Medical Device DevelopmentConcept to Commercialization

Jahnavi Lokre

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What is a Medical Device?

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

– recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

– intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

– intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Source: US Food and Drug Administration

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What is Innovation?

• New idea, device, or method• Disruptive

– Creates a new product, service or process– Has significant impact on society

• Incremental– Series of small improvements to existing product, service or process– Used to improve efficiency, performance, user experience or differentiation

• Technology is enabling innovation in medical devices at a rapid rate– Machine learning and Artificial Intelligence– Virtual and Augmented reality– 3D printing– Internet of Things

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Technology Adoption LifecycleInn

ovato

rsEar

ly Ado

pter

s

(Visi

onar

ies)

Early

Majorit

y

(Pra

gmati

sts)

Late

Majorit

y

(Con

serva

tives

)

Lagg

ards

CHASM

EARLYMARKET

TORNADO

BOWLINGALLEY

MAINSTREET

Source: Crossing the Chasm, Geoffrey Moore

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My Medical Device Chasm ModelInn

ovato

rs

Unmet

need

Early

Adopt

ers

(Visi

onar

ies)

Early

Majorit

y

(Pra

gmati

sts)

Late

Majorit

y

(Con

serva

tives

)

Lagg

ards

Source: Crossing the Chasm, Geoffrey Moore

Early

Believ

ers

KOL, VC La

te Beli

ever

s

VC, Clin

ical S

ites,

Regula

tory

Cadaver, Animal Studies

Clinical Studies/Trials

Regulatory Approval,

Reimbursement

Chasm

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What is Lean?

• The Toyota Production System– Maximize customer value while minimizing waste– Creating more value for customers with fewer resources– A way of thinking and acting applicable to all business processes

• Software Development– Agile– Scrum– Extreme programming

• The Lean Startup by Eric Reis– Eliminate uncertainty– Work smarter not harder– Develop an MVP– Validated Learning

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FDA Total Product Lifecycle and Development Pathway

Source: FDA CDRH Medical Device Innovation Initiative White Paper

Implement under Design Controls

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Ideation & Concept

• Research, brainstorming• Protect your Intellectual Property• Assess opportunity, market need and size• Build your team• Identify KOL• Draft your business plan • Form your company• Secure funding

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• Not under design controls• Show feasibility, reduce risk• Breadboard critical components and sub-systems• Use rapid prototyping • Identify critical components, processes and technology• Conduct preliminary tests • Draft regulatory strategy

– World-wide coverage – FDA: IRB/IDE/510(k)/PMA/DeNovo– CE Mark

• Draft reimbursement strategy

Phase 0 Discovery

Phase 01-3 months

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Learning #1

• Eliminate uncertainty, reduce risk• Solve the hard problems first• Iterate as many times as you need

Impo

rtan

ce

Difficulty

Piece of cake Show stopper??

Do this later A mountain to climb

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Design ControlsFDA Regulation 21 CFR 820.30

• Design and Development Planning / Design Inputs– Establish project, quality, design and development plans– Document Intended Use, Product Requirements

• Design Output– Define and document design

• Design Review– Formal and documented reviews

• Design Verification– “Did we design the device right?”

• Design Validation– “Did we design the right device? ”

• Design Transfer– Translation of the design into manufacturable specifications

• Design Changes– Change control procedure

• Design History File– Clear documentation of the entire process in a design history file or DHF

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Design ControlsMedical Devices Directive

• Medical Devices Directive (MDD 93/42/EEC)• Medical Device Regulation

– final draft published February 2017– 3 year transition period begins when enacted– Medical Device and IVD versions

• Harmonizes the laws relating to medical devices within the European Union

• Design controls implemented by ISO 13485 compliant Quality System

Phase 0 1-3 months

Phase 11-3 months

• Establish project, quality, design and development plans• Document intended use, user needs• Define product requirements – functional, safety,

performance, regulatory, test• Start risk analysis• Create industrial design concepts• Update as required

– Regulatory strategy– Reimbursement strategy– Business plan

Phase 1 Design Input & Planning

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Learning #2

• Define the requirements– Don’t wait to know every small detail – Draw a line in the sand– You can make changes later if you need to

• Identify and rate the hazards (severity and probability) accurately– Will impact design decisions – Will impact verification and validation activities

• Look at what the “Minimum Viable Product” is– Cannot apply the same definition of MVP as we would for tech

products– Need to keep in mind what impact changes would have on regulatory

testing

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Phase 0Variable

Phase 11-3 months

Phase 26-18 months

Phase 2 Design and Development

• Develop, document, build, test, iterate– Industrial design– Design descriptions, schematics, models, source code

• Incremental milestones• “Talk to FDA”• Build engineering (alpha) prototypes• Test performance, functionality, usability

– Pre EMC/safety tests– KOL input– Animal studies

• Design for cybersecurity• Final risk analysis• Design reviews

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Learning #3

• Get customer / KOL input frequently• Track requirement changes as they occur• Lock down the industrial design and UI early• Practice agile design techniques

– Software development– User Interface development– Use OTS components and evaluation boards– 3D printing

• Consider usability requirements• Consider design for manufacturability (DFM)• Consider target price requirements

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Phase 0Variable

Phase 11-3 months

Phase 26-18 months

Phase 33-5 months

Phase 3 Design Evaluation & Release

• Build controlled, traceable (beta) units• Develop test protocols and reports • Verify design

– Functional, Safety, EMC, Environmental, Packaging, etc.• Validate design

– Usability, Functional• Traceability matrix• Design reviews• Prepare regulatory

submissions

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Regulatory Testing Standards

• IEC 60601 for medical devices– Frequently used collateral standards

• 60601-1-2: EMC• 60601-1-6: Usability• 60601-1-8: Alarms• 60601-11: Home Use

– Particular Standards• IEC 61010 for IVD• ISO 14971 for Risk Management• ISO 10993-1 for Biocompatibility• IEC 62366 for Usability• IEC 62304 for Software Development • CB Scheme for more international subtleties

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Regulatory Submissions

• USA– Clinical trials under IRB or IDE– Device clearance under 510(k)– Device approval under PMA– DeNovo

• EU– CE Mark– Self certify or submit technical file based on class of device

• Approval time will vary based on the type of application

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Learning #4

• Don’t wait until now to talk to the FDA• Develop test protocols as you develop the specifications• Do informal Safety and EMC tests during design phase• Setup a pre-test review for the safety testing package before

you submit

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Phase 0Variable

Phase 11-3 months

Phase 26-18 months

Phase 33-5 months

Phase 43-6 months

Phase 4 Transfer to Manufacturing

• Identify manufacturing partner• Order long-lead parts • Setup pilot production build• Complete process validation• Setup post market QMS• Register with FDA• Register with Notified Body

– ISO 13485 certification

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Commercialization

• Be prepared for an FDA visit• Sales and forecasting• Warranty and service• Obsolescence • Post market surveillance

– Safety & effectiveness– Cyber security

• MDR & Complaints

• It is time to think of the next generation!!

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THANK YOU