The Impact of New Laws When Selling Medical Device to Europe: Part I

Here’s the dilemma that has faced US medical device manufacturers looking east to Europe for an easier path to increase sales: for years it has been easier to get medical devices to market in Europe.

The reason, of course, was that European regulations allowed devices to be sold as long as they performed “as intended” and were “likely to be safe.” That meant they could get to market faster. Submitting a technical file was easier and the overall review process was simpler and much faster. There was a cost; studies showed that medical devices first approved in the European Union had a higher rate of safety issues than devices first approved by the FDA.

In an effort to reduce safety issues and risk, European medical device regulations were fundamentally changed in 2010, affecting every medical device sold in Europe. An amendment to the Medical Devices Directive (MDD) 93/42/EEC essentially mandated that every medical device sold in Europe, regardless of its classification, must have a clinical evaluation (CE) report in its technical file. The issue was that the CE report was simply a literature review. The thought was if the body of literature showed that the device was safe and effective then the risk would be lowered. The report was to augment or substitute for any clinical data that is submitted to the notified body.

Unfortunately this did not reduce the number of large recalls and safety events including the high-profile events: metal on metal hip replacements recall and the ruptured breast implant crisis. A report by the European Commission’s Medical Device Experts Group (MDEG) concluded that most manufacturers didn’t have adequate clinical evidence for their medical devices and that most notified bodies didn’t thoroughly verify the clinical evidence that was provided to them by manufacturers. The findings applied to Class I and Class IIa devices, as well as Class IIb and Class III devices. This report prompted urgent regulatory reforms to the medical industry and the European Commission started looking at significantly changing the law in September 2012.

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3 Reasons for Medical Device Consulting

Few industries evolve as rapidly as healthcare and medical device manufacturing. Digital transformation, healthcare reform, technological advances, and regulatory compliance issues can all significantly affect medical device design, manufacturing, and sales. It’s no wonder medical device manufacturers are increasingly turning to consultants for help.

If you’re a medical device equipment manufacturer considering hiring outside assistance for your next product or to address a looming compliance issue, here are three major reasons why turning to MEDIcept:

  1. Streamline FDA regulatory approval

The medical device development process is a complex one with twists and turns that can cause unexpected and costly delays. Every reviewer is looking for something different. Submission deliverable requirements keep changing. Our experienced medical device consultants fully understands the FDA submission process for 510(k)s and premarket approvals (PMAs)and can help craft a regulatory strategy based on your needs. With the right help, you can optimize your submissions to save time, money, and effort.

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Mock FDA inspections can help ensure regulatory compliance

Few industries are as heavily regulated as medical device manufacturing. Developing and producing a medical product is an expensive and time-consuming process even when everything goes smoothly.

Things can quickly become even more expensive and challenging if your company and staff are not prepared to deal with complex FDA regulations and any inspections or audits associated with them. Regulatory compliance is the cornerstone of success for any medical device and its manufacturer. Any medical device manufacturer out of compliance is essentially out of business.

Like any complex undertaking – especially one that potentially threatens life and limb if not executed properly – medical device manufacturing is all about preparation and practice to avoid unexpected and expensive stumbling blocks put in your path by FDA regulations.  That’s why it’s so important to prepare for a possible regulatory inspection to ensure that your staff is familiar with the FDA’s Quality System Inspection Technique (QSIT) and can handle an inspection with relative ease and efficiency.

FDA regulatory compliance best practices include working with a regulatory compliance expert to conduct a mock inspection and audit designed to uncover any potential weak areas in your staff preparation, processes, and documentation before you begin marketing your product. It’s important to understand and evaluate your quality system’s overall status and how to anticipate the types of questions and requests you may receive from FDA inspectors.

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Think about package validation early in product development

Medical devices are often complicated and expensive machinery that must be treated with care. People’s lives may depend on these devices functioning properly, so why risk damaging the devices with shoddy packaging? Medical device testing is a rigorous and complex process that demands careful planning and attention to detail. Working with experienced professionals for your package validation is one way to ensure a streamlined process without all the stress.

Unfortunately, some medical device manufacturers don’t think about packaging early enough in the product development process. Perhaps that’s because they relegate packaging to second-class citizen status – almost an afterthought after all the sweat and effort expended designing and prototyping the product itself.

It’s important to keep in mind that the purpose of a package is to protect the contents from external interactions that could damage the item. During transit, packages may be bumped, dropped, shaken, stored upside down or sideways.  Even when taking every precaution, there’s simply no predicting what weather your packages will encounter along the way — from sunny and warm to freezing and rainy. Without package validation and thorough testing, you just might be sending your devices to their doom.

Another factor to take into account is how well the packaging is going to age — materials don’t last forever.

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Health Canada Single Use Medical Device Commercial Reprocessing Requirements

Single use medical devices (SUD) are devices that are intended to be used only once and then disposed of. However, due to costs savings associated with the reuse of these devices hospitals and other organizations are reprocessing them through cleaning, disinfecting and sterilization.

In 2000 FDA published the guidance document “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” which describes FDA’s enforcement priorities to third parties and hospitals that reprocess SUDs. Other countries have similar regulatory reprocessing requirements including Canada which recently under the existing Food and Drugs Act and Medical Devices Regulations established requirements for organizations, other than hospitals, that engage in reprocessing of SUDs. Health Canada will continue to allow oversite provided at the provincial and territorial levels to hospitals.

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IVD Genetic Testing Direct to Consumer (DTC) FDA Approval: Case Study

The area of genetic testing has expanded significantly in recent years with more types of testing becoming available for both clinical and non-clinical applications. The AMA states there are more than two thousand genetic tests available to aid in the diagnosis and treatment of more than one thousand different diseases

Clinical genetic testing can consist of diagnostic and predictive medicine which identifies whether an individual has a certain genetic disease or an increased risk for a particular disease. Pharmacogenomics evaluates an individual’s genetic makeup to determine whether a drug is suitable for a particular patient and whole-genome and whole-exome sequencing examines the entire genome or exome to discover genetic alterations that may be the cause of disease. Genetic testing can include breast, ovarian, and prostate cancer; Crohn’s disease, deafness, Huntington’s disease, sickle cell anemia, and cystic fibrosis to name a few.  Non-clinical genetic testing is also performed to determine characteristics such as ancestry and paternity.

Most genetic testing is available only through a healthcare provider; however the emerging field of direct-to-consumer (DTC) testing provides the possibility of obtaining test results directly from a company without the involvement of a healthcare provider or genetic counselors.

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Postmarket Management of Cybersecurity in Medical Devices

Many medical devices currently in commercial distribution today incorporate some type of software. Some devices use software to control certain aspects of the device or perform data analysis while others use it to connect to the Internet and health care provider networks for monitoring and sharing data.

The U.S. Food and Drug Administration (FDA) is becoming increasingly concerned about the vulnerability of these devices to hacking, jeopardizing their safety and efficacy while putting patients at risk. In response to this increased threat, the FDA recently published a guidance document called the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and, as a part two to their cybersecurity efforts, has issued a draft guidance document entitled Postmarket Management of Cybersecurity in Medical Devices.

Suzanne Schwartz, M.D., M.B.A., the associate director for science and strategic partnerships and acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health said, “All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities — some we can proactively protect against, while others require vigilant monitoring and timely remediation. (The) draft guidance will build on the FDA’s existing efforts to safeguard patients from cyber threats by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.”

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How can I benefit from Quality Assurance Services?

Quality assurance (QA) is a crucial part of any medical device manufacturing and assembly process. When you’re providing a product or service, health care professionals expect you to deliver exactly what they need without any flaws or mistakes. Providing poor quality products can be extremely harmful to patients and medical personnel in addition to damaging your company’s reputation. Even if you’re the expert at making the product you offer, it can still be easy to overlook potential problems from the user end.

How can MEDIcept quality assurance services benefit you? Here are just a few ways:

Identify possible flaws.  It can be dangerous to release a product without testing it thoroughly. Failures can lead to personal injury or death. Regulatory agencies including the FDA may even shut you down if your product is considered harmful. Don’t let your company join those ranks.

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What is Due Diligence?

Due diligence is a concept that has been around for a long time. In basic terms, it means doing your homework before making any major decisions about finances, investments, equipment, or more. For medical device manufacturers, it often involves a little more work in order to pass FDA scrutiny. That means conducting a thorough risk/benefit evaluation and financial review as well as determining if there are any concerns about the company’s regulatory standing with the FDA that could lower the manufacturer’s valuation, damage the company, or severely affect product development.

If you’re an investor looking for a smart investment or a company looking to acquire new products or capabilities, it can be difficult to research an organization or technology if you’re unfamiliar with the rules and regulations governing it. At MEDIcept, we understand the regulatory landscape and clinical strategies. We know what it takes to get a medical product to market — we work with medical device manufacturers on a daily basis. We have assessed investments for companies with a combined value of over $800 million.

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Premarket Submissions for Management of Cybersecurity in Medical Devices

The same data management technology used in consumer devices such as personal computers, smartphones, and tablets is increasingly being found in medical devices and is used to manage and transfer critical health information over wireless networks.

To address the issues related to cybersecurity, the FDA has published the guidance document “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices“. This guidance document identifies cybersecurity elements that manufacturers should consider in designing and developing medical devices, as well as in preparing premarket submissions for those devices.

The FDA identifies effective cybersecurity management as a means “to reduce the risk to patients by decreasing the likelihood that device functionality is intentionally or unintentionally compromised by inadequate cybersecurity.” While medical device manufacturers should develop a set of cybersecurity controls to assure device functionality and safety, the FDA recognizes that there is a shared responsibility between healthcare facilities which incorporate those devices into their systems, and the patients and providers who operate them.

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