Reflecting on my journey through the Medical Device Discovery Appraisal Program (MDDAP), I had the privilege of visiting several leading medical device manufacturers across various countries. While confidentiality agreements prevent me from disclosing company names, I can share insights into the diverse range of products these companies specialize in and the impact of MDDAP on enhancing medical device quality.
Diverse Product Portfolios During my visits, I observed the production of an array of medical devices, including:
Orthopedic Implants: Comprising joint replacement solutions for hips, knees, and shoulders, as well as trauma-related products like plates, screws, and intramedullary nails.
Cardiac Devices: Encompassing pacemakers, implantable cardioverter-defibrillators (ICDs), and advanced catheter-based technologies for minimally invasive heart procedures.
Renal Care Products: Including hemodialysis machines, peritoneal dialysis solutions, and related consumables designed to support patients with kidney conditions.
Neuromodulation Devices: Such as spinal cord stimulators and deep brain stimulation systems aimed at managing chronic pain and neurological disorders.
Sports Medicine and Biologics: Featuring products for ligament repair, joint preservation, and biologic solutions to enhance the body’s natural healing processes.
Insights into MDDAP The MDDAP is a collaborative initiative involving the Food and Drug Administration (FDA), the Medical Device Innovation Consortium (MDIC), and industry stakeholders. It leverages the Capability Maturity Model Integration (CMMI) framework to help medical device manufacturers assess and improve their capabilities to deliver high-quality products.
Benefits of MDDAP Participation Engaging with MDDAP offers several advantages:
Enhanced Product Quality: Participants have reported reductions in defects and rework, leading to more reliable devices.
Improved Communication: The program fosters better alignment of objectives across company departments, promoting a culture of continuous improvement.
Proactive Problem-Solving: Companies shift from reactive to proactive approaches, anticipating and preventing potential issues before they arise.
Regulatory Flexibility: The FDA offers adjusted regulatory activities and submission requirements for participating manufacturers, supporting their improvement journeys.
Personal Reflections Witnessing firsthand the commitment of these manufacturers to quality and innovation was inspiring. The integration of MDDAP principles not only enhances product quality but also cultivates a culture that prioritizes patient safety and continuous improvement. This experience underscored the importance of collaborative efforts in advancing healthcare outcomes globally. In conclusion, the MDDAP serves as a pivotal framework for medical device manufacturers aiming to elevate their processes and product quality. By embracing its principles, companies can achieve significant improvements, ultimately benefiting patients worldwide.
Happy Lunar New Year from the Demix team.
Reflecting on 2024 and Looking Ahead to 2025 by Pieter van Zyl Director | HM Lead Appraiser | MDDAP Lead Appraiser
As I look back on 2024, it has been a year filled with travel, growth, and meaningful contributions to the Medical Device Discovery Appraisal Program (MDDAP).
The year began with my first MDDAP appraisal in Switzerland, transitioning from the warmth of South Africa to Switzerland’s snowy landscapes. The appraisal reinforced the value of the CMMI best practice model in assessing an organization’s ability to deliver high-quality medical devices and services while benefiting from regulatory efficiencies.
In October, I had the privilege of conducting an MDDAP appraisal in Germany, accompanied by Melanie, who joined as an ATM (Appraisal Team Member). From there, I returned to Singapore before heading to Costa Rica in November as an observer, witnessing the expansion of the program with skilled professionals joining the effort.
December marked the final MDDAP appraisal of the year in Malaysia, a special occasion shared with my family. Melanie once again contributed as an ATM (Appraisal Team Member), making it a memorable way to conclude the year.
One of the most significant moments of 2024 was returning to China for the first time since COVID-19. Having previously travelled there frequently for CMMI High Maturity Benchmark appraisals, this trip was my first MDDAP experience in the country. China’s continued development remains impressive, and adapting to its digital payment systems was a unique experience, made easier with the help of my translator, Demi.
Throughout the year, I also had conversations about the differences between a CMMI Benchmark Appraisal and an MDDAP Appraisal. While CMMI Benchmark Appraisals focus on process maturity and optimization across various industries, MDDAP is designed specifically for the medical device industry, complementing regulatory compliance and focusing on product and service quality. Both play critical roles in driving continuous improvement and operational excellence.
As I step into 2025, the journey is already underway, with my first MDDAP appraisal of the year completed in Switzerland. Following this, I travelled to Singapore, where I was joined by Elmo Scheffer, another Demix employee who successfully passed his observation and is now a certified ATM (Appraisal Team Member) in the program. With the program expanding and evolving, this year promises to be a significant one for MDDAP’s growth. Looking forward to what lies ahead.
Contributions for the February Issue of The Best Practice Magazine
Submit your article about (PMW) Planning and Managing Work – (EST) Estimating, – (PLAN) Planning, – (MC) Monitor and Control for next month’s issue of The Demix Best Practice Magazine.
Send your Articles / Presentations / Tools to info@demix.org
(IMP) – Process management (PCM), Managing performance and measurement (MPM) & Process asset development (PAD)
Improving Performance (IMP)
Process Management (PCM) Intent Manages and implements the continuous improvement of processes and infrastructure to: Support and accomplishing business objectives Identify and implement the most beneficial process improvements Make the results of process improvement visible, accessible, and sustainable Process Asset Development (PAD) Intent Develop and keep updated the process assets necessary to perform the work.
Value Provides a capability to understand and repeat successful performance
Managing Performance & Measurements (MPM) Intent Manage performance using measurement and analysis to achieve business objectives
Value Maximizes business return on investment by focusing and improvement efforts on cost, schedule, and quality performance management
Business needs for process improvement projects are changing. Organisations expect faster results from their investments; they want their improvement projects to adapt to and follow changing business needs and be more engrained with the organizational way of working. The agile way of working, used more and more in software development, contains several mechanism that support these business needs. So the question is: Could a process improvement project be performed in an agile way and what would be the benefits?
In this paper I start by looking back to my first software development project. I managed that project in a way that would now be called agile, to be able to meet the needs of my customer and of the organization. Next I’ll give a brief description of process improvement, and of agile; just the basics needed to understand how they can be melted into an agile process improvement approach. Then I’ll go into the reasons to do it process improvement in an agile way, and the benefits that can be expected from it. I will discuss a distributed process improvement project that has been managed in an agile way, to share the learnings and benefits. Finally I’ll describe some “golden rules” that help to improve agile working along the way, and to become even more effective in it.
After an employee receives a poor performance review, management can give him a final chance to step up his game through a performance improvement plan (PIP or sometimes also called a performance action plan).
A performance improvement plan provides the employee with clear objectives to meet to avoid dismissal, demotion, or transfer.
Discover:
What is a Performance improvement plan? The purpose and benefits of a performance improvement plan Performance improvement plan examples How to write a performance improvement plan How to respond to a performance improvement plan How to survive a performance improvement plan
Years ago, the COBIT® 5 Process Assessment Model (PAM) was commonly used to assess the maturity level of a COBIT® implementation. The PAM provided indicators for nine attributes and six process capability levels and was used to guide auditors and IT departments.
There is no PAM for COBIT® 2019, but Capability Maturity Model Integration (CMMI) can be used to measure capability levels and combine that information with other factors to give value to the organizational process for measuring maturity. With that information, it is possible to create custom schemas and tools.
When searching for ways to improve your organization, in many situations, the best place to start is from within.
When executed properly, improvements within your company can be beneficial for driving performance and encouraging employee progress.
Be engaging, learn the metrics, utilize training methods and place a focus on the business; all of these are simple ways to improve your organization.
Organizational improvements are an ongoing process, and each organization has its own specific needs; however, there are common improvements that are necessary for many organizations on an ongoing basis, including:
Strategy and mission: Changes in strategy and mission are often difficult to map out, but, as a business owner, you need to continually monitor how well – or if – your organization is meeting your mission, and you need to be prepared to change strategies if needed.
Organizational structure: This concerns the roles, objectives, and responsibilities of individuals, departments, and teams. Structures change, some are relatively minor, while some such as mergers are considered extreme and intense.
People: Organizational improvements in regards to personnel consist of turnover, hiring, training and other changes that will be beneficial for the organization.
Knowledge: Changes/improvements to the knowledge of an organization is critical for process, progress and initiative.
Formal performance management programs have been around since the Industrial Revolution. In those days, the manager of a manufacturing plant would set a quota and give his subordinates annual goals. Those subordinates will give goals to their subordinates and those goals will trickle down as annual quotas for frontline employees. Work has changed substantially since that era, but annual performance reviews are largely the same.
Today, technology is knocking down the old methods to make room for an updated and more effective method to improve employee performance. Unfortunately, many government agencies are lagging behind. Their current systems are often paper-and-pencil based and don’t always focus on improving employee skill sets, achieving the agency’s mission or developing future leaders.
To meet the demands of the ever-changing performance management landscape in government, agencies must stay up-to-date with cutting-edge best practices and solutions. If you’re still completing employee performance reviews with a pencil, here’s a jumping-off point to get you caught up. The Power of Tech in Performance Management Using an advanced performance management system, employee and agency goals have a better chance of success; best practices can be implemented successfully; and they allow the entire process to be managed more efficiently.
Editor’s note: This is the second in a weeklong series of ISACA Now blog posts sharing guidance on how to start 2025 strong across digital trust professions. Today, we focus on risk.
As we look ahead to 2025, risk professionals face a landscape characterized by macroeconomic, geopolitical and regional uncertainties. The evolving nature of risks requires a proactive and strategic approach to start the new year strong.
The global economy continues to face challenges driven by political instability, trade tensions and regional conflicts. These uncertainties demand that risk professionals stay informed and agile in their decision-making processes.
Below are five key strategies that risk professionals should prioritize for success in 2025.
1. Leverage Reliable Information Sources
The current political instability and the diverse forces at play are significantly affecting the decision-making process due to an information void and the prevalence of disinformation in this era. Obtaining high-quality security information is increasingly challenging, complicating risk assessments for personnel, facilities, and projects, as well as the development of effective mitigation strategies.
Reflecting on 2024 and Looking Ahead to 2025 by Pieter van Zyl Director | HM Lead Appraiser | MDDAP Lead Appraiser
