Modernizing FDA for the Age of Medical Product Connectivitysites.nationalacademies.org/cs/groups/pgasite/... · Modernizing FDA for the Age of Medical Product Connectivity Bradley

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Modernizing FDA for the Age of Medical Product Connectivity Bradley Merrill Thompson

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Unique features of connected technologies

Unique features of connected business models

Topics for Discussion

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Ambiguity and the entrepreneur

FDA Modernization ideas


Contemplate the network No predefined clinical intended use

Interoperability

Standalone software that plays clinically significant roles

Remote site of service Home use and mobile type considerations

Human factors

Telemedicine type issues The impersonal touch

New FDA Regulatory System Requirements: Technology

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Collaboration among IT technical experts, clinicians, medical device developers and scientists of many sorts.

Virtual development processes

Even shorter product lifecycles

Modularization of software

Easier entry for those not experienced in health

New FDA Regulatory System Requirements: Business Model

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Ambiguity can be good or bad

Good Bad

Liberals arts majors

Regulatory standard

Engineering majors

Scope of FDA regulation

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A holistic regulatory system for a connected care delivery system

Needed: A Systems Approach

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Connected health technologies, including standalone software

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Regulatory Reform Blueprint


Disease v. wellness

Accessory rule

Software modules

Clinical Decision Support

We do need to anticipate new technologies and

we do need flexibility to provide for learning more about risk.

Resolving Ambiguity

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Specific Needed Improvements

Innovation Factor Needed Regulatory Change

1. Cost and timelines for developing products

Clarity and predictability in the pathway

Classification: I, II or III

2. The accessibility of regulatory requirements to small business

More outreach

User-friendly web-based information

Face-to-face educational programs

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New Approach


3. Components for unspecified systems Tool intended uses

Accessory classifications

4. Release of beta software programs Clarification on how investigational device rules apply to regulated software

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New Approach


5. Frequent incremental improvements to software

Clear triggers for premarket requirements

6. Key role of standalone software Guidance on

Premarket data requirements

Quality system regulation

Postmarket reporting obligations

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New Rules Needed for Scientific Exchange

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Allow manufacturers to collaborate with customers actively

Build virtual collaboration tools and in person events for scientific exchange

Use their own people, including commercial, to build the community through proactive outreach

Allow their own scientific people to engage in the scientific discussion by sharing data, including journal articles

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Good guidance practice 2.0

It’s time


How would FDA answer questions if it were located in Silicon Valley?


Opportunities for Improving Guidance

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Technologies such as Chat room capability and

Electronic knowledge databases

Best practices for handling handle external communications

Shift the laboring oar to industry


Watch the innovation blossom


Bradley Merrill Thompson (202) 861.1817 [email protected]

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Documents

Modernizing FDA for the Age of Medical Product Connectivitysites.nationalacademies.org/cs/groups/pgasite/... · Modernizing FDA for the Age of Medical Product Connectivity Bradley