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Qualtrax

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by

Miles Ross

on 10 December 2012

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Transcript of Qualtrax

Patient Protection and Affordable Care Act Advertisements in special literature
Multiple industries
Narrowed focused
Stressed features/benefits
Tradeshows
Low opportunity cost Competition Marketing Very focused
Advertisements in specialized literature
Sales force driven
Push/Pull strategy
Tradeshows Device Manufacturer Marketing $19.6 million in sales (Hoovers)
About 150 customers
Extensive advertising
Website available in multiple languages
Customer reviews through blogs, testimonial listings
Provides professional & technological services Pilgrim Software Deals with clients focused only in the healthcare sector only
16 customers – 4 Industries (Pharmaceutical, medical device, biotech, clinical research organization)
Similar to Qualtrax in its offerings
Offers legacy based systems’ transformation to UI friendly versions
High spending on advertising
Elaborate website content development
Webinars and customer case studies available on the website
Articles and publicity events held for various tech websites like Techcrunch and business magazines like the Business Journal NextDocs 19 Clients – 100,000 + users
$ 4.67 million sales (Hoovers)
Supported for PC, Mac and iPad versions
Offers similar solutions like Qualtrax
Global server deployments available for small scale manufacturers
Partners life sciences events to reach potential customers in MDM industry
Encourages partnerships and networking across sectors and industries – Strategy consulting, technology, sales etc. Q- Pulse $26.4 million annual sales (Hoovers)
High Advertising spend
Elaborate solutions & product offerings hosted on the website
Customer recommendations and competitor differentiation
Desired solution to available product mapping available on the website
Functional software solutions
Technical whitepapers and product information hosted on the website
$170k + (per Ivy Biomedical) MasterControl 29 Customers
Flexible Reliance Platform
ERM
SAP Integrated
Sustainable
iPad Support
Provides eMDR – electronic submissions
Features
Complaint Handling
Validation Services
Change Management
Reports & submission Flag
Accommodates Contract Manufacturing ETQ ETQ
MasterControl
Q-Pulse
Nextdocs
Sparta Systems
Pilgrim Software
Doc Lineup Major Competitors FDA provisions for automation
ISO standards are vast
Managers need to know where they stand
Qualtrax tracks compliance needs and standing
Process delegation
FDA-400,000 medical device reports per year
Simplification How Does Qualtrax Help? Growing Regulations
Start-ups
K2M
H and H Associates
Ivy Biomedical FDA Opportunities Level of Compliance changes for each class
Qualtrax should focus on Class II and III
H and H Associates
Does not feel ISO 9001 is satisfactory alone
Attempts to be close to ISO 9001 and 13485
Basic Guidelines for Design and Manufacture
Requirements are tailored to specific products
Qualtrax FDA Part 11
Ivy Biomedical
H and H Associates
Electronic Records
Equivalent to paper
501(k)
New Devices FDA U.S. Food and Drug Administration regulates all things medical
Quality System Regulation
Current Good Manufacturing Practices (CGMP)
Regulates
Design
Packaging
Labeling
Storing
Installing
Servicing FDA Current Customers
Familiarity
Globalization ISO Opportunities Specific to medical device industry
Often works hand in hand with ISO 9001
Shares aspects of ISO 9001, but adds other aspects as well
Dictates that the quality system must be maintained properly (does not require continuous improvement) ISO 13485 International Organization for Standardization
Set of standards that deals with quality management
Over one million companies certified worldwide
Formal quality policy
Followed by all employees
Quality System
Frequent auditing
Past and Potential Problems ISO 9001 Important aspect for Qualtrax
Very regulated with high quality standards
ISO 9001
ISO 13485
FDA
Current Good Manufacturing Practice
Part 11 Regulatory Environment Founded in 1992
Does not provide information about members but is a great resource for compliance issues
MDMA’s main purpose is to improve regulatory and legislative environment for medical manufacturers
Claims to to be a champion of small businesses
Patient Protection and Affordable Care Act (ObamaCare) is a main concern Medical Device Manufacturing Association $106.6 Billion industry
16, 423 enterprises
Top 4 companies make up 17.9% of revenue
Average number of employees is 19 Medical Instrument Manufacturing Split into two smaller industries
Medical Device Manufacturers
Medical Instrument and Supply Manufacturers

Qualtrax is looking at customers with less than 500 employees Industry Overview Bhavna Hazrati
Bobby Leeper
Miles Ross
Rob Stanton Smaller Medical Device Manufacturers Partnering
Q-Pulse with TechPubs
Reach large market
More control
Licensing
Fujitsu with MasterControl
Use someone else’s resources and client bank to reach consumers
Less control Partner/Licensing Option Revenue driven
Short decision chain
Cost/Benefit analysis Device Manufacturer Purchases Competitor Analysis $ 23.5 million in sales (Hoovers)
Provides similar solutions to Qualtrax
Also, non-conformance, product registration tracking, risk management services & supplier quality assurance
Medical device regulation compliance
Medical device reporting
Pre-market notification
Investigational device exemption
QS regulation
Extensive Advertising
Videos
Webcasts
Promotions & discounts
Extensive media coverage on manufacturing magazines and FDA and MDDI Sparta Systems Small business provisions
Limited paperwork
Cost justification
Is there a need?
Some FDA Compliance is new territory for Qualtrax
Unfamiliarity
Established competitors FDA Challenges FDA designates devices as Class I, II, or III based on riskiness FDA Firms that satisfy 13485 do not have to also satisfy ISO 9001
True in many cases
“The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.” ISO 13485 Aids in Compliance to ISO and other standards
Document Revision Tracking
Document Security
Internal Processes
Handling Training Records
Complaint Handling
CAPA (Corrective and Preventative Action) Management What Does Qualtrax Do For Manufacturing Firms? $64.7 billion industry
828 Total MDMs
3 Companies (30.7% of market):
Medtronic (13.6%),
GE (12.9%)
St. Jude Medical (4.2%)

50% of the firms employ 20 or less people
Highly competitive
Many segmented tradeshows Mecical Device Manufacturers Brief Industry Overview
Qualtrax Overview
Structure of Research
Regulatory Environment
Standards
Challenges
How does Qualtrax Help?
Competitor Analysis
Marketing Trends
Purchase Decisions
Potential Customers Agenda References http://clients1.ibisworld.com/reports/us/industry/competitivelandscape.aspx?entid=764
www.medicaldevices.org)
www.qualtrax.com
http://en.wikipedia.org/wiki/ISO_9001#Contents_of_ISO_9001
http://www.tuv-sud.co.uk/uk-en/activity/auditing-and-systems-certification/iso-13485-quality-management-system-for-medical-devices
http://en.wikipedia.org/wiki/ISO_13485
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm)
http://www.etq.com/medicaldevice/
http://www.qualtrax.com/industries/profile/manufacturing
American Action Forum - The Medical device Industry.pdf
http://www.gaelquality.com/manufacturing/
http://www.nextdocs.com/en-us/compliance.aspx
http://info.nextdocs.com/FSECloud_Registration.html
http://www.mastercontrol.com/md/medical_device_software.html
http://www.etq.com/medicaldevice/ 2.3% tax levied on all medical device sales
Equates into 15% additional tax on profits
Razor thin margins as-is
Many small companies face up to 50% tax
Affect purchase decision?
Focus on cost savings aspect Potential Customers Potential Customers H&H Associates Miracle Ear 6 Employees
Franchised Location
Easy to manage
No Intention 40 Employees

Current Systems Ad Hoc

Similar to Ivy Biomed
Part 11

Waiting for Growth

Paul Harder's Observations Community Home Care Services Trade Shows

FDA CGMP National Optronics 120 Employees
Tom Doyle
Director of Quality Assurance
Currently Strategizing ISO 9000
Currently UL Compliant & ETL Listed Mark
Document Management
Ad Hoc
Not integrated
Training
Already Acquiring Funds Plan to ISO 9000: 1.Introductory training sessions led by consultants, so they know what’s required.

2.Formalize infrastructure and write procedures/work instructions required by standard.

3.For the first half of 2013, they will work on it in-house.

4.For the second half of 2013, they will hire consultants for additional training

5.They will then perform an audit phase.

6.Sometime in 2014 the hope to be certified. Current Customers Ivy Biomedical

Sponsorship

Search Engine Optimization

Recurring Business Model

Geography
Charlottesville
Massachusettes Upgrades

5-8 More Licenses in 2013
Eventually entire firm.

FDA Workbook

Indicated Industry Growth LinkedIn
Credible Firms
Similar Firms
Testimonials Methods: BIT Department

Dr. Abrahams
Pay-per-click
Experienced
Willing SEO: Has Desire To Spend! Further Information?
Full transcript