The pathway from design to commercialisation for a new medical device can be complex and full of uncertainty. A specific product claim or intended use can lead to varying product classification and registration path due to differences in laws and regulations of different markets. A regulatory strategy will help you to bring into consideration the various regulatory issues and put together a plan that will bring your medical devices into the target markets.
A regulatory strategy is often a formal document that aligns the regulatory activities, together with the business strategy, to bring a new or modified medical device product to market. It identifies the important regulatory elements to be addressed and provides overall definition and direction to the project team. It should outline which path to take and the rationale of why a specific path is selected or recommended.
A well-planned regulatory strategy should be balanced, realistic and achievable to support the organisation’s mission and vision. It should also be easily understood, as it will need to be communicated to the development team.
Regulatory strategy should be planned at the earliest possible stage of product development.
It usually consists of key information such as:
- Medical device intended use and its technology
- Target markets for commercialisation
- Medical device classification
- Regulatory requirements
- Overall project milestones and timeline
Medical Device Intended Use And Its Technology
“What is the device? How is it to be used? Is this a new/novel product or is it a modification of an existing device?”
Intended use is the intended purpose of the medical device. It should indicate what it is supposed to be used for according to the manufacturer’s specifications, instructions, and other information.
It is important to craft an intended use that best describe your medical device. This is because it defines the classification and the assessment of risk of your medical device. It will also affect design validation in your design controls when you need to ensure that your design output meets user needs and intended use.
Technology of your medical device will also define the classification your medical device. It will influence the assessment of risk by taking into account of the type of technology involved and whether the technology is mature or new.
Target Markets For Commercialisation
“What countries will the medical device be sold and marketed in?”
In order to introduce a new medical device into the market, several important factors need to be considered and evaluated. These factors include market size, pricing and reimbursement, medical practices and distribution activities.
Additionally, regulatory regimes differ between markets, and thus an understanding of your target markets is important. Every medical device is regulated in some way by respective regulatory agencies. These regulatory agencies have defined their regulations regarding medical devices.
For example, U.S. FDA , European’s directives and Singapore’s HSA all classify medical devices based on risk that the device posed. However, the classification scheme is significantly different. The exact medical device may be grouped under different classification in different regimes.
Some medical devices may be more easily cleared for market under one regime compared to another. This may have a significant effect on how the company moves forward, including regulatory and marketing strategies.
Medical Device Classification
“Which classification does the medical device belong to?”
As mentioned above, medical device classification is important in establishing the pathway to the specific market.
Knowing how your medical devices is classified matters for the following reasons:
- Product classification helps you understand the risk profile of your medical device as well as competitors’.
- Product classification will help you establish your medical device’s requirements during design controls and risk management.
- Know what is required allows you to determine the verification and validation scope required, estimate cost, as well as to determine the timeline to bring your medical device to market.
When the classification is established, the requirements and options for "route to market" become clearer. This ensures that your product is developed with a “go-to-market” strategy, starting with the specific countries’ regulatory requirements.
For more information on how to classify your medical devices in U.S. and Singapore, you can refer to our previous post.
Standards To Comply
“Which standard should the medical device be compliant to?”
A standard is a document that is established by consensus and approved by a recognised body. It usually provides information based on feedback and best practices by experts from the industry, regulatory bodies and other international organisations, with the objective to provide consistencies for companies of similar industries and/or products.
For a medical device to be supplied in the market, the essential principles of safety and performance for the medical device must be met. They prove that the medical device is safe and performs as intended. Different countries have different version of essential principles checklist.
With the establishment of the intended use, target market, classification and information on similar devices (your previous generation or competitors’ product), the required standard can be identified to fulfill the essential principle checklist items.
For more information about SG HSA Essential Principles of Safety and Performance, you can refer to our previous post here .
“What type of pre-clinical information should be collected?”
Pre-clinical trial is essential for the provision of reasonable evidence of safety and efficacy of medical device prior to clinical trial. The pre-clinical data should include a comprehensive description of the medical device.
If a medical device is not found safe for use in animal models, the product cannot proceed to clinical trials on humans. Also, if the product does not prove effective, investigation will end in the preclinical phase.
In the regulatory strategy, you will need to list out the parameter or types of pre-clinical trials for your medical device. This will also help you in the allocation of time and budget needed for the pre-clinical trial.
One example is biocompatibility testing - how compatible a selected component or material is upon contact within an expected duration. This is an important consideration for device that is in direct contact with patient. For in vitro diagnostic medical devices, information such as limit of detection, precision, accuracy, interfering substances are usually the parameters of interest during the pre-clinical phase.
“ Is clinical trial required for my medical device?”
Clinical evaluation is usually performed first to understand the risk profile of the product. It will help to determine if clinical trials are required. Regardless of their classification, all medical devices require a clinical evaluation - demonstrate safety and performance of a medical device.
There are generally two methods to provide clinical evidence. Firstly, clinical data may be collected through clinical investigations conducted with the respective medical device. The second method is to provide evidence demonstrating safety and performance based on data already publicly available. This could be scientific publication or documented clinical evaluation of equivalent devices (previous generations or based on competitors’ products).
In general, new/disruptive technologies (devices) would require clinical trials to prove the safety and performance of the medical device.
Overall Project Milestones And Timeline
By indicating all the key information mentioned above, you will have a good grasp on your product development timeline as well as the cost to bring your device to the market!
What If Your Product Is So Disruptive That There Is No Relevant Comparison for Reference?
In the event where there is no reference/predicate device for your device, eg new technology, we would recommend you to discuss with your consultants, as well as speaking with notified bodies and officers from regulatory agencies (eg, formal pre-submission with US FDA reviewers) to get an early indication of your regulatory roadmap.
At Yeng & Leong Medtech Consultancy, we have worked with great companies that have disruptive products and often we face these challenges. There is no one-size fit all strategy. We leverage on the good relationship with partners in the US and EU in the aspect of regulatory affairs, as well as clinical management. We work together to gather information sufficient to engage and discuss early conversations with the relevant authorities, so as to ensure we are on the right track. And that’s to us the most pragmatic way moving forward!
Interested to setup and implement a QMS for your company? Contact us now for more information, including a 30-minute complementary gap analysis to understand what's needed for you to get or stay compliant!