honing, lapping and polishing machines produced by the Swiss Stähli Group, Stähli Läpp-Technik GmbH is now part of the group. Its core competences include engineering, sales, and contract processing. The latter represents an ideal way into superfinishing – and to much more besides, as Bögelein makes clear.

The Stähli Managing Director describes the three main groups of users who contact him. These come primarily from the automotive and electrical industries, medical technology, mechanical engineering, and the optical industry. The first group of users is not (yet) concerned about the investment costs for both the 2- and 3-wheel flat honing machines and the 1-wheel lapping and polishing machines because their production quantities are too low. Then comes the second group which needs high, if not extremely high, quantities, but which "specifically wants to avoid taking care of these processes, and all they involve, within their own company". Lapping machines in particular bring their own challenges and do not fit into every production operation, Bögelein admits. It is a demanding process which still requires a lot of manual work – and specially trained and highly motivated employees.

Finally, there is a third group of users. These run test series at Stähli. Until the series is working smoothly, they would first like to familiarize themselves with the process and the machine, and take advantage of the service and know-how offered by Stähli Läpp-Technik. The company also offers the entire range of consumables and accessories for this, including everything from CBN wheels and diamond suspensions through to testing equipment. Uli Bögelein notes that trade fairs are very important and are often used for making the first contact. Visitors come with drawings and workpieces, but also specific machine inquiries, and to have the technology explained to them. Specific technological know-how is required in cases involving manufacturing tolerances in the submicrometer range and filigree functional surfaces.

Drivers of industry development
According to Thomas Harter, product manager at Supfina Grieshaber, based in Wolfach in the Black Forest, companies’ increased motivation to concern themselves with surface quality and finishing and superfinishing processes stems from clearly identifiable "development drivers.” Supfina has many years of experience in the field of superfinishing and grinding. It develops machines and conducts related research – and will also be exhibiting at GrindingHub.

Harter cites examples from the automotive technology field. For example, the expected legal regulations for Euro 7 and the associated reduction in particulate matter are driving the development of the brake disc market. Future brake discs, he says, will probably feature hard coatings that are difficult to machine. As a development partner, Supfina takes care of developing the process for grinding the coated brake discs. The know-how is used in the development of the entire process chain, ultimately enabling cost-effective production of the brake disc.

e-mobility is also placing new demands on superfinishing. Future-proof solutions are needed to reduce noise in the powertrain, the steering or when adjusting seats and windows inside the vehicle. For example, Supfina has developed a machine series for the economical production of low-noise roller bearings.

Defining specific surface parameters
Dr. André Wagner, Head of Grinding Technology at Hermes Schleifmittel, Hamburg, makes clear just how much the demands on surface quality are changing and how important precise coordination with customers is becoming as a result. While some processes, such as high-performance steel cutting, are optimized primarily for productivity and cost-effectiveness, processes such as gear grinding must yield high workpiece quality, says Wagner. The goal of reducing surface roughness to a minimum, which was common in the past, is increasingly being replaced by that of achieving specific surface characteristics. However, the selection and definition of the desired surface properties depends to a great extent on the particular gear application and the specific goal. "Effective communication between the customers and the grinding tool manufacturer is therefore essential," Wagner emphasizes. The general machine conditions, the quality requirements for the component being produced and also the productivity of the process have to be clearly defined and coordinated in advance. According to Wagner, ideal process results can only be obtained by setting precise objectives and designing the grinding process on an application-specific basis. In the case of gears, for example, this would ensure maximum efficiency of the transmission and reduce noise emissions, which are crucial for electrically driven vehicles. All process-defining parameters such as machine environment and cooling lubricant supply must be taken into account when selecting and designing suitable grinding tools. "High-performance tools aren’t always necessary. In many cases, less exacting specifications may also suffice if the process as a whole is designed correctly," says André Wagner.

Scientists focusing on process chains
Finishing and superfinishing processes can play a role in creating unique workpieces. The Institute for Machine Tools and Factory Management (IWF) at the Technical University of Berlin believes that “...there is a noticeable trend toward manufacturing individualized products in small batches. This is giving rise to an increasing need for manufacturing processes that can be adapted to changing product requirements." Research is being conducted into robot-guided machining processes for finishing and superfinishing by the Institute. "Robot-guided machining processes can be used on many different components, especially in combination with flexible or freely movable tools, as in abrasive brushing, belt grinding or vibratory grinding," explains Institute Director Prof. Eckart Uhlmann. "Honing processes that are conventionally performed on rigid machine tools can also be taken care of using robot-guided honing tools to rework bores in different positions." Uhlmann, who is also a member of the WGP (German Academic Association for Production Technology), believes that the main advantage of using a robot as a universal processing machine is that it allows the different processing steps to be linked flexibly. Process chains can then be adapted to the respective component requirements with little effort.

Interest in the research proves that greater use is expected to be made of innovative finishing and superfinishing processes in the future. However, they are still fraught with problems for many companies. It is true that the industry offers both technologically advanced machines and tools as well as extensive specialized knowledge for creating surfaces of tribologically stressed functional surfaces. Yet the special machines are too expensive for small and medium-sized companies and for relatively small or medium batch sizes, the automation is complex and knowledge about cause-effect relationships is limited to specialists. Trade shows such as GrindingHub offer an opportunity to showcase machines, tools, processes, and work results.