Medical Device Regulations and IP Strategy: Part 1
All medical devices must undergo stringent regulatory approval in order to gain access to market, to ensure that not only are they safe to use, but also perform as intended.
Intellectual property (IP) is a pathway that runs closely alongside the regulatory approval process. Assisting these companies with gaining exclusivity and a competitive advantage strengthens their portfolio, which could attract greater investment opportunities.
Appreciating how these two pathways intersect helps clients to better understand how to maximise the commercial potential of their medical device products at various stages of the regulatory process, which is the focus of the present article.
What is Meant by a Medical Device?
The definition of a medical device is somewhat aligned globally.
In Australia, according to the Therapeutic Goods Administration (TGA), a medical device is “any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended for human use for medical purposes, excluding pharmacological, immunological or metabolic action as its principal effect.”
In the US, the Food and Drug Administration (FDA) defines a medical device under Section 201(h) of the Food, Drug, and Cosmetic Act as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease… intended to affect the structure or any function of the body … and which does not achieve its primary intended purposes through chemical action within or on the body… and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o)”
In Europe, the Medical Device Regulation (MDR) defines a medical device under 2017/745 as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specific medical purposes… and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”
Crucially, in Europe the definition is broader as it has been expanded to include software and other products that are intended for medical use. For example, devices that monitor and support health, including those that do not directly serve a medical purpose but may have similar risks.
The European definition also does not include an accessory, which is defined according to its intended use, mode of action and performance. Specifically, an accessory is defined as not having an independent medical purpose of its own (e.g. a remote for controlling an operating table). Although accessories for medical devices are still subjected to the same regulatory framework as medical devices.
Regulatory Frameworks in Australia, Europe and the US
In Australia, the TGA is responsible for ensuring the safety and well-being of the individuals who use therapeutic goods in Australia. It is able to perform this role by authorising the commercial supply of therapeutic goods for use in Australia through the Australian Register of Therapeutic Goods (ARTG) database and authorising manufacturers to produce the product at an appropriate standard and monitoring the safety of these goods using information obtained from a variety of sources, including from healthcare providers, the community, overseas regulators, sponsors and manufacturers of the product.
The TGA regulates these therapeutic goods by using a risk management approach, reducing the risk to an acceptable level. The TGA regulates therapeutic products both before they enter the market and afterwards once in commercial use. Its role also extends to ensuring that overseas manufacturers’ therapeutic goods are produced to the required standards.
Outside of Australia, the US Food and Drug Administration (FDA) and the European Medical Device Regulation (EU MDR) are the two most important regulatory frameworks that govern medical devices globally. While they both ensure safety and efficacy of medical devices, there are differences to the requirements and approaches used in both jurisdictions. Often medical device companies seek to commercialise in both these markets. Thus, it is important to understand the differences in navigating both these jurisdictions’ regulatory frameworks .
In the US, the main focus of the FDA is on pre-market review; granting clearance or approval based on robust scientific evidence. Post-market monitoring is also required, particularly if potential problems have been raised such as device recalls, however, much of the emphasis is on pre-market validation rather than on life cycle management.
This differs from the focus of the EU MDR, which uses a life cycle approach, having strict requirements for clinical evidence, risk management and post-market surveillance (PMS). Continuous monitoring and documentation are required on the devices to ensure these remain safe and effective throughout the life cycle. In Europe there are also independent organisations, Notified Bodies, who work with manufacturers to conduct these conformity assessments, review technical documents and ultimately issue European Conformity, “CE” marks. This differs from the US, where manufacturers deal directly with the FDA.
Medical Device Lifecycle
During the commercialisation process, medical device innovations often undergo a number of product design changes between the time of initial conception to delivery of the final product. The main stages of the product life cycle for medical devices include:
- Concept & Early Feasibility
- Pre-Market Submission
- Market Entry
- Post‑Market Surveillance & Iteration
This series will discuss each stage and the IP considerations associated with each. The remainder of part one will focus on stage one of the life cycle: Concept & Early Feasibility.
1. Concept & Early Feasibility
The success of a medical device product depends heavily on the patient/clinical need, thus some level of market research must have been conducted at this early stage. Other innovative ideas that do not address patient/clinical needs usually end in commercial failure. In other words, in order for a product to have success, it must be both scientifically and economically feasible and commercially viable.
Early feasibility studies provide opportunities for data collection to help guide future development of the product, as many products at this early developmental stage have not yet been finalised in their design.
It is advisable that prior to commencement of these early feasibility studies, companies have at least filed a provisional patent application. This safeguards the product before any public disclosure being made. Such disclosures may inevitably be made during the process of developing the prototypes and through discussions concerning bench and clinical testing. Securing early protection of IP helps to deter competitors and often makes a company’s portfolio attractive to investors and partners, which contributes towards a company’s long-term success. Ideally, a freedom to operate search may also be done at this stage to identify any patents that may act as a commercial roadblock. Again, this information would be useful from the perspective of attracting funding from investors.
Given the product is at an early stage, the device may be used in only a few patients, which does help to improve patient access where limited alternatives are currently available on the market and where there is an unmet clinical need. These studies are essential to gaining insight into proof of concept with respect to safety, performance, and usability, or even may provide insight into the characteristics of the ideal patient for the device. Such outcomes are expected to be incorporated into the future development of the device.
Since device testing is conducted, as and when needed during these early feasibility studies, they therefore offer a facilitated review process, allowing for modifications to be made to the device during the course of the early feasibility study. In some cases approval of the device may even be achieved during this time. Whilst no formal regulatory submissions are required during the course of these early feasibility studies, this type of contingent approval process means that regulators, such as the FDA, are involved earlier during the development process, which can help to better guide companies into understanding what is needed in terms of data for achieving regulatory approval. In fact, 80% of companies that proceed through these early feasibility studies have been shown to have gained approval of their device in the first review cycle, according to FDA statistics.
Early feasibility study programs are available in a selection of countries. Apart from the US, Japan is also a participant in this type of program.
Coming Next
This brings us to the end of the first installment of MBIP’s series on medical device regulations and IP. Part 2 will discuss the next stage of the medical device lifecycle in depth: Pre-Market Submissions. All published parts of this series can be found here: https://www.mbip.com.au/category/series-medical-device-regulations-and-IP-Strategy
