Survey Results of Medical Device Professionals
In March, the ASQ Biomedical Division surveyed more than 150 medical device professionals about the 13485 transition. The ASQ Biomedical Division was uniquely positioned to design the survey and analyze the results because its mission is “to promote the awareness and use of quality principles, concepts, and technologies in the biomedical industry.”
A five-question survey was designed to be delivered via the ASQ Division LinkedIn group page and in-person. The questions were as follows:
1. Have you completed the transition to ISO 13485:2016? If no, do you have a date for your audit?
2. What are the challenges you experienced or are experiencing right now obtaining the new Standard?
3. For your current quality procedures, do you use flowcharts as part of the documents?
4. Do you conduct management review meetings more than once a year?
5. Do you have an electronic documentation system? If yes, what is the name?
From the beginning of March to the end of April, 133 responses were received from the ASQ Division LinkedIn group page, and 23 in-person responses were collected. Statistical significance could not be calculated because the exact number of individuals who viewed the LinkedIn survey could not be determined.
Metrics—Completion in the Transition
At the time of the survey, only 37 percent had completed the certification process (Figure 1).
You may be surprised to see the low number of companies that have achieved their certification thus far. When the ASQ Biomedical Division probed this further, it was learned that the major factor to completing it was by starting the plan and activities a year ago, as well as scheduling the audit early in the year. Most ISO Registrars were available in the beginning of the year, but as the year progresses, their capacity has diminished. In fact, the next question provides more insight into the availability of ISO Registrars and scheduling an audit date.
Challenges to Reaching the Goal
Survey participants were permitted to provide multiple answers regarding the challenges they experienced or were experiencing now (Figure 2). It is very interesting to see that 44 percent of respondents were challenged by resources to update the procedures, while 37 percent were challenged by updating the procedures themselves. This demonstrates the changes needed to upgrade their ISO Quality procedures took more effort than originally anticipated.
Another observation made from the results of this question is that only 24 percent of the respondents identified MDSAP preparation as a competing priority. Although an inquiry was not posed to better understand why MDSAP was not a competing priority, it’s quite possible these companies were not working toward this certification or didn’t have other resources in place to assist. Those who have gone through the MDSAP journey, however, know the amount of work required to prepare for these intense audits.
Three additional challenges in obtaining the new Standard were identified from the survey results:
• Scheduling a date from ISO Registrar/Availability of ISO Registrar
• Resources needed to comply with the requirements
• Competing priorities
It has been observed at other companies that the amount of time and resources needed has been under estimated. In addition, the need to make several changes within the procedures was not realized regarding the amount of time it would take to implement them. For example, the changes to the supplier controls and having quality agreements as applicable was not a simple task to implement. This required cooperation from the Purchasing and Legal departments, as well as review time by the suppliers.
Making Procedures Easier with Flowcharts
It has always been the direction of quality professionals to make the procedures easy to read and follow. If reading a procedure is as challenging as reading a college thesis, one can predict that people will have a challenging time following it. Therefore, one approach shown to be effective is the use of flowcharts, either to replace the paragraphs or supplement the procedure.
It was a positive sign to see more than 60 percent of the respondents stated they use flowcharts as part of their procedures and 4 percent stated they don’t currently, but plan to in the future (Figure 3). The reasons for not employing flowcharts may be due to the time constraints companies faced to prepare for their Stage 1 (documentation) reviews. These reviews are usually performed a month before the on-site audit.
Management Review Is an Annual Thing, Right?
Frequency of management reviews is one of those topics for which there are always pros and cons. Some believe management reviews should only be once a year due to the amount of work involved with collecting the information. Others would prefer to review critical metrics and quality objectives more frequently, believing if these indicators are not going in the right direction, it’s easier to make the necessary adjustments quicker.
It was observed that over 75 percent of the respondents stated their companies perform more than one management review every year (Figure 4). The conclusion is those companies see the value of keeping the objectives as a priority in running their businesses.
Quality Software Tools in Use
The majority (56 percent) of respondents stated they are using electronic documentation systems (Figures 5 and 6). In addition, 24 percent of the respondents stated they use another form of electronic management system, such as network directories. Based on the vast cloud-based, validated systems available today, it was surprising to see 20 percent of respondents still using a hard copy documentation system. In further studies, it would be helpful to understand the challenges these companies faced to migrate to an electronic system.
We did not ask the time involved to implement the software nor the cost, but both are critical factors when considering documentation software systems. Software systems and software validation will be future topics under consideration by the Biomedical Division.
It has been a quite a journey for quality and regulatory professionals this year. Just as previous occasions when a new Standard was released, there was a learning-curve period during which to determine the optimal method to achieve these requirements. Fortunately, members of industry will learn from each other over the next couple of years as more companies achieve their ISO 13485:2016 certification.
The ASQ Biomedical Division looks forward to using the survey information and input from its members to create training venues and seminars to help showcase best practices. As such, suggestions, best practices, and creative ideas to make compliance easier and improve product safety for patients are welcome.
I would like to personally thank George Marcel, biomedical division marketing chair (director, quality—Focal Therapeutics) for his support in getting this survey posted and the countless hours promoting our Division through LinkedIn. Also, I’d like to thank Teresa Cherry, biomedical division chair (primary consultant/owner—Cherry Tree Quality Consulting) for her support in putting together the article. Special thanks go to Scott Moeller, ASQ Board of Directors/division member (vice president, quality and regulatory—GI Supply) who assisted with the writing of this article. Success is accomplished by surrounding yourself with great people.
Jim Shore is currently the chair-elect of the ASQ Biomedical Division (chief quality officer—Quality Lean Solutions). Those interested in joining the ASQ Biomedical Division should visit the LinkedIn group page.