MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Sitemap


Articles from 2017 In May


Reusable Devices: How Effective Is Your Cleaning Validation?

If you're developing a medical device that will be reprocessed, you've got a lot to consider.

Daphne Allen

Alpa Patel, B.S. RM (NRCM)

Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them?

"There have been many issues over the last 7 years, so there's increased scrutiny of cleaning validations," explained Alpa Patel, B.S. RM (NRCM) of Nelson Laboratories. "FDA published the 2015 guidance, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.' Yet a lot of uncertainties and inconsistencies remain regarding cleaning validation plans."

Patel will explore such issues in the presentation "Key Factors that Determine a Successful Reusable Device Cleaning Validation" on Wednesday, June 14 at MD&M East 2017.

Cleaning validations are inherently challenging because "reprocessing entails multiple steps and involves both manufacturers and healthcare facilities," she told Qmed. "When manufacturers design cleaning validations, they need to keep in mind the healthcare environment and FDA guidelines as they possess challenges to designing a successful validation.

"There's also the impact of repeated use and how to evaluate the impact that repeated use has on the ability to effectively reprocess a medical device," she continued. "There are still a lot of unknowns. There are many factors that play a role, and one wrong move can lead to a failure mode."

Other challenges arise when "manufacturers seek reprocessing consultations and testing just before product launch," she said, speaking of Nelson Laboratories' services. "Cleaning validation should be considered during the design phase of engineering--not at the end. It's not uncommon to see these types of validations submitted when manufacturers are in final preparations for a 510(k) submission."

It is common to see instructions for use (IFUs) as an afterthought when medical device manufacturers should actually be thinking about them from the start, she added. "There is the chance that during the validation, the instructions for use and the cleaning process wouldn't meet the acceptance criteria," she said. Such criteria are offered in AAMI Technical Information Report (TIR) 30, "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices," which specifics a benchmark.

"This benchmark, however, is not necessarily applicable for all devices. The benchmarks to evaluate the effectiveness of a cleaning validation specified in TIR 30 was designed from an endoscope study, and the thinking is that all other reusable devices could fall under the same acceptance criteria umbrella," she said. "The question now in everyone's mind: 'Is this benchmark specified in TIR 30 appropriate for all types of reusable medical devices?' The answers to this question are yet to be determined."

To offer some assistance, ASTM did recently publish the new standard, F3208 "Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices." Patel, who helped write this standard, believes that it will help resolve the confusion surrounding selecting the right test soils. "There are many more ASTM standards to come to address different steps performed for cleaning validations. However, the process will take a couple of years before every step is ironed out," she said.

In terms of future developments, Patel points to new acceptance criteria for chemical analysis for protein and hemoglobin that may be established in ISO documents.

Image courtesy of Nelson Laboratories

There is also a lot of movement in AAMI regarding addressing cleaning for reusable medical devices, she added. TIR 12, "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers," has formed a working group to  classify devices into six categories according to the complexity and design of the reusable medical device in an Annex. "This will help manufacturers identify the appropriate IFU for cleaning procedures for their devices," Patel said. She would like to see standardized IFUs so that personnel working in the central processing areas in healthcare facilities have one type of IFU to refer to for a particular device. "Think of the confusion if every scissor manufacturer had a different IFU," she said.

As industry working groups continue to address these questions, Patel offers this best practice in the meantime: "Always test the cleaning validation on device prototypes. Think about cleaning validation studies with biocompatibility studies during the design phase," she said. "When you put off thinking about a cleaning validation at the end of product development, you often find difficulty achieving the final goal."

For more details, attend Patel's presentation as well as Nelson Labs booth #1933 at MD&M East.

Patel co-authored the whitepaper Successful Medical Device Cleaning Validations: What You Need to Knowwhich is a free download available through Nelson Laboratories's Web site.

Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to Qmed. Reach her at daphne.allen@ubm.com and on Twitter at @daphneallen

Is AngioDynamics Right to Pick a Fight With Bard?

AngioDynamics is suing Bard for allegedly violating federal antitrust laws by tying the sale of its tip confirmation system to its own line of PICCs.

Amanda Pedersen

AngioDynamics is none too pleased with competitor C.R. Bard's sales practice in the peripherally inserted central catheters (PICC) market.

The Albany, NY-based company is suing Bard for allegedly violating federal antitrust laws by tying the sale of its tip confirmation system to its own line of PICCs. This puts AngioDynamics at a competitive disadvantage, the company said, because customers who want to buy Bard's tip location system must also buy Bard's PICCs. AngioDynamics sells the BioFlo PICCs, and claims that they are superior. Tip location systems are designed to aid clinicians in the bed-side placement of a PICC.

The lawsuit could potentially hurt BD, which recently agreed to buy Bard for a whopping $24 billion in cash and stock. AngioDynamics filed the lawsuit in the U.S. District Court for the Northern District of New York.

"This case involves a classic violation of the antitrust laws," said Philip Iovieno, of Boies Schiller Flexner, who is representing AngioDynamics in the case.

"We are committed to fighting Bard's illegal scheme that has been detrimental to patients, reduced competition, and led to increased cost in the marketplace, and violated the federal antitrust laws," said Jim Clemmer, president and CEO of AngioDynamics.

The company not only aims to end Bard's so-called "illegal scheme" but also wants to recover what it considers to be treble damages for its losses.

According to Chad Campbell, senior vice president and general manager of AngioDynamics's vascular access division, the BioFlo PICCs include the company's Endexo technology, which he said has been shown to reduce thrombus accumulation by 87% compared to traditional PICCs.

Amanda Pedersen is Qmed's news editor. Contact her at amanda.pedersen@ubm.com.

[Image courtesy of Pixaby]

Can the Newest Da Vinci Robot Smash Cost Barriers?

The newest addition to Intuitive Surgical's da Vinci family provides a lower-priced surgical robot with the option to upgrade to more advanced features as needed.

Amanda Pedersen

The new da Vinci X could address a major adoption barrier in robotic surgery by offering a lower-cost system that customers can upgrade as their needs grow.

Intuitive Surgical added a new robot to its da Vinci family, reinforcing the company's dominance in a space that is expected to see some competitive disruption within the next couple of years.

FDA clearance of the da Vinci X comes about a month after the system received a CE mark, and the Sunnyvale, CA-based company said the new robot will be offered at a lower price point compared to some of the other da Vinci systems. Intuitive said it will launch da Vinci X to the US. market later this year.

Get up to speed on the latest trends in product design and development at the MD&M East conference and expo, June 13-15, 2017, in New York City.

Cost has been a major adoption barrier for robotic surgery but Intuitive and other companies fighting for a piece of this market have been making significant efforts in recent years to improve the value proposition of the technology. Analysts have struggled to assess the adoption rate and peak penetration of newer surgical robots, but some surgical specialties - like orthopedics, for example - appear more enthusiastic about the technology than others.

While the da Vinci X is expected to provide some of the features of the company's more advanced da Vinci Xi system, but at a lower cost, the international opportunity for the new robot is expected to be greater than the U.S. opportunity because international markets tend to be more price sensitive, according to Wells Fargo's Larry Biegelsen.

The analyst's report, issued Tuesday, suggests that the has been a higher degree of interest in the da Vinci Xi in international markets compared to the U.S. market, but in some cases, the price of the Xi is too high. According to Biegelsen, Intuitive has indicated that the price of the da Vinci X in Europe is EUR1.3 million with the first year of service included, which represents a value of about EUR130,000. That implies a list price of EUR1.187 million for da Vinci X compared to the Xi list price of EUR1.85, making the new system about EUR530K less than the da Vinci Xi, adjusting for the service fee, Biegelsen said.

In terms of features, the newest da Vinci robot appears to strike a balance between the da Vinci Xi, which is Intuitive's most advanced system, and the Si, which is the company's lowest cost platform.

"From a physical standpoint, the X is taking the Si patient cart and replacing the Si arms with the more advanced Xi arms, and adding the Xi operating system and Xi features," Biegelsen noted in his report. "This gives the X the ability to use the same instrument set and imaging technology and ease-of-use features that are found on the Xi system."

He added that the da Vinci X does not have the Xi's multi-quadrant access with the boom architecture and table motion.

"Customers around the globe have different needs from a clinical, cost, and technology perspective," said Gary Guthart, CEO of Intuitive Surgical. "Intuitive's goal is to meet those needs by providing a range of products and solutions. The da Vinci X system helps us to continue to do so."

Because the new system uses the same vision cart and surgeon console as the da Vinci Xi system, customers who buy the less expensive da Vinci X will have the option of adding advanced capabilities, or upgrading the system down the road if their practice and needs grow.

"The da Vinci X system is a value-oriented option for hospitals that are just starting their robotic-assisted surgical program, and for our existing customers who want to expand their existing robotics programs," said Henry Charlton, senior vice president of U.S. sales for Intutitive. "As customers' needs grow, the da Vinci X system can grow with them."

Intuitive will likely continue to hold a monopoly in the field of robotic surgery, but the company is expected to face significant competition in the next couple of years. Medtronic plans to launch a robotic system in various international markets by April 2018, and in the United States sometime in the first half of 2019. According to Canaccord Genuity's Jason Mills, Medtronic is likely to be Intuitive's first major competitor.

"Medtronic has the ability to directly leverage its existing open and laparoscopic product portfolio, incorporating these technologies alongside its robotic platform into a full sales bag, carried by reps with deep, long-standing relationships in several surgical fields," Mills wrote in a report issued Tuesday in which he boldly downgraded his recommendation from "buy" to "hold."

Mills said he expects Medtronic to try to provide a better value proposition compared to existing robotic surgical technology. As for Intuitive, the analyst acknowledged that the company had a "phenomenal year" in 2016 and that he expects Intuitive to deliver solid results again this year and in 2018.

"On the flip side, however, investors' exuberance about the company's strong performance over the past few years has driven the stock to unprecedented valuation levels," Mills noted.

For quite a while, Transenterix was posed to become a good David vs. Goliath story with its SurgiBot system. But the company got the wind knocked out of it last year when FDA decided its SurgiBot robotic system needed a new 510(k) application because the SurgiBot was not substantially equivilant to a predicate device. Since then, Transenterix has shifted its attention to a second surgical robot, the Senhance system, which is currently one of the most anticipated devices of the year.

Amanda Pedersen is Qmed's news editor. Contact her at amanda.pedersen@ubm.com.

[Image credit: Intuitive Surgical]

Time for Change—Understanding the New European Medical Device Regulations

Time for Change—Understanding the New European Medical Device Regulations

Medical device manufacturers are currently faced with a three-year transition period before full application of the new European Medical Device Regulation (MDR) in 2020. The MDR will replace the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) in providing requirements and EU market access. There is a lot to do in this relatively short time-frame, including assessing all currently marketed medical device products against the new guidelines. This is a particularly onerous task with changes to the classification of some medical devices under the new MDR.

To comply with the regulations, it is essential for medical device manufacturers to identify which of their products will be affected by the new classifications and plan ahead to ensure that they remain compliant. 

Where Will the Biggest Impact Be?

One of the biggest changes to classifications will occur in the orthopaedics space, mainly due to concerns around their long-term performance. Under a previous amendment to the MDD, all hip, knee, and shoulder joint replacements were reclassified from class IIb to class III. The MDR will add to this with all joints (ankles, elbows, toes, fingers, etc.) now being up-classified from IIb to class III devices. Ancillary components such as screws, wedges, plates, and instruments will remain classified as IIb, however, also in the orthopaedics space, many spinal implants will also be up-classified to class III. This means that every device will require detailed review of technical documentation by the appropriate Notified Body, which will lead to greater scrutiny in relation to the clinical data that is required to ensure patient safety.

New Rules to Consider

The new regulation will also introduce new rules, including specific requirements addressing the classification of software. The new classifications cover diagnostic, therapeutic, and physiological purposes, with the potential impact on patient safety and treatment determining the classification.

  • Class III--software intended to provide information used to take decisions for diagnostic or therapeutic purposes that has the potential to cause death or an irreversible deterioration in health.
  • Class IIb--software intended to provide information used to take decisions for diagnostic or therapeutic purposes that can cause the serious deterioration of a person's health or a surgical intervention. Also covers software intended to monitor vital physiological parameters that could result in immediate danger to a patient.
  • Class IIa--software intended to provide information used to take decisions for diagnostic or therapeutic purposes or to monitor physiological processes.
  • Class I--all other software.

Another new rule involves the classification of active therapeutic devices. Those with an integrated or incorporated diagnostic function that significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, will now be classified as class III. Devices incorporating nanomaterial are addressed with a special new rule under the new MDR and they will now range from class I to class III, depending on the potential for internal exposure. Elsewhere, devices intended to administer medicinal products by inhalation, which are designed to treat potentially life-threatening conditions, will be up-classified from class IIa to IIb respectively. These are just some of the reclassifications. It will be important to study the new and amended classification rules for devices particular to your business.  

Adopt Early to Stay Ahead

For all manufacturers that intend to place or continue placing devices into the European market, understanding and complying with the new regulations is of critical importance. Companies are responsible for making sure that their products will meet the clinical data requirements and the safety and performance requirements as laid out in Annex I. While this is consistent in many ways with the current requirements, it may be challenging for many legacy devices to fully address without new data and/or robust clinical evaluations. At the outset of the implementation of the new regulations, manufacturers, Notified Bodies, and competent authorities will be learning together about the practical challenges of compiling, reviewing, and accepting sufficient data.

Start by compiling the compliance data and technical documentation for one or two of your products (maybe with different classification profiles) as an example for Notified Bodies to evaluate and accept or to identify any areas of weaknesses. Once you have calibrated your submission against the Notified Bodies' expectations, it will be easier to confidently and efficiently implement changes across your wider legacy product portfolio before the new regulations come into full force.

There is no quick fix solution. Undertaking a gap analysis will enable you to evaluate how the changes to the criteria will affect your products and take your first steps towards compliance. Furthermore, it is likely that all technical documentation will need to be updated and all labeling will also need to be reviewed for compliance. The time pressure that this can place on a company should not be underestimated.

With only three years to go, early preparation and adoption will be the key to future success, and may even help to differentiate some medical device manufacturers from their competition. No doubt, our understanding of the MDR will be much stronger after three years of experience implementing and evaluating, but taking the time to start this process early will mean you remain compliant, competitive, and fully operational in the EU market.  

Paul Brooks is executive director at the Regulatory Affairs Professionals Society (RAPS). He has more than 25 years' experience within the medical device regulatory affairs environment and during his 35-year career he has worked with the British Standards Institution (BSI), where he served most recently as senior vice president, BSI Americas Healthcare and previously was head of the medical device EU Notified Body. 

Brooks will be presenting at a RAPS Workshop: 'EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations' on July 4th and 5th in Brussels.

[Image courtesy of VENTRILOCK/FREEDIGITALPHOTOS.NET]

How A Wearable is Making Diabetes Management More Efficient

The wearable, known as the V-Go, aims to make insulin delivery for patients with Type 2 diabetes simpler and more efficient.

Kristopher Sturgis

New data suggests this insulin patch, known as the V-Go, has cost benefits as well as ease-of-use perks for diabetes patients

People with Type 2 diabetes may have an innovative new treatment option that could not only make managing their disease easier, but also much cheaper. Valeritas reported the results of two new studies that examined the effectiveness of its flagship product, the V-Go wearable insulin delivery device.

"We've consistently shown throughout almost every study that this device has improved diabetes control for patients, and we're now seeing some real world cost effectiveness," said Scott Abbott, the company's director of medical development. "V-Go is a wearable and disposable insulin delivery device used by patients who require insulin, primarily patients with diabetes, and can be used to administer basal insulin over a 24-hour period."

The device was designed to deliver a continuous preset basal rate of insulin over a 24 hour period, while also providing on-demand dosing at mealtimes to help patients control blood sugar levels. The wearable doesn't require the setup of an infusion site, and instead is filled before placing on the body under the clothing. Once applied to the skin, the device inserts a small needle into the skin that can allow patients to move freely throughout the day without feeling the needle.

The element of discretion was something the company worked hard to achieve with the new device, Abbott said, as many patients have noted during trials the burden of using needles in public when administering treatment to manage the disease.

"I've had the opportunity to talk with a number of patients as part of our research, and one thing they love is discretion," Abbott said. "You can be very discreet when using this device, as V-Go is worn underneath the clothing, on top of the skin. Patients can then just reach under their clothing and press the little buttons. This allows them to be less concerned about injecting their insulin in public. Instead, they can do it quite discreetly without that burden or worry."

Abbott says that the device has been made readily available through pharmacy benefits and most insurance providers, as the company looks to provide a new technology that can be available to as many patients as possible. Abbott said Valeritas designed the device to address many of the concerns that diabetes patients deal with on a daily basis. The goal was to design a device that is just as easy to use, if not easier, than any traditional insulin delivery method that most patients are accustomed to.

"This device was designed for patients with diabetes, and a lot of our patients have found that when you apply it to your body and press a button, it isn't any harder to use than trying to inject yourself multiple times a day using different forms of insulin," Abbott said. "In a lot of ways, this device can be even simpler to use than traditional insulin therapies. When you have to inject yourself with different insulin multiple times a day, a device like this can help take that burden away."

As the company moves forward, Abbott said its mission remains the same: to help patients better manage diabetes with technologies that are more efficient, easier to use, and more cost-effective. Valeritas is also trying to further enhance the V-Go to expand its use and hopefully reach more patients.

"The company motto is 'improving health and simplifying life for people with diabetes,'" Abbott said. "That is our primary focus at this company. The V-Go device was developed to help people do that, and to help patients get control over their diabetes. We even have technologies in development to help further advance this technology, so we're making strides to further improve upon and expand the use of our technologies to make diabetes management easier for patients." 

Kristopher Sturgis is a contributor to Qmed.

[Image credit: Valeritas]

New Startup Aims to Change Diabetes Management

New Startup Aims to Change Diabetes Management

Kristopher Sturgis

Amalgam Rx, a new digital health company launched this month, might be one of the startups in 2017 worth keeping an eye on--especially if you're one of the 30 million people managing type 2 diabetes in this country. The digital health pioneers just announced the launch of their first next-gen technology known as iSage Rx, the world's first FDA-cleared insulin titration app for all brands of basal insulin.

One of the painstaking requirements for patients who manage type 2 diabetes is the need to inject insulin on a daily basis to help control blood sugar levels in the body. Typically, doctors will prescribe sub-optimal doses of insulin as they observe how each individual patient's body reacts. With the new iSage app, doctors will now be able to choose from multiple clinically-validated basal insulin algorithms so that they can individually tailor insulin level treatments to the specific needs of each patient.

Suzanne Clough, MD, the chief medical officer and cofounder of Amalgam Rx, said the company is currently recruiting patients for an in-depth clinical study that can examine all of the insulin algorithms that will help the company polish a technology that can titrate all brands of insulin. This will provide patients with a tool that can help them consistently reach their glucose targets.

Learn about "Busting Conventional Medical Device Development Myths" at the 2017 MD&M East Conference and Expo in New York City, June 13-15.

The clinical trial will demonstrate proof of concept, Clough said, and is expected to enroll 30 patients in the treatment arm. This will be compared against a matched retrospective control group. The study is slated to be completed this year, with findings anticipated to be shared in 2018.

The iSage Rx platform from Amalgam Rx

Clough said that the iSage technology was designed to be easy and intuitive so that virtually any physician can share the technology with their patients with ease. The system comes with telephone support and training programs to help familiarize the physicians with the platform, and can even be customized to fit patient-specific treatment protocols.

"A physician can simply input some basic information about the patient, such as their name and prescribed insulin to register them in the system," Clough said. "They can then choose the algorithm that best fits the patient's needs, or we can help them customize and save algorithms if they want to use their own treatment protocols. In a way, the system can allow them to have standing orders that can be implemented by a nurse or medical assistant. It should take less than a minute for the office staff to complete the prescription, and once patients use the product, providers can access their data online and make updates when necessary."

The iSage Rx technology will be the first in what the company hopes will be a diverse line of clinically validated digital health therapies that can empower and engage patients with chronic diseases. Ryan Sysko, CEO and cofounder of Amalgam Rx said that innovative new digital health platforms can transform chronic disease management, and that Amalgam Rx can leverage these new technologies to enable patients to self-manage their condition without so many of the costs that come with many of the advanced platforms currently available.

"We're incredibly passionate about the potential for digital health to transform the way that care for chronic disease management is delivered," he said. "If we can develop and scale digital health solutions that are engaging and effective, we have a tremendous opportunity to significantly improve patient outcomes and reduce healthcare costs."

That's something Amalgam Rx has set out to do with their very first product. The company brought together experienced members from research and development, testing, regulatory, and commercialization backgrounds to collaborate and work together to create new digital therapies that are accessible and easy to use.

"We're developing a platform that combines the necessary clinical, behavioral, and psychological interventions and technologies to support patients across many chronic disease domains," Sysko said. "Our technology architecture will allow potential partners to pick and choose from the interventions to create custom solutions."

The company has already partnered with a life sciences company to help bring the iSage Rx to market, and Sysko said that Amalgam Rx has plans to announce a new partnership in the coming months that will forge a new application focused on psoriasis and psoriatic arthritis. He said that growing the company's non-diabetes partnerships will be a key to growing their success beyond 2018, and that new digital health technologies will be crucial when it comes to enabling patients to self-manage chronic diseases.

"Our hope is to leverage all of our experience in developing and commercializing digital health products in combination with the latest cutting edge technologies to engage and support patients with chronic diseases," he said. "We believe this is a key missing component in healthcare. If we can more effectively support and teach a patient self-management, we're bound to improve healthcare outcomes and reduce costs." 

Kristopher Sturgis is a freelance contributor to MD+DI.

[Images courtesy of AMALGAM RX]

Meeting a Shifting Demand for Sterilization

A supplier of both turnkey sterilization systems and contract sterilization services shares its perspective.

Cosmed recently built a 13-pallet, truck height (110") sterilizer.

After acquiring a contract ethylene oxide (EO) sterilization facility in Erie, PA, Cosmed Group Inc. is returning to the medical device industry.

Cosmed purchased the facility from iuvo BioScience in December 2016. Clark W. Houghtling, VP, business development and technical affairs for Cosmed, told Qmed that changing demand prompted Cosmed to reinvest in serving the needs of medical device manufacturers.

"The medical device manufacturing industry is expressing demand for increased competition and custom processing in response to changes in their businesses and in the sterilization industry," he said. "With the many corporate consolidations in the medical device and related industries, there are fewer choices available today. Further, decades-old business models are being challenged by global competition while the increasing complexity of medical devices is forcing changes in sterilization processing."

It is this "changing landscape" that encouraged Cosmed to respond, Houghtling explained. "At one time our company was among the largest contract ethylene oxide (EO) sterilization suppliers in the United States, until we divested our healthcare facilities approximately a dozen years ago. Based on the needs and requests from numerous medical device manufacturers, the time to return to this industry was right. Our approach is to identify customers and markets requiring custom sterilization processes developed around the product, as opposed to the more common one-process-fits-all sterilization business model."

Houghtling also points to a recent trend toward in-house sterilization. "This is quite a shift in momentum," he said. "Two or more decades ago there was a movement away from in-house to contract sterilization. At the same time, some companies attempted to convert some of their products to irradiation sterilization. Today, those trends are reversed."

He also sees growth in EO sterilization. "EO has grown as a percentage of the whole, and it remains the number one industrial sterilization method," he said. "In addition, companies are optimizing their sterilization processes by integrating logistics, distribution, materials, and other factors into decision making. As a result, the move towards EO from other modalities, and the ongoing investment in in-house sterilization, are evident. Of the top-three industrial sterilization methods (EO, gamma, and electron beam), the easiest to move in-house, and the most widely acceptable, is EO."

Cosmed supplies both turnkey sterilization systems and contract sterilization services. "Cosmed's 35-plus years' experience in designing, building, and operating contract sterilization facilities allows us an unrivaled perspective in operating sterilization equipment," he said. "This core competence is integrated into every piece of equipment that we build. In addition, the sterilization systems we have installed for our customers reflects not only our intimate knowledge of the equipment, but also the effective and efficient design and layout of their facilities. Along with our experience with equipment and operations comes our integrated knowledge of regulatory affairs, product flow, quality assurance, and logistics." 

Offerings such as parametric release, all-in-one processing, cycle optimization, and other related services have enabled Cosmed to offer some of the potentially fastest turnaround times in the EO sterilization industry, he added.

Iuvo BioScience will continue to operate its laboratory in Rush, NY, as a separate business entity. "Our daily courier service transports samples to its site allowing samples to be on test within hours of the completion of the sterilization process," Houghtling said. "This reduces turnaround time and provides a secure chain of custody. We recommend iuvo Bioscience as an option for our Erie customers."

Cosmed can also assist customers through ongoing support. "We regularly field technical questions that would be impossible to resolve without our working knowledge of the sterilization business and the ethylene oxide sterilization equipment. We don't simply install our equipment and then disengage from the project. Our company becomes deeply involved long term partners in the projects in which we participate."

Houghtling believes such support and efficiency will help medical device manufacturers meet future challenges. "With the rising cost of healthcare, and the new political arena, overall cost becomes an increasingly important component of the medical device supply chain," he explained. "Medical devices continue to evolve in their complexity and the sterilization industry must provide solutions for processing. The use of age-old sterilization processes designed to meet the business model of a contract sterilization service provider is inefficient and creates cost for the industry. Custom processing, top quality, fast turnaround, and superior customer service have become increasingly important in the healthcare sterilization industry." 

He also believes that Cosmed can provide manufacturers with competitive advantages such as reducing inventory, improving cash flow, and latest technological advances.

He further suggests that manufacturers have more than one sterilization supplier. "Historically, the large multi-national manufacturers opted for a single source for their sterilization needs," he said. "The expectation was that this would provide leverage on pricing, service, and quality. The exact opposite has proven true, and companies are realizing that maintaining flexibility in sterilization options is the best way to manage their businesses. We hope to be the one of the options."

At MD&M East in New York City in June, Cosmed will demonstrate its EO sterilizer control system. "As opposed to the more common, one-size-fits-all approach, our process control system is designed to replicate existing sterilization processes, addressing concerns about the impact on established processes, and reducing the cost associated with requalification," Houghtling said.

Cosmed is also inviting the industry to an ethylene oxide sterilization seminar at the Erie, PA facility in September. "The forum will focus on applied sterilization concepts, allowing our customers to connect the technical issues (e.g. process validation, cycle development, optimized lethality, etc.) with the sterilization hardware. The seminar will be held in the training room and on the floor of the sterilization facility. It will be a truly hands-on experience."

Visit Cosmed at MD&M East Booth #1562 June 13-15.

Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to MD&DI and Qmed. Reach her at daphne.allen@ubm.com and on Twitter at @daphneallen

The Zen of Anytime Audit Readiness

The Zen of Anytime Audit Readiness

You know an FDA audit can happen at any time, but would you really be prepared if it happened today?

Isabelle Noblanc

FDA in December posted the most recent list of inspection observations issued during the agency's 2016 fiscal year, which ran from October 1, 2015, to September 30, 2016. FDA issues Form 483 inspectional observations or warning letters following an inspection to let the company know that its quality practices are not in compliance with regulatory standards.

The agency is increasing both the number and intensity of its inspections using a risk-based approach and many organizations are feeling the heat. Companies in the medical device space are second only to those in the "foods" category. With 934 citations given, "devices" organizations received more 483 warning letters than organizations producing drugs, bioresearch monitoring, biologics, veterinary medicine, and others.

Don't miss the MD&M East Conference and Expo, June 13-15, 2017, in New York City.

The top five 483 warnings for devices are as follows:

  • Procedures for corrective and preventive action have not been [adequately] established.
     
  • Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.
     
  • Written medical device reporting procedures have not been [developed] [maintained] [implemented]. 
     
  • Procedures have not been [adequately] established to control product that does not conform to specified requirements.  
     
  • Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. 

The pattern is clear. The vast majority of issues are centered on procedures. Warning letters follow when companies are working under no established procedures that comply with the FDA regulations in one or more areas; the procedures they have conform to FDA standards, but are not followed; or the company's procedures conform to FDA regulations and they are followed, but they are not documented in a way to effectively prove that they are within compliance.

One of the key lessons to be learned from 483s and warning letters is to be prepared for the ever-present reality that an audit by FDA can happen any time. Companies are often faced with two options. First, when notified of an audit, they can scramble to get ready or, second, build an organization that functions in a state of anytime audit readiness.

This zen-like state is not only possible; it is also practical, but it does require some forethought, planning, and continuous monitoring and upkeep. Audits shouldn't be a one-and-done event. The purpose is not to work hard to pass, then go back to the way it was before. Being always ready for an audit is a proactive stance; it should not simply focus on addressing regulatory scrutiny for the sake of complying with regulation, but rather should enable the organization to always function so that it is following proper procedures as a force of habit. When this happens, audits and inspections become a non-issue.

The following are some of the actions that can be taken to achieve anytime readiness:

Readiness Assessment Exercises

Readiness assessment exercises can be similar to the more familiar "mock audit" but are more comprehensive, taking each employee's actions and responsibilities during the exercise into account. This way, the person or team conducting the readiness assessment can capture opportunities to correct processes and fix the "root causes" that cause observations. During a readiness assessment, reviews of critical and high-risk areas should be conducted. These include the following:

  • Management control
     
  • Corrective and preventive action (CAPA)
     
  • Design controls
     
  • Production and process controls
     
  • Material control
     
  • Document/record/change control
     
  • Facility and equipment control

Supplier Audits

A successful supplier management program requires companies to establish detailed procedures related to the qualification of suppliers and, in some cases, supplier quality agreements. Using a risk-based approach, companies set up an auditing cycle for their qualified suppliers. The frequency or depth of audit can be commensurate with the risk posed by that supplier or the materials it provides.

Training, Training, and More Training

Helping staff learn not only how to function appropriately in their own jobs and responsibilities, but also on how to prepare for an FDA audit cannot be understated. They should be trained to understand the FDA inspection process, with emphasis on how to interface with FDA investigators. This will help minimize risk by examining the key areas of FDA focus and most common audit findings.

When there is a breakdown in process, people, and technologies, it can often result in an observation. Looking at these elements in a holistic way will help to eliminate process redundancies, ensure control at each work stream, reduce operating costs, and ensure anytime readiness.

Isabelle Noblanc is the vice president and general manager of UL Compliance to Performance. For more information, visit www.ulcompliancetoperformance.com.

[Image courtesy of TANTE TATI/PIXABAY.COM]

Senseonics’ $41M Raise Fuels Confidence in Eversense CGM

Roche's participation in the stock sale is seen as a good sign, with proceeds expected to carry the company through the FDA process by the end of the year.

Amanda Pedersen

Roche and other key investors are showing continued confidence in a Germantown, MD-based company that is trying to bring its implantable continuous glucose monitoring (CGM) system to the U.S. diabetes market. Senseonics said it raised about $41 million in a stock sale, thanks in large part to its international distribution partner Roche.

The company said the offering included about 29 million shares priced at $1.41 each, and that Roche has agreed to buy roughly 21.3 million of those shares. New Enterprise Associates also helped out by picking up about 7.1 million shares.

Senseonics said it will use the proceeds to launch its Eversense CGM in the United States, pending FDA approval, and to continue developing future configurations of the device. The company went public last year, and submitted a PMA application to FDA in October.

Senseonics landed a distribution agreement with Roche this time last year, giving the better-known diabetes player the right to sell the Eversense technology in Germany, Italy, and the Netherlands. The system consists of a long-term wear sensor, which is implanted subcutaneously and can be worn for up to 90 days, a transmitter, and a mobile app.

Senseonics' Eversense CGM consists of an implantable, long-term wear sensor (up to 90 days), a transmitter, and a mobile app.

The offering comes at a good time for Senseonics, which ended the first quarter with about $13 million in cash and marketable securities, and has been burning through about $11 million a quarter, according to BTIG analyst Sean Lavin. The new funds should help the company at least get through the FDA process, hopefully by the end of the year, Lavin noted in his report.

Roche's participation in the offering can be seen as a big positive, he added, as the investment shows increased confidence in the product's merits.

During Senseonics' first quarter earnings call, CEO Tim Goodnow characterized the company's discussions with FDA as "collaborative and productive," and that a panel meeting can be expected as part of the review process.

Goodnow also talked during the call about the company's efforts to gain a CE mark amendment to extend its sensor life labeling for up to 180 days. That version of the device will be marketed as Eversense XL, he said, and could be rolled out in Europe as early as the third quarter.

"As you can imagine, the combination of an even longer term sensor that can provide continuous readings for up to 180 days will show rapid evolution of the product, and having this coupled with the slim gen 2 transmitter will create yet another level of convenience for our users," Goodnow said.

He also noted that the company is expanding commercialization in Germany from a controlled launch to a full launch, based on positive clinician and patient reception of the technology. That means Roche will be increasing its footprints from four reps to its entire team of intensive diabetes sales reps to cover all of Germany, Goodnow said.

The company's stock (NYSE: SENS) was up 20.57% to $1.70 at 12:40 p.m. EDT on Friday, with trading volume well above average.

Amanda Pedersen is Qmed's news editor. Contact her at amanda.pedersen@ubm.com.

[Image credit: Pixabay and Senseonics]

In the Rush to Develop Telemedicine Services, Be Aware of Legal Issues

In the Rush to Develop Telemedicine Services, Be Aware of Legal Issues

On April 18, lawyer Dillon Brozyna of Edelson PC, on behalf of lead plaintiff Joan Richards of Utah, filed a class action against MDLive, a telehealth provider based in Sunrise, Florida.

MDLive offers an app that connects patients to doctors, pediatricians, and therapists 24/7. The complaint alleged MDLive's app transmits screenshots of users' health information to a third-party vendor, Israel-based Test Fairy. Test Fairy uses that information to "possibly identify bugs."

In its motion to dismiss the suit, MDLive referred to its Terms of Use Contract, which users must agree to. The contract's privacy policy states that it may disclose information to contracted third parties to support its business, according to an MDLive statement. The company also said Test Fairy is bound by a confidentiality agreement.

When dealing with sensitive health information, is that enough?

The dispute raises serious privacy and security concerns about telemedicine platforms and related mobile apps, both of which are becoming more widely accepted. Over the past few months, senators have introduced two bills to expand Medicare's telehealth services and one to eliminate the Department of Veterans Affairs' restrictions on telehealth across state lines. This comes not long after Congress approved a bill to make telehealth services available under the U.S. Department of Defense's TRICARE health plan for active duty military members and their families.

Prioritize Privacy and Security

As with other providers, certain telemedicine services must abide by HIPAA privacy and security rules. The privacy rule provides guidance that only the minimum health information necessary to care for the patient shall be used or shared. The security rule sets standards for securing patient data.

The Federal Trade Commission's privacy rules also apply. Any app or software developer whose product accesses personal information should pay attention to FTC rules. If a company's user agreement is unreasonably vague relative to the data collected, stored, and shared, the FTC could allege an unfair and deceptive trade practice violation.

"The FTC focuses on making sure policies are transparent, clearly outlined, and cover all the ways in which a company might use or disclose the consumer's health information and other personal data," said Jade Kelly, a partner in Arent Fox's San Francisco office and a member of its Health Care and Privacy, Cybersecurity & Data Protection Groups. "A privacy policy should be as specific as possible and put consumers on notice as to what the company does with their data."

Learn about "Turning Clinical Ideas into Market Opportunities" at the 2017 MD&M East Conference and Expo in New York City, June 13-15.

Because privacy and security are closely intertwined, a telehealth provider should be as detailed as possible in designing its security protocols. If a telemedicine company doesn't have proper security measures in place, it should get them fast, lest they risk violation of FTC and HIPAA regulations, federal wiretap laws, invasion of privacy, and even simple breach of contract.

"When you buy something, you are relying on what a company says they will do to protect your information," said Christopher Dore, a partner at Edelson PC who focuses his practice on emerging consumer technology and privacy issues. "If they don't do that, then you're not getting the benefit of the bargain."

Telemedicine technology should employ HIPAA-compliant security measures, including fully encrypted data transmission, peer-to-peer secure network connections, and unique user identification, among other protocols. The trouble is, some tech companies, in a rush to take advantage of telemedicine's growth, don't take the time to implement these policies, putting them at risk of a security breach as well as a lawsuit.

"Companies are competing to get to market, and that comes with speed," said Dore. "As a consequence, they often aren't putting the time, effort, and resources into security protocol. Take the time to design your product and your service correctly and use the most up-to-date security standards."

Transparency Is Key

The legal issues surrounding telemedicine technology don't stop with privacy and security. Providers must also be mindful of federal and state fraud statutes.

With some exceptions, under the antikickback statute, it is a criminal offense to knowingly offer, pay, solicit, or receive money to induce referrals of items or services reimbursable by a federal health care program. The Stark Law prohibits physicians from referring Medicare patients for designated health services to an entity with which the physician has a financial relationship.

Generally, to comply with the antikickback statute, Stark Law, and any related state laws, the physician, service vendor, health system, or any combination thereof must have a carefully structured written and signed agreement in place that sets forth the service provided and compensation in advance. Compensation must not vary with the volume or value of any referrals or business generated between parties. These laws are very nuanced, Kelly said, which is why specificity and transparency are important.

As technology develops, rules and regulations directed toward telemedicine and health-related mobile apps will likely increase, especially in the realm of privacy and security.

"With almost 100 percent certainty, people are very resistant to sharing medical information," said Dore. "There is a heightened standard, and the law has recognized that in some respects. As we expand into new technologies, steps have to be taken to make sure protection extends to all the different mediums."

Heather R. Johnson is a freelance writer based in Oakland, California.

[Image courtesy of DIGITALART/FREEDIGITALPHOTOS.NET]