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Substantial Equivalency: By Comparison or By Performance?

Substantial Equivalency: By Comparison or By Performance?

On April 12, FDA released a draft guidance document, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. Comments on the draft will be accepted until July 11. As comments are received they can be reviewed here.

An Abbreviated 510(k) is one that uses guidance documents, special controls, and/or FDA-recognized consensus standards to establish substantial equivalence in whole or in part without direct comparison of the candidate device to one or more predicate devices. The Abbreviated 510(k) has existed since at least 1998 as part of The New 510(k) Paradigm. The other two types of 510(k)s are Traditional and Special.

Device manufacturers may choose to submit an Abbreviated 510(k) when there are FDA-established performance criteria. As identified in the 510(k) database, there were 76 abbreviated 510(k)s cleared in 2017 and 17 in 2018 through April 20. Reviewing the corresponding product codes shows the applicable standards, but not guidances or special controls. The latter may be listed with the CFR regulation number. In some cases, multiple consensus standards are cited for the product code, and it is not clear from the public record whether the submission cited compliance with all of these, a subset, or just one. For example, the product code for an anti-snoring device that was cleared with an Abbreviated 510(k) under current rules lists three biocompatibility standards. It is perhaps noteworthy that no standards are listed for this product code (LRK) that relate to actual device performance. Similarly, the product code for a syringe cleared via an Abbreviated 510(k) (FMF) lists 18 separate standards.

Inherent in the Abbreviated concept is the notion that there must be both established performance requirements and associated test methods. The draft suggests that while the existing Abbreviated program allows for the use of established criteria to demonstrate equivalence for some performance characteristics, the new expanded program would involve demonstration that all of the performance characteristics necessary to support a finding of substantial equivalence have been met. This requires that such criteria be specifically enumerated by FDA. When there are such standards, FDA states in the draft that it intends to rely on a declaration of conformity by the submitter without the submission of actual data, although a summary of the data may be needed. However, FDA says that it can request the data as needed. When data does not have to be included, this should simplify the 510(k) itself, although not necessarily the underlying work.

An interesting question about reliance on the factors that allow for an Abbreviated 510(k) is whether the guidance document, special control, and/or standards capture all of the important factors that define the performance and substantial equivalency of a device. Of course, this question also applies to Traditional 510(k)s where it is assumed that some set of comparisons captures everything we need to know about real-world device performance. This reliance on a specific set of factors overlooks the fact that the actual demands of clinical performance may be different from often idealized, and always limited, test conditions. For example, the laboratory conditions of a mechanical fatigue test may not capture the variety of geometries and loadings that may occur in actual use. Similarly, human factors testing may miss actual conditions of use.

An Appendix to the draft describes the content of an Abbreviated 510(k) under the proposed expanded applicability. Most of this content is familiar. Notably, a substantial equivalency discussion is still required, including identifying a predicate device, but without the necessity for direct comparative testing. Similarly, such a 510(k) should include proposed labeling and information on sterilization and shelf life, biocompatibility, software, electromagnetic compatibility, and electrical safety.

The real appeal of the expanded Abbreviated 510(k) format may be that, when applicable, there will be specific performance criteria and, in some cases, corresponding test methods. While this reduces uncertainty about what needs to be measured, and how it needs to be measured, it may or may not mean less testing in comparison to a Traditional 510(k). Furthermore, the criteria for some devices could become more demanding compared with what you might otherwise have gotten away with. While the Traditional 510(k) would still be available, it seems unlikely, if not bizarre, that you could be successful doing less in support of a Traditional than you would be expected to do under an expanded Abbreviated. In this regard, “abbreviated” may in some cases prove to be a misnomer.

In order to implement this program after the comment period and any revisions that the comments may provoke, FDA will have to enumerate specific devices that the expanded Abbreviated 510(k) applies to, presumably in terms of their product codes, as well as establish the required performance criteria for each. This might take a while, although they may have some queued up.

2018 Medical Design Excellence Awards Finalists

2018 Medical Design Excellence Awards Finalists

The Medical Design Excellence Awards competition is the medical technology industry's premier awards program. Since 1998, the MDEAs have recognized achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility.

Each year, a panel of jurors comprised of designers, engineers, and clinicians awards bronze, silver, gold, and best-in-show honors to the most innovative products on the market in nine categories.

Take a look at this year's finalists. We'll announce the winners June 12, 2018, in a special ceremony at MD&M East.

1.  Cardiovascular Devices—devices and equipment used to diagnose or treat conditions of the heart and circulatory system

2.  Drug-Delivery and Combination Products—including pre-filled syringes, misting devices, dry powder inhalers, patches, pouches, or combination implants with biologic agents, etc.

3.  ER and OR Tools, Equipment, and Supplies—including critical care, general surgery, plastic surgery, and anesthesiology products

4. Implant and Tissue-Replacement Products—including cochlear, corneal, orthopedic, neurological, and tissue implants and instruments

5. Nonsurgical Hospital Supplies and Equipment—including general medical equipment and supplies used in hospitals and doctor's offices, such as stethoscopes, blood lancets, medical carts, ventilators, hospital beds, blood pressure monitors, etc.

6. Over-the-Counter and Self-Care Devices

7. Radiological, Imaging, and Electromechanical Devices

8. Rehabilitation and Assistive-Technology Products—including wheelchairs, walkers, crutches, hearing aids, prosthetic devices, etc.

9. Testing and Diagnostic Products and Systems—including products that fall into FDA categories of chemistry, hematology, immunology, microbiology, pathology, and toxicology

Don't Sweat the Ortho Ups and Downs, Stryker Says

Pixabay Don't Sweat the Ortho Ups and Downs, Stryker Says

Now that Johnson & Johnson, Zimmer Biomet, and Stryker have all reported earnings results from the most recent quarter, some analysts have pointed out that procedure volumes seem to be down across the industry, particularly for hip and knee surgeries.

While Stryker reported strong quarterly growth across its businesses and continues to train more surgeons on Mako Total Knee procedures, quarter-to-quarter variability is pretty typical in orthopedics, CEO Kevin Lobo assured analysts during the company's earnings call.

"Let's see how the second and third quarter play out, but this is not unusual. We had a pretty strong fourth quarter, a little bit softer first quarter. We've seen that movie multiple times over the past five years," Lobo said, according to Seeking Alpha transcripts. "I still see the market as very stable from a procedural standpoint and we're really much more focused on driving our growth through share gains."

Katherine Owen, vice president of strategy and investor relations at Stryker, said there doesn't seem to be any indication that the underlying demand for hip and knee reconstructive procedures has changed.

One thing that did seem to impact the first quarter procedure volumes, at least in Europe, was a particularly nasty flu season, and Owen said some patients in the UK were turned away from surgery because of the flu.

"Again, we just think this is one of those quarters, based on all the data points we have, that was sequentially softer," Owen said. "And how much of that seasonality is a normal quarterly variability, difficult to know, but we're not seeing anything that suggests a change in fundamentals."

Lobo said the UK is where Stryker has the most share within Europe, so the flu issue did make an impact in both hips and knees there, which he said happened a couple years ago also. Just as volumes did bounce back that year after the flu season passed, Lobo said he expects this year to be no different.

"I'm not going to comment specifically on what we're seeing right now, it's very early in the second quarter, but we would expect a normal resumption of procedural volumes just as we've seen in the past," he said.

Spry Health's Wearable Keeps Patients and Docs In the Loop

Spry Health's Wearable Keeps Patients and Docs In the Loop
Pierre-Jean Cobut

Patients just don’t get a lot of one-on-one time with their physicians. But what if there was a way to give doctors more time so they could get better insight on their patient’s health.

That’s something Spry Health, a company formed in July of 2014, is seeking to address by providing continuous monitoring for patients.

Elad Ferber and Pierre-Jean Cobut founded the Palo Alto, CA-based company, which has developed the Loop Wearable Wristband.

“This is our first healthcare company, but we were really interested in healthcare because the opportunities here can make a huge impact in patients’ lives,” Cobut told MD+DI. “

Spry Health, the winner of MD+DI’s 2018 Medtech Startup Showdown, said Loop, is the first clinical grade wearable that measures blood pressure, pulse oximetry, respiration rate, and heart rate. The data is streamed to the system's analytics platform for tracking and analysis in an effort to pinpoint the earliest signs of patient deterioration in advance of any new symptoms noticeable to the patient. In the clinical setting, the data can be used to help providers intervene earlier.

The company is seeking to get a nod from the FDA to market the technology.

“We’re in the process of an FDA submission and we’re submitting with the agency as a Class II Device,” Cobut said.

Spry Health has about a dozen employees and is looking to recruit another six within the next few months. The firm had a seed round of $1.5 million in 2015 and a series A round of $5.5 million last year.

A key focus of the company is to develop technology based on the user experience. Cobut said that many companies in medtech design devices based on functionality as opposed to the patients that are using it, and that needs to change.

“What is missing in medtech in general is user experience,” he said. “When I think about the way medical technology is usually designed, it’s designed for function. That’s totally fine for products that are going to be used in a clinical environment and are going to be used by professionals. But as care is moving into the home, then that is a system that just doesn’t work anymore.”

Double-digit growth forecast for global medical 3D-printing market

Double-digit growth forecast for global medical 3D-printing market

Increasing adoption of direct digital manufacturing and the expiration of key patents of 3D printed products will contribute to global growth of the 3D printed medical device market, according to a report from MarketsandMarkets (Northbrook, IL). Furthermore, the growing number of applications for 3D printing in the healthcare industry is being driven by surgeons using 3D printing in surgical procedures.

Growth stock art
Image courtesy Stuart Miles/

The market is segmented on the basis of technology, component type and region. On the basis of component, it is segmented into three broad categories: Equipment, materials, and software and services. The equipment segment is expected to register the highest growth from 2017 to 2022. The development of technologically advanced 3D printing equipment by leading market players for a number of healthcare applications and the rising adoption of 3D printing for manufacturing medical products are the key factors driving demand for 3D printing equipment in the healthcare industry, according to the report.

In the area of technology, medical 3D printing is segmented into electron beam melting, laser beam melting, photopolymerizaton, droplet deposition or extrusion-based technologies, said MarketsandMarkets. The laser-beam melting segment is expected to register the highest growth during the forecast period. This technology is primarily used to accurately produce small parts for dental applications and minimally invasive surgery.

According to MarketsandMarkets, the key players in the global 3D printing medical device market include Stratasys, 3D Systems Corp., EnvisionTEC GmbH, Materialise NV, EOS GmbH, Arcam AB, Concept Laser GmbH and Renishaw plc.

In 2016, North America accounted for the largest share of the market due to factors such as increasing government initiatives and rising demand for organ transplants. However, the Asia-Pacific region is expected to register the highest compound annual growth rate during the forecast period. The establishment of new 3D printing research, training and education centers, and efforts by leading market players to expand their distribution networks in emerging Asian countries are factors propelling growth of the 3D printing market for medical devices in the Asia-Pacific region.            

Zimmer CEO Says Righting the Ship Will Take Two Years

Pixabay Zimmer CEO Says Righting the Ship Will Take Two Years

Zimmer Biomet CEO Bryan Hanson told investors Thursday that he believes the company can get back into positive market share growth, but it will be a two-year turnaround. Hanson said this insight is based on the input he has received from both employees and customers in his four months on the job.

Areas where the company needs improvement, Hanson said during Zimmer Biomet's first-quarter earnings call, include gaps in demand planning, portfolio management, resource allocation processes, and a lack of manufacturing automation.

Hanson confirmed during the call that FDA concluded a re-inspection earlier this week of Zimmer Biomet's Warsaw North campus (previously referred to by the company as the legacy Biomet facility). This is the facility that was hit in December 2016 with an unusually long Form 483 based on quality control problems. In the latest inspection, FDA issued additional observations and Hanson said the company plans to submit its formal response in the coming weeks.

"This latest inspection confirmed that quality remediation progress has been made, but we still have work to complete, and we're obviously, not satisfied with the current state of our quality system at the Warsaw North facility," Hanson said, according to Seeking Alpha transcripts of the call. "Unfortunately, there is no quick fix, but our team is working tirelessly to make the necessary improvements."

Having just received the outcome of this latest inspection, Hanson declined to provide too much detail as the company works through the information and prepares its response to FDA.

"We're not just looking at this internally, we also have our external advisers taking a look at it with us as well," he said.

In terms of supply recovery, Hanson said the company is still on track with its goal of restoring supply in "substantially all" its key brands by the beginning of the third quarter.

"For us, the primary focus will always be patient safety," Hanson said. "If at any time, we think that we're putting patients at risk ... we're going to take the right actions to make sure we take care of those patients."

One component of getting the company's quality and supply issues under control is closing the culture gap that Hanson noticed when he first joined the organization.

"I really do believe we're going to need to see a shift in the culture and the engagement of this organization," he said.

The new observations were less than the agency's previous observations at the facility, Hanson reluctantly admitted.

"But to me, it doesn't matter. The fact is, we have observations," he said. "We don't mess around when it comes to quality. Any observation is not a good thing, and we are going to tackle it as aggressively as we would even if that was more. It doesn't matter if it's less or not to me, I want to tackle these things extremely aggressively."

At a higher level, Hanson has made several changes to the company's leadership team since he joined. The company hired Cole Lannum as senior vice president of investor relations; Ken Tripp as senior vice president of global operations and logistics, and Rachel Ellingson as the senior vice president of strategy.

"I've also been augmenting our reporting structure to encourage a more inclusive and responsive organization that is more deeply in tune with the needs of the business," Hanson said.

That means several business heads as well as the company's chief ethics and compliance officer now report directly to Hanson, he said.

Agilyx and Ineos Styrolution sign MOU to advance circularity of polystyrene

Agilyx and Ineos Styrolution sign MOU to advance circularity of polystyrene

Agilyx Corp. (Tigard, OR) and Ineos Styrolution (Frankfurt, Germany) have signed a memorandum of understanding (MOU) for deploying Agilyx’s de-polymerization technology at or near an Ineos Styrolution facility in North America. The aim is to convert post-consumer polystyrene waste into styrene monomer that can be used to re-manufacture new polystyrene products.

The cooperation objectives defined in the MOU between Agilyx and Ineos are the natural next step to setting up a chemical recycling infrastructure and establishing a circular economy for polystyrene.

Image courtesy Agilyx.

Agilyx, an environmental solutions company that extracts value from waste plastic streams, opened its first commercial waste polystyrene-to-styrene oil chemical recycling plant on April 19, 2018. At a ribbon-cutting on April 24, speakers representing Agilyx strategic partners included local government representatives from Tigard City Council and Washington County, and individuals representing the American Chemistry Council (ACC) and American Styrenics LLC. 

Mike Levy, Senior Director of ACC’s Plastics Foodservice Packaging Group, noted, “Agilyx is an innovator in finding new ways to capture and convert used plastics into valuable products. Delivery of a polystyrene-to-styrene oil/monomer solution is a major step toward greater sustainability and circularity.” 

Jon Timbers, Senior Manager for Sustainability and Innovation at American Styrenics, congratulated Agilyx on “taking the linear process of plastics and bending the line to close it into a loop—the new circular plastics economy,” said a joint release from Agilyx and Ineos.

The plant is the first commercial-scale closed-loop chemical recycling process for polystyrene in the world. It will recycle up to 10 tons per day of previously unrecoverable polystyrene waste and produce high-quality styrene oil that will be processed by styrene manufacturers Ineos and American Styrenics to manufacture consumer goods, said Agilyx.

The process involves “breaking the chemical bonds in the polystyrene, hence the term ‘chemical recycling’ as opposed to ‘mechanical recycling,’” Agilyx confirmed to PlasticsToday

Ineos Styrolution is committed to driving the advancement of the de-polymerization technology. Together with several research institutions, the company is working on a technical feasibility study and is aiming at the development of a holistic recycling concept in collaboration with waste management companies. 

Both companies are committed to driving the chemical recycling technology forward, which is based on the de-polymerization of post-consumer polystyrene waste. This technology aims at achieving virgin, high-quality polystyrene ultimately suitable for both food-contact and medical applications.

“We are very excited to expand our partnership with Ineos Styrolution focused on creating a true circular pathway for polystyrene using our existing chemical recycling platform,” said Joe Vaillancourt, CEO of Agilyx. “This collaboration not only looks to support deployment of a new chemical recycling application, but it also helps create a new, innovative supply chain that bridges both the plastics and waste management industries. This combination creates a new circular economy reality for polystyrene.”

Alexander Gluck, President, Americas Ineos Styrolution, commented, “We are excited to advance our partnership with Agliyx to the next level and further demonstrate our commitment to chemical recycling and the circular economy of polystyrene. Jointly exploring site options for scaling the new technology will help with accelerating our development program that we announced back in October of 2017.

“We are eager to lay down the foundation for polystyrene to be recovered and recycled and build the eco-system around chemical recycling,” Gluck added. “This will help us continue to enjoy the great benefits of polystyrene delivering substantial contributions [to] advances in healthcare and food preservation.”

StackTeck to demo Thin Recess Injection Mold system using MuCell process at NPE2018

StackTeck to demo Thin Recess Injection Mold system using MuCell process at NPE2018

StackTeck at NPE2018StackTeck Systems Ltd. (Brampton, ON, Canada), a global manufacturer of high-volume production molds for thin-wall packaging, closures, medical, and mold bases, will be demonstrating its first thin-wall TRIM (Thin Recess Injection Mold) system using the MuCell process at the Trexel booth, W551, at NPE2018.

This MuCell microcellular process introduces the P Series, which, for the first time, allows for the use of ultra-fast cycle times. Attendees can view an in-mold label (IML) TRIM MuCell cup running in a 220-ton Milacron Ferromatik machine. IML automation is supplied by Ilsemann. The TRIM panels in the cup are just 0.008 inches (0.2 mm) thick, representing one of the thinnest injection molded parts in a usable packaging format, according to StackTeck.

Microcellular molding is the controlled use of gas injected into the melt stream via the molding machine. This process creates uniform micro-bubbles in a “foaming” action to disperse the plastic evenly within the cavity walls, explained StackTeck.

Benefits of MuCell technology include reduced resin consumption; less clamp tonnage needed; thin-to-thick wall material flow; and lower melt viscosity, which can help in difficult-to-fill areas.

TRIM and MuCell have benefits that complement each other. TRIM enables up to 40% part lightweighting but requires increased clamp tonnage, whereas MuCell reduces clamp tonnage in a similar proportion. Additionally, the microcellular approach brings additional lightweighting, beyond the benefits of TRIM. 

Stunning designs rock AWA sleeve label awards

Stunning designs rock AWA sleeve label awards

Supplier Stories for the Week of April 22

This is a compilation of the latest news from suppliers in the medical device industry.If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]