Is your HIT or medical device company mature enough for the market demands?

How do you determine the quality of a company and product?  Is it based on just the bells and whistles of the product, or their employee's experience and the corporate brand's reputation?  Or, is it the list of prominent clients, catchy commercials, or regulatory hurdles?

All of those have value, but those are typically reactive, most often subjective and have the ability to bounce back from major setbacks, such as how Martha Stewart's brand which posted higher revenue post-incarceration. 

Not all industries are equal, and even in the highly regulated industry of medical devices, FDA leadership has publically noted that meeting regulatory requirements is not a guarantee of a quality product.    

We have all seen this play out when an HIT or medical device fails, and the health care provider, or medical specialty deem a product unsafe or unreliable.  The ability to rebound is expensive and can be detrimental to a brand.  From the Metal-On-Metal (MOM) hip replacement recalls leading J&J- Depuy brand todiscontinue manufacturing the $300+ million MOM business, and Fitbit's stocks declining since the sleep tracker lawsuit filing, the cost of low quality can be catastrophic.

Professionals in the healthcare industry can be a major contributing factor to this. Fom primary care physicians, to specialists and surgeons, they have been trained based on applying critical thinking to scientific evidence.  Their careers are under the scrutiny of peer-review journal publication status and outcomes based performance. So in this industry, more-so than other industries, the cost of brand management has a higher premium. 

This means that the infrastrucure to create a corporate culture of quality becomes an asset with whch to lead, while regulatory enforcement follows behind to bring non-conforming products into regulatory alignment.  Relying on regulatory enforcement alone will always leave your brand playing catch-up in the quality department.

So what is at the core of quality? Companies will tout their skilled people and their processes to meet what Deming coined the "plan-do-check-act" continuous-improvement loop. Yet the nut to crack is - how to measure the people and processes at a wholistic while preventing an infrastructure that stifles that which is at the core – the continuous-improvement loop.  It is not from a shortage of quality process organizations: SixSigma, the FDA's QSR, ISO QMS, to IEEE and CMMi.  Each spearheading the challenge of creating an infrastucture that is mature enough to prevent poor quality, yet not too ridgid to prevent continuous process improvement.

While Six Sigma has gained in popularity and Jack Welch brought name recognition to the process improvement methodology, the underlying assumption to Six Sigma is that it has a product with a locked down design, so that the focus can remain on the manufacturing process cycle times, allowing a reduction of waste and cost, so that there is an increase in profits and customer satisfaction.  However, HIT and many medical devices iterate, so that the incremental changes require an agile approach.  FDA QSR is actually a very comprehensive methodology, but because of the combination of the audits creates a "checklist" culture, and the myopic view of the FDA requirements, the process exists in a vacuum dictated by the FDA on to a company.  ISO 9000 - Quality management is also very valuable, yet focused on the seven principals: 1) QMP 1 – Customer focus QMP 2 – Leadership QMP 3 – Engagement of people QMP 4 – Process approach QMP 5 – Improvement QMP 6 – Evidence-based decision making QMP 7 – Relationship management. All of the principles have value, yet in implementation ISO 9000 is overly focused on inspections and audits.  While the arguments between the proponents can lead to passionate debates, Smith (2007) assessed ISO certification in 2005 and found that Chinese companies lead the world in ISO 9000 certifications, while Bristow's 2007 study found that Chinese companies frequently made headlines due to dangerous from product manufacturing (pet food, lead-based paint on children's toys, poisoned toothpaste, and tainted cough syrup).  While new ISO 9001:2015 is hopefully going to helps customers get more consistent, good quality products and services, we still need to see how that will play out.  While software industry embraces IEEE 730 Software Quality Assurance Processes, it is very focused on the software aspects of the product manufacturing.  Having used Six Sigma, ISO QSM and IEE-730, they each have their value. Yet in their own way they are each very ridgid to a subset of methods, or lead to a culture of checklist implementation.

While we all know we want quality, and in many ways we know quality when we see quality, what is required to implement and measure for an organization to encourage behaviors that consistently produce quality is no easy task. 

I have found CMMi to be the strongest of the methodologies, because of two primary focus points.  First,  the process of focusing on implementation, rather than creating a check list.  Througout my career it was fairly easy to identify what was needed for an ISO inspection or IEEE, as the list was straightforward and required only sufficient resources and effort.  However my first CMMi conversation felt more like nailing jello on the wall.  Most of my questions were answered with "it depends on how you are doing it".  Looking back with the advantage of hindsight, the CMMi secret ingredient is in the lanuguage.  The methodology focuses on Goals and Practices.  From General Goals and Specific Goals, to General Practices and Specific Practices.  CMMi speaks language similar to that of a world class athelete.  One that has to set goals and then establish the practices necessary to attain the goals.  Each of the Goals and Practices are set in 22 Practice Areas. Which is something most technical, management and scientific minds can relate to, such as: requirements, configuration management and measurement and analysis.  But a great CMMi consultant will not let you gravitate to those from the onset of your CMMi journey in the traditional sense, which is to map into familar checklists.  If anything at Level 1 they will force you to step back and first thoroughly question "who is my client" and at Level 5 expect that your communication is so well established between all of your clients, that the artifacts and evidence demonstrate that which is at the core of quality – thinking about your products, caring enough to do the right thing and monitoring with discipline that at any time you know what is going on with your product.

And this is why CMMi is so ideal for HIT and medical devices.  The origin of HIT and medical devices has the same ingredient as CMMi – people dedicated serving clients by improving the quality of life of fellow citizens.  Though all industries involve serving clients, the healthcare industry ultimately serves all of us, as we all need good health and healthcare.  The second reason it matches so well is about the process.  Just as healthcare is a practice of medicine, which evolves with time and experience, so do the goals and practices of an orgnization that embraces the CMMi methodology.

he next installments of this series will walk you through my personal expereince bringing CMMi into numerous companies, from small health IT companies starting their journey achieveing Level 2 and Level 3, to my programs that were able to obtain Northorp Grumman's Health Division CMMi Level 5, using Agile software development.

-- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™