Behind every innovation, there are years of hard work, passion, and perseverance. A medical device based on innovation, meticulous planning, and excellent execution goes a long way in changing the lives of many. To protect our innovations we file patents, hire lawyers and get NDAs in place, but sometimes tend to overlook the need of or importance of recording the most critical element of our innovation – DESIGN. Design evolves and goes through a journey of development, as the product is fine-tuned to meet its user’s needs.
The need for a DHF
Section 7.3.10 in ISO 13485:2016 and 21 CFR part 820.30 permeates that ‘each manufacturer shall establish and maintain a DHF for each type of device. The Design History File (DHF) shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part’. The design of the product with its specifications, design review, verification and validation, and so on should be recorded in a Design History File (DHF). In simple words, a DHF is nothing but a compilation of design history records of a finished device.
Once the design of the medical device is frozen, it is transferred to manufacturing. The design transfer indicates that the DHF is finalized. After the design transfer, any changes to any design specifications, or software updates must undergo a Change Control Process. This process details the change, what is being affected, what inputs or outputs are affected, the risk, priority level, activities needed to implement the change such as regulatory approvals or verification/validation of design change, and a verification that the change has been implemented. Following this the DHF should be updated to reflect the change.
DHF Remediation an important but forgotten endeavor
It is evident that the DHF is typically a living file that requires constant updation throughout the design life cycle. This is where persistence plays a vital role for any medical device company, as it has to maintain constant compliance with the several regulatory design control requirements and regulations which are dynamic. However, several years back neither was there a good understanding on how often and when the DHF should be updated, nor did the Auditors or Inspectors check frequently for updation; as a result, amidst the fast pace of sales, marketing, changing team members, shifting priorities, post-marketing surveillance, more often than not the DHF update was forgotten. In such cases, or in cases of a significantly changed standard or regulation, DHF remediation is certainly called for to protect what device companies have innovated and to prevent any eventual market recall issues.
Remediation – Easier said than done
Remediating a DHF is a colossal endeavor that requires multiple resources’ time and effort to complete this detail-oriented task and companies often have to dedicate personnel from other functional teams for remediation, which is not very efficient or in the best interest of the company. That’s where Elexes could step in and support these companies in conducting the remediation process for accurate updates to the DHF, charted on a predetermined timeline.
How should companies really go about implementing a DHF Remediation. HERE ARE SIMPLE FIVE STEPS:
STEP 1: Define the purpose
The purpose for DHF Remediation must be defined in order to lay down objective steps for the remediation. DHF could be remediated for:
- 93/42/EEC (MDD) changing to Medical Device Regulation (MDR)
- ISO 14971:2007 to ISO 14971:2012
- MEDDEV 2.7/1 Rev 3 to MEDDEV 2.7/1 Rev 4
- Legacy products that have to be retested to new standards
STEP 2: Conduct a Gap Assessment
This is an important step to understand the “delta” between what is the target (based on the purpose defined in step 1) and what exists now. This step will reveal all the gaps that need to be addressed for complete DHF remediation.
STEP 3: Conduct Impact Assessment and create a plan
Once the gap assessment is complete, the impact of the each of the “delta” must be evaluated, e.g., if re-testing needs to be done, if risk assessment needs to be updated and what kind of update (creating a risk-benefit analysis, or adding more hazards based on product’s field experience). This impact assessment would help enlist action items based on which a plan that would be elementary to the successful execution would be defined. A plan should contain:
WHO – People and the kind of expertise, background and skill set that should be involved
HOW MANY – Number of personnel to be involved both for planning and for execution
TOOLS – Checklists, cloud-based platforms to collaborate, or document repository
TIME – Overall time required
STEP 4: Execution
This is the most time-consuming step and involves the implementation of the plan to the most minute action items. Successful execution requires a strong team who is committed to achieving the end goal.
STEP 5: Closing DHF Remediation
This is the last step where everyone signs off on the revised DHF and it forms a solid base for the product for many years to come.
For medical device manufacturers, an organized DHF is ideal for laying a good foundation of the quality system through the design and development, verification and validation testing, clinical trials, and post-market phases. The indispensable need to align the strategies adopted with regulatory requirements is perhaps discernible.
Let’s protect our innovations of the past with equal diligence with which we protect the new ones. For any questions/comments please write to firstname.lastname@example.org