This FDA warning letter outlines issues with a clinical investigation conducted by Dr. Thomas Beilke between 2008-2009. The FDA inspection found that Dr. Beilke failed to properly conduct or supervise the clinical investigation according to regulations. Specifically, the letter cites that Dr. Beilke did not personally conduct or supervise the investigation as required. The FDA concluded that Dr. Beilke did not adhere to statutory requirements and regulations governing clinical investigations.
4. Medical Product
Technological
Solution
Market
Medical Need Analysis
Regulatory
R l t
Patentability Scientific
Evidence &
Reimbursement
Funding
December 2011
7. Medical Device
Definition
• an instrument apparatus … implant in
instrument, apparatus, implant,
vitro reagent, or other similar or related
article,
article including a component part or
part,
accessory
• Used for the diagnosis treatment or prevention of
diagnosis,
disease or condition
and that
• Affects the structure or function of the body
• Does not achieve its function through chemical
action
• Is not metabolized to achieve effect
December 2011
9. Project Steps (
j p (Life Cycle)
y )
• Research & Proof of Concept
• Regulatory Strategy (for regulated products)
• Project initiation – System/Market Requirements
• Specifications and Risk Analysis / Traceability Matrix
• R&D framework
• Verification and Validation: bench, ex-vivo, in vivo
• Clinical
• Submission/s market approvals
• Market penetration
December 2011
10. Regulatory Path
g y
•Proof of Concept
•Requirements
q
•Risk Assessment
US EU
Regulatory Pathway Finalize discussion with Notified
gy
and Clinical Strategy body for Strategy
Pre-
IDE
Development +
Quality System
Q
Verification & Validation
Poolability
Clinical Study
(OUS)
IDE Clinical Study
(US and OUS)
IDE
CE Mark
510(k) Clearance/PMA
Approval
December 2011
11. Regulatory Strategy
• Intended use & Indications for use (Claim)
• Regulatory Cl
R l Classification
ifi i
• Applicable standards and guidelines
• Proposed pre clinical Testing
pre-clinical
• Clinical Strategy (pre and post market)
• Re-assess intended use and/or indications for use
• Re assess technological (engineering) approach and R&D plan
Re-assess
• Re-assess business plan – designated product, timelines and
budget
Alternative approaches
12. Claim / Intended Use
Intended U
I t d d Use:
What is being done
g
Sometimes where it is being done
Sometimes why it is being done
Indications:
Diseases
Patients
Subsets
December 2011
13. Implications of Claim
SPECIFICITY LEVEL
1. Identification of function Tool Claim
2. Identification of tissue type
an organ system or
(higher clinical
Identification of a specific evidence))
organ
3. Identification of a particular
disease or target population
4. Identification of an effect on
clinical outcome
Clinical Claim
December 2011
14. CDRH’s Risk Based Paradigm
g
Class I
Class
II
Class III
December 2011
16. Classification
Determination of Risk
User/Pt g
Mitigation
Environment Generic
type
Circumstances Claim
December 2011
17. Risk-Benefit
(Safety / Efficacy)
•A great deal of emphasis is placed on the importance of
clinical data in demonstrating the safety and effectiveness
of a medical device.
Still….Non-clinical data also can be critical to
understanding device safety and effectiveness.
Medical devices often h
M di l d i ft have attributes th t cannot b t t d using
tt ib t that t be tested i
clinical methods alone and that play a major role in the safety or
effectiveness of the device.
FDA Guidance (Aug 2011): “Factors to Consider when Making Benefit-Risk
Determinations in Medical Device Premarket Review”
Clinical and non-clinical data play a
role in the benefit-risk determination
December 2011
19. R D
Animal
Design
Ex i
E vivo Bench
B h
& Development
Clinical
December 2011
20. System Requirements
• Intended use
• Target population (indications)
• Product description
• Applicable Standards And Guidelines
• Requirements (safety, performance, usability,
marketing):
– Output / Outcome (measures or outcome of treatment),
accuracy / efficacy
– Biocompatibility, cleanness (
p y, (sterility)
y)
– Mechanical and electrical properties
– Compatibility with target anatomy
– C
Compatibility with other products (
tibilit ith th d t (accessories, additional
i dditi l
under the same procedure….)
– End user
December 2011
23. Standards and Guidelines
• General:
– Regulatory decisions and Classification
– Design Control
– Clinical
Cli ical
– Biocompatibility
– Electrical
El t i l
– Software
•S
Specific / Special
ifi S i l
– Specific to that family of devices or specific
properties of device (material, energy type and
i fd i ( i l d
level, etc.)
December 2011
25. Traceability Matrix
Functional Clinical Clinical Risk Verification & Validation
Requirements Risk Mitigation by Type of Evaluation Specific Procedures
Biocompatible Systemic Materials and Biocompatibility Compliance with ISO 10993-
p
adverse design testing; animal 1:2009 Biological evaluation
reaction, testing, clinical data of medical devices - Part 1
death (e.g., Cyotoxicity,
Sensitization, Etc.))
Electrical and EM Serious Design and Electrical and EM Test Report demonstrating
safe burns, IFU Testing compliance with EN 60601-1
death (2006) + A1 & A2 - Medical
Electrical Equipment - Part
1: General Requirements for
Basic Safety And Essential
Performance
Compatible with
C tibl ith Injury,
I j Design d
D i and Specific b
S ifi bench tests,
ht t
other equipment In death (e.g., IFU animal testing,
the clinical arena pacemaker clinical data
will not
function)
f ti )
Functional Injury, Design and Specific functionality
(mechanical/tissue death IFU tests, animal testing,
interaction/target clinical data
organ))
December 2011
26. Risk Analysis
• Patient Injury
Effect of (expected
Failure complications)
Harm • Device
Deterioration
• Design
Cause of
Failure • Manufacturing
• User Error
• Design
• Protective measures
Mitigation
g in manufacturing
process
• Labeling (IFU)
December 2011
28. Risk Assessment Table
(1st approach)
Mode of Effect of Cause of Risk Control Verification
Failure / Failure / Harm Failure (Mitigation)
Hazard
Hazards Related
to BIOLOGICAL
Hazards Related
to
MECHANICAL
Hazards Related • Loss or 1. Inadequate 1. Design (e.g., Device Functionality Testing
to Deterioration of
D t i ti f specification
ifi ti designed with
d i d ith
PERFORMANCE Device. 2. Insufficient integrated radiopaque
• Patient Injury control of markers)
manufacturin 2. Protective measures in
g processes manufacturing process:
QC inspections during
production
Hazards Related Patient Injury re-use of single Labeling IFU includes the following warning:
to DEVICE USE use device “The System is a single-use device
and is intended for single patient
use only. Re – using the device is a
potential for cross-infection. Do not
attempt to clean or re-sterilize the
System. Reprocessing the device
may damage the device making it
unsafe for use. ”
December 2011
29. Project / Product Milestones
Always use
Science
&
Regulatory Based Tools!!
December 2011
30. Project / Product Milestones
• Ongoing Development
•Quality System
Q y y
• Design Freeze
• Pre clinical V&V •Manufacturing
• Premarket Clinical Investigation
P k Cli i l I i i
• Submission for market clearance/approval
• Postmarket activities (clinical study/ies)
December 2011
31. The V&V Loop
p
Animal
A i l
Design
Ex vivo Bench
& Development
Clinical
December 2011
33. Safety / Performance / Usability
Evaluations
• Correlate with Risk Assessment / Traceability
Matrix
• Plan a matrix of tests where more than one safety
and/or efficacy aspect can be evaluated at once,
using the same group of devices
• Design
• Objectives (safety and/or performance and/or usability) and
EndPoints (mechanical usability ….)
(mechanical, usability, )
• Measures: quantitative, qualitative (scores)
• Success criteria
• Number of repetitions (confidence/reliability)
• Conduct
• E
Experimental set-up
i t l t
• Validated set-up (the model, calibrated tools)
35. Safety / Performance / Usability
Evaluations
• C
Correlate with Risk Assessment / Traceability
l t ith Ri k A t T bilit
Matrix
• Design
• Objectives (safety and/or performance and/or usability) and
EndPoints (biological, mechanical, usability, ..)
• Success criteria
• Measures: quantitative, qualitative (scores)
• Animal model and target anatomy in the animal
• Study group/s (& sample size)
• Follow up periods (acute, xx–day)
• Experimental Procedure
• Simulated clinical procedure / relevant aspects and arena
• Histology – analysis approach and parameters with a
gy y pp p
recognized pathologist
36. The Animal Lab
Conduct (from day 1)
• Selection of appropriate animal laboratory
(GLP, other accepted certification? No
certification)
tifi ti )
• Pre-visit to selected laboratory (facility, staff)
• Di
Discuss with the investigator and staff your
ith th i ti t d t ff
planned study
• Conduct of a controlled and monitored study
(Case Report Forms, accountability and
traceability of: investigated devices, animals,
y g , ,
explanted parts)
38. Clinical Strategy
gy
Post-market
Post market
.
.
.
Study # 3
Study #2
FIM
Investigational/pre-market
December 2011
39. Clinical Strategy
gy
Correlated with Risk
Assessment / Traceability
Matrix
December 2011
40. The Key to Market Penetration
y
A breakthrough technology is great but does not
ensure
ens re market s ccess
success
Regulatory approvals are meaningful milestones
•In creating value for strategic agreements
and funding
•In entrance to the market
Clinical evidence (data) is the leading force
to successful market penetration and
positioning
December 2011
41. Clinical Strategy
MEDDEV 2 7 1
2.7.1
Stage 1* Stage 2
Identify clinical data from Appraisal of individual data sets
• Suitability
• Literature searching &/or
• Clinical experience &/or • Contribution of performance
• Clinical investigation and safety
Generate new or additional
clinical data
N
O
Is clinical evidence
Stage 3
sufficient to be
able to declare Analysis of relevant data
conformity with • Strength of overall evidence
relevant ERs ? • Conclusions about performance
and safety
Y
E
S
Produce clinical evaluation
report
December 2011
42. Safety / Performance / Usability
Evaluations
E l ti
• Design
• Define type of study (example: single arm,
prospective, open label)
• Define Objectives (safety and/or performance and/or
usability) and EndPoints (safety/complications,
mechanical, usability, efficacy/clinical outcome….)
• Determine indicated population (eligibility criteria)
• Determine success criteria
• Define measures: qualitative (scores), quantitative
• Define study group/s ( & sample size)
• Define the appropriate follow up periods (acute, xx–
follo p (ac te
day)
• Experimental Procedure = Clinical procedure
December 2011
43. Safety / Performance / Usability
Evaluations
E l ti
Clinical Demonstration of Risk /
Benefit
Design is based on scientific claims,
relevant peer li
l literature & regulatory
l
submissions
December 2011
45. Some Common Pitfalls
• Bad study design
• Inappropriate selection of sites and/or investigators
• Incomplete and/or inappropriate study management
tools (procedures, logs CRFs…)
• Using under-qualified clinical research personnel
( p
(sponsor and/or site)
)
• Poor compliance with GCP– not only necessary for
regulatory reasons b also to reduce the company’s
l but l d h ’
risk from potential adverse publicity and lawsuits
December 2011
46. IP
Site Selection
Laws of
Country
Costs
Scientific
Publications
Location /
Market
Availability
Personnel &
Facilities Regulatory
Expected subjects eligibility
subjects-
December 2011
50. FDA Warning Letter (1)
Between July 26 and August 24, 2010, Thomas R. Beilke, representing the
U.S. Food and Drug Administration (FDA), conducted an investigation of your
former practice
practice.
During the course of the inspection, Mr. Beilke met with you to
review your conduct of a clinical investigation (Protocol (b)(4), titled
"(b)(4)") performed for (b)(4). You were the investigator for this clinical
investigation between March 2008 and March 2009……..
From our review of the establishment inspection report and
the documents submitted with th t report, we conclude th t
th d t b itt d ith that t l d that
you did not adhere to the applicable statutory requirements
and FDA regulations governing the conduct of clinical
investigations.
1. You failed to ensure that the investigation was conducted
according to the signed investigator statement, in that you failed to
g g g , y
personally conduct or supervise the clinical investigation [21 CFR
312.60].
2. You failed to ensure that the investigation was conducted
acco di g to the investigational plan [21 CFR 312 60]
according i estigatio al la 312.60].
December 2011
51. FDA Warning Letter (2)
This Warning Letter is to inform you of objectionable conditions observed
during the Food and Drug Administration (FDA) inspection conducted at
Orthocon, Inc.
Orthocon Inc ...
The purpose of this inspection was to determine whether activities as
sponsor of the clinical studies (b)(4) and (b)(4) complied with
applicable federal regulations.
This letter also requests prompt corrective action to address the violation
cited and discusses your written response dated September 23 2010 to the
23,
noted violation. Failure to secure the investigator’s compliance. [21
CFR 812.46(a)]: Sponsors are responsible for monitoring and
ensuring compliance of clinical investigators participating in the
investigation.
A sponsor who discovers that an investigator is not complying with the
signed agreement the investigational plan applicable FDA regulations or
agreement, plan, regulations,
any conditions of approval imposed by the reviewing IRB or FDA shall
promptly either secure compliance or discontinue shipments of the device
to the investigator and terminate the investigator’s participation in the
investigation.
December 2011
52. FDA Warning Letter (3)
During an inspection of your firm located in Or-Akivaon June 20, 2011, through
June 23, 2011, an i investigator f
i from the United S
h i d States Food and Drug
d d
Administration (FDA) determined that your firm manufactures the XX and the
YY. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the
Act), 21 U.S.C. § 321(h), these products are devices because they are intended
for use in the diagnosis of disease or other conditions or in the cure, mitigation,
treatment, or prevention of disease, or are intended to affect the structure or
function of the body……
Specifically, the XX and the YY were cleared under Kxxxxxx and Kxxxxxx,
respectively. Our inspection revealed that your firm modified the
devices by (b)(4) to the XX and the YY (b)(4). A new 510(k) is required
for this modification as it represents a significant change to the design
of the devices……
As
A a result, FDA may t k steps t refuse th
lt take t to f these products, k
d t known as
"detention without physical examination," until these violations are
corrected.
December 2011
53. In Summary
Clinical & Regulatory Affairs is about
implementing cost effective strategies and
i l ti g t ff ti t t gi d
tools for a valuable project
It is the umbrella, from early development through
market approval and up to p
pp p post-marketing activities
g
(market penetration), to support the Company in the
bringing to the markets a reasonably safe and effective
product
It is the right means to create value and
minimize (mitigate) liability in a least
burdensome way
December 2011
54. Standards G id li
St d d & Guidelines
Some Useful Links
December 2011
55. Global and EU
• Link for European directive and Guidance documents (MEDDEV)
http://www.meddev.info/
http://www meddev info/
• Link for standards of all directives (medical and non medical) in Europe
http://ec.europa.eu/enterprise/policies/european-
h // / i / li i /
standards/documents/harmonised-standards-legislation/list-references/
December 2011
56. Global and EU (Cont.)
( )
• Link for standards non active implantable medical devices in Europe
http://ec.europa.eu/enterprise/policies/european
http://ec europa eu/enterprise/policies/european-
standards/documents/harmonised-standards-legislation/list-
references/medical-devices/index_en.htm
• Link for standards active implantable medical devices in Europe
http://ec.europa.eu/enterprise/policies/european-
standards/documents/harmonised-standards-legislation/list-
t d d /d t /h i d t d d l i l ti /li t
references/implantable-medical-devices/index_en.htm
• GHTF
http://www.ghtf.org
December 2011
57. FDA
• FDA basics for Industry
http://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm
http://www fda gov/ForIndustry/FDABasicsforIndustry/default htm
• FDA general:
http://www.fda.gov/default.htm
h // fd /d f l h
• Medical Devices:
http://www.fda.gov/MedicalDevices/default.htm
• Combination products:
http://www.fda.gov/CombinationProducts/default.htm
• Device Advise
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/defa
ult.htm
December 2011
58. FDA (Cont.)
• Search for FDA Guidance Documents (by office/ year/keyword):
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guid
http://www fda gov/MedicalDevices/DeviceRegulationandGuidance/Guid
anceDocuments/default.htm
• Link to FDA databases (510(k) PMA Adverse Events Classifications
(510(k), PMA, Events, Classifications,
Registration and Listing, Standards, TPLC, 21CFR, etc)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
• CDRH Organization structure and directors (personnel)
p g
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm
127854.htm
• CDRH post approval studies database:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm
December 2011
59. 2010 - 2011 Interesting FDA
Guidance
• D f Guidance f I d
Draft G id for Industry and F d and D
d Food d Drug Administration S ff -
Ad i i i Staff
Investigational Device Exemptions (IDE) for Early Feasibility Medical
Device Clinical Studies, Including Certain First in Human (FIH) Studies
• Draft Guidance for Industry and Food and Drug Administration Staff -
Applying Human Factors and Usability Engineering to Optimize Medical
Device Design
• Draft Guidance for Industry and FDA Staff: FDA a d Industry Procedures
a t Gu da ce o dust y a d Sta : and dust y ocedu es
for Section 513(g) Requests for Information under the Federal Food, Drug,
and Cosmetic Act34
• Guidance for Industry and FDA Staff: General Considerations for Animal
Studies for Cardiovascular Devices3
December 2011
60. 2010 - 2011 Interesting FDA
Guidance (Cont.)
• Draft Guidance for Industry, Clinical Investigators, Institutional Review
Boards, and Food and Drug Administration Staff - FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations
• Draft Guidance for Industry and Food and Drug Administration Staff - De
Novo Classification Process (Evaluation of Automatic Class III
ovo C ass cat o ocess ( va uat o o uto at c C ass
Designation)2
• Oversight of Clinical Investigations — A Risk Based Approach to
Risk-Based
Monitoring
• D f Guidance f I d
Draft G id for Industry and F d and D
d Food d Drug Administration S ff -
Ad i i i Staff
Factors to Consider when Making Benefit-Risk Determinations in Medical
Device Premarket Review
December 2011
61. Useful Links
2010 - 2011 Interesting FDA
Guidance
• Draft Guidance for Industry, Clinical Investigators, and Food and Drug
y, g , g
Administration Staff - Design Considerations for Pivotal Clinical
Investigations for Medical Devices
• Guidance for Industry and FDA Staff - 510(k) Device Modifications:
Deciding When to Submit a 510(k) for a Change to an Existing Device
• Draft Guidance for Industry and FDA Staff - Commercially Distributed
In Vitro Diagnostic Products Labeled for Research Use Only or
Investigational Use Only: Frequently Asked Questions
December 2011
62. Useful Links
2010 - 2011 Interesting FDA
Guidance (Cont )
(Cont.)
• Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device
Studies - Frequently Asked Questions
• Draft Guidance for Industry, Third Parties and FDA Staff: Medical
Device ISO 13485:2003 Voluntary Audit Report Submission Program
December 2011
63. The Innovation Paradigm:
Good or Bad?
Maier Fenster
Copyright 2011 All rights reserved
No Portion may be Copied or Otherwise Reproduced without Express Written Permission
64. Disclaimer
• The purpose of this presentation is to
communicate concepts. There is no
guarantee that the information presented
is complete or up-to-date.
• Also, information is not legal advice. Legal
advice is when you apply information to a
situation.
• Go to a lawyer for legal advice.
• Go to a patent attorney for patent-related
advice.
• Go to a regulatory expert for regulatory
advice.
65. Why are we having this talk
• We all live innovation, but sometimes it
seems like too much of a good thing
• Try to illustrate the tensions between
innovation and success, with special
emphasis on regulatory affairs and
clinical trials
• Will attempt to give tools to model, not
always solve, the problems
• An experimental talk
66. Outline
• What is the innovation paradigm
• What is the ideal regulatory process
• What is the ideal development process
• What is the reality & why
• A suggested attitude
• Some practical examples
• Q&A and discussion
67. The Innovation Paradigm
• Premise: We will succeed because our
product is better
• Assumption: Our product is better
because we have secret discovery/better
engineers/better understanding/blind luck
• Conclusion: we need to show that our
product is better
• Corollary: we hire people and work hard
to make our product better
• Emphasis: not “better”; “MUCH better”
68. Ideal regulatory process #1
• Plan new product based on existing
market/product
• Develop new product
• Show equivalence of new product & old
product
• Ta-da
• Insight: more innovation requires more
proof
• And: small improvement requires more
proof
69. Ideal regulatory process #2
• Have great new idea
• Develop great new device
• Run clinical trials
• Succeed
• Ta-da
• Insight: all’s well that ends well
70. Ideal development process
#1
• Have idea
• Create design, taking into account ideal
manufacturing method and usage
method
• Build device
• Have it work first time
• Ta-da
• Insight: we all like risk-free R&D
71. Ideal development process
#2
• Have idea
• Build prototype
• Test prototype - fast
• Redesign device based on test
results & user input
• Repeat until great product is created
• Ta-da
• Insight: moving fast with lots of
money is good
72. Reality knocks - basics
• Only the lucky ones have innovation
which does not affect functioning
• New product can be better in:
– Manufacturability
– Shelf life
– Ease of use
– Reliability in body
– Function
– Side effects/Safety
– Other
73. Reality knocks - basics,
cont.
• New device might (only) be different,
not better
• When will we find out that device is
better?
• Will the market change?
• Will competition change the game?
• Experimental failure is bad
74. Reality knocks - process
• What are chances experiments will work
as advised?
• How long must we wait for that (e.g.,
avoid adverse results)?
• Will there be NO inputs from users? data
analysis?
• What if a problem is discovered?
• What if device is not good enough?
• What if a better device is possible?
75. Reality knocks - people
• People involved believe in innovation
• People involved want to cure patients
• Researchers are NOT mere technicians
• Hype, advisors & investors
• Engineers do not just change gears
• Building the company brand
• Pressure from agile development
processes
76. Reality knocks - IP
• There is a war going on – enemy is watching
• One must think several steps ahead
• What you tell one government agency, others will
know about
• Several court cases on point
• Device development cycle is slower than IP cycle
• IP can drive development by publishing ideas
• IP & device specs do not fully overlap
• When is innovation understood? And if it changes?
• Make IP match the selection for regulatory approval
• Problems and opportunities
77. What is your reality?
• Be aware of conflicting forces that encourage,
discourage and/or channel innovation and
discussion of innovation. Who is involved for
each “party”?
• How do you balance need for showing
innovation with need for showing lack of
innovation.
• How is innovation channeled?
• Money. Business. Working product. How are
they linked to innovation and its consequences?
• Are all “risks” from experiments taken into
account?
78. Some suggested activities
• Micro-level
– Collaboration between IP and regulatory advisors,
and also with publishing bodies, such as researchers
– re-consider (everything) based on changes in target,
on a regular basis
• Divert innovation activities to:
– clear “stage II” products/features
– less regulated issues
• Play the country game
• Prepare alternative pathways
– File IP based on prediction of results
– Develop and advance designs based on IP problems
• Experiment also for IP - Early
79. Case study – unneeded battle
• Story of a client who was not careful
• They wanted to get a patent – so they explained
innovation
• They wanted 510(k) so they explained how
innovation was same as prior art
• Then they got threatened, with other side basing
its belief on the 510(k)
• Good news: they came to us
• We did lots of stuff, including a new 510(k) filing
• We won. But (Sun Tzu):
– The greatest victory, is the battle not fought.
80. Case study - hindsight
• What FDA wants to get comfort on is not exact
opposite of what patent office wants to see for
inventive step
– USPTO does not care much about safety. FDA does
– FDA is happy if device works same as old device
due to lack of insight in the past into operation
mechanism and its consequences; USPTO would
be happy too
• Somebody could have made an educated
decision
• Somebody could have coordinated between the
“professionals”
• One should be aware of case law
81. More hindsight
• Talking about your own previous and
current devices is bad enough
• Talking about the competition is worse
• Any statements can be used against you
in a court of law
• Courts (& management) tend to confuse
patent and product. Don’t help them get
confused
• Risk: (partial) admission of infringement
• Risk: admission of fraud
• Risk: attracting litigation
82. Case study – loose lips sink ships
• Client wanted 510(k). Presented device as
substantially equivalent.
• Client wanted investor hype. Published
paper showing innovation
• FDA was not happy.
• Hindsight – if you generate hype, make
sure it does not reflect on your regulatory
processes.
• Nice if hype does reflect on your IP
processes.
83. Principles of Law-I
• In determining infringement it is settled law
that the accused device should be
compared to the patent claims and not to a
particular product manufactured by the
patent holder.
• Nevertheless, this idea is sometimes
confusing to patent holders and also to
courts, which find it easier to compare the
accused device to a concrete device than
to compare it to abstract claims.
• Furthermore, such admissions can be
used an opening to claim willfulness or
fraud on the patent office.
84. Principles of Law-II
• Even if the admission is not
considered a complete admission of
infringement, the wording of the
510(k) could still help the patentee by
positively mentioning some of the
features of the claims as being the
same in both devices.
85. Principles of Law-III
• In Pall Corp. v. Hemasure Inc., the
Federal Circuit used the disclosure in
the 510(k) as a guide to determine
whether there was infringement.
However, there apparently was no
utilization of the patentee’s device as a
predicate.
86. Principles of Law-IV
• In Electro Scientific Industries Inc. v.
Dynamic Details Inc., the Federal
Circuit discussed whether the
information in the FDA 510(k), which
was not supplied to the USPTO,
could be considered fraud on the
patent office, in that the submission
contained drawings made by a sub-
contractor. Based on the facts of the
case it decided that this did not raise
an inventorship issue.
87. Principles of Law-V
• In United States Surgical Corp. v. Hospital
Products International PTY Ltd., the US District
Court for Connecticut made the following
statement:
• “The defendants have gone so far as to cause
statements to be made that may be construed as
admissions of infringement. For example, on
October 28, 1980, HPI submitted to the United
States Food and Drug Administration a §510(k)
pre-market notification, signed by Blackman, of
its intention to sell its 30, 55, and 90 medium and
large series of DLUs, as well as its GA/ANAST
(an earlier name for the defendants’ ILA DLU). It
was stated in the notification that these devices
were equivalent to their USSC counterparts.”
• However, the court did not utilize this admission
in finding infringement.
88. Principles of Law-VI
• In a footnote in Clintec Nutrition Co. v. Baxa
Corp., the US District Court for the Northern
District of Illinois states:
• “Clintec also relies on Baxa's Section
510(k) submission to the Food and Drug
Administration (“FDA”), representing that
Baxa's and Clintec's compounders are
“substantially equivalent.” Clintec does not,
however, point me to an affirmative
representation in the submission that
Baxa's compounders “sort.” … Baxa
gained the Agency's approval to market its
compounders without undergoing a more
extensive approval process, because Baxa
was able to demonstrate that its
compounders were “substantially
equivalent” to Clintec's. “
89. Principles of Law-VII
• “A device is ‘substantially equivalent’ if it has
the same intended use and the same
technological characteristics as those of the
existing device.
• “Thus, the 510(k) submission compares the
accused product, Baxa's compounders, with
the commercial embodiment of the ‘010
patent, Clintec's compounders. “ [I]t is error for
a court to compare in its infringement analysis
the accused product . . . with the patentee's
commercial embodiment.” …Although in the
recitation of facts, the court in United States
Surgical Corp. v. Hospital Prods. Int'l Pty. Ltd.,
remarked that statements in the Section
510(k) submission “may be construed as
admission of infringement,” the court did not
rely on the submission in the infringement
analysis.”
90. Principles of Law-VIII
• It seems clear that a court will consider
statements made in a 510(k) as being
statements against interest. The extent of
the damage will depend of course on the
statements made and how they impact on
the issues before the court.
• Thus, it is important to weigh carefully all
statements made in a 501(k). This is not
limited to comparisons with predicate
devices but also includes statements
regarding the operation of the device, etc.
91. Summary
• Innovation is good, but at some point it
needs to be controlled and/or
channeled
• IP and regulatory processes interact.
Strongly. And both are affected by
experiments.
• Use a good regulatory advisor
• Like lots of life – timing, expectation
matching and risk management
• Not all bad – one can get synergy by
matching business, IP and regulatory
94. Agenda
1. What
2. When 1. What (is ‘Reimbursement’)
3. How
4. Where
2. When (Should We Start Dealing With It)
3. How (Do We Take Care of It)
4. Where (In Which Countries First)
3 / 51
95. What is ‘Reimbursement’?
1. What
2. When 1. What (is ‘Reimbursement’)
3. How
4. Where
2. When (Should We Start Dealing With It)
3. How (Do We Take Care of It)
4. Where (In Which Countries First)
4 / 51
98. What is ‘Reimbursement’?
Stakeholders
1. What
2. When
Healthcare Providers: Patients:
3. How Hospital
4. Where
ASC / Imaging Center
Physician
Payers:
Government
Insurance Companies / Sickness Funds / Primary
Care Trusts
7 / 51
99. What is ‘Reimbursement’?
Financing a Healthcare System
1. What
2. When
3. How
4. Where
Financing a
Healthcare
System
8 / 51
100. What is ‘Reimbursement’?
Financing a Healthcare System
1. What
2. When
Public / Statutory:
3. How
Sources (Citizens): Collection (Payers):
4. Where
Taxes from the general
population
Social health insurance
from:
• Employers:
• Employees
9 / 51
101. What is ‘Reimbursement’?
Financing a Healthcare System
Sources Collection Paid To For
1. What
(Citizens): (Payers): (Providers): (Patients):
2. When
3. How
4. Where
Public / Statutory Out of Pocket
Reimbursement
Private / Complementary
10 / 51
102. What is ‘Reimbursement’?
Reimbursement Workflow
1. What
2. When
3. How
4. Where
Reimbursement
Workflow
11 / 51
103. What is ‘Reimbursement’?
Reimbursement Workflow
1. What 1. The healthcare provider uses CODES
2. When to tell the Payer:
3. How
a. The problem Diagnostic Code/s
4. Where
b. The service Procedure Code/s
c. Add. details Age, Sex, etc.
2. The Payer checks if the above
combination has COVERAGE
3. If positive, the Payer reimburses the
healthcare provider according to the
applicable PAYMENT schedule
12 / 51
104. What is ‘Reimbursement’?
Reimbursement Workflow
1. What For each setting: There are different:
2. When
3. How Inpatient CODES,
4. Where Procedures
COVERAGE
Outpatient guidelines, and
Procedures
PAYMENT levels
Office based
Procedures
13 / 51
105. What is ‘Reimbursement’?
1. What
2. When
Meaning of Life
3. How “While I can explain the
4. Where meaning of life, I don’t
dare try to explain how
the reimbursement
system works”
14 / 51
106. Agenda
1. What
2. When 1. What (is ‘Reimbursement’)
3. How
4. Where
2. When (Should We Start Dealing With It)
3. How (Do We Take Care of It)
4. Where (In Which Countries First)
15 / 51
107. When Should We Start Dealing With It?
Past
1. What Past
2. When
Healthcare costs Containable
3. How
4. Where Following FDA/CE Reimbursement is
‘given’
Decision Makers for a Healthcare Providers
market launch
Reimbursement Not important
strategy
Planning for Just prior to launch
reimbursement
16 / 51
108. When Should We Start Dealing With It?
Past
1. What
2. When
3. How
4. Where
17 / 51
109. When Should We Start Dealing With It?
Present
1. What
2. When
3. How So, what has changed?
4. Where
18 / 51
110. When Should We Start Dealing With It?
Present
1. What Past Present
2. When
Healthcare costs Containable Soaring
3. How
4. Where Following FDA/CE Reimbursement is Reimbursement only if
‘given’ there’s clinical +
economic value
Decision Makers for a Healthcare Providers Healthcare Providers +
market launch Payers
Reimbursement Not important Required by Investors,
strategy inc. resources and
timelines
Planning for Just prior to launch At an early stage
reimbursement
19 / 51
111. When Should We Start Dealing With It?
Past
1. What Errors Solutions
2. When
• Product features prevent utilization of • Consider reimbursement implications
3. How existing reimbursement mechanisms during product design
4. Where
• Targeted applications / indications / • Consider reimbursement implications
settings / populations - delay when defining your market /
reimbursement marketing strategy
• FDA/CE application prevents • Consider reimbursement
reimbursement implications before applying for FDA
clearance or CE mark
• Clinical trials not leveraged to also • Add reimbursement parameters to
generate reimbursement evidence your planned clinical trials
• Price not optimized when launching • You know what to do…
product or negotiating with a potential
20 / 51 investor/buyer
112. Agenda
1. What
2. When 1. What (is ‘Reimbursement’)
3. How
4. Where
2. When (Should We Start Dealing With It)
3. How (Do We Take Care of It)
4. Where (In Which Countries First)
21 / 51
113. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision 4. Evidence Planning 9. Implementation
Landscape Report Makers
• Value story • User base, stakeholders’ support
2. When • Codes, coverage • Economic model
& payment Healthcare • Issue a Billing Guide, utilize existing
Providers • Points for clinical
• Reimbursement reimbursement mechanisms
3. How study protocol
strategy
• Stakeholders’
4. Where Payers
feedback
• Apply for new reimbursement
mechanisms
2. Regulatory Class I (NS/M) •Technical file
Landscape
8. Preparation / Application
Report Class I (S/M) 3. Quality
EU Manag.
•Regulatory Class IIa System
status
Class IIb •Design
•Device Control 5. Clinical 6.Perform 7.Quality
classification Class III procedures Study Clinical Manag. •Design dossier
•Intended use Protocol Study System
•Other QS
& indications •Review / •Clin. Eval. •FDA QSR /
Class III aspects for •PMA
for use write report ISO 13845
US/EU pre-
•Regulatory Class II study •510(k)
route compliance
Class I
US
22 / 51
114. How Do We Take Care of It?
1. What 1. Reimbursement Gather data
Landscape Report
– Determine relevant For each setting: There are different:
2. When • Codes, coverage
& payment settings. Inpatient CODES
3. How • Reimbursement Procedures
strategy
Outpatient COVERAGE
4. Where guidelines
Procedures
PAYMENT levels
Office based
Procedures
– Check for relevant 1. The healthcare provider uses CODES
codes, coverage policies to tell the Payer:
and payment rates. a. Problem Diagnostic Code/s
b. Service Procedure Code/s
c. Details Age, Sex, etc.
2. The Payer checks if the above combination
has COVERAGE
3. If positive, the Payer reimburses
the healthcare provider according
to the applicable PAYMENT
23 / 51 schedule
115. How Do We Take Care of It?
1. What
2. When
3. How
4. Where
24 / 51
116. How Do We Take Care of It?
1. What 1. Reimbursement Gather data
Landscape Report
– Determine relevant For each setting: There are different:
2. When • Codes, coverage
& payment settings. Inpatient CODES
3. How • Reimbursement Procedures
strategy
Outpatient COVERAGE
4. Where guidelines
Procedures
PAYMENT levels
Office based
Procedures
– Check for relevant 1. The healthcare provider uses CODES
codes, coverage policies to tell the Payer:
and payment rates. a. Problem Diagnostic Code/s
b. Service Procedure Code/s
c. Details Age, Sex, etc.
2. The Payer checks if the above combination
– Statistics has COVERAGE
3. If positive, the Payer reimburses
the healthcare provider according
to the applicable PAYMENT
25 / 51 schedule
117. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision This enables us to:
Landscape Report Makers
2. When • Codes, coverage •Define the most relevant Decision Makers for the
& payment Healthcare
Providers reimbursement of you’re the product.
3. How • Reimbursement
strategy
•Formulate an initial reimbursement strategy for the
4. Where Payers new product in the selected markets (Europe, US).
26 / 51
118. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision In parallel, a Regulatory Landscape Report determines the
Landscape Report Makers
product’s classification, intended use, indications for use
2. When • Codes, coverage
& payment Healthcare and the anticipated regulatory route.
Providers
3. How • Reimbursement
strategy
4. Where Payers
Regulatory
2. Regulatory Class I (NS/M)
Landscape
Report Class I (S/M) Reimbursement
EU
•Regulatory Class IIa
status
Class IIb
•Device
classification Class III
•Intended use
& indications Intended use Affects possible reimbursement
for use Class III
•Regulatory Class II
route Substantially equivalent = substantially equivalent
Class I
US payment
27 / 51
119. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision At the next stage, when the company prepares for its
Landscape Report Makers
clinical study (if needed), it typically:
2. When • Codes, coverage
& payment Healthcare
Providers •Implements the relevant parts of its Quality Management
3. How • Reimbursement
strategy System (e.g., Design Controls and other QS aspects
4. Where Payers
essential for US and EU pre-study compliance).
•Starts writing its clinical study protocol.
2. Regulatory Class I (NS/M)
Landscape
Report Class I (S/M) 3. Quality
EU Manag.
•Regulatory Class IIa System
status
Class IIb •Design
•Device Control 5. Clinical
classification Class III procedures Study
•Intended use Protocol
•Other QS
& indications •Review /
Class III aspects for
for use write
US/EU pre-
•Regulatory Class II study
route compliance
Class I
US
28 / 51
120. How Do We Take Care of It?
Long before the clinical study begins, we
1. What 1. Reimbursement Main Decision 4. Evidence Planning
Landscape Report Makers plan the required ‘evidence’ for the
• Value story
2. When • Codes, coverage • Economic model
product’s reimbursement :
& payment Healthcare
Providers • Points for clinical
3. How • Reimbursement study protocol
• Value Story: Claim for clinical AND
strategy
• Stakeholders’ economic benefits compared to current
4. Where Payers
feedback alternatives.
• Economic Model: Quantify the economic
benefit, allow for sensitivity analysis and
use as a sales tool.
2. Regulatory Class I (NS/M)
Landscape • Reimbursement Related Parameters:
Report Class I (S/M) 3. Quality
Manag.
Integrate in the study protocol.
EU
•Regulatory Class IIa System
status • Stakeholders’ Feedback: Verify support
Class IIb •Design
•Device Control 5. Clinical
of the relevant Decision Makers, if the
classification Class III procedures Study claims in the Value Story are proven
•Intended use Protocol according to the presented clinical study
•Other QS
& indications •Review /
Class III aspects for protocol.
for use write
US/EU pre-
•Regulatory Class II study
route compliance
Class I
US
29 / 51
121. How Do We Take Care of It?
1. What
2. When
Regulatory Approval ≠ Reimbursement
3. How
4. Where Regulatory entities Reimbursement entities
(FDA, NBs, …) (CMS, Sickness Funds, …)
Does the product: do what it claims? improve outcomes?
Is the product: safe & effective? reasonable & necessary?
Data from: controlled settings real world
Support of: KOLs medical society/ies
Cost: not relevant may be key
30 / 51
122. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision 4. Evidence Planning Now, the clinical trial may be
Landscape Report Makers conducted and the resulting
• Value story
2. When • Codes, coverage • Economic model ‘evidence’, substantiating the claims
& payment Healthcare
• Reimbursement
Providers • Points for clinical in the Value Story, should be
3. How study protocol
strategy published.
• Stakeholders’
4. Where Payers
feedback
2. Regulatory Class I (NS/M)
Landscape
Report Class I (S/M) 3. Quality
EU Manag.
•Regulatory Class IIa System
status
Class IIb •Design
•Device Control 5. Clinical 6.Perform
classification Class III procedures Study Clinical
•Intended use Protocol Study
•Other QS
& indications •Review / •Clin. Eval.
Class III aspects for
for use write report
US/EU pre-
•Regulatory Class II study
route compliance
Class I
US
31 / 51
123. How Do We Take Care of It?
Seed Funding Round A
1. What 1. Reimbursement Main Decision 4. Evidence Planning
Landscape Report Makers Raise funding:
• Value story
2. When • Codes, coverage • Economic model • At this stage, in order to finance
& payment Healthcare
• Reimbursement
Providers • Points for clinical their clinical trial, many companies
3. How study protocol
strategy raise their growth funding round
• Stakeholders’
4. Where feedback (also referred as Series A round).
Payers
2. Regulatory Class I (NS/M)
Landscape
Report Class I (S/M) 3. Quality
EU Manag.
•Regulatory Class IIa System
status
Class IIb •Design
•Device Control 5. Clinical 6.Perform
classification Class III procedures Study Clinical
•Intended use Protocol Study
•Other QS
& indications •Review / •Clin. Eval.
Class III aspects for
for use write report
US/EU pre-
•Regulatory Class II study
route compliance
Class I
US
32 / 51
124. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision 4. Evidence Planning Completion of QMS
Landscape Report Makers
• Value story
2. When • Codes, coverage • Economic model If the company has not already done
& payment Healthcare
Providers • Points for clinical so, the quality management system
3. How • Reimbursement study protocol
strategy can be completed to ensure it
• Stakeholders’
4. Where feedback complies with US and/or European
Payers
requirements.
2. Regulatory Class I (NS/M)
Landscape
Report Class I (S/M) 3. Quality
EU Manag.
•Regulatory Class IIa System
status
Class IIb •Design
•Device Control 5. Clinical 6.Perform 7.Quality
classification Class III procedures Study Clinical Manag.
•Intended use Protocol Study System
•Other QS
& indications •Review / •Clin. Eval. •FDA QSR /
Class III aspects for
for use write report ISO 13845
US/EU pre-
•Regulatory Class II study
route compliance
Class I
US
33 / 51
125. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision 4. Evidence Planning • Europe: Submit the Technical File
Landscape Report Makers or the Design Dossier
• Value story
2. When • Codes, coverage • Economic model
& payment Healthcare • USA: apply for FDA Clearance (510
Providers • Points for clinical
3. How • Reimbursement study protocol (k)) or Approval (PMA).
strategy
• Stakeholders’
4. Where Payers
feedback
2. Regulatory Class I (NS/M) •Technical file
Landscape
8. Preparation / Application
Report Class I (S/M) 3. Quality
EU Manag.
•Regulatory Class IIa System
status
Class IIb •Design
•Device Control 5. Clinical 6.Perform 7.Quality
classification Class III procedures Study Clinical Manag. •Design dossier
•Intended use Protocol Study System
•Other QS
& indications •Review / •Clin. Eval. •FDA QSR /
Class III aspects for •PMA
for use write report ISO 13845
US/EU pre-
•Regulatory Class II study •510(k)
route compliance
Class I
US
34 / 51
126. How Do We Take Care of It?
1. What 1. Reimbursement Main Decision 4. Evidence Planning 9. Implementation
Landscape Report Makers
• Value story • User base, stakeholders’ support
2. When • Codes, coverage • Economic model
& payment Healthcare • Issue a Billing Guide, utilize existing
Providers • Points for clinical
• Reimbursement reimbursement mechanisms
3. How study protocol
strategy
• Stakeholders’
4. Where Payers
feedback
• Apply for new reimbursement
mechanisms
In case existing reimbursement mechanisms •Technical file
(Codes, Coverage, Payment) exist, we will
8. Preparation / Application
• Develop a dossier to convince Healthcare
Providers to purchase your new product. 5. Clinical 6.Perform 7.Quality
Study Clinical Manag. •Design dossier
Protocol Study System
Otherwise: •Review / •Clin. Eval. •FDA QSR /
•PMA
write report ISO 13845
• After verifying a sufficient user-base and •510(k)
support from the medical community, we
will apply for new codes, coverage policies
and favorable payment rates.
35 / 51
127. How Do We Take Care of It?
1. What
2. When
3. How
4. Where
36 / 51
128. Agenda
1. What
2. When 1. What (is ‘Reimbursement’)
3. How
4. Where
2. When (Should We Start Dealing With It)
3. How (Do We Take Care of It)
4. Where (In Which Countries First)
37 / 51
129. Where (In Which Countries First)?
1. What
2. When 1. Potential market
3. How
2. Supportive environment:
4. Where
IP protection
Regulatory process
Reimbursement
38 / 51
130. Where (In Which Countries First)?
Potential Market
1. What
2. When 1. Potential market
3. How
2. Supportive environment:
4. Where
IP protection
Regulatory process
Reimbursement
39 / 51
131. Where (In Which Countries First)?
Potential Market
1. What
3 Types of Healthcare Systems
2. When
3. How
Private Payer and Provider are separated entities
Payers
4. Where Clearer definition of covered procedures.
Detailed reimbursement lists.
Statutory
Sickness
Funds
There must be an accurate procedure code (with its
coverage and payment rate).
Payer and Provider are not so separated
No need for a clear definition of coverage.
NHS
Reimbursement also relies on ‘block contracts’,
‘balance Grants’, etc.
40 / 51
132. Where (In Which Countries First)?
Potential Market
1. What
Healthcare Expenditure per Capita ($US PPP)
2. When
3. How
Private 7,538
4. Where Payers
Statutory 3,737
Sickness
Funds 3,696
3,129
NHS 2,870
2,902
41 / 51 $US
Source: OECD Indicators 2008 (http://stats.oecd.org)
133. Where (In Which Countries First)?
Potential Market
1. What
Healthcare Expenditure per Capita (% of GDP)
2. When
3. How
Private 16.0%
4. Where Payers
Statutory 10.5%
Sickness
Funds 11.2%
8.7%
NHS 9.1%
9.0%
42 / 51 $US
Source: OECD Indicators 2008 (http://stats.oecd.org)
134. Where (In Which Countries First)?
Potential Market
1. What
Healthcare Expenditure Sources
2. When
3. How
Private (47) (12)
(41)
4. Where Payers
Statutory (77) (10) (13)
Sickness
Funds (78) (15) (7)
% Public / Statutory
(83) (11)
% Private / Complementary
NHS (77) (20)
% Out of Pocket
(73) (21)
43 / 51 $US
Source: OECD Indicators 2008 (http://stats.oecd.org)
135. Where (In Which Countries First)?
Potential Market
1. What
Spending on medical technology: €187B
2. When
3. How • US: 42% Medical technology is defined as
wheelchairs, pacemakers, orthopedic
4. Where • Germany (DM): 11%
shoes, spectacles and contact lenses,
• Japan (JP): 10% insulin pens, hip prostheses, condoms,
• France: (FR): 05% oxygen masks, dental floss, MRI
scanners, pregnancy tests, surgical
• UK: 04%
instruments, bandages, syringes, life-
• China (CH): 02% support machines, etc.
CH UK FR JP DM US
0 10 20 30 40 50 60 70 80 90 100
44 / 51 Source: Eucomed Medical Technology Brief, May 2007
136. Where (In Which Countries First)?
Potential Market
1. What
Medical Technologies Funding (% of GDP)
2. When
3. How
Private 0.71%
4. Where Payers
Statutory 0.92%
Sickness
Funds 0.62%
0.36%
NHS 0.5%
0.46%
45 / 51 $US
Source: AdvaMed, UK Medical Technology Issues, CEO Toolkit, January 2005
137. Where (In Which Countries First)?
Supportive Environment
1. What
2. When 1. Potential market
3. How
2. Supportive environment:
4. Where
IP protection
Regulatory process
Reimbursement
46 / 51
138. Where (In Which Countries First)?
Supportive Environment – IP Protection
IP protection :
1. What
9 – Best 7
2. When 0 – Worst
6 Germany
3. How France
USA
4. Where Japan
5 UK
China Israel
4
IP
India
Brazil
3
2
1
Software piracy rate
80% 60% 40% 20% 0%
47 / 51 PWC Innovation Scorecard
139. Where (In Which Countries First)?
Supportive Environment – Regulatory
Ease of regulatory
1. What
approval: 9
9 – Easiest Israel
2. When
0 – Most difficult 8
3. How
7 India France
4. Where
6 UK
Germany
5 Regulatory
USA
4
Brazil
3 China
Japan
2
1
Regulatory approval
time, months
30 24 18 12 6
months months months months months
48 / 51 PWC Innovation Scorecard
140. Where (In Which Countries First)?
Supportive Environment - Reimbursement
1. What
2. When
3. How
4. Where
Reimbursement
49 / 51 PWC Innovation Scorecard
141. Where (In Which Countries First)?
Supportive Environment
1. What
2. When
3. How
4. Where
IP
Regulatory
Reimbursement
50 / 51 PWC Innovation Scorecard
142. The End
1. What
2. When Thank You For Listening
3. How
4. Where
Amir Inbar, CEO http://www.mediclever.com
amir@mediclever.com http://twitter.com/mediclever
050.837.1711 http://mediclever.com/blog
UK Office: Israel Office:
• 27 Old Gloucester St., • 6 Te’ena St.,
• London WC1N 3AX • Modiin 71799
• uk@mediclever.com • il@mediclever.com
51 / 51 • +44.208.099.7435 • +972.50.837.1711
143. A Notified Body perspective when
revising and judging the conformity of a
device for granting CE marking Hester Hasper
144. Contents
Introduction to DEKRA: bigger picture & business line medical
DEKRA’s expertise & market access
Conformity assessment by the notified body & the D&D process
New applications (dossier): what are we looking at?
Review of the approach to obtain CE
Changes / revisions / extension: what is the approach followed?
145. Bigger picture: Business Line Medical within DEKRA
DEKRA GROUP
(HQ Stuttgart, Germany)
DEKRA
Operating in 29 European countries
as well as in North America, Brazil, 21 000
South Africa and China.
Organized in 4 Business Units
comprising a total of 180
consolidated companies. DEKRA Industrial
5 000
Generating 1.7 billion euros in sales
and employs 21000 staff.
Testing &
DEKRA Testing and Certification is Certification
1000
part of the Business Unit DEKRA
Industrial with 5000 business and Medical
technical professionals.
146. Business Line Medical
Characteristics Competence areas
● Involves testing and certification of medical ● Audits
devices, and auditing of medical device companies ● Product assessments
● Certification
● A leading top 5 global Notified Body in Medical
device certification ● Product testing (IEC 60601)
● Training
● Recognized market leader in high risk devices
● Strong positions in Netherlands, Germany & USA CE0124 & CE0344
● Recognized body by EU, the FDA, Health Canada
● Test labs in Arnhem, Stuttgart & Dresden.
147. Business Line Medical Global Network
One global team of experts, Arnhem CE0124
Paris
no country organizations, Stuttgart
CE0344
no barriers
San Francisco
Philadelphia Tokyo
תל אביב
148. Expertise and Knowledge at DEKRA
Cardiovascular Products with
surgery animal tissue
Minimal invasive High-tech start-up
surgery companies
Ophthalmic
Intravascular
surgery
catheters
Wound care
Intra ocular lenses products
Soft tissue implants Body contouring
implants
Active Implantable
devices Active Medical devices
High tech start-up companies Emerging technologies High risk products