The Path to Market Guide contains information and recommendations on on the process for medical device and software as a medical device (SaMD) companies to get their product to market. This guide divides the process into 4 phases, and outlines activities and deliverables for each phase. Ultimately, the specifics of each company's path to market will vary based on their unique products and circumstances.
Before your 50th, 20th or even 5th prototype iteration, it is important to have a strategy for how your product will create value (be safe[er], [more] effective, or less expensive) and how you will get it to market. Your strategy may evolve over time but it's important to assess how the product, the design and development process, the production process, and the sustaining/maintenance post-market processes all meet the various applicable regulatory requirements. Phase 1 and Phase 2 often proceed in parallel, which is normal, but Enzyme recommends the Phase 1 strategies always outpace the prototyping.
During this phase, also asses the skills and expertise of your current team. Determine if these are sufficient to implement your product through all the phases. It is important to hire individuals, or consultants that can advise the company and help get the product to market.
Your overall Path to Market strategy is comprised of several functional strategies:
Intellectual Property (IP) Strategy
Perform research to determine how your product is different from those on the market. If you have an innovative product and it cannot be compared to any other products on the market, you can apply for a patent. It is vital to protect your company's intellectual property. Furthermore, this will benefit you during your pre-submission, if applicable, by demonstrating how your product is different from predicate devices.
Research&Development (R&D) Strategy
As part of your R&D strategy, it's important to document details of prototype iterations and changes as well as to study and document your product risks . This will help address them early while you are still designing your product and avoid issues later. The best risk mitigations are those implemented within the design of the product. Prior to finalizing the design, it's important to be mindful of how to test the various requirements being developed. This allows for more accurate predictions for development, testing and submission milestones. Furthermore, understanding your product risk classification and product code will inform the details that need to be assessed and included in your product development, testing and submission. Read our Risk Classification guide to learn more about how to categorize your product's risk class.
FDA's product classification database allows you to research other similar products on the market. This helps determine the appropriate product risk classification for your device, and drives your development strategy and submission type/requirements. It may be important to choose a Regulatory Affairs Consultant (or company) who can help with your FDA submission. If your in-house team does not include a Regulatory Affairs (RA) professional, retaining one (or a firm) on a consultant contract will help facilitate identifying product risks and best regulatory strategies to expedite the development and submission processes.The earlier this happens, the better the result. Waiting too late can lead to the need for remediation activities and cause significant delays in a planned submission. Companies have gone out of business by not adequately navigating this phase during their path to market.
Intimately tied to the regulatory strategy is the clinical strategy. Some products based on their risk require mandatory human clinical trials; whereas low-risk products with clear predicates (similar devices) may not require any clinical testing. Factoring in whether your product will require a clinical trial and the costs of that endeavor are important to understand early so sufficient funding can be raised. You also have think about how clinicians and patients will use your product and how they will report results. As part of the clinical strategy, it is essential to demonstrate how your product improves the cost and standards to existing diagnosis and treatment options.
Enzyme recommends you start with small studies so you can collect data from a small population to show the efficacy of your product. Then you can expand to include larger studies. As you are developing your protocol, you'll have to apply to one or more hospital Institutional Research Boards (IRBs) or even directly to FDA if the trial poses moderate to significant risk to patients. It is wise to consult with an IRB and/or FDA as applicable for feedback on the clinical strategy before submitting for approval.
Establishing a quality management system (QMS), and a "culture of quality", creates and aligns standard business practices and procedures. It ensure all employees understand how they directly or indirectly impact product quality and therefore patients' lives. It drive consistency in work steps and deliverables to facilitate predictable business results and consistently safe and effective product. It also helps your company comply with regulations and applicable regulatory standards. The QMS you implement is both a business best-practice as well as a regulatory necessity, and it is vital to ensure your company meets customer, regulatory, and investor expectations. Learn more about establishing a QMS in our Intro to QMS Guide.
Marketing and Stakeholder Strategy
Develop a plan for how to market and sell to the customer, and meet investor and shareholder expectations. Payer (insurance) coverage is not guaranteed after receiving FDA clearance or approval to market a product. Therefore, it is far easier to obtain payer coverage if the new product can be categorized within an existing reimbursement code. For novel devices/treatments, new codes may be necessary, and this requires significant reimbursement knowledge to navigate through the healthcare, including Medicare/Medicaid and private payer, system. Understanding the purchaser's (often an administrator for a hospital system or conglomerate) needs will help drive your sales and adoption. Having a strategy for this well in advance of any submission will help inform the likelihood of whether your product will be profitable.
Prototyping should occur after sufficient planing has been completed (i.e Phase 1). Initially, simple proof-of-concept prototypes are very common, and the goals usually involve addressing the key problem(s) you are solving. As the prototype iterations evolve, conditions for use and usability become more important without sacrificing core functionality. Evaluating procedural and use risks contribute to safety-based design modifications.
Eventually revisions will be made to the materials used (if its a physical product), sourcing requirements such as specifications for suppliers of parts or services will coalesce, and documenting user needs will all become a necessity to maintain scope of the product/project. Generally at this point, you have to begin documenting your design choices, and that is when the Quality Management System (QMS) is warranted. Documenting design history, including why decisions were made and which of those led to prototype failures, becomes extremely valuable as your product evolves. Evaluating procedural, use hazards and potential harms also contribute to safety-based design modifications. This is the beginning of your Design History File (DHF) and is a business- and regulatory-necessity.
When you are first rolling out your QMS, if you don't have in-house QMS expert that your company contract with, then a Regulatory Affairs (RA) consultant or company (such as Enzyme) that can help you implement and navigate your QMS. You will need a variety of standard operating procedures (SOPs) which define your business processes. Since regulations can be very specific and vague elsewhere - someone with industry experience will greatly inform this process and ensure your company complies with requirements while not being overly-restricted for the size and stage of your company. At this point it's best practice to delegate an employee be named your "management representative" (MR), a regulatory term indicating he/she is responsible for owning, speaking to, and managing your company's QMS.
During this phase, you must thoroughly document elements of Design Controls (Design Inputs, Design Outputs) into the QMS. Risk management documentation for the product, including the steps being taken to mitigate that risk, are to be documented within the QMS as well. Read the Quality Management 101 Guide to learn more about establishing a QMS.
Clinical studies and research may happen iteratively during this phase and may continue to the Verification and Validation phase. Similarly, in an iterative software design and development life cycle, verification testing can happen during this phase.
With your in-house or external RA resources, the regulatory strategy will likely revise and approach a final stage where you should start drafting the items needed for the regulatory submission. We recommend routine meetings to maintain a cadence toward completing submission deliverables, otherwise it can pile up and create unnecessary burdens and costs to complete. Depending on your product and regulatory strategy, pre-submission ("pre-sub") may be appropriate, which includes requesting a meeting with FDA and providing a package of information in advance of the meeting. Your RA consultant can help you set up pre-submission meeting. During the meeting be sure to create minutes so you can follow up with your regulatory body later. Read our Risk Classification Guide to help you determine your product's risk class and our FDA 101 guide to learn more about what the FDA and other regulatory bodies are looking for during a submission.
Once the product is in its final stages of development, final verification and validation (including human factors) should occur. Verification and validation activities include testing, analysis, simulation and must have traceability to released requirements in your QMS. Validation also frequently involves user testing (e.g. physician, nurse, patient, etc.) to best replicate the environment in which the product will be used.
Since the product is now in production, you can set up your QMS for Complaints, Non-conformances, CAPA and production controls. These are in preparation for when you launch the product.
Once you have finished your final prototype and corresponding verification and validation, you can then submit to the FDA. Be sure that all your verification and validation is documented in your QMS.
Once you know your product's risk classification, it will determine the type of submission you will need. For devices there are several types of submissions:
Premarket Approval (PMA): Most Class III devices require a PMA. The company must prove evidence that their product is safe and effective for it's intended use.
510 (K): Some Class I and most Class II products require a 510(K). The company must show that their product is substantially equivalent to a device that's already on the market.
De Novo: If your product is a new device that does not have predicate to which it can be compared, then you'll have to apply De Novo approval.
Humanitarian Device Exemption (HDE): Class III devices that are intended to benefit patients with rare diseases can submit for HDE. The company must first apply for the Humanitarian Use Device designation.
Class 1 devices generally do not require a submission. Software as a Medical Device (SaMD) product have additional classifications they need to follow. Our FDA 101 Guide discusses in depth what each each classification requires and what the FDA is looking for.
Once your product is on the market, you must monitor the product for issues and complaints and make product improvements to mitigate any issues. You can capture all customer complaints in the QMS you determine if these complaints must be escalated to an NC or CAPA. High risk products may be audited by the FDA to ensure their safety and efficacy.