Launch to Market
Launch
Count on our experience to help you take your product to the market.
Launching your new product requires a comprehensive strategic plan that involves understanding not only the regulatory pathways available to you, but how FDA may perceive your product in light of features, benefits and risks. We integrate quickly with your team to help with the project planning and execution.
Paladin Medical’s® expertise and commitment to high standards have resulted in countless successful product submissions and robust compliance training for our clients. We welcome the opportunity to help make your medical product a success.
Andiamo!
1. Send us your confidential disclosure agreement (CDA) or we can provide you with a template.
2. We begin with a regulatory assessment for your project.
Give us a basic device description and a comparison of your product with alternative devices or technologies. Tell us the differences your product will offer. (Your existing presentation materials are often sufficient.)
3. We can write a brief regulatory assessment at no charge to ensure we understand the nature of your device, how FDA would regulate it, and what we anticipate for the regulatory submission. (We also offer regulatory assessment for submissions to countries other than the USA for a small fee.)
Once we have completed the preliminary assessment, we can begin to develop a work estimate for your project. We will send you our template consulting agreement and initial retainer invoice so we can get started right away. Our goal is to develop a submission plan for you as quickly as possible to integrate with your development and marketing plans. Refer to Submissions
Pre-Clinical / Clinical
Assure your protocols will yield the evidence you need to support your submission.
Pre-Clinical Study Design
Pre-clinical in-vitro and in-vivo (animal) studies must produce results that support product approval submissions and design validation. Animal ethics boards must approve and monitor animal trials. Our expertise in matching regulatory requirements and preclinical study plans makes Paladin Medical® an invaluable resource to your firm.
Routine biocompatibility testing according to ISO 10993 has become one of the most commonly conducted preclinical studies and many of those studies require animal subjects. FDA and international regulatory agencies are emphasizing the development of a Biological Risk Assessment prior to the conduct of standardized testing. FDA has issued numerous guidance documents concerning the level of biocompatibility testing for certain products, how to interpret the latest ISO 10993 and its various parts, and specialty guidance documents that indicate what type of testing is recommended for a particular type of product. Paladin Medical® will work with your team, your lab and the FDA to assure you conduct only the tests necessary, that your product samples are prepared properly and that you have a sound description of the biomaterials to be tested before launching very expensive studies. Refer to Biomaterials in Specialty Services
Animal functional studies are those intended to demonstrate the safety and performance of the device, including integration of biomaterials and restoration of function. These require careful planning, oversight, and reporting. The study protocol must produce the outputs that support the submission. The most critical studies are those which are required prior to “first in man” clinical studies. Standardized performance studies described by standards and FDA guidance documents are just as critical to get right the first time. We provide standardized templates to help you assure critical content, help finalize study protocols and assure study archives. We often recommend a pre-sub meeting with FDA prior to launching pivotal animal trials. Refer to Submissions and Good Laboratory Practices in SPECIALTY SERVICES
Clinical Trials
We ensure that clinical trials have clear objectives, with outcomes supporting regulatory submissions, marketing claims, and third-party payer requirements. We work with the IRB coordinators and investigator’s staff, to make sure that all study deliverables, such as investigator brochures and case forms, are properly prepared and available for timely review. Our specialty is “First in Man” trials that can make or break your future regulatory pathway.
Clinical Trial Monitoring and Management Clinical study planning, management, and field monitoring requires trained employees and coordination between the investigators, the sponsor, the IRB and FDA. Paladin Medical® provides ongoing support for study management. We can provide study monitoring and data audits. We can ensure sites are trained, test product is delivered, and required case forms and reports are completed.
Clinical Trial Study Design
A well-constructed clinical study must have a sound protocol to deliver the evidence the company needs for submission and yet assures patient safety. Clinical trials in support of new medical device applications have different objectives than do academic research trials. Planning your study to meet your objectives is critical. Firms often become ensnarled by research preferences of a primary investigator and may have difficulty establishing a clinical study plan that results in data suitable for FDA submission. Paladin Medical® has the experience to work with all the stake holders in the process required to develop a suitable clinical trial plan.
Human Factors and Usability Trials typically involve volunteer users and blinded studies to evaluate the user’s ability to follow instructions, apply the device properly and address warnings and error codes. Please consult Human Factors and Usability Studies in SPECIALTY SERVICES
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Investigational Device Exemption (IDE) Regulations and Applications
All studies of medical devices on human subjects are governed by Investigational Device Regulations. Clinical trials of an unapproved new medical device can be either Non-significant Risk (NSR) or Significant Risk and this determination is made not only on the type of device but also on the type of study you plan. Any significant risk study requires an IDE application and prior approval of the study and the basic safety of the device by FDA. A non-significant risk study does not require an IDE application but the device integrity at the time of the study must be under Design Control and Review quality regulations. Refer to Design Control and Review. We help you to determine and document if your study may be non-significant risk and integrate this rational into the Risk Analysis requirements of your Design Control and Review documentation. We can help you understand the issues associated with your protocol design, case form and data collection, electronic data collection systems and FDA reporting of results.
Beyond the IDE regulations, medical device manufacturers must also meet the requirements of the local human subject committees in each clinical or hospital (IRB). Paladin Medical® offers assistance with:
- Design of clinical trials with clear objectives and outcomes supporting regulatory submissions
- Pre-qualification of investigators and study sites
- Informed consent forms, case reports and Investigator’s manuals
- Support and training of study sites
- Packaging and labeling that meet IDE regulations
- Product tracking to study sites and product use auditing
- Device retrieval safeguards and analysis
- Electronic data capture with internet access
- Sample size determination and statistical data analysis
- Compliance with IDE regulations and reporting requirements
- Clinical trial management and monitoring
- Clinical trial report development
- Sourcing investigators, laboratories, and testing services
Submissions
Prepare applications meeting up-to-date requirements including global strategies
Pre-Submission Planning:
In order to plan a premarket submission, it is necessary to understand the various options for clearance or approval.
- As a part of our LAUNCH planning we confirm the type and scope of your first submission and confirm that you need one! Not all medical devices need premarket clearance of approval directly by FDA. Read more in Launch
- We help your team integrate the requirements of a submission into your Design Control and Review Quality Systems Regulations. Read more in Design Control
- We will also help you determine if you might benefit from a Pre-Submission to FDA. Read more in Pre-Submission Planning
- FDA publishes hundreds of guidance documents and recognizes a multitude of international and national standards. We can help you make sense of it all for your new product. We can lead you through the maze.
Determination of Classification and Risk:
The first fundamental task to planning a likely regulatory pathway to market is the determination of device classification and risk. We start with helping you identify the proper classification and assessing the relative risk of your product to prior art. FDA has exempted hundreds of medical devices which formerly required a 510(k), yet Class I devices may still require a submission if the new product falls outside the technological similarities of the predicate devices or FDA’s original regulation description.
Substantial Equivalence is a technical comparative argument at the core of the 510(k) application. Most Class II devices are cleared to market through the 510(k) pathway, and some new Class II devices may not be substantially equivalent to their predecessor (known as a predicate.). For a US 510(k) we must assess the similarities and differences between your product and a prior product legally on the US market. There are various conditions by which your product may not qualify as “equivalent”. A few Class III devices may even clear through 510(k). A new device with new technology and new risks could require pre-market approval if FDA determines that safety mitigations are not adequately addressed by testing. Some may be candidates for “deNovo”. We help you figure this out!
Device risk classifications can differ between the US and jurisdictions outside the US. In most cases we recommend a US application first for a US based company because the overall regulatory structure in the US is typically easier for a start-up US based company to manage.
International Submissions: Read more about Global Strategies in SPECIALTY SERVICES
Pre-Submission Meeting with FDA
Pre-submission meetings with the FDA require careful preparation for a successful outcome. Pre-submissions can be disastrous without a regulatory strategy and clear objective for the meeting.
The Pre-submission development effort can save time and money when done right. Paladin Medical® will:
- Help you decide if a meeting is warranted
- Prepare your pre-sub documentation with your team
- Submit the pre-sub in the proper format
- Make the arrangements with FDA
- Prepare you for the teleconference if you choose to conduct one
- Help you express your company’s professional position and sound technical judgment
- Prepare minutes and help you turn your findings into actions
FDA Regulatory Pathways and Submission Types
Some of the pathways to market you may not have heard much about.
- Special 510(K)
- Traditional 510(k)
- Abbreviated 510(k)
- PMA and PMA supplements
- HDE/HUD
- De Novo
- Combination Product Read more about Combination Products in SPECIALTY SERVICES
Investigational Device studies may be required to support any of these pathways. We provide services to assure they are conducted properly when needed. Read more in CLINICAL STUDIES
A submission may be needed when there is a change to a device that is already 510(k) cleared. We can help you assess the changes and prepare a submission if required. Read more about deciding when to submit in SPECIALTY SERVICES.
Submission Preparation, Filing and Support:
Now, more than ever before, you need a Champion for your Successful submission. Our strategic planning and careful preparation can minimize delays and optimize your timetable. These services include:
- Task planning for submission deliverable documents based upon Refuse to Accept guidance
- Review of protocols and all testing plans and review of test reports as produced
- Assist in proofreading and editing of critical documentation such as labeling and DFU
- Assuring proper construction of statements of indication for use and intended use
- Draft preparations of the full submissions as deliverables become available
- Compilation of documents and double-checking content for completeness.
- Document production according to FDA electronic submission requirements
Some FDA challenges are based on communication differences or the special requirements of your new product that the FDA reviewer may not have previously encountered. Timely and well-crafted responses to deficiencies make the difference.
