How Much Quality Can a Startup Stand?

Posted on: February 5, 2019

Are you unsure about when to introduce a quality management system for your early-stage medical device venture? Perhaps the step seems daunting and you’re putting it off?

Nicolle Cannon, founder of Cannon Quality Group, will be addressing this topic in an upcoming webinar on March 7. (More information here: https://bit.ly/2Wraz1y)

Some see it as the classic Goldilocks principle – if you start too early with installing your quality management system, you may run the risk of handcuffing your development process with rigid standard operating procedures and rules and thereby dangerously slowing your pace when what you want most of all is to get to market fast.

Or, if you start too late, you may have to backtrack and fill in gaps – possibly even retrace some steps and repeat some actions just for the sake of documenting them properly.

So when is the Goldilocks moment for medical device development?
It all depends on the company goals and milestones to market. What are the financing milestones? Feasibility Study, first in man, CE Mark? What kind of financing are you looking to have? Venture Capital, friends and family, strategics? Each of these items will drive the priority and the goldilocks moment.

At the end of the day, we are all here to improve patient’s lives and innovate health care with safe effective solutions. In this sense, no matter the end goal, having the documentary foundation of your design process will serve you well.

Early on in the process, when it’s just you, or just a few of you working nights and weekends, keeping track of the threads between user needs, how that informed design decisions, how that played out in the design outputs, and how you are testing that can be done with fairly simple off the shelf tools like spreadsheet apps and can play dividends in the long run. Before long, as you get closer to getting your design locked in, you’ll want to consider bringing on professional quality management resources.

“That doesn’t have to be a full time employee or even an inevitably increasing cost center,” says Nicolle Cannon. “In fact, in many cases, resources are deployed early on to get initial QMS needs established, then the ongoing quality activities can be fairly modest and stable for some time as you hammer out your final design. After which the next phase of your QMS can be implemented as it aligns with the company goals.”

This curve can wait to ramp up again until the flurry of activity around certifications and submissions.

Given the up and down nature of the quality activity, some startups are better served by outside contracted resources than employees. It’s a good investment for a number of reasons:

  1. Having a quality voice at the table helps you to avoid big (expensive) mistakes;
  2. It preserves cash and flexibility compared to an employee;
  3. It builds credibility with critical constituents like the board, investors, and early clinical supporters you’ll need on board;
  4. It increases your chances of a successful exit if your quality management system has been designed from the beginning to be “strategic partner friendly”.

For more on this topic, tune in to Nicolle’s live webinar on Thursday, March 7th at 10 am Pacific by registering here: https://bit.ly/2Wraz1y

About Us: Cannon Quality Group provides outsourced Quality Management System solutions to startup medical device companies that are engineer focused and compliant. Cannon’s number one priority is delivering QMS solutions that make sense for the stage and goals of its clients’ business. Cannon Quality Group’s mission is to be the Change in Quality. www.cannonqualitygroup.com

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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