Regulatory Strategy as a Competitive Advantage
This article is an excerpt from the Regulatory strategy as a competitive advantage ebook.
Table of Contents
- The regulatory revenue opportunity
- Regulatory responsibilities
- Limitations of the "cost-center" approach to regulatory affairs
- Regulatory as a revenue function
- Competitive advantage #1: Faster time to market
- Competitive advantage #2: Cost avoidance
- Competitive advantage #3: Out-pacing competitors
- Why invest in regulatory/revenue alignment?
- Getting started - 3 steps to move towards a revenue-aligned RA team
It is well known that medical technology (medtech) companies are highly regulated, given the potential risks their products present. Understanding and complying with the complex regulations in each country is, therefore, a necessary part of marketing and selling medical devices. To realize any revenue from a medical device, it must not only demonstrate compliance with all applicable regulations, it must also receive and maintain market clearance from each country in which it is to be sold. No market clearance means no revenue. Given the key role regulatory compliance plays in revenue attainment, regulatory teams, tools, and processes present a significant opportunity for differentiation for organizations willing to invest in them.
For the majority of medtech companies, however, regulatory departments have traditionally been treated as operational cost centers, with departmental improvements focused on cost reduction and efficiency improvements. Limited investment in people and tools, and limited interest in digital transformation, have left regulatory teams across the medtech industry underfunded and under-resourced.
This has led to great resourcefulness within the RA community, where most members can point to heroes within their team who worked long hours to meet a submission deadline, headed off a disaster by uncovering a pending expiration, created ad-hoc systems to organize information and streamline communication between the RA and QA teams for smoother audits, or have otherwise gone above and beyond their typical responsibilities.
Regulatory teams, however, have the potential to be a revenue-driving competitive weapon for companies that are willing to look at them a little differently and invest in regulatory performance above regulatory cost-effectiveness. Well-supported regulatory teams can provide a true competitive advantage by providing the resources and direction to:
- Capture market share by being first to market with novel devices.
- Avoid lost revenue by effectively tracking and planning for registration renewals/updates.
- Out-pace competitors and grow market share by adapting to regulatory changes more quickly and taking advantage of competitors’ non-compliance or inability to enter a new market.
We believe we are entering a new era for regulatory affairs within the medtech industry. One in which RA teams have a seat at the table when go-to-market, competitive positioning, and strategic decisions are being made.
In the medtech industry, regulatory affairs (RA) teams have a broad range of responsibilities across the product lifecycle:
Premarket regulatory strategy
Obtaining market clearance for a new medical device is the primary activity typically attributed to RA teams. It is not unusual for a regulatory team to be given market entrance projects with little warning, but ideally, the RA team would be brought in as early as possible to contribute to go-to-market discussions.
Premarket regulatory strategy, at a minimum, involves:
- Determining the most appropriate pathway to market approval. For example, a 510(k) or PMA submission in the U.S.
- Working with quality, product, and other teams to gather information needed for market submission.
- Establishing communication with applicable regulatory bodies and third-party approved auditors.
- Compiling and submitting required documentation for market approval. This includes managing follow-up activities, questions, and requests for additional information throughout the approval process.
Forward-thinking organizations often look to bring in RA teams even earlier in the process. As regulatory experts, RA professionals can provide unique insight into product development plans. In consultation with R&D teams, can help to refine product strategies, and steer development in areas that will reduce regulatory hurdles when new products are ready to be commercialized.
Maintaining regulatory compliance for existing products
While the primary focus of regulatory teams is often considered to be new market submissions, the majority of their time is actually spent on maintaining compliance for products that are already in-market. Even in situations where market registrations do not expire, constant vigilance is required to ensure that devices remain compliant with current regulations. These efforts take a considerable time for a typical RA team because information is often spread across disparate systems, where it can be difficult to find and confirm.
Maintaining regulatory compliance for approved devices includes:
- Staying on top of changing standards and making changes as required to existing technical files and other documentation.
- Submitting appropriate documentation updates when there is a change made that could potentially affect the efficacy or safety of the product, such as a material switch or facility change.
- Understanding pending regulatory changes and proactively addressing any that have an impact on devices currently in-market.
- Tracking registration expirations and preparing for timely re-submissions to ensure there is no lapse in market clearance.
Post-market activity
Post-market surveillance and vigilance activities are required by most countries and should involve the cooperation of the quality and regulatory teams. Ensuring that changing post-market reporting requirements are understood and complied with is an important regulatory responsibility.
Regulatory teams typically play a role in:
- Post-market surveillance of adverse events, complaints, and any issues associated with a device in the field.
- Assembling and submitting any required periodic safety reports to country/regional health authorities.
- Post-market vigilance and reporting of serious events to the appropriate regulatory agencies.
- Any required communication with regulatory authorities regarding adverse events or concerning trends in product quality.
Ask any RA professional, and they are likely to tell you that they work long hours and are often scrambling to meet looming deadlines...
To continue reading this ebook, download the full version.
Is a medical device accessory a medical device?
Rimsys’ own James Gianoutsos recently contributed an article on www.meddeviceonline.com discussing FDA’s guidance document describing accessories and classification pathways.
On Dec. 20, 2017, the FDA issued Medical Device Accessories – Describing Accessories and Classification Pathways: Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) for combination products.
The guidance document offers welcomed clarity on the role of an “accessory” and its regulatory relationship to its parent device. As always, guidance documents are not legally enforceable; rather, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The guidance explains which devices FDA generally considers “accessories” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories. In other words, it specifically details what is and is not an accessory, as well as the regulatory routes to classification.
The updated guidance was derived from an August 2017 amendment to section 513(f) of the FD&C Act (FDA Reauthorization Act of 2017 (Pub. L. 115-52)) to state that “the Secretary shall … classify an accessory under [section 513] based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.”
The amendment allows for some accessories to have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class. As classifications for accessories are now risk-based, it provides manufacturers with regulatory flexibility to loosen some of the regulatory burdens on accessories that may not have the same risk profile as their parent devices.
For example, an accessory to a class III parent device may pose lower risk that could be mitigated through general controls, or a combination of general and special controls, and thus could be regulated as class I or class II. A common example of this would be a ventilation system (parent device) with a face mask (accessory).
Additionally, the guidance details the applicable definitions within Section IV: Definitions:
- Accessory — “A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.”
- Component (21 CFR 820.3(c)) — “[A]ny raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”
- Finished Device (21 CFR 820.3(l)) — “[A]ny device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.”
- Parent Device — “A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.”
Accessory classification policy
The risks of an accessory are the risks it presents when used with the corresponding parent device as intended. To classify an accessory, FDA addresses the following two questions:
- Is the article an accessory? This can be answered by determining the intended use of the accessory. Is it intended for use with one or more parent devices, and does it support, supplement, and/or augment the performance of one or more parent devices?
- What is the risk of the accessory when used as intended with the parent device(s), and what regulatory controls are necessary to provide a reasonable assurance of its safety and effectiveness? This can be answered by providing a detailed risk assessment, outlining the potential hazards and reasonable regulatory and quality controls necessary to assure the accessory’s safety and effectiveness.
Individual accessories may be classified pursuant to the same regulation as a corresponding parent device, when appropriate, or be regulated independently.
Once an accessory has been classified, there is another consideration manufacturers need to decide: the Unique Device Identifier (UDI) rule. Not only does your parent device need to have a UDI, but any and all accessories each need to be assigned a UDI.
As 21 CFR 801 Labeling, Subpart B, Section 801.20(a) states: “(1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter,” and “(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.”
Further, 21 CFR 830 UDI, Subpart A, Section 830.3 defines “finished device” and “device package” as follows:
- Finished device* means any device or accessory to any device that is suitable for use or capable of functioning.
- Device package means a package that contains a fixed quantity of a particular version or model of a device.
*Note that, although “medical device” and “finished device” are not consistent terminology used within the chapters, the terms are one and the same.
In short, any sellable finished device must bear a UDI, either on the device itself, on the device package, or both. Components to the finished device (i.e., service components and spare parts kits) are not considered accessories, and therefore are not required to bear a UDI.
What does this ultimately mean for manufacturers?
If there was any confusion as to whether a specific accessory is classified as a medical device, it has now been clarified, or at least partially clarified, depending on your specific situation. If there is still confusion among your engineering and regulatory teams, FDA recommends contacting them, via the accessory classification process outlined in the guidance, to classify the accessory appropriately. FDA will treat each accessory classification request as a Q-Submission. Requests may be for a new accessory type (new classification), an existing accessory type (reclassification), or classification of a new accessory type through the de novo process.
A gap analysis should be performed to identify a thorough and complete list of your current and future accessories to determine applicability to the guidance document. Justification also should be documented, should an accessory not apply to the guidance document. Additionally, internal procedures and the process associated with assigning UDIs may need to be updated to ensure there are no compliance gaps.
Podcast – Streamlining the MDSAP device marketing authorization and facility registration process
I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process.
If you are not familiar with this topic, you need to hear this.
We discuss:
- Why your regulatory team may be perceived as a bottleneck and why it is important everyone needs to be on the same page about when the product can be released.
- The connection between marketing authorization and facility registration required for various countries – United States, European Union, or elsewhere.
- The need to get organized, get better systems in place, and stay compliant when an auditor comes through your door or when you plan to sell into markets.
- Why small and large companies need to get organized now (i.e. small companies have too much information to maintain, organize, and track while large companies may have resources but suffer from miscommunication and disjointed processes.)
- The need to not be complacent and not be afraid to change systems. Rimsys was created to help regulatory professionals successfully and efficiently handle documentation.
You can hear the podcast below or at the Greenlight Guru blog.
