Innovation Forum - AAGL · 2020-01-30 · Non Provisional Application $10,000 USProsecution $25 000 US Patent 7 Provisional Application ($5000) PCT Application $5000 National Stage

Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

Innovation Forum

PROGRAM CHAIR

Eric R. Sokol, MD

PROGRAM CO-CHAIR

Jon I. Einarsson, MD

Stuart Hart, MD Samuel Kesner Donald Min, JD

Professional Education Information Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 I have an Idea: Now How Do I Negotiate Legal Contract? D. Min ........................................................................................................................................................... 4 I Have an Idea: Now How Do I work with Institution to Develop a Product? S. Hart ............................................................................................................................................................ 7 I Have an Idea: What Do Industry Developers Look For? S. Kesner ...................................................................................................................................................... 16 Cultural and Linguistics Competency ......................................................................................................... 23

INNOVATION FORUM Eric R. Sokol, MD, Chair

Jon I. Einarsson, MD, Co‐Chair

Faculty: Stuart Hart, MD, FACS, FACOG – Physician Inventor;

Samuel Kesner, Harvard Engineer; Donald Min, Registered Patent Attorney

Course Description This course provides a forum for attendees to learn basic knowledge needed to translate an innovative idea into a marketable product. The target audience is minimally invasive surgeons who often find themselves with innovative ideas to improve surgical care (such as a surgical device) but don’t know what to do with those ideas. The program will take the participant through the legal aspects of patents and contracts with a patent attorney, through the experiences of a physician‐inventor who has worked with an academic institution to develop a product, and finally to see what developers look for in the process of product design and development from an engineer. At the end of the forum, there will be time for questions and discussion. Following completion of the session, attendees should have a broader understanding of several important aspects of the process of turning an innovative idea into a reality, and be better able to avoid the pitfalls and costly errors that others may have experienced. This will hopefully motivate entrepreneurial physicians to start the process of surgical innovation. Starting the process is the most important step!

Learning Objectives At the conclusion of this activity the participant will be able to: 1) discuss how to start to negotiate a legal contract; 2) review how to avoid common negotiation pitfalls, and understand elements of a beneficial contract; 3) define the pros and cons of working with an Academic Center Innovation Group; 4) evaluate what industry developers look for when evaluating new products; 5) recognize pitfalls of product design and development (even after securing a patent); and 6) use the learning process to translate an idea into a viable product.

Course Outline 11:00 Welcome, Introductions and Course Overview E.R. Sokol, J.I. Einarsson 11:05 I Have an Idea: Now How Do I Negotiate Legal Contract? D. Min 11:35 Questions & Answers 11:40 I Have an Idea: Now How Do I Work with an Institution to Develop a Product? S. Hart 12:10 Questions & Answers 12:15 I Have an Idea: What Do Industry Developers Look For? S. Kesner 12:45 Interactive Panel Session All faculty 1:00 Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties - CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium - Ethicon Endo-Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor - Intuitve Surgical FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Eric R. Sokol Grants/Research Support: Contura Jon I. Einarsson Consultant: Ethicon Endo-Surgery Donald Min* Samuel Kesner*

2

Stuart R. Hart Consultant: Covidien, Boston Scientific Corp. Inc. Speaker's Bureau: Covidien, Boston Scientific Corp. Inc., Stryker Endoscopy Asterisk (*) denotes no financial relationships to disclose.

3

I Have an Idea: Now How Do I Negotiate a Legal Contract?

Donald MinJ.D. George Mason UniversityJ.D. George Mason University

PartnerMonument IP Law Group

Financial Relationships

• I have no financial relationships to disclose.

Disclaimer

• This presentation is for informational purposes only and does not constitute legal advice.

• Receipt of this information does not create an• Receipt of this information does not create an attorney‐client relationship.

Goals for this presentation

• How to proceed when you have a new idea and want to negotiate with another party.

• Learn basic tips of patent process.

I Have an Idea: Now what?

• Do you “own” the idea? – intellectual property

• How can I establish ownership of intellectual property?

d i i / h l f• How do I maximize/gauge the value of my intellectual property?

Intellectual Property: Patents

• The predominant form of intellectual property in medical devices is patents.

• Patent results from a patent application filed with the U S Patent Officewith the U.S. Patent Office

– Disclosure

– Drawings

– Claims

4

Typical Timeline for a Patent

and beyondYear 5Year 4Year 3Year 2Year 1Start

Non Provisional Application$10,000

US Prosecution

$25 000

US Patent

7

Provisional Application($5000)

PCT Application$5000 National Stage Prosecution

$25,000

$20,000 / country

OUSPatent

Tips for protecting your idea

• New/Solo inventors often

fall prey to certain pitfalls

or mistakes along the

patenting process.

h

Maintain ConfidentialityMaintain Confidentiality

Take Good NotesTake Good Notes

Don’t DelayDon’t Delay

Choose Your Partners CarefullyChoose Your Partners Carefully

• This presentation

provides some helpful

tips and tricks.

Prepare a Patent & Development BudgetPrepare a Patent & Development Budget

Perform Thorough Patent SearchesPerform Thorough Patent Searches

Keep Your Patent Attorney on TrackKeep Your Patent Attorney on Track

Pace Yourself and Be Prepared for the Long HaulPace Yourself and Be Prepared for the Long Haul

8

Tip #1: Maintain Confidentiality• Keep your ideas confidential.

• If you are collaborating with one or more co‐inventors, these rules apply to each inventor.

• Exceptions are:

Avoid slipping up during “dinner party” talk

Avoid slipping up during “dinner party” talk

Require an NDA prior to disclosure to a company or

individual

Require an NDA prior to disclosure to a company or

individual(a) Your attorney;

(b) Any co‐inventor; or

(c) Any engineer(s) hired to help you develop the idea or prototype

(d) Any contractual partners (i.e., universities, hospitals)

9

individualindividual

Public Public Disclosure Disclosure

Prior to FilingPrior to Filing

Loss of Your Loss of Your Patent RightsPatent Rights

=

Don’t create the unintended co‐inventor !

Tip #2: Take Good Notes• Proper record‐keeping can

save you!

• Examples of things to record:

(a) Dates;

(b) Names; and

( ) D i Ch i

• Witness signatures

• Notary publicCorroborationCorroboration

• Names (titles if appropriate), times and dates

f f

Collaboration and

Disclosure

Collaboration and

Disclosure(c) Design Choices

• Good recordsmay save you in obtaining the patent, during negotiations, and, if needed, in court.

10

• Brief summary of meetingsDisclosureDisclosure

• If possible, document the problem you are trying to overcome

• Document the current state of the art

• Document any design alternatives

Document the Inventive

Process

Document the Inventive

Process

Tip #3: Don’t Delay• It is extremely valuable to

have the earliest filing date possible.

• Waiting too long to file a patent application could jeopardize your

Don’t “sit” on the idea for years and years

Don’t “sit” on the idea for years and years

Put a realistic patent plan i l ith t

Put a realistic patent plan i l ith t

j p yopportunity to patent your invention.

• Delay can be costly!

11

in place with concrete milestones

in place with concrete milestones

Seek professional help –don’t go at it alone unless

you are experienced

Seek professional help –don’t go at it alone unless

you are experienced

Tip #4: Choose Your Partners Carefully• Putting together a

professional team to help you throughout the patent process will make it easier on you and ensure better results.

• Your team may consist of:

Look for professionals who have experience with your

technology

Look for professionals who have experience with your

technology

Professionals with patent Professionals with patent Your team may consist of:(a) Patent attorney;

(b) Colleagues or experts who are co‐developing the invention with you; and

(c) Engineers or manufacturers

12

licensing and negotiating experience a plus

licensing and negotiating experience a plus

Shop around before settling on your final

choice

Shop around before settling on your final

choice

5

Tip #5: Prepare a Budget• The patent process can be

expensive – have a plan to cover costs associated with it.

• Develop a filing strategy with the ultimate owner in mind d h

Find opportunities to work with large companies who will absorb the patent costs

Find opportunities to work with large companies who will absorb the patent costs

Don’t file blindly without aDon’t file blindly without aand use that to prepare a corresponding budget.

• Assume that you will bear the costs for the patent prosecution into the national foreign phase.

13

Don t file blindly without a plan in place

Don t file blindly without a plan in place

Always consider filing a provisional application to

delay costs

Always consider filing a provisional application to

delay costs

Tip #6: Consider Patent Searches• A thorough patent search

performed on your invention early on in the process is highly recommended.

Understand the value of your patent / application

relative to others

Understand the value of your patent / application

relative to others

Identify target companies by seeing who owns related

Identify target companies by seeing who owns related

• A good search can help you to determine if, how, and where you should file your patent application.

14

seeing who owns related patents or applicationsseeing who owns related patents or applications

Assess the trends in current needs or interests through

recent filing activities

Assess the trends in current needs or interests through

recent filing activities

Tip #7: Keep Your Patent Attorney on Track

• Once the application has been filed, keep communicatingwith your patent attorney.

• New changes or

Don’t be afraid to ask for aggressive prosecution tactics such as

personal interviews with the patent examiner

Don’t be afraid to ask for aggressive prosecution tactics such as

personal interviews with the patent examiner

Don’t assume your attorney is it i fili i d t

Don’t assume your attorney is it i fili i d t• New changes or

developments to your design or concept need to be considered even though the application has been filed.

15

monitoring new filings or industry trends on your behalf

monitoring new filings or industry trends on your behalf

Don’t micromanage – you will unnecessarily run up the legal billDon’t micromanage – you will

unnecessarily run up the legal bill

Tip #8: Pace Yourself & Be Prepared for the Long Haul

• The patent process is long and arduous.

• Pace yourself!

Pendency currently around 18+ months at the US Patent &

Trademark Office

Pendency currently around 18+ months at the US Patent &

Trademark Office

Typical medical device patent Typical medical device patent

• Be prepared for delays and bumps in the road –all patent offices usually reject patent applications at first.

16

application will issue 3‐6 years from the filing date

application will issue 3‐6 years from the filing date

Make the delay work to your advantage by aggressively pursuing potential buyers before a 1st office

action

Make the delay work to your advantage by aggressively pursuing potential buyers before a 1st office

action

Final Thoughts

• Don’t forget the value of other forms of protections. Example: an associated trademark for branding

i iThank you for your

your invention.

17

attention!

6

IHaveanIdea:NowHowDoIWorkwiththeInstitutionto

DevelopaProduct?Stuart Hart, MD, FACOG, FACS

Assistant Professor

Division of Female Pelvic Medicine and Reconstructive Surgery

Department of Obstetrics and Gynecology

Director, USF Center for the Advancement of Minimally‐Invasive Pelvic Surgery (CAMPS)

Medical Director, Tampa Bay Research and Innovation Center (TBRIC)

USF Center for Advanced Medical Learning and Simulation (CAMLS)

University of South Florida College of Medicine

Disclosures

• Grants/Research Support: American Medical Systems

• Consultant: Astellas, Ethicon Women's Health & Urology, Boston Scientific Corp. Inc.

We all want to create the next great medical device

Unfortunately…the reality is that most ideas are never successfully implemented

How much of a need is there How much of a need is there for innovation in Medicine?for innovation in Medicine?

Is there need for innovation in Medicine?Is there need for innovation in Medicine?

1816 First stethoscope1816 First stethoscope

Transporation 1816

http://www.hhmi.org/biointeractive/museum/exhibit98/content/b6_17info.htmlhttp://www.hhmi.org/biointeractive/museum/exhibit98/content/b6_17info.html


First refined total abdominal hysterectomy, First refined total abdominal hysterectomy, performed by Wilhelm Alexander Freund in 1878performed by Wilhelm Alexander Freund in 1878

1878 car Jaquot‐‐Steam 1878 Odhner calculating machine

Miyazawa K. Technique for total abdominal hysterectomy: historical and clinical perspective. Obstet Gynecol Surv. 1992 Jul;47(7):433‐47.

7


1968 First non1968 First non‐‐invasive invasive fetal monitor fetal monitor

1968 Toyota Corolla

Princeton Supercomputer IBM 7090

Medical Device InnovationMedical Device Innovation

MedicalMedical

MarketplaceMarketplace••SizeSize••CompetitionCompetition••BarrierstoentryBarrierstoentry

RegulatoryRegulatoryAffairAffairWHY???WHY???

CurrentCurrentTechnologyTechnology

DisruptiveDisruptive

ManufacturingManufacturing

DeviceorDeviceorTechnologyTechnology

IntellectualIntellectualPropertyProperty

Disruptive,Disruptive,TransformativeTransformativeorIncrementalorIncrementalInnovationInnovation

CostofCostofCommercializationCommercialization

LicenseorLicenseorManufactureManufacture

UserNeedsUserNeedsandTrainingandTrainingRequirementRequirement

DistributionDistribution

SalesandSalesandMarketingMarketing

Medical Device ProcessMedical Device Process

Create Create Multidisciplinary Multidisciplinary

TeamTeam

BusinessBusinessConception Conception and Designand Design

CommercializationCommercializationManufactureManufactureMarketingMarketingDistributionDistribution

Health Health Technology Technology AssessmentAssessment

Research/DiscoveryResearch/Discovery Product Development/CommercializationProduct Development/Commercialization

PrototypePrototype

EngineersEngineers

Regulatory AffairsRegulatory AffairsLegalLegalHealthcareHealthcare

ProofProof‐‐ofof‐‐Concept Concept TestingTesting

Intellectual Intellectual Property Property ProtectionProtection

RedesignRedesign

FDA Part 820FDA Part 820ISO 13485ISO 13485

Regulatory Regulatory Design PhaseDesign Phase

How do we innovate in medicine?How do we innovate in medicine?

I just thought of the best I just thought of the best idea???idea???

How do we successfully How do we successfully innovate in medicineinnovate in medicine

Culture + Invention + Innovation + Culture + Invention + Innovation + Entrepreneurship =Entrepreneurship =Entrepreneurship =Entrepreneurship =

Commercialized Medical DeviceCommercialized Medical Device

BuildBuild

FocusFocus

How do we innovate in How do we innovate in medicinemedicine

CultureCulture + Invention + Innovation + + Invention + Innovation +

Entrepreneurship =Entrepreneurship =Entrepreneurship =Entrepreneurship =


BuildBuild

FocusFocus

8

Medical CultureMedical Culture•• Does your institution Does your institution

encourage invention and encourage invention and innovationinnovation

•• Does your institution own Does your institution own your intellectual property?your intellectual property?

•• What are the TechnologyWhat are the Technology•• What are the Technology What are the Technology Transfer revenue allocation Transfer revenue allocation rules at your institution?rules at your institution?

•• Does your institution provide Does your institution provide startstart--up assistance?up assistance?

•• Are there grants for Are there grants for innovation available at your innovation available at your institution?institution?

““The New England Journal of Medicine The New England Journal of Medicine reports that 9 out of 10 doctors agree reports that 9 out of 10 doctors agree that 1 out of 10 doctors is an idiot.that 1 out of 10 doctors is an idiot.””

--Jay LenoJay Leno

Medical CultureMedical Culture


Culture + Culture + InventionInvention + Innovation + + Innovation +

Entrepreneurship =Entrepreneurship =Entrepreneurship =Entrepreneurship =


BuildBuild

FocusFocus

InventionInvention•• Is the creation of a new or improved idea, Is the creation of a new or improved idea,

product/deviceproduct/device, , process/method process/method or technologyor technology

•• CreativeCreative

•• ExperimentalExperimental

•• Multidisciplinary teamsMultidisciplinary teams

•• Will your institution fund invention???Will your institution fund invention???


Culture + Invention + Culture + Invention + InnovationInnovation + +

Entrepreneurship Entrepreneurship Entrepreneurship =Entrepreneurship =


BuildBuild

FocusFocus

InnovationInnovation••Is the implementation and use of a new or Is the implementation and use of a new or improved idea, product / device, process / method or improved idea, product / device, process / method or technologytechnology

••Meaningful and transformativeMeaningful and transformative

••May integrate multiple inventionsMay integrate multiple inventions

••Create valueCreate value

9


Culture + Invention + Innovation + Culture + Invention + Innovation +

EntrepreneurshipEntrepreneurship ==EntrepreneurshipEntrepreneurship ==


BuildBuild

FocusFocus

EntrepreneurEntrepreneur

••Individual(s) who assembles and organizes the resources Individual(s) who assembles and organizes the resources needed (capital, manpower, knowledge and management needed (capital, manpower, knowledge and management strategy) to transform an invention or innovation into a strategy) to transform an invention or innovation into a viable businessviable business

••Initiative and riskInitiative and risk



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign




••What is so great about this product or What is so great about this product or idea???idea???

••Does anyone want this product?Does anyone want this product?

••What is the Market??? What is the Market???

••What is the business landscape?What is the business landscape?

••Can this be a successful business? Can this be a successful business?

••Can I make a profit?Can I make a profit?••Can I make a profit?Can I make a profit?

••Can I get funding???Can I get funding???

••What are the regulatory hurdles?What are the regulatory hurdles?

••Can this product or technology be Can this product or technology be protected?protected?

••Is the technology available to develop this Is the technology available to develop this product?product?

••Is this product a disruptive or evolutionary Is this product a disruptive or evolutionary innovation to the market?innovation to the market?

1. Nima Samadi. Medical Instrument & Supply Manufacturing in the US IBISWorld Industry Report 33911a. September 2011

2. Mountaintop Medical. Worldwide Minimally Invasive Surgery Devices Market: A Kalorama Information Market Intelligence Report. May 2011

0

2000

4000

6000

8000

10000

12000

2008 2009 2010 2011 2012 2013 2014 2015

Reve

nue in m

illions of dollars at the

man

ufacturer’s leve

l

Year

Current and Projected Revenue by Surgical Specialty

Gastrointestinal

Urological and Gynecological

Orthopedic

Neurosurgery

ENT and Respiratory

Cardiovascular

Market Research.com

FinancialsFinancials

10

EntrepreneurEntrepreneurFunding???Funding???

•• How much risk are you How much risk are you willing to take for this idea?willing to take for this idea?

•• What is your skin in the What is your skin in the game???game???

h ih i•• Who is your management Who is your management team?team?

•• How are you going to pay How are you going to pay your staff?your staff?

•• What percentage of the What percentage of the company are you willing to company are you willing to give up?give up?

•• Angel fundingAngel funding

•• Venture Capital FundingVenture Capital Funding

•• Licensing product or Licensing product or technologytechnology

Intellectual Property Protection Intellectual Property Protection StrategyStrategy

PatentPatent

TrademarkTrademark

C ightC ightCopyrightCopyright

Trade SecretTrade Secret

TimerequiredtogetaUSpatentTimerequiredtogetaUSpatentOverview of the Patenting Process using the PCT SystemOverview of the Patenting Process using the PCT System

International Preliminary Examining Authority(IPEA)

International Searching

Authority(ISA)Invention

Receiving Office

is filed with

Patent application

is the object of

PCT

transmit application

transmit reports*

communicate

tReceiving Office(local patent office)

Patent application PCTInternational Bureau

publish

International Publication

Designated Offices(foreign patent offices)

Patents

grant

Months from Priority Date

File Local Application

(Priority Date)

0 16 18 22 28 3012

File PCT Applicationwith Receiving Office

(International Filing Date)

ISR & Written Opinion

(IPRP I)

International Publication

File Demand for IPRP II(optional)

IPRP II National Phase Entry(where Applicants seek Protections)

* ISA transmit International Search Reports (ISR) & the Written Opinions / IPEA transmit International Preliminary Reports on Patentability II (IPRP II) (optional)

International Phase National Phase

•• Medical Device ClassMedical Device Class•• Class I Medical DeviceClass I Medical Device

•• Class II Medical DeviceClass II Medical Device

•• Class III Medical DeviceClass III Medical Device

Device classification depends on the Device classification depends on the intended useintended use of the device, of the device, indications for use and riskindications for use and risk

Regulatory Affairs StrategyRegulatory Affairs Strategy

•• FDA Regulatory Approval ProcessFDA Regulatory Approval Process•• The device classification regulation defines the regulatory The device classification regulation defines the regulatory

requirements for a general device type. requirements for a general device type.

•• Most Class I devices are exempt from Premarket Most Class I devices are exempt from Premarket Notification 510(k)Notification 510(k)

•• Most Class II devices require Premarket Notification 510(k)Most Class II devices require Premarket Notification 510(k)

•• Most Class III devices require Premarket Approval.Most Class III devices require Premarket Approval.

•• International Regulatory Approval ProcessInternational Regulatory Approval Process

Design InputsDesign Inputs

11


Moore, G.A. 2001, 'Crossing the Chasm – and Beyond', in Strategic Management of Technology and Innovation, eds Burgelman, R.A., Maidique, M.O., and Wheelwright, S.C., 3rd edition, McGraw-Hill, B t 269

Medical Device LifecycleMedical Device Lifecycle

Center for Advanced Medical Learning & SimulationCenter for Advanced Medical Learning & Simulation

How do we innovate at the University of South How do we innovate at the University of South Florida?Florida?

Transforming Healthcare through Transforming Healthcare through Innovation, Collaboration and Innovation, Collaboration and

TechnologyTechnology

How do we innovate at the How do we innovate at the University of South Florida?University of South Florida?

I just thought of the best I just thought of the best

We look at Health Care problems and We look at Health Care problems and work backwardswork backwards

j gj gidea???idea???

A lot of urinary tract injuries occur A lot of urinary tract injuries occur during a hysterectomy procedure. during a hysterectomy procedure.

Over 600,000 procedures performed Over 600,000 procedures performed annually with approximately 4% risk annually with approximately 4% risk

of injury to urinary system.of injury to urinary system.

LetLet’’s find a solution???s find a solution???

The Solution:The Solution:Look at the Problem Differently…Look at the Problem Differently…

Urinary catheterUrinary catheter…is an ideal stethoscope …is an ideal stethoscope

…that can collect unique …that can collect unique acoustic signatures which acoustic signatures which

can signify injurycan signify injury

http://www.tabers.com/tabersonline/ub/view/Tabers/143162/29/urinary_bladder_catheterization

The Solution:The Solution:Look at the Problem Differently…Look at the Problem Differently…

Acoustic TransmissionAcoustic Transmission

12



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign





TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign



Medical Device InnovationMedical Device Innovation

MedicalMedical

MarketplaceMarketplace••SizeSize••CompetitionCompetition••BarrierstoentryBarrierstoentry

RegulatoryRegulatoryAffairAffairWHY???WHY???

CurrentCurrentTechnologyTechnology

DisruptiveDisruptive

ManufacturingManufacturing

DeviceorDeviceorTechnologyTechnology

IntellectualIntellectualPropertyProperty

Disruptive,Disruptive,TransformativeTransformativeorIncrementalorIncrementalInnovationInnovation

CostofCostofCommercializationCommercialization

LicenseorLicenseorManufactureManufacture

UserNeedsUserNeedsandTrainingandTrainingRequirementRequirement

DistributionDistribution

SalesandSalesandMarketingMarketing



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign



Intellectual Property Protection StrategyIntellectual Property Protection Strategy

•• Provisional then nonProvisional then non‐‐provisional patent filed provisional patent filed with USPTOwith USPTO

•• Patent Cooperation Treaty (PCT) filedPatent Cooperation Treaty (PCT) filed

•• USF revenue allocation:USF revenue allocation:45% / 35% / 10% / 10%45% / 35% / 10% / 10%

•• USF Technology Transfer CriteriaUSF Technology Transfer Criteriagg•• PatentabilityPatentability•• Breadth and depth of expected claimsBreadth and depth of expected claims•• Expected freedom to practiceExpected freedom to practice•• Difficulty to reverse engineerDifficulty to reverse engineer•• Ability to detect Ability to detect infringementinfringement•• Ability to withstand litigationAbility to withstand litigation•• Patent activity in fieldPatent activity in field•• Extent of prior artExtent of prior art•• Availability of foreign rightsAvailability of foreign rights



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign



13



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign



The Solution:The Solution:Convert a catheter into an electronic stethoscope Convert a catheter into an electronic stethoscope

NonNon‐‐invasively monitor invasively monitor acoustic signatures through a acoustic signatures through a device attached to the balloon device attached to the balloon channel of a urinary catheterchannel of a urinary catheter

NonNon‐‐invasively monitor invasively monitor acoustic signatures through a acoustic signatures through a device attached to any device attached to any catheter inserted in the bodycatheter inserted in the body



eCath could lay the foundation for the field of eCath could lay the foundation for the field of insideinside‐‐thethe‐‐body acoustic monitoringbody acoustic monitoring with applications in:with applications in:

Cardiovascular and Cardiovascular and pulmonary monitoringpulmonary monitoring

Detection of organ Detection of organ damage during damage during

surgerysurgery

Labor and delivery Labor and delivery monitoring (L&D)monitoring (L&D)



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign





TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign



14

First Steps Towards First Steps Towards CommercializationCommercialization

•• Grant fundingGrant funding

•• Developed Business Developed Business planplan

•• Won Cade Museum Won Cade Museum Prize for Healthcare Prize for Healthcare InnovationInnovation

•• Speaking with Speaking with private equity firmsprivate equity firms

•• Launched Launched BioAcousTechBioAcousTech LLC.LLC.

ConclusionConclusion



TeamTeam





PrototypePrototype

EngineersEngineers




RedesignRedesign



15

I have an Idea: What do Industry Developers Look For?

Samuel Kesner, PhDTechnology Development FellowTechnology Development Fellow

Wyss Institute, Harvard UniversityCambridge, MA, USA

I have no financial relationships to disclose.

At the conclusion of this activity, participants will be better able to:

– Navigate the device development process

Determine possible development pathways for– Determine possible development pathways for their device idea

– Work with engineering partners to produce proof of concept devices

Background on the Speaker• BS, MS in Mechanical Engineering from MIT

• PhD in Biomedical Engineering from Harvard

• Lecturer on Mechanical design at Harvard

• Serious about inventing and idea development

(Kesner, 2011)(Hopkins 2012)

How I Learned Med Device Dev• Medical Device Design courses at MIT

• PhD research in cardiac surgery at Harvard/Children’s Hospital

• Mentoring student design teams

• Side projects, start ups, personal interests

“I have an idea….now what?”

• Organize the idea

– Specific and clear. Ready to communicate

• Preliminary background research

if only…

– Existing products, research papers patents

• Thinks about next steps…

16

Device Scale

• What is the “scale” of your idea

– Better bandages or a new MRI machine?

– $0.10 ‐> $10,000,000 (capital investment)

• I focus on “handheld” scale devicesI focus on handheld scale devices

– Tools, instruments, devices, diagnostics

– Single‐use or sterilizable

– A new, innovative, or specialized technology (not commodity)

Development Pathways

How will you transform your idea from concept in to a real device?

Options:p

–Big company

–Commercialization partner

–Academic institution

Develop Duration

How long does it take to develop a new device?

3 Months*

*Approximate time to develop only a proof of concept device, assuming it is

composed of existing technology, all of the required resources (funding, equipment, skilled labor, etc.) are available, and you have an experienced person working full time.

How long will the entire development process take?

Commercialization Step Shortest Typical Longest

Idea Generation 1 hour(napkin sketch)

1 year 5 years(academic research)

Proof of Concept 3 months(acute animal study)

6 months 2 years(mult. animals with implantable)

Pre‐clinical Testing 6 months 1 year 2 years

Pilot Study 2 months(acute device)

9 months 2 years(chronic condition)

Pivotal Study 6 months 2 years 4 years

Regulatory Approval 6 months(510k without clinical)

1 year 2 years(PMA)

Reimbursement Coverage

1 second(already exists)

2 years 4 years(need to do more studies)

Podium Presentations 6 months 1 year 2 years

Sales Force Pushing 1 year 2 years 3 years

TOTAL 3 years & 5 months 11 years & 3 months 26 years

Development Process

• Academic and Innovative Startup Method

• “Bed‐to‐Bench‐to‐Bed” method

• Requires a deep understanding of

– Clinical need

– Environment where device will be used

17

Biodesign Lab Approach• Identification• Validation

• Characterization• Optimization

• Collaborate with physicians

• Elucidate elegant • Invention• Realization

• Evaluation• Commercialization

gengineering solutions

• Minimize complexity

Inspiration from Biology and Medicine

• Identification• Validation


• Invention• Realization


Analytical and Experimental Models• Identification• Validation




Conceptual Idea to Prototype





Clinical Testing and Licensing/Start‐ups





Device Development Examples

18

Example 1:

Cranial Drill with Retraction Safety Mechanism

• Traumatic brain injury– 1.4 million per year in U.S.

– $75‐100 billion estimated financial burden

• Brain damage can increase pressure– Penetrate the skull to relieve

i ll

Medical Need

pressure or install sensors

• Neurosurgeon needed to drill hole– 2.2% of head injuries receive

pressure monitoring

Herniation schematic from Robbins and Cotran, Pathologic Basis of Disease, 7th ed. Philadelphia: Elsevier; 2005.

Statistics from Center for Disease Control and National Trauma Data Bank

Camino Intracranial Pressure Monitorhttp://Aparaty-do-fizykoterapii.gortomed.pl

Current Tools

• Operating Rooms: use safety drill Acra‐Cut

• Emergency Settings: Integra hand drill

• Safe drill for Operating Rooms: Acra‐Cut (Codman)

– Attaches to pneumatic drills

• Requires air compressor and hose

Current Tools

– Minimum diameter is large

– Unable to continue a hole if interrupted

– Removes excess bone

Plunging leads to morbidity Design Requirements

Clinical:

– Cheap

– Robust

– Portable

– Hand held

Engineering:

– Retract drill bit after skull penetration

– No sensing/actuation

– Varying diameter holes

19

• Inputs (requirements):

– Safe penetration distance

– Drilling forces

• Outputs (design):

– Minimum rotational speed

– Mass of weight

Mechanism Analysis

Mass of weight

– Linkage geometry

Prototype Design

Clinical Workflow

Affiliation Auto. Drilling

Safety mechanism upon penetration

Changeable bit

Restart the same hole

Driving force limitation

Approx. Price

FDA Approval

Auto-retractable drill

HARVARD Yes Yes Yes Yes Spinning speed ~$250 Not yet

Competitive Analysis

Acra-cut ACRA-CUT Yes Yes No No Torque $90 Yes

Hand drill INTEGRA No No No Yes Hand

power $250 Yes

Example 2:

Locking Mechanism for Articulating Ultrasound Needle Guide

Ultrasound Guidance

Procedures where accurate placement of a needle in the body is required

Examples:

• Nerve blocks• Joint injections• Aspirations

20

Needle Alignment Limitations of Free‐Hand technique

• Large amount of experience and training is required

• Often two people are needed

Proper vs. improper needle alignment

• Problems Aligning needle and ultrasound beam

SystemFinal Design

Activationbutton location

Ultrasound Probe

Needle

Final Prototype Competitive Analysis

21

Summary

• Developing a device requires

– Partners, time, and money

• Process:

Id if h i li l– Identify, characterize, realize, evaluate, commercialize

• Physician‐inventor can best contribute by understanding the problem & context

Additional Resources

• Biodesign: The Process of Innovating Medical Technologies, Zenios, Makower, Yock, CU Press Human factors

• Designing Usability Into Medical Products, Wiklund and Wilcox, CRC press

• Harvard Biodesign Lab

• Wyss Institute: Wyss.harvard.edu

• S. B. Kesner, L. Jentoft, F. L. Hammond., R. D. Howe, M. Popovic, “Design Considerations for an Active Soft Orthotic System for Shoulder Rehabilitation”, IEEE Engineering in Medicine and Biology Conference (EMBC), 2011.

• B. J. Hopkins, H. Wu, W. H. Marks, Q. Quan, S. Kesner, C. K. Ozaki, C. Walsh, "Hemodialysis Graft Resistance Adjustment Device", Journal of Medical Devices, in press, 2012.

• Patent: “Device for the Minimally Invasive Surgical Removal of Internal Tissue” A. Slocum, Z. Williams, C. Brown, D. Buckley,S. Kesner, D. Stewart‐Hernandez. Status: Filed February 2008.

• S. B. Kesner, R. Howe, “Position Control of Motion Compensation Cardiac Catheters”, conditionally accepted to IEEE Transactions on Robotics, 2011.

• S. B. Kesner, R. Howe, “Force Control of Flexible Catheter Robots for Beating Heart Surgery,” IEEE International Conference on Robotics and Automation (ICRA), Shanghai, China, 2011.

• S B Kesner R Howe “Design and Control of a Motion Compensation Cardiac Catheters” IEEE International Conference on R• S. B. Kesner, R. Howe, “Design and Control of a Motion Compensation Cardiac Catheters”, IEEE International Conference on Robotics and Automation (ICRA), Anchorage, 2010.

• M. Gelabert‐Gonzalez, V. Ginesta‐Galan, R. Sernamito‐Garcia, A.G. Allut, J. Bandin‐Dieguez, R.M. Rumbo, “The Camino intracranial pressure device in clinical practice. Assessment in a 1000 cases,” Acta Neurochirurgica, 148: pp.435‐441, 2005.

• M. Faul, L. Xu, M.M. Wald, V.G. Coronado, Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002–2006, Atlanta (GA): Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2010.

• J.D. Caird, K.A. Choudhari, “‘Plunging’ during burr hole craniostomy: a persistent problem amongst neurosurgeons in Britain and Ireland,” British Journal of Neurosurgery, 17(6), pp. 509‐512, 2003..

• L. Brattain, C. Floryan, O. Hauser, M. Nguyen, R. Yong, S. B. Kesner, S. Corn, C. Walsh, Conor, “Simple and Effective Ultrasound Needle Guidance System”, IEEE Engineering in Medicine and Biology Conference, 2011.

22

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsianIndo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

23

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

Documents

Innovation Forum - AAGL · 2020-01-30 · Non Provisional Application $10,000 USProsecution $25 000 US Patent 7 Provisional Application ($5000) PCT Application $5000 National Stage