When
powerful new technologies emerge, unbridled excitement often reigns. The
possibilities are endless and markets are undoubtedly huge. Artificial
intelligence and machine learning in medicine are at an early stage and the
potential to improve medical care is solidifying. Many opportunities are
being pursued including enhancing and supporting the decision-making process of
physicians, individualizing patient care with precision medicine and using near
real-time information to improve care.
Early ideas such as wearables that monitor activity levels or heart rate have been on the market for some time and have mixed results as tools for patient health management. Technology platforms such as Watson from IBM have shown amazing capabilities. AI- related applications have progressed to a point where formal medical device development is occurring, but challenges remain.
Early ideas such as wearables that monitor activity levels or heart rate have been on the market for some time and have mixed results as tools for patient health management. Technology platforms such as Watson from IBM have shown amazing capabilities. AI- related applications have progressed to a point where formal medical device development is occurring, but challenges remain.
Innovators are often fearless and can be blind to the real
risks and business difficulties to commercialize emerging technology. On
the other hand, the mainstream medical device community can perceive that
innovation exposes threat of the long-timelines, high-costs and painful
failures.
The reality is probably in between both extremes and risk can be mitigated with a deliberate approach to regulatory strategy.
The reality is probably in between both extremes and risk can be mitigated with a deliberate approach to regulatory strategy.
Regulatory Challenges
Regulatory requirements require transparency and regulators need to understand how and why a result came about. Many AI applications are a black box with little transparency and daunting complexities.
AI applications can produce valid conclusions that are counter intuitive to those which individuals or even teams of experts derive. Traditionally to gain marketing clearance for a medical device, substantial equivalence to a predicate device needs to be demonstrated. Regulators review and clear a device as a system that will not change without considerable deliberation; in fact, manufacturers go to great lengths to ensure that a device manufactured years after initial clearances demonstrates the same performance as the original device. However, one of the more powerful aspects of some AI applications is that the accuracy of output information can continually improve with continued use. This will produce a perpetually dynamic system by design.
There are solutions to this dynamic situation. Making applications as seamless as possible is where the challenges and opportunities are. Independent demonstration of the safety and effectiveness of the dynamic system through the Pre-Market Approval (PMA) process could be necessitated, albeit this regulatory path is much more costly, complex and difficult.
Regulatory Strategies to Address these
Challenges and Opportunities
1. Build your case, if
regulators cannot or do not yet understand a technology, they will struggle to
establish ways to assess the safety and effectiveness of your product.
· Find clinical and
regulatory information throughout the world that is supportive of what you are
trying to achieve. If negative information is uncovered, do not ignore
it; instead, address it.
· Do not plan on submitting a
“black box.” Spend the time to develop ways to communicate how and why a
particular result comes about.
· Seek related credible
sources, publications, guidance documents and experts, reference them, and
utilize them.
2. Plan on early and frequent
meetings with regulatory authorities. Gaining regulatory clearances for
emerging technologies benefits from building solid working relationships with
regulatory bodies. These relationships are built over a series of meetings
that begin early in the development process, aiding both parties as they learn
together. These early collaboration meetings provide a venue for industry
to explore new ideas with regulators. Based on working with many novel
products, we recommend the following considerations, particularly in working
with the FDA.
· Start with a solid
pre-submission package. Make certain to follow established guidelines for
pre-submissions, setting the tone that your organization has done its homework.
Additionally, a complete pre-submission package enables regulators to
prepare for the meeting and identify the appropriate experts needed.
· Be ready for questions
surrounding mechanism of action. In traditional medical devices, a key
component of the submission surrounds the mechanism of action, or how the
device is perceived to work. Be prepared to explain what your novel
technology does and how it does it.
· Prepare for the meeting.
Before the meeting or teleconference, identify your question areas and
structure your questions to get the specific information needed without using
open-ended formats. Avoid introducing new information that the FDA is not
prepared to discuss.
· Set an open tone during the
meeting. Be transparent about the information you have and the areas that
are lacking. In early development cycles, gaps exist and it is important
to be candid so you get accurate early feedback. Set aside any fears that
your organization is setting precedent by not having complete information and
instead, work to close those gaps as you progress through the product
development process.
· Set specific but realistic
expectations for meetings. Your device is novel and that means regulators
have not seen anything like it before. Expect regulators will have questions
that will be challenging to answer. Remember, agencies can only provide
feedback on what you have presented--what your device is currently-- and not
what you hope it will be in the future.
· At all times, be
professional and seek to understand their questions. Early collaboration
around emerging technologies is a two-way street. When you provide information
the FDA needs, they will provide direction to guide your product development.
And remember, the agency is a resource. Be open to the answers you
receive, so your processes can evolve and improve.
Cultural
Challenges
There are cultural differences that exist between the Silicon Valley visionaries that are pushing novel technologies forward versus the deliberately cautious, stepwise approach taken by traditional medical device development teams. In advance of nearly any new, disruptive technology being adopted by broader medical establishments and nearly always in advance of solid profitability, teams of brilliant visionaries have been embraced and included by traditional medical product development organizations.
Team Building Strategies to Address Culture
Challenges and Opportunities
·
Build effective multidisciplinary teams by
addressing cultural divides. When building regulated medical products
based on AI, organizations will benefit from vertical structures and need to
bring in key leaders from the industry early in the business. Building medical
device products requires deep subject matter expertise. Combining subject
matter with technical expertise and embracing the multidisciplinary approach
drives innovation, making it possible to accurately model the vision, answer
the key questions and realistically hold leaders accountable for results. Team
evolution needs to be intentional and designed. If you are unable to set
the joint domain early, one side dominates, and it becomes a challenge to bring
in world-class experts from the other side. Top people recognize such
unbalance and the byproduct that they will not achieve the parity in authority
and respect.
·
Create solid regulatory affairs teams with
prior experience in addressing uncertainty surrounding quality systems and
regulatory approval, specifically:
·
Members with a focused subject matter
expertise in the AI/machine learning space and the mindset/ability required to
work in a highly complex multidisciplinary environment.
·
Regulatory expertise introducing and gaining
FDA clearance or approval for new technologies and with the intention and
ability to communicate with the developers.
·
Direct expertise developing software for
medical devices and developing and managing quality systems for software
development.
·
Where clinical trial work is required, the
CRO and strategic regulatory experts need to work closely together to generate
the type of clinical data that supports the safety and effectiveness of the
underlying product. Also the regulatory team needs to develop and conduct
the studies in ways that bring transparency and simplify the “black box”
aspects of the product.
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