Off to College: Cannon Quality Group Supporting Future Entrepreneurs

Posted on: May 7, 2019

On May 20, a small group of California Polytechnic State University alumni and supporters from the medtech industry will gather in San Luis Obispo to meet with select students, faculty, and Center for Innovation and Entrepreneurship (CIE) staff for a 1-day planning summit. Among them will be Nicolle Cannon, founder/CEO of the Cannon Quality Group (class of 1997, mechanical engineering).

The CIE is making a new thrust into the world of medtech and medical device. The vision is to create an ecosystem and opportunities for entrepreneurial Cal Poly students who want to create transformative healthcare companies, products, or technologies. Nicolle will be there to represent the quality management side of medtech, but also to bring in the experience she has in working with a wide variety of startups both as an employee but also for the last ten years as a service provider to startups.

Working primarily outside of medtech so far, the CIE has made impressive inroads in other entrepreneurial markets, accumulating 89 companies started to date, over $200m capital raised, and 10,000+ hours of alumni mentor hours.

Two of those 89 companies have been in medtech, and their alumni mentor, Jan Haynes, provided the spark to create a focus within the CIE on medtech startups. Jan is a co-founder of FzioMed, Inc., a privately held medical device company headquartered in San Luis Obispo.

“Jan has made it her mission to encourage more entrepreneurial paths among Cal Poly students”, Cory says.

The CIE’s director of development, Cory Hy Karpin, says Cal Poly has most of the other pieces of the puzzle – a well-respected engineering department, a biomedical engineering program, and a great business school.

Cory believes the time is right for the new medtech focus.  “The current generation of students is driven to change the world in some way – there’s this need to have an impact in a meaningful way, and the response from students is huge. Often it’s a career path they didn’t know was there.”

Not all students will be drawn to the startup life after graduation, Cory said, but the program will be successful in his eyes if students who are interested have a path to follow, and if they have partners in the industry that allow students to get out of the classroom and see theory in practice.

Nicolle Cannon is well-suited for the role as advisor to the CIE.

“We don’t come with a black and white quality management solution but we first take into account the stage of your business and help you get your product to market with that in focus.”

Nicolle describes the approach with early stage organizations of helping them see their milestones and making sure they don’t take on too much burden with their quality system too soon.

“You can get started too early and it can handcuff you and you can spend way too much money too soon, or you can get started too late and again you can spend way too much money catching up and possibly delay launches.”

Nicolle says that for founders, a good rule of thumb is that as you move toward putting more money in the business, you want to systematically put some controls in place to reduce risk to your investment.

“When you’re funding a clinical that’s going to support a submission, supporting a claim, that’s a lot more money, so you want to be sure that design has some control around it.”

Testimonials

"My Manager reviewed and approved this validation, and he called me to say it would be the gold standard for spreadsheet validations for all Nordson Medical D&D sites from this point forward!"

-Kim Trottier/Quality Information Systems Manager, Nordson Medical

"Our notified body commented that he was impressed with the focus and professionalism of the Emboline team during a recent audit. This is largely a credit to the Cannon Quality Group team. Your team, as always, was extremely organized, well-prepared and professional. Thank you!"

-Scott Russell/President and CEO at Emboline, Inc.

"Everything about the audit process including scheduling, the audit itself, and results & follow-up were seamless and enabled LamaMed Solutions, Inc. to fulfill its requirements for Internal Audit and assessment of QMS conformance with ISO 13485:2016 in advance of our Notified Body audit."

-Lloyd Griese/Quality and Regulatory Consultant, LamaMed Solutions, Inc.

"Our SVP of QA/RA performs mock-FDA audits across all our global facilities. So it was huge compliment for us when, after reviewing all aspects of a software validation authored by Cannon Quality Group, he said it was as good a validation as he had ever seen."

-Ron Koronkowski/Director of Quality & Regulatory, Vention Medical, Inc.

"Cannon Quality Group's staff was highly engaged and responsive to our needs. They were easy to work with and provided a high-quality work product."

-Caroline Jewett/Consultant for PvP Biotech

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc.

"Don’t stress. Call Cannon Quality Group for great project support."

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc.

"My 3rd party ISO 13485:2016 audit was extremely beneficial to my company. The auditor was very knowledgeable about the standard and current trends that notified bodies are looking for."

-Tom Mason/Director QA, Vactronix Scientific

"When strategic partners were doing due diligence, I think they expected to find an empty drawer where the Quality Management System would be. We started showing them the procedures and design files that Cannon Quality Group helped us establish, and they were pleasantly surprised to get just what they wanted…The ability of…"

-Don Bogue/President/CEO, Compact Imaging

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services

"CQG has been with my organization from the nascent stages of our QMS.  Their team of experts coached us on the ISO standards, provided training classes, furnished sample QMS documentation, and were always quick to respond to our endless questions.  Most importantly they were present at our crucial certification and customer audits. …"

-Kathleen Perry/Twist Biosciences

"Working with Cannon was a pleasure. They helped us create our first formalized Quality Management System with just the right balance of rigor, detail-orientation, and practicality. I would definitely work with Cannon again in the future on quality management projects."

-Gideon Wald/CTO Welkin Health

"JenaValve would like to extend a very appreciated “Thank You” to the whole Cannon Group team in supporting us, JenaValve, through the quality system improvements and associated activities. Your organization has been exceptional in supporting the chaotic schedule and the Cannon Group team members have performed above and beyond the…"

-Peter Wulff/CFO JenaValve

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

-Mark Adler/Senior Director of R&D JenaValve

"CQG has really shattered my preconceptions of what contracted support can do for a quality system. They are true professionals from the advice they provide, work they produce, and the integrity of actions. From complicated design control issues, to Process Validation, to Doc Control, they have been a huge resource…"

-David Hesting/QA Director, Profusa, Inc.

"Amy has done an amazing job here and we appreciate all her help. Communication with everyone/doc control is good/responsive, and we especially appreciate the quick turnaround on hot DCO’s – they find everything."

-Bijesh Chandran/VP of Quality, R2 Dermatology

"Cannon Quality Group is an absolute pleasure. For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system has allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance."

-Andrew Hosford/Director of Engineering, Gauss Surgical

"Our startup was working with a skeleton quality system and struggling to apply QSR standards, when we brought in the Cannon Quality Group. They overhauled and sharpened our quality system so that it complied with the QSR, in only a few months, which allowed us to have a flawless audit.…"

-CQG client/

"When a key employee quit just as the load on my QA group exploded because of a clinical build, CQG stepped in immediately with the resources we needed to keep us going. I hope nothing like this ever happens to us again but, if it does, I’ll know exactly whom…"

-Ari Zak/Sr. VP, Clinical, Regulatory & Quality and Corporate Counsel, PowerVision

"Prior to CQG, our startup worked with another company which made quality slow, very expensive, and highly frustrating. Comparatively, CQG has been a game changer for our company. They have made QSR development and compliance enjoyable and easy, which has allowed us to work at the fast pace required by…"

-CQG Client/

"Kudos to the Cannon Quality Group for helping us get through our FDA audit with zero 483s and just a few CAPAs.Their expertise in quickly turning our bare bones QMS into a robust system is exactly what was needed."

-Shaun R. Bagai/CEO – RenovoRx, Inc.

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

-Kityee Au-Yeung/Profusa

"As a new Quality Director at a young start-up company, I am happy to leave a recommendation for Cannon Quality Group. Cannon Quality Group has an innovative and efficient process in place to bring a working Quality System to a start-up company in a short amount of time. Cannon retains…"

-Delane Dale/Quality Director – BioInspire Technologies
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