Laser solutions for medical...
Transcript of Laser solutions for medical...
Lasers and optics for personalized medicine and better life.
Dr. Petteri Uusimaa, VP & CTO3rd Jan 2020
Laser solutions for medical applications
fModulight, Inc.❑ The only vertically integrated PDT
laser manufacturer in the world❑ Profitable privately held company
with 19 years track record❑ Exclusive supplier to 10+ pharmas
& world leading cancer centers in USA & Europe
❑ Long track record of making all kinds of semiconductor lasers & pumps (400–2000 nm)
❑ Certified ISO13485 QMS in 2011, ISO9001 & 14001 in 2002
❑ Co-branded & OEM products currently shipping to all continents except Antarctica
❑ 600 000 pcs of 9xx-nm pulsed lasers in 2015 for LIDAR
Custom & industrial Services
Regulatory & engineering • Lifecycle support
Life sciences❑ Medical laser systems
❑ Oncology
❑ Ophthalmology
Subsystems for challenging optics & electronics • Processing
❑ Optogenetics
❑ Pharmaceutical safety & testing
Worldwide laser markets €15B
Medical laser markets €1.2B (GAGR 10%)
Surgical, therapy and ophthalmic laser markets €400M
Source: Strategies Unlimited
Growth drivers for medical lasers
Wider acceptance of laser based cosmetics and disposable based business models
Compact size and cost efficiency of diode based medical laser technology →handhelds, handset inregration, home use
Health monitoring lifestyle with various optical sensors, increase of outpatient treatment and mobile hospitals
Aging population in welfare countries increases demand for ophthalmics, oncology and other late age illnesses
Hip surgery
Actinic keratosis
PerkinElmerPlate reader
❑ Small / medium (10s/100s / 1000s) + High volume partnerships
❑ Regulatory support / FDA visits / 3rd party customer audits support + Vigilance reporting
❑ Sell-out reporting & customer intimacy analytics
❑ Example: PerkinElmer plate reader❑ GDPR / HIPAA: Yes
STANFORDPEDIATRICCARDIAC
NeuroOpthalmic solutions
Laser Induced
Skull surgery
DISCOVERY & INNOVATION
❑ Optical pacing / Optogenetics❑ Nerve stimulation / Ischemic
stroke – accelerated FDA track❑ Light activated drug release
liposomes❑ Example: Stanford pediatric
cardiac project
PROTOTYPING
❑ Novel opthalmictreatment❑ MRSA / Hip surgery (UCL)❑ Light activated skull pin
fixation ❑ In-vivo illumination kits❑ Actinic keratosis❑ Surgical lasers❑ Non-invasive glucose
monitoring,
PRODUCTIZATION❑ Design for manufacturing❑ Example: Glioblastoma❑ Data collection, Cloud monitoring of
clinical trials, future sell-out monitoring, Efficacy improvement & analytics, pre-emptive maintenance
❑ Phase 3 simultaneously or after❑ GDPR / HIPAA: Yes❑ Modulight as production partner
TESTING / CONCEPT VALIDATION❑ Validate business idea /
product / clinical trial / efficacy
❑ Product improvement❑ Example: Uveal melanoma
case Aura❑ Data collection & analysis❑ GDPR / HIPAA: Often yes
LIFE CYCLE MGMT
❑ Post market support❑ Vigilance reporting❑ Warranty & service❑ Calibrations❑ EXAMPLE:
Visudyne/Photofrin/ PerkinElmer Envision
❑ Online / cloud materials and user support
PRODUCTION
Ophtalmiccancer
treatment laser
Infra structure Capabilities❑ In-house laser production & design
– come and see❑ True supply chain control❑ Independence from third party
decisions ❑ Full traceability to the level not
available from competing laser companies
❑ MADE IN FINLAND - quality controlled and ethical work place
❑ Premises and factory all owned by Modulight
❑ Comprehensive regulatory, lifecycle & field support
❑ Demonstrated capability to develop numerous laser related products and exceed customer expectations – talk to us for more!
Design capabilities❑ Laser chip & structure❑ Electronics & software❑ Usability & regulatory❑ Field service & lifecycle support
E U R O P E U S A
REGULATORY SERVICE
MODULIGHT CE MARKModulight creates technical file and applies for CE mark on behalf of customer
PRIVATE LABEL CE MARKModulight provides technical content for CE mark submission
IND / IDEModulight assists with regulatory submission
510 (k)FDA approved device
PMAModulight has solid experience delivering fullFDA PMA regulatory submission file
PROCESS Product tested towardsCB certification
Modulight manages CE applicationprocess and initial factory audit
Subsequent factory audits and unannounced inspections
Modulight can ship products directly to end user
Modulight manages medical devicereporting and post-market surveillance
Registration with local healthauthorities (Clinical evaluation providedby customer)
Product tested towardsCB certification
Product manufactured according to customer specification under Modulight ISO 13485 certified quality system❑ Customer required to have certifications
for QMS, including post-market surveillance and medical devicereporting and registration with localhealth authorities, customer responsiblefor managing factory audits and unannounced inspections, and CE marking submission including clinicalevaluation
❑ Agreement with Modulight for allowingcustomer NB to audit Modulight as critical subcontractor
❑ Customer needs to have physicalprescence in Europe
Modulight provides limited technical fileas deliverable to customer
Product tested towards CB certification
Modulight applies for NRTL ATM, manages IFA and subsequent quarterly audits by theNRTL representative❑ Customer registers for IND / IDE,
required to report to FDA
Modulight provides technical file as devicemaster file (MAF) to FDA, customer refersto MAF in their applicationOR Modulight provides technical file as deliverable to customer
Product tested towards CB certification
CDRH submission and yearly reports byModulight (or customer)
Modulight applies for NRTL ATM, manages IFA and subsequent quarterly audits by theNRTL representative
Modulight (and/or customer) registered as manufacturer for the product at FDA
Modulight provides technical file as devicemaster file (MAF) to FDA, customer refersto MAF in their application
Modulight applies for NRTL ATM, manages IFA and subsequent quarterly audits by theNRTL representative
Modulight registered as manufacturer for the product at FDA❑ Modulight registered as manufacturer
for the product at FDA❑ Agreement with Modulight to provide
access to FDA for on-site inspection❑ CDRH submission and yearly reporting
by customer (Modulight providestechnical content)
QUALITY
MANAGEMENT
ISO 13485 certified93/42/EEC and 2007/47/EC requirements
ISO 13485 certified USFDA QSR requirements21 CFR 820 and 21 CFR 1040 requirements
USFDA QSR requirements21 CFR 820 and 21 CFR 1040 requirements
USFDA QSR requirements21 CFR 820 and 21 CFR 1040 requirements
DURATION months months months months months + xxx days
CASE
EXAMPLES MODULIGHT
ML7710
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8 10+ 10 x 16
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Regulatory knowhow and quality management services
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3
2
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University / hospital collaboration❑ We are about making lasers for
Doctor, Patient and Hospital❑ Many pharma customers come
to us through introduction from our customers
Ophthalmic treatment station
❑Modulight ML6710i laser with slit lamp adapter
❑Mountable to Zeiss SL120/SL130/SL115C and Haag Streit type slit lamps
❑ iPad control and remote treatment planning
❑ IP connectivity and cloud based data collection and AI driven medicine
Modulight as a medical device company
✓ Medical application knowhow from in vitro to clinical use and lifecycle support
✓ In-house product design and manufacturing from laser chip to connected medical devices to hospitals with true security of supply
✓ Proven knowhow on medical device design and regulatory documentation for pharmaceuticals and all medical approval
✓ Partnerships with leading medical and cancer centers globally
✓ Generic product platforms with user friendly GUI and connectivity technologies supporting cloud based business models and AI boosted medicine
Summary❑ Modulight has been >19 years in
business and is well profitable❑ Long history of quality driven
products and certifications❑ Exclusive provider of medical
lasers for 10+ pharmas❑ ISO9001 & 14001 in 2002 &
ISO13485 certification in 2011❑ CE approval in 2012 & FDA
approval in 2016❑ Wide, long expertise in
semiconductor lasers & solutions
Thank you!
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This presentation was presented at
EPIC World Photonics Technology Summit 2020
Funded by