The medical device industry has had a tough time recently when it comes to its reputation for addressing defects.

Analyst and strategic advisory firm Axendia recently found that device compans are too much in “firefighting” mode over defects and only pay lip service to process improvement initiatives.

Medical device giant Medtronic has not been immune when it comes to run-ins with regulators. FDA regulators in September hit Medtronic with a warning letter over issues associated with its Paradigm-branded insulin infusion pumps. This comes on top of a Class I recall this past summer over a faulty part in the infusion pump system.

Vipul Sheth, vice president of quality for Coronary Cardio Vascular at Medtronic, is the one of the executives working to maintain quality and make sure such situations don’t happen in the first place. It is a task that Sheth says can be especially tough when a device appears to be doing well in the field, creating a false sense of comfort.

Medtronic recently shared some answers from Sheth, who responded to Qmed and MPMN questions over the challenges that quality control people such as Sheth face. Here are edited excerpts below:

MPMN: What are your thoughts about the Axendia study?

Sheth: This study by Axendia cites lack of resources and lack of focus by management as the major reasons for the industry to be slow in addressing defects. Based on my experience in this industry, working in large and small medical companies over the last 20 years, I would cite the following reasons for the industry to be viewed as slow in addressing defects:

External environment and expectations. In the medical device industry, quality and reliability (safety and effectiveness) performance are a “given,” but at the same time, innovation is the name of the game. The device designs, features and regulations continue to become more complex (combination products becoming common) at the same time the pricing pressures leave manufacturers to focus on cost reduction opportunities. The success mantra for every company in this environment is “faster, cheaper and better.” In an ideal world, companies would be able to achieve fast innovation at low cost and with better quality; the reality is that quality of the products ends up being subpar some times. … If quality problems are identified, the expectation from customers is that the company acknowledges and fixes the problems right away. While the expectations are high, and understandably so, the reality is that making design and manufacturing improvements to reduce cost or to fix quality issues is not easy or fast given that regulatory approvals alone can take anywhere from 30 days to six months. …

Too much emphasis on compliance and not on quality/reliability. The regulatory inspections conducted by FDA and other notified bodies highlight quality system and compliance gaps–which take the focus of management and key technical resources on closure of compliance gaps, which sometime have no direct correlation to prevention or resolution of product quality issues.

Management focus and expertise. Many general managers understand the importance of quality only peripherally, but have no direct experience in creating a culture of quality. The training in business schools prepares them well in areas of marketing, business development, finance and operations, but managing quality especially in a medical device company is something that is acquired only through experience. Leaders who manage quality well were typically exposed to quality crisis earlier in their careers. In my experience, leaders that I have worked with who understand and created a quality culture had already lived through not one, but a few quality and compliance crisis (high profile recalls, warning letters) in their careers.

Organization design and development, structure. In many companies which lack a quality culture, strongest technical resources are deployed in R&D or chose to work in R&D/manufacturing and not in the quality department. … The “A” technical team players are focused on innovation and not necessarily on preventing or fixing quality problems. In some companies, quality employees are not exposed to the customers directly and don’t understand clinical implications, environment and other market factors very well. …

MPMN: What advice would you provide the industry on how to reduce defects and improve regulatory compliance?

Sheth: The best way to reduce defects is to prevent them in the first place. It is easier and cheaper to fix defects early on in the product development cycle. Improving compliance and quality requires everyone in the company to understand their role in the quality system and to follow the procedures every time, be “audit ready every day”. To create this culture of quality, there also has to be an environment where employees feel safe in bringing up quality issues and not “sweep issues under the proverbial rug.”  

My advice to companies:

Key quality and compliance metrics should get as much visibility and focus as the top and bottom line numbers. The company needs to be careful in terms of identifying the right metrics for the audiences. It is important to ensure that the metrics and success criteria are well thought out and defined. The accountability of achieving the performance targets has to be well defined at all levels of the organization and incorporated into formal performance review process.

A clear quality and compliance escalation criteria, process and governance structure has to be in place that ensures that quality issues on the production floor or in the field or in product development are identified and escalated to right levels in the organization as soon as possible. Management at right levels should be engaged in the review of the issues. … Employees should feel comfortable to bring up quality issues and concerns without fear of the “messenger getting punished”.

The quality performance should be integrally linked with the recognition and rewards systems. If the annual performance bonus or merit increase incorporates performance against key quality indicators, everyone in the company would have a vested interest in supporting the quality objectives.

To attract top engineering talent into the quality department, ensure that the positions are competitive in salary, title and compensation with R&D, manufacturing and other engineering jobs. The perceived status and respect has to be consistent with R&D and other engineering jobs in the company.

Create a knowledge tool kit and development plan for all quality jobs.

Provide quality engineers opportunities to interact with customers. Other development opportunities for quality department employees have be consistent with other functions in the company.

There are very few universities that offer degrees in quality management or quality engineering. The body of knowledge required to be a good quality engineer or technician or auditor are available through ASQ certifications. This body of knowledge is quite extensive; companies should support quality employees to achieve ASQ certifications consistent with their jobs. If the company has training departments, there should be training curriculums developed on specific basic quality topics. …

MPMN: How can device companies continue to ensure the quality of their products while also accommodating the growing pressure to cut costs?

Sheth: The most prevalent cost-cutting strategy is to manufacture in tax sheltered or low labor cost countries. This may mean outsourcing to OEM in countries where English may not be the first language and a quality culture may not be prevalent. Outsourcing and managing quality of suppliers in faraway countries is not easy; companies need to think very hard about developing systems, processes and a multi-cultural talent pool in the area of supplier quality and manufacturing transfer as they conduct more manufacturing operations overseas. These employees must be willing to travel internationally and stay there for extended periods.

Reduction in material costs can occur by ensuring high yields by automation, process engineering and by ensuring that the components are sourced from reliable suppliers. Many companies are implementing engineering practices such as design for reliability and manufacturability, Lean Sigma, cell operating systems and single piece flow and the like to identify and eliminate non value added activities to gain efficiencies. Use of latest IT technologies also plays an important role in connecting people and processes across the continents. Use of web based systems to review and approve documents electronically, to review inspection data from a supplier on a web portal, to file complaints through tablets and MDRs electronically are some examples of IT technology that improve efficiencies and cut costs.

In summary, cost cutting must be strategic and systematic and not by reducing headcount or product testing and inspections haphazardly.

MPMN: How does a small-to-medium-sized device company’s approach to quality differ from a large device company’s (such as Medtronic’s) approach to quality? How can a medical device startup work to ensure quality while keeping costs under control?

Sheth: Many small companies have small budgets or funding which are applied to critical focus areas such as R&D, marketing-sales, clinical trials and regulatory approvals in their early stages. In many cases, there are no dedicated quality resources or a couple of quality resources that wear many hats and do the best they can, given the time and limited knowledge they have in the area of quality and compliance. To make matters worse, these companies do not invest much in terms of employee skill development and expect them to work long hours within poorly designed quality systems. My suggestion to startups and small companies that don’t have dedicated quality staff or very small quality staff:

Look for employees with quality and compliance background or experience when you fill your R&D and other engineering positions.

Ensure that someone in the management team has quality and compliance experience and can be the champion for quality and compliance.

Invest in employee education and skill development; it is an investment, not an expense. Well trained employees will be more effective and efficient.

Take time to build a good quality system and build a process to identify and escalate quality issues in a timely manner.

Address quality issues. Disregarding them will only make them bigger and worse later.

MPMN: I understand that you started out your career as a R&D design engineer but you later transitioned to the quality engineering space. What advice would you give other engineers with similar backgrounds who would like to follow a similar career path to yours?

Sheth: I ended up in the quality department by accident early in my career. I had such an enriching experience that I made a permanent switch from R&D into quality and have never regretted it. Quality engineers in most companies get involved in product development activities under one of more titles such as “reliability engineer”, “design assurance engineer”, “safety engineers”, “supplier quality engineer”, “test method engineer” or like. These engineers play a very important and technical role in the product development process. Quality engineers play an integral role in transferring designs to OEM or to manufacturing sites and participate in process validation activities. These activities require them to visit manufacturing facilities, many times in different countries. Quality engineers are also involved heavily in terms of setting up manufacturing controls and in resolving manufacturing quality issues. The quality department usually leads post market surveillance activities. …

In summary, the quality professional is involved in the entire product life cycle. …

I would suggest that any employee who thrives on “action,” likes to understand the entire product life cycle, [is] comfortable making decisions in grey areas under stressful conditions, [leads] multi-functional teams, [enjoys] creating policies and procedures would enjoy being a quality professional.

MPMN: What advice would you give to medical device companies that have acquired new device technologies? How do you recommend companies integrate harmonize their quality systems approach

Sheth: … Assume you will need a lot of resources and money to fix design and manufacturing issues. You can only scratch the surface of the device and technology during due diligence activities, and there will be a lot of information about the device or technology that will not be as good or robust as it was presented to you. Also, assume that the subject matter experts of the acquired company will leave the organization, so prepare to build the knowledge and expertise as soon as possible.  …

MPMN: What would you say is your biggest professional challenge as a quality professional, and how do you work to tackle the problem?

Sheth: The biggest challenge for a quality leader is to ensure focus on quality processes and systems when there are no quality or compliance issues. When product quality is good in the field, when manufacturing yields are great, when there are no product or service disruptions due to quality [issues] and there are no compliance issues such as FDA 483 or warning letters, there is a tendency for management and employees to get comfortable and lose focus on good quality practices that are the reason behind “good times”.

… The most senior leaders of the organization  [must] understand and visibly support management of quality and compliance. A culture of prevention has to be established and prevalent throughout the organization.

MPMN: We recently polled our audience of medical device engineers on what they thought was the weakest function of medical device companies. The leading choices were executive leadership and quality affairs. Financial pressure came in at a distant third place. Beneath that were external political forces.

This poll was not scientific but it does seem like the audience is quite concerned about regulatory affairs (I would imagine much of that is directed at FDA’s slow approval process).

What are your thoughts on the results? Do you think there is widespread sentiment from medical device engineers that quality affairs are a key issue?

Sheth: There is an acute shortage of highly skilled and trained regulatory affairs and quality professionals, since these skills can only be acquired through experience. Highly skilled RA and QA professionals have many choices when deciding to find a company that best fits their career aspirations. Most RA and QA professional choose to work in high tech, well-established companies with a strong culture of quality and compliance with adequate resources. Some may choose to work in high tech startup companies if they are averse to bureaucracy of larger companies or in lure of high payouts possible upon IPO or acquisition.  

This leaves many companies that have relatively low-tech products (Class 1 and 2) with RA and QA professionals that are not highly trained or skilled. Unfortunately, these companies don’t have the infrastructure or culture to develop or train these employees so the problem is exacerbated. In many small companies, RA and QA professionals wear many hats and are not able to build expertise but end up doing more “paper work” such as conducting audits, ensuring the DHF and other quality records are documented and filed properly.

From:MDDI;https://www.mddionline.com/medtronic-exec-how-move-past-compliance-quality