Case Studies
Successes Navigating the Regulatory Approval Process
Bringing a European Implantable Stimulator to the U.S. for a Neurological Client
Goal
When this European neurological client wanted to enter the US market with their neuro-implantable stimulator, they needed to start with getting approval to conduct a clinical study through the US FDA. That meant needing a parter to first help get a pre-IDE meeting with the FDA to gain alignment on the design of the clinical study.
Problem
The US FDA pre-market approval process can seem daunting to firms outside of hte US, as it differs from conformity assessment pathways around the world, including Europe. This client had obstained CE Mark on the productl however, they were going to need new clinical data to support the safety and effectiveness of the system before submitting a pre-market application in the US.
Solution
Clinical studies in the U.S. require both technical and medical professionals, from primary investigators with an M.D, to R&D experts and bio-engineers. Therein lies one of the advantages of working with JW Regulatory Consulting, where we’re able to connect and translate medical device regulation among manufacturers, SME’s, clinicians and other stakeholders, to better ensure the success of clinical trials. In addition, we’re constantly improving communications between manufacturers, technical experts and the regulators in the approval process by understanding the device’s intended use, performance testing and risk information and marrying that with what regulators need to see.
Working with JW Regulatory Consulting
Clients come to us in scenarios like this because we have a tremendous background in what we call “Navigating the Grey”. By speaking the languages of everyone from the manufacturer to the technical experts and the regulators and legislators, we translate the highly technical lingo from the medical device industry side to the regulatory side and back again. We’re business partners helping both parties understand what the other needs to gain approvals. In doing so, we’ve already outlined potential risks and approved solutions, paving a more efficient pathway to approval.
Cardiovascular Client Looking for Expansion-of-Use in the United States and Introduction In Europe
Goal
This cardiovascular startup was looking to obtain FDA clearance of a labeling change in the US and to gain entry into the EU. The labeling change was for adding an alternative method to obtain the same outcome using RF energy. This required submission of a new 510(k) to demonstrate substantial equivalence to other devices already on the US market. At the same time, a CE Marketing strategy was developed to prepare for compliance to the new EU Medical Device Regulation
Problem
Demonstrating that a product is safe and effective can be a difficult task. The regulations tell us what needs to be demonstrated but they do not tell us how. That puts the burden on medical device manufacturers with regards to figuring out how to demonstrate that safety and effectiveness. For Europe, the authorities are still developing the strategies for implementing the new Medical Device Regulation, so it provides even more uncertainty on manufacturers who are trying to pull together deliverables necessary for their EU Design Dossiers.
Solution
“Navigating the Grey” once again, the team at JW Regulatory understands what regulators are looking for, so we can help solve for ‘how’ while demonstrating that products are safe and effective. By keeping abreast of the latest EU MDR developments, we can outline a strategy to get the CE Mark while confirming items with the Notified Body along the way, as well as drafting a design dossier and drawing comparisons with products already on the market. We help the client solve for ‘how’ and remove the unnecessary confusion from the process.
Working with JW Regulatory Consulting
Paving the pathways to approvals both here in the United States as well as in Europe is a specialty, and decades of experience allows us to help clients like this navigate the unknown with regards to figuring out how to demonstrate safety and effectiveness. It saves time and money all while removing the guesswork of the approvals process.
Urological Client Navigating Regulatory Risk of M&A
Goal
Acquisitions are common in the medical device industry, and just as common is acquiring legacy products that may have fallen out of compliance. This client needed help with regulatory and quality due diligence to ensure the urological system being acquired presented no significant compliance risks to the business.
Problem
As with many acquisitions, there were compliance issues with the devices’s design history file (DHF) and associated product registrations. The gap analysis and due diligence report positively influenced the deal to ensure the acquiring firm was not taking on additional regulatory risk. The legacy firm agreed to remediate the DHF and submit a catch-up 510k to bring all changes to the device back into compliance.
Solution
JW Regulatory Consulting has participated in a multitude of acquisitions, and because of that can lend expertise and a playbook for how to “Navigate the Grey” of onboarding products from another company. By conducting a gap analysis, we were able to provide essential information and a strategic path for our client to influence their counterpart to remediate prior to the completion of acquisition.
Working with JW Regulatory Consulting
By providing strategic insight, facilitating the remediation process and acting as a trusted advisor along the way, we helped this client save significant amounts of time, money and effortwhile also enabling them to buy a product that was up to code and industry standard.
Navigating the Approval Process in Multiple Countries
It’s not uncommon for companies to already have approvals in one country, but need help navigating that very same process in another. Patients from all over the world benefit from medical devices made in other countries, and regardless of the country of manufacture, we make it our mission to enable those businesses to reach patients in need. As regulatory processes change from country to country, and you’re in need of additional data, testing, research or design – we’re your partner in the process. Translating the technical into the understandable, whatever the country, is an undertaking we’ve been through hundreds of times, and we’re here to make transitions between processes more seamless and your journey to approval more efficient.
Contact us to learn more about how we can help you bring new medical devices to the US, EU and Canadian market, maintain necessary product registrations, get additional approvals outside the current market of implementation, or remediate your current product registration and technical files.