This post is dedicated to young startups and small companies currently facing numerous challenges, more than ever before. From our experience, we have, unfortunately, learned that during crises, there is often a tendency in young companies to neglect regulatory and quality issues. This is done to accelerate product development and meet investor timelines, under the belief that these matters can be addressed later. However, bypassing essential development stages and neglecting coherent documentation may lead to future difficulties, especially during regulatory submission.

Therefore, we have summarized a concise list of things you shouldn't compromise on now, to ensure minimal investment when seeking regulatory approval later:

1. Intended use and Indications for use:

Define early on the official description that outlines the purpose for which the product is intended, including its medical function, conditions of use, types of diseases or medical conditions it addresses, and the intended user population. This definition is critical for the regulatory process as it determines the regulatory pathway, impacts clinical requirements guides the verification and validation testing of the product.

This task appears relatively simple, but in reality, it is not so. The Intended Use must be defined based on a deep understanding of the market and medical use, alongside regulatory expertise.

Additionally, it is crucial to consider medical reimbursement options, where alignment with both regulatory approval and reimbursement is necessary.

One common and crucial mistake among startup companies is attempting to define the regulatory classification and pathway of their device on their own, despite having no regulatory expertise, to save money. This can be a costly mistake that may result in significant expenses and time delays later when seeking regulatory approval. It is highly advised to invest the money and hire an expert to develop the regulatory strategy for you – defining the product classification, predicate device (for the US), main V&V tests, clinical aspects, and main QMS requirements for your product and of course the main stages for regulatory submission. The regulatory strategy shall be market-specific.

Another common mistake among startup companies or small firms is assuming that upon regulatory approval, they can immediately start selling the product. In reality, there indeed are companies that received FDA or CE approval but failed to penetrate the market because the product lacks medical reimbursement or an attractive sales channel.

2. Device description:

While it may seem self-explanatory, device description is a critical definition that sets the intentions and boundaries of product development. It must correspond with the intended use, and describe how the product will archive it. It's important to specify what the product does, its features, design specifications, materials used, functional capabilities, operating principles, and any relevant performance characteristics. Additionally, it may include information on indications for use, contraindications, warnings, precautions, and instructions for use to ensure safe and effective use of the device in clinical settings.

The device description is not marketing material but more of an official statement of the company regarding its product. This will be used as the basis for regulatory submissions and labeling.

Marking materials will be based on the intended use and the device description as they are approved by the regulators. Therefore, it should be done carefully, and taking into account both marketing and regulatory aspects.

Unfortunately, we’ve seen more than once a startup that failed to define an accurate device description and as a result faced many inconsistencies and confusion, especially between what is presented to investors or in the marketing materials and what is permissible under regulation.

3. Risk management:

Besides being a mandatory requirement in most regulations, early-stage (during the planning of the design and development) risk management according to ISO 14971 allows for identifying potential hazards. This early identification enables to define the required verification and validation testing (including the necessity and the scope of pre-clinical and clinical trials) and make corrections and improvements to the product design before costly testing and validation begin.

For risk management to be beneficial in an early stage, more than the product’s design, EMC and SW should be considered. We suggested evaluating the risks of the manufacturing process and user-related form the beginning.

Manufacturing Process- when designing a device, the methods of its manufacturing should weigh into the design. Specially, if the product requires any special process or environmental conditions. For example, if you design a sterile finale product that has a built-in buttery, you will need to identify specific risks inherent in the sterilization of a buttery, and consider materials for the proper sterilization and design the product and its packaging to mitigate the identified risks.

In that matter, scaling up the manufacturing process might raise unexpected process risks, especially for products that require special technologies or specific knowledge. When identified early, the manufacturer might be able to avoid the pain of redesigning the product to scale up the manufacturing process.

User-related risks - once the intended user and environment are determined, risks related to user information perception, cognition, and actions should be identified. Then, when designing the product, you should consider possible controls for these risks.

Specifically, medical device reprocessing by the user may raise a lot of concerns and risks. Reprocessing of medical devices should be as simple and straightforward as possible for the user. When designing with such intention, you should be careful to identify who will conduct the reprocessing and what is their technical understanding (medical care professional? technician? layperson?). Equally important is to identify the environment for the reprocessing process. These considerations have a major effect on the required device’s durability, appearance, how its disassembled or connected, and more.

It important to understate that risk management is not a document but a continuous process that spans the entire product’s lifetime. The earlier it is initiated, the more accurate, comprehensive, and ultimately beneficial it will be.

4. Verification and Validation (V&V) planning:

Planning and conducting V&V activities early in the development phase, guided by risk analysis, are essential for regulatory compliance and product quality assurance. But, for young companies and startups, in ultimately important for budget planning.

Planning V&V early and documenting it systematically can help identify connections between processes, requirements, and tests, potentially saving on expensive laboratory trials later. Mapping required V&V tests also anchors budget management due to their high costs.

While planning the V&V tests, it is critical to conduct a thorough study of the applicable regulations, standards, and guidelines for your device.

5. Adherence to proper development stages and documentation:

Documenting milestones in product development, including version differences and actions taken for each version is crucial even for small teams. Clear documentation ensures consistency and facilitates a comprehensive understanding of project progress, particularly when managing tight deadlines and concurrent tasks.

It's important to note that the above list outlines only the topics that are not recommended to be neglected even in difficult situations. This list is the bare minimum, and additional quality and regulatory requirements will be required depending on the market you intend to target. Of course, ideally, the development of the product should go hand in hand with quality and regulatory requirements.