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At ComplianceQuest, we’ve worked with 100+ customers in the medical device ecosystem, helping them adopt a next-generation EQMS for their quality management workflow.
Thanks to this experience, we believe the following 7-step approach will be really helpful for quality leaders at medical device companies, who’re just embarking on the digital transformation journey of their quality processes:

  • Step 1: Understand the regulatory landscape
  • Step 2: Design your Quality & Compliance Process
  • Step 3: Benchmark against industry best practices
  • Step 4: Design standard operating procedures
  • Step 5: Create a Master Quality & Regulatory checklist
  • Step 6: Quality Analytics to derive insights from Quality Data
  • Step 7: Continuous Improvement

In this blog, we highlight the role of why benchmarking your QMS workflow with industry best practices can be extremely useful.

Benchmark your QMS against medical device industry’s best practices for quality excellence

Business is sometimes about beating the competition to improve your growth prospects. There are many ways to do that, but the one that gives long-term benefits is the battle fought on quality and value proposition. This requires a great understanding of the industry’s best practices and imbibing them in one’s organization. This could be in quality practices, digital transformation, through collaborations and data management.
Quality and Compliance Practices – The five areas where you can establish benchmarks include:

  1. Supplier quality management by tracking and managing global suppliers, establishing metrics for their performance for the purpose of training if they fall short,
  2. Change management through the enforcement of rigorous change control procedures across the organization,
  3. Complaint handling by integrating the process from the time of registering the complaint to discharging it, to the satisfaction of the complainant or the relevant authorities,
  4. Electronic medical device reporting (eMDR) by automating and streamlining report submission processes for greater efficiency and accuracy in compliance, and
  5. Corrective and preventative action (CAPA) management to trace the root cause for manufacturing deviations, correct them and implement measures to prevent future product safety issues

Digital Transformation & Automation

To improve competitiveness and keep costs low in these times of high competition and heightened customer awareness, businesses are turning to Industry 4.0 or digital transformation technologies for greater efficiency and productivity. These include:

  1. Integration of Internet of Things with telemedicine and telehealth technologies called Internet of Medical Things (IoMT)
  2. Wearable medical devices to measure critical health parameters
  3. Mobile-ready solutions
  4. Leveraging artificial intelligence and machine learning to reduce human intervention
  5. Use of augmented reality/virtual reality for simulating situations in medical research for greater accuracy and insights
  6. Data management and analytics for gaining insights into current practices, understanding their implications and projecting future trends

According to McKinsey, the use of Industry 4.0 technologies such as advanced analytics, robotics and automation can change the way the life sciences industry works and productivity has increased by 30 to 40 percent in mature and efficient lab environments. Further digitization can improve it to 50 percent, while ensuring better quality and compliance, reducing manual errors and variability and enabling quicker and effective resolution of problems. There can be 65 percent reduction in deviations, 90 percent faster closure times, cost savings due to better compliance, improved agility, shorter testing times and faster releases.

Collaboration & Mobile Readiness

Manufacturers are compelled to shrink time-to-market while keeping their cost of manufacturing low. In a bid to keep costs low, consumers are aggregating their buying through group purchasing organizations (GPOs) or centralized purchasing groups, which is further driving down prices.
On the other hand, it takes a medical device three to seven years of time-to-market on an average, and the cost could range from $31 million to more than $90 million for high risk products and thus averaging a cost of $30M/year on the high end to $3.50M/year on the low end. Any reduction in time to market has a significant impact on the Company’s financial performance and thus to the shareholder returns/value.
This is compelling medical device developers to collaborate with contract manufacturers and suppliers to reduce their cost of development and manufacturing and protect them against any delays in supply and production challenges. Proactive collaboration is proving to be a key risk management solution, leveraging the resources of the partners to cut down on overheads.
For effective collaboration, the following Partner traits are essential:

  1. An understanding of the capabilities and market reach,
  2. Commitment to collaboration,
  3. Driven to manufacturing safe and effective devices,
  4. Risk management capabilities, and
  5. Transparency

Seamless integration of processes between the collaborating teams and mobile-readiness has become important.
In this Whitepaper, we share “A 7-Step Guide to Quality & Compliance for Medical Devices Companies” based on ComplianceQuest’s experience of serving 100+ customer customers in the medical device space.
Read it here: http://www.compliancequest.com/whitepaper/a-7-step-guide-to-quality-compliance-for-medical-devices-companies/

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