Patient Centric Ecosystem
The Healthcare Industry is focused building an ecosystem to deliver high-quality, patient centric care. This is important because the Medical Device Industry provides products used within that ecosystem. Medical device manufacturers, more so now than ever before, must shift their mindset to being patient centric within the ecosystem of the medical device industry to better support the ecosystem of the healthcare industry. To enable this, the quality of the products provided for use across the healthcare industry ecosystem must be understood by medical device companies to be the primary focus. The work of every single person within the ecosystem of the medical device industry contributes the quality of patient care. How is this managed?
The formula for a responsible patient centric approach within the medical device industry foundationally resides in the ability to foster an organizational culture to strategically measure, manage and improve the quality of process and product.
There is that word… ‘culture’ that sometimes inhibits people. I believe that is because it is not well understood. People place soft and spongy definitions on the concept of ‘culture’. For that reason, I will define just what a patient centric quality culture, is based upon the generic definition of ‘culture’, as follows:
Patient centric quality culture: Manifestations (plural) of intellectual achievement, focused on patient centric quality, and regarded collectively.
Otherwise stated, a patient centric quality culture requires a strategic approach that can be applied individually to the work of every single person who contributes the quality of patient care, and of which the results are capable of being measured both individually and collectively. The following questions must then be answered:
1) What is the patient centric strategic approach?
2) How are the results capable of being measured both individually and collectively?
3) Who are the participants within the medical device Industry ecosystem?
These questions must be answered, and solutions implemented, post haste. Time is of the essence, more so now than ever before, because the medical device industry is operating within an era of unprecedented change. Across industry, the requirements for managing quality are fast becoming better defined and more highly regulated. The European Union Medical Device Regulation (EU MDR) is a great example of such significant change. The purpose of the EU MDR is to ensure safety, control, and transparency of the quality of medical device products. EU MDR clearly requires manufacturers to be more accountable for quality across a product’s lifecycle, and they expect this to be accomplished through the compliance and effectiveness of the Quality Management System (QMS) of medical device companies, and they expect it now. With no provision for ‘grandfathering’, medical device organizations are now working to ensure their products will remain available to the European market after the 2020 EU MDR implementation deadline.
What is a patient centric strategic approach?
This strategic approach begins with a focused measurement strategy that provides responsible management with improved visibility and consistent understanding of product and process quality, enabling them to more effectively manage emerging issues that could impact patient safety, and to continuously improve the patient centric operational results expected by our stakeholders. This strategic approach to product and process quality measurement is used in addition to the singularly ineffective use of key process indicators (KPI), to focus on what truly matters:
1) Product quality measurement focused on patient harm and the critical to quality (CtQ) controls associated with those failure modes causing harm to the patient.
2) Process quality measurement focused on compliance to regulation, effectiveness in obtaining results and efficiency in operational execution.
3) Cost of poor quality (COPQ) measurement focused on the business costs associated with internal CtQ production process control failures, external product failures, and Quality System process failures.
Strategic measurement alone isn’t enough. These measures of product & process quality must be monitored, reported and reviewed to be used as a bridge to enable the responsible management of what matters the most to important stakeholders who demand accountability for ensuring extraordinary results. The expected results come in the form of ensuring compliance, maintaining control and improving constraint. Improvement initiatives must continually address constraints of compliance, effectiveness, efficiency and critical to quality (CTQ) control, facilitating product & process quality improvement.
How are the results capable of being measured both individually and collectively?
Business leaders, operating fully within a patient centric environment, must also satisfy both business and regulatory stakeholders. The challenge of satisfying stakeholders can be difficult, at best, without an overarching plan to ensure high-quality performance, today, tomorrow…every day.
The overall performance of an organization is dependent upon the effectivity of the system of processes that it utilizes to achieve its mission, and upon the capability of the workforce to execute those processes competently. An organizations’ performance plan must be built upon a foundational understanding of the quality of both people and process, with the additional understanding and clarity of performance in alignment with the organizational structure.
Organizations are built in many configurations and sizes, from entrepreneurial start-ups to globally matrixed Enterprises. The quality of the system of processes is managed through the organizations Quality Management System. Every company has an organizational structure, providing ownership and responsibility for the system of processes the organization utilizes to achieve its mission.
Performance measurement for any organization, regardless of organizational structure and scale of operations, is achievable when based upon a foundation of performance measures that are capable of aggregation, from the functional group level all the way up to the Enterprise level.
Performance measurement extends beyond the status of operational performance that might be expected for management review of an individual process. That is typically just what key process indicators (KPI) provide. Consider instead that performance measures must be reviewed process by process, group by group, etc. Performance measurement must be capable of being viewed from the highest level of aggregation, and being deconstructed downward to identify the highest (or most impactful) constraint, all the way down to the functional/process level, regardless of where that resides within the organization.
Performance measurement must also provide the visibility into process improvement and change management initiatives. Why measure performance, if not to improve our constraints?
Finally, the performance measures described herein should be additive, and not in replacement of the current process KPI measurements, for improved understanding of individual process performance as well as that of the entire system.
Such a performance measurement solution can truly enable a patient centric quality culture that facilitates the management of extraordinary performance within an ecosystem focused upon patient centric care.
Who are the participants within the medical device Industry ecosystem?
It could be argued that I should address ‘Regulators’ first, however, compliance ≠ quality. Focusing first on patient centric quality through a lens of compliance to regulation is not enough to ascertain and ensure quality… nowhere near enough. For too long, medical device companies have been primarily focused on managing compliance versus continuously improving quality. High-quality product does not come from compliance to regulation. High-quality product is resultant from high-quality performance, by good people, utilizing high-quality processes that produce high-quality results. Good people and good processes produce good product. Therefore, I have arranged the discussion of the participants within the medical device Industry ecosystem to be in accordance of three main groups who operate within the medical device industry… 1) Medical Device Companies, 2) Regulators, 3) Third Party Providers.
1 - Medical Device Companies
Medical device companies must be well prepared to meet the challenge of changing regulation and standards that are harmonizing requirements around a patient centric quality outcome. Accountable leaders have more responsibility placed upon them now than ever before, requiring a high-performance Quality Management System (QMS) to enable the delivery of the operational results that their stakeholders expect. Additionally, beyond a clear patient centric safety focus, there exists ever increasing market pressures due to dynamics associated with various aspects of the Healthcare ecosystem, such as the healthcare payer system, that will demand economic value on a fast approaching horizon.
The quality of the product an organization provides to the market is a ‘reflection’ of the quality of operations. The quality of operations is a ‘reflection’ of the quality of the Quality Management System (QMS). Within medical device companies, the Quality organization primarily supports the organization’s operations through the management of the execution of the company’s Quality System. This typically occurs through Quality Operations roles such as quality control (QC), quality assurance (QA) and quality engineering (QE) activities. However, to appropriately execute the Measure | Manage | Improve strategy, Quality Management must also consist of a ‘Quality Systems’ function that is focused on the measurement, monitoring, reporting, review and improvement of the quality of the Quality System to continuously improve the quality of operations. Quality Management = Quality Operations + Quality Systems
Most organizations are not built to properly measure, manage, report, review and improve the Quality System. In my thirty-plus years of experience working within the medical device industry, I can confidently state that this is an area of real weakness within the industry.
The quality of the products provided by an organization are resultant from the work processes that are executed by the workforce. People are the difference. A good process, poorly executed, produces poor results. The quality of the services and/or products that the organization provides is dependent upon the capability of people to consistently execute the organization’s work processes in achieving the required results. This consistency in execution only comes from a satisfied workforce. People make quality happen. What then does it take to achieve job satisfaction for people?
- Work processes that are well designed and well defined
- Possession of a base skill-set that the process requires
- High quality training
- Development of competency to do the work required of the process
The focus, however, must extend beyond the people doing the work. Organizations must also provide competent leaders who inspire their team through personal interaction and processes that are properly managed. Competent leadership ensures:
- Communication of the requirements of the processes/function/subsystem must be routine and fully understood.
- Accountability of every individual supporting the process must be known and understood.
- Management. Process design requires an adequate number of people (not too few, nor too many) to efficiently achieve effective results, based upon the volume of work needed in the time frame required.
- Trust is essential in support of trained and competent people.
- Respect is required and must be first provided if it is to be reciprocated and continually earned.
- Communication of the results of the processes/function/subsystem must be routine to provide an understanding of results.
- Changes must be made for product and process performance improvement, when necessary.
- Communication of the results of the Company must be routine to provide an understanding of security.
A satisfied workforce is essential for a patient centric quality culture. This requires the satisfaction of the people who individually do the work required to produce the services and/or products that the organization provides. People are important. Their work is important. Managing that work within a patient centric quality culture requires a strategic approach that can be applied individually to the work of every single person who contributes the quality of patient care, and of which the results are capable of being measured both individually and collectively.
It has become extremely important to the compliance, effectivity, and efficiency of the QMS within your organization. Your Quality Management processes must be appropriately designed such that they can be executed in a manner that is compliant in meeting defined requirements, effective in continually confirming the ongoing benefit-risk of the products you market, and efficient in the execution of the processes within the operations of the organization. Your Quality Management System must work properly to enable the manage and control over the quality of your products and processes, as your stakeholders expect, since quality management is necessary to minimize risk to the patient, manage the regulatory risk to the organization, and provide ongoing value to the market.
However, due to the time pressures referenced earlier, it may be time to consider how the company can effectively and efficiently transform the Quality Management System (QMS) by adding the strategic dimension of alignment. Aligning with strategic partners, operating within the medical device ecosystem, who support medical device companies collectively to provide a patient centric quality outcome. These strategic partners are the regulators and third-party providers, who are collectively aligned with a patient centric strategic approach.
2 - Regulators
As was stated earlier, the medical device industry is operating within an era of unprecedented change. Across industry, the requirements for managing quality are fast becoming better defined and more highly regulated. The European Union Medical Device Regulation (EU MDR) is a great example of such significant change. With no provision for ‘grandfathering’, medical device organizations are now working to ensure their products will remain available to the European market after the 2020 EU MDR implementation deadline.
Currently, the Regulators are harmonizing regulatory requirements that are applicable to the medical device industry. The purpose of the new EU MDR requirements and the associated harmonization of global regulatory requirements is to ensure safety, control, and transparency of the quality of medical device products. However, compliance ≠ ‘quality’. When operating in a regulated environment, compliance to regulation is a requirement, however compliance is only one aspect of quality.
To additionally address the improvement of product quality, medical device manufacturers are expected to be more accountable for quality across a product’s lifecycle, and the expectation is that this is to be accomplished through the compliance and effectiveness of the Quality Management System (QMS) of medical device companies.
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. One part of their Mission is to assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. In support of this, the FDA launched its Case for Quality initiative in 2011 following an extensive review of device quality data, as well as feedback from inside the agency and from industry stakeholders. The FDA's analysis had identified certain widespread or common manufacturing risks that negatively impact product quality, and they wanted to do something about it beyond focusing on compliance. The review also showed that manufacturers who focus on managing those risks often become more productive, receive fewer complaints and CAPAs, and experience lower quality-related product costs than their competitors. Thus, the need to focus on quality over compliance.
The Case for Quality program will ultimately enable the FDA to identify device manufacturers that consistently produce high-quality devices. This would allow the Agency can better focus its resources upon helping other manufacturers raise their quality level. The Case for Quality program will enable the FDA to identify and promote best practices for quality manufacturing, and to align its regulatory, enforcement, and compliance approaches with those practices.
It seems clear that the FDA is willing to work collaboratively and in alignment with the medical device industry participants to forward the case for quality. This certainly supports a patient-centric medical device ecosystem.
3 – Third-party Providers
I previously stated that, due to time pressures, it may be time for medical device companies to consider aligning with strategic partners operating within the medical device ecosystem, and who support medical device companies collectively to provide a patient centric quality outcome. I have already discussed the ‘Regulators’ strategic role. I must, however, broadly categorize the many different types of companies that provide products and/or services to the companies within the medical device industry as ‘third-party providers’, with additional understanding that the products and services they provide are varied and many. Third-party providers can be broadly described as follows:
Solution Providers are those companies who offer products or services that they implement to fulfill a requirement and/or solve a problem.
Independent Consultants are individuals with specialized knowledge and/or industry experience who contribute through their participation in support of an organization’s initiatives, typically on a contracted basis.
Consultants are organizations who provide consulting activities in support of the needs of a medical device company, typically utilizing W2 ‘bench’ consultants, and potentially augmented with contracted 1099 Independent Consultants. They often specialize in various areas of expertise.
Contractors are organizations who do not directly provide consulting activities in support of the needs of a medical device company, however, they do provide resources in support of the initiatives that a medical device company may have needs for, typically on a contracted basis. The resources provided are primarily 1099 contracted resources, potentially augmented with W2 ‘bench’ resources. Their strength lies in the recruiting of people to fulfill the contract needs of companies within the medical device industry.
Note: Medical device companies are often confused with the difference between Consultants and Contractors. Consultants are people who come with solutions. Contractors provide people to fulfill your resourcing needs. Be cautious of contracting companies who blur the line by providing case studies, yet their only role in that case study was to have found and provided the contracted people that served the resourcing needs for the project being run by the contracting medical device company. Those results are not necessarily repeatable simply from engaging the contracting company. Very misleading.
Conclusion | Summary
During this era of unprecedented change, a patient centric quality culture will require a strategic and aligned patient centric approach within the medical device industry ecosystem of participants. This will be necessary to deliver high-quality medical devices for the provision of high-quality patient care for use within the healthcare industry.
Medical device companies must effectively and efficiently transform the Quality Management System (QMS). Aligning with strategic third-party partners, also operating within the medical device ecosystem, and who are strategically aligned to provide a patient centric and quality outcome will produce the best results.
Medical Device companies can no longer afford to waste time in consideration of every single third-party provider competing for their attention by trying to differentiate themselves. Although each individual provider may something of value to offer, none can provide the holistic support they would receive from a strategically aligned consortium of third-party provider, dedicated to providing a patient centric quality outcome.
Leaders must adopt holistic solutions that enable the organization to transcend the focus on compliance, and focus on those that provide sustainable organizational success, resultant from efforts of transformational improvement towards becoming fully compliant and efficiently effective.
“Am I truly effective (doing the right thing) or am I merely efficient (doing things right)? Success requires being efficiently effective.” - Peter Drucker
Sustainable success begins with a complete understanding of the baseline performance of the current QMS, enabling the creation of a ‘roadmap’ necessary for planning and conducting QMS transformational improvement activities in a strategic and focused manner. Leaders begin by becoming fully informed. This is resultant from measuring the baseline quality of an organizations’ people, process and product. This baseline measurement of QMS performance provides responsible management with the systemic understanding necessary to enable true management control over the quality of the management system. Once informed, management can responsibly act to ensure the ongoing capability of the company to conduct the transformational improvement required to become efficiently effective.
This will assure that patients and providers within the healthcare ecosystem will have timely and continued access to safe, effective, and high-quality medical devices, provided from a strategically aligned patient centric medical device industry ecosystem.
"Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives."Unknown