If your company is currently registering with the US FDA, you are probably reviewing the guidance document this month for the FY2013 user fees. On page 6 and 7 there is a table of these fees, but you might have overlooked 513(g). Section 513(g) is a provision in the law that allows for companies to request device classification information from the FDA.
During Labor Day Weekend, my family went to the Southern Vermont Garlic Festival in Bennington, VT. We were fortunate enough to hear Molly Durnin play songs from her new album on acoustic guitar. We loved it and bought the CD—which is also available on iTunes. Here’s my favorite track from the new album.
If your company was developing a new product, and you were having difficulty identifying the regulatory pathway, 513(g) is your friend. In my opinion, these fees are modest: $3,348 = Standard Fee; and $1,674 = Small Business Fee. Most consultants will charge at least ten hours of consulting to identify the regulatory pathway for a company. I would charge quite a bit less, because it takes me a lot less than ten hours. I still think the FDA’s pricing is a good deal, because getting information directly from the source is always more valuable than an “expert”.
The US FDA has published a guidance document explaining the process for 513(g) requests. This guidance document was released on April 6, 2012. The guidance explains what information companies need to provide in order to submit a 513(g) request. The guidance also has a fantastic list of FDA resources on page 5. These are the very same resources that the “experts” use—including yours truly.
Just as any good lawyer tries to avoid asking questions that they don’t already know the answer to, I recommend that you first try using these resources yourself. Once you think you know the answer, your request for classification information will be easier to organize.
Here’s how I would proceed:
Step 1
Identify another device similar to yours. If you can’t do this, you need serious help. You need a similar device that is already sold on the market to use as a predicate device. If you cannot identify a predicate, then you can’t use the 510(k) process—or you don’t know your competition. Either way, you’re all buggered up. For example, if you are trying to launch a new topical adhesive made from cyanoacrylate—“Dermabond” might be the first predicate device that comes to mind.
Registration and Listing Database Entry Form
Step 2
Use the registration and listing database on the FDA website to find the company that makes the device. The link for this is #4 on my helpful links page. This link also will provide you with connections to the classification database—which you can use to find the classification for any device. However, the registration and listing database is less likely to lead you astray. When I type “Dermabond” into the field for the proprietary device name, I get a list of five different product listings.
Listings for “Dermabond”
Step 3
Clicking on any one of these five will take you to a listing page for the corresponding company. On that page, you will find the three-letter product code that identifies the device classification and the applicable regulations for that device.
One of the 5 Dermabond Listings
Step 4
Clicking on the three-letter product code (i.e. – “MPN” in our Dermabond example), this takes you to the Product Classification page. This is where you will find that Dermabond, and other tissue adhesives, are Class 2 devices that require a 510(k) submission. In addition, the Product Classification page identifies an applicable guidance document to follow for design verification and validation testing. This is also called the “Special Controls Document”.
MPN Product Classification
Step 5
Click on the “TPLC Product Code Report” link. This link will provide you with a report of all the 510(k)’s recently granted to your competitors, the problems customers have experienced with their products, and the recalls for the past five years. This is extremely valuable information as a design input—as well as competitive information for your marketing team.
TPLC Report for Product Code “MPN” – Topical Adhesive
I’m sure that there are some that disagree with my determination that the latest revision of EN 14971, revision 2012, is unnecessary (the European Commission certainly does).
And here’s another cheeky attitude from the UK…(sorry, this is not a family channel).
Therefore, I would like to clarify why I feel this way by reviewing how risk is addressed in the MDD (93/42/EEC as modified by 2007/47/EC).
The term risk is mentioned only 4 times in the Articles in the MDD
The term risk is mentioned once in Annex II and III, twice in Annex VII, and three times in Annex VIII and X—for a total of 10 times.
The other 41 times risk is mentioned are in the Essential Requirements (i.e. – Annex I).
When companies submit a Design Dossier for review by a Notified Body, an Essential Requirements Checklist is included. This references, in table format, how all the requirements of Annex I are being met—including those related to risks. Throughout Annex I, a similar phrase is repeated many times. For example, in the first Essential Requirement (ER1) it states: “…any risks which may be associated with [a device’s] intended use [shall] constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.” In ER2 it states: “the manufacturer must…eliminate or reduce risks as far as possible…”. There is no room in the MDD for consideration of cost or economic impact when the manufacturer is designing a device with regard to risks and benefits.
If a company’s Risk Management Procedure has been found to be acceptable by a Notified Body, and the company has addressed all the Essential Requirements (ERs) with regard to risk, then there should be no impact from these 7 deviations identified in EN 14971:2012. However, if your company has not addressed each of these ERs, then you might want to consider each of these areas:
Treatment of negligible risks
Discretionary power of the manufacturer as to the acceptability of risks
Risk reduction “as low as possible” (ALAP) verses “as low as reasonably possible” (ALARP)
Information of the users influencing the residual risk
My final advice is to review Annex I and Annex X from the perspective of risk management. You may realize that you have some gaps that nobody noticed. After all, audits are just a sample.
PS – I think it’s ironic that the origins of the ALARP principle are UK case law (see link above).
Unique Device Identifiers (UDIs) are nothing new. MASH tents in the military use 2-D bar coding to track the use of instruments in mobile operating rooms in the field. Just image how hard it is to count forceps and vascular clamps during a wave of shelling from a nearby front. That’s just one way UDI’s can be used to benefit patients and healthcare providers. Click here for the proposed rule.
For this week’s entertainment, I picked something a little different.
This is the unique device identifier example provided by the US FDA.
If you are trying to recall product, the last thing you want is to continue to send out letters three and four times to facilities that have no idea when or if your product was used. The medical facilities want to close out these requests for information quickly too. UDIs present a solution for assuring correct and complete responses by hospitals the first time.
How UDI Helps with Recalls
Locating devices in inventory
Locating product in distribution centers
Identifying product after it is removed from the outer box
Tracking product to each individual patient
How UDI Helps with MDRs
If you’ve been in the business long enough, you have seen more than one complaint about a product that you don’t even make. When this happens the company is obligated to open an investigation to make sure and the complaint gets recorded in the complaint files. The proposed rule includes identification of the manufacturer. Therefore, 100% of complaints should go to the correct company. Also, the company should always receive a lot number—something that almost never occurs.
What do you think about UDIs?
Has your company already taken steps to implement UDIs?
Sorry if you feel mislead, but this is a regulatory fantasy. I thought I would experiment with something different to celebrate 5,000 views! I call it a novelblogg. I should probably trademark the term but that’s just nonsensetalk. I hope you enjoy the music video selection this week, because listening to The Smiths never goes out.
April 2013
Jim, the Director of Engineering at The Cat’s Meow (TCM), bumps into Caroline in the hallway as they both rush to the board room for a surprise meeting with the CEO. Caroline is the Director of QA/RA, and Steve is the CEO.
“Caroline, do you know what the meeting is about?”
“No, but I’m sure it must be related to AAOS. Steve has been pissed ever since he got back from the show.”
Steve enters the conference room with a stack of handouts which he hands to Caroline and asks her to pass the stack around to the rest of the group.
“Thank you for being on-time everyone. I have important news related to The Bees Knees [TBK], and I want everyone to take this information back to their individual teams after this meeting. TBK had a small group of orthopedic surgeons in one of the private meeting rooms at the show. One of these surgeons is friendly to TCM, and they were kind enough to give us the inside track. [pause] TBK is developing a new metal-on-ceramic total knee system, and they plan to launch it at AAOS next year.”
Jim made a low whistle, and Caroline said, “None of the ceramic materials cleared by the FDA could withstand impact from a metal femoral implant. Is it a new material?”
“Great question Caroline. I have been researching that question ever since I got back from AAOS and I finally discovered which material they are using. The femoral component is titanium with a nitride coating, and the tibial component is a single piece of ceramic with a nano-coating. The combination was invented by a start-up company developing a new ceramic wheel bearing, but the company went out of business. They never followed-up their provision patent with a patent application. Now the material has no patent protection and TBK has already started their verification testing.”
“Who’s selling the ceramic?”
“I can’t be 100% certain, but I think the original company supplied TBK with prototype samples for durability testing. Now they are developing an in-house casting process. The chemist I spoke with believes that the nano-coating is a special mold release agent that becomes fused with the ceramic when they sinter the parts in a vacuum furnace.”
“So what’s our counter attack?”
“That’s why you are all here. I was hoping the team might have some ideas for a new product we can launch by next year’s AAOS meeting. In order to launch by AAOS, we need to submit the 510(k) by when Caroline?”
“Well…actually the FDA just announced a pilot program for 510(k) submissions using a new software system. They promise it will dramatically reduce review timescales, but I don’t have any details yet. I already took the on-line training webinar, and I received a password to the beta version of the software. Pilot programs are risky, but this might be the only way we could catch TBK.”
“Jim, what would we need to change about the Orion Knee in order to adapt it for use with a ceramic tibia?”
May 2013
Caroline and Jim have a pre-submission conference call with an FDA reviewer involved in the pilot program.
“Jim and I were reading through the guidance documents you sent to us, and we were hoping you could explain the optional modular submission pathway to us.”
“Sure Caroline. The FDA’s PMA process has a modular submission pathway as well. This was the basis for the modular 510(k) pilot process. The intent was to allow companies to define the content of the submission up-front and allow the company to submit modules as they are completed instead of waiting until all testing is completed.”
“The durability testing of our ceramic tibial component is expected to be the last verification testing protocol that we complete. Can we submit this as a separate module?”
“Exactly. Shelf-life and durability testing is typically the last testing completed prior to submission. Since these tests have well-defined ASTM test methods, I can assign a reviewer independent from the other modules. You mentioned that this ceramic component will be cast and then sintered in a vacuum furnace to create the nano-coating?”
“Yes, that’s our plan.”
“Make sure you use production material rather than production equivalents for the durability testing. The FDA cannot accept verification data for ceramics based upon prototype material. This has resulted in recalls and adverse events for other ceramic implants.”
“That could be a problem. Jim tells me that we will have twenty different size castings, and the process validation won’t be completed on all the sizes prior to the start of our durability testing.”
“Have you identified which size casting represents the worst-case device?”
“Yes. The smallest size is the thinnest and will therefore be the most susceptible to damage. Therefore, we plan to use this for our verification testing.”
“That’s good, but you will also need to demonstrate that the samples used were made under conditions that are validated to produce the weakest implant such as the extreme high or low temperature in your process range.”
“We have determined that the sintering process is the most critical factor in producing a strong implant. At lower temperatures the sintering is not sufficient to produce a dense implant and the implants are sometimes brittle. At higher temperatures, the sintered implant is nearly indestructible.”
“You will need to provide some preliminary data to this affect before I can agree to using implants sintered at the lower temperature limit, but this seems like an appropriate solution.”
“Can we submit the verification protocol along with the preliminary data in order to get the FDA’s acceptance of the durability testing protocol?”
“Yes, you should submit the protocol and the preliminary data prior to submission of that module. I will assign a reviewer with expertise in ceramics to ensure that the protocol and data are reviewed thoroughly.”
June 2013
Caroline and Jim submit the protocol and preliminary data to the reviewer. The reviewer identifies a problem with the protocol. The force chosen for cyclic testing simulates the average theoretical weight of a person walking down a flight of stairs. However, the reviewer indicates that adverse event trends for ceramic implants indicate that most of the device failures occur with heavier patients walking down stairs. Therefore, the reviewer indicates that the force should simulate the 99th-percentile of weight for an adult male walking down stairs. Jim decides to repeat finite element analysis (FEA) with the higher force requirement. The FEA report indicates that implants sintered at the lower temperature may not be thick enough for this force. Therefore, Jim has to modify the casting mold for the four thinnest implant molds. The smallest was sent back to the manufacturer to be modified first and the testing protocol was updated.
July 2013
The revised casting for the smallest implant was received and implants were sintered at the lower limit of the temperature range for sintering. The protocol was executed in early August and the duration is 104 days. Therefore, the final report and module should be completed just before Thanksgiving 2013.
In parallel with TCM’s durability testing, TBK is conducting its own durability testing on prototype material, because the process validation of the new casting is not completed. Their regulatory director has drafted a rationale for use of production equivalents, but there has been no discussion with the FDA regarding TBK’s traditional 510(k) submission. Therefore, no reviewer is identified and no sections of the submission will be reviewed until all testing is completed in October.
September 2013
TCM receives confirmation that all submitted modules have been cleared by the FDA—including labeling and other marketing materials. The initial marketing content included a claim that the new metal-ceramic material “lasts longer than conventional UHMW polyethylene implants.” The FDA reviewer, however, would not allow comparison statements in the marketing literature because the 510(k) process only allows for substantial equivalence. Caroline and the Director of Marketing spoke with the reviewer directly the Tuesday after Labor Day. The Director of Marketing asked if it would be acceptable to share side-by-side video of the durability testing that is in progress with a caption that states “TCM’s new metal-ceramic materials are ‘not inferior’ to TCM’s current UHMW polyethylene implants.” At the time of the question, the metal-ceramic materials were showing almost no signs of wear, while the UHMW polyethylene implants were showing signs of creep and pitting on the polished surface. By the end of the verification testing, everyone expected catastrophic failure of the UHMW polyethylene implants. “Not Inferior” would be a gross understatement, but an accelerated video demonstration of the 104-day study would be more powerful than words or pictures.
TBK has all of the sections of their 510(k) submission ready—with the exception of the durability testing.
October 2013
TCM is waiting to complete the durability testing. TBK hires a courier to deliver the 510(k) submission on October 22, 2013.
November 2013
TCM has delays in compiling the final durability report, and the submission of the final module is not until Tuesday, December 2, 2013.
TBK has not received any questions regarding the submission yet.
December 2013
TCM receives a 510(k) clearance letter on Friday, December 19—only 17 days after submission of the final module.
TBK’s Director of Regulatory Affairs receives a request for data demonstrating that the prototype ceramic material used for durability testing represents worst-case for durability testing.
January 2014
TCM’s 510(k) letter is posted on the FDA website the first week of January. TBK’s regulatory director is fired the second week of January.
March 2014
AAOS is a huge success for TCM. TBK does not exhibit at AAOS in 2014.
Q2 2014
TCM sets an all-time quarterly sales record. Caroline and Jim get big bonuses. TBK receives a 510(k) letter on June 23, 2014—244 days after submission. The new Director of RA starts work on at TBK on the same day. The person is already trained on the new modular 510(k) submission process and received their first 510(k) letter using the pilot process in January.
Modular submissions are already used for PMA submissions. Self-surveys and scorecards are tools that most companies utilize to evaluate vendors. Why not implement these solutions to make 510(k) reviews more efficient?
For entertainment we have Pomplamoose’s cover of “Single Ladies”. My wife Lisa is a big fan of Pomplamoose, and this song is one of my favorites.
In my previous posting about the Triage pilot program, I suggested using the existing FDA traditional 510(k) screening checklist and converting this into a similar “SmartForm”. Another way to think of this concept is by comparing it with a “Self-Survey.” Self-surveys are sent by companies to suppliers in order to gather information about the supplier as justification for approving the supplier; Elsmar Cove has some discussion threads specific to the supplier self-surveys if you are unfamiliar with this method of torture. The critical step in the design of surveys is to require the submitter to provide references to procedures and forms or to explain why something is not applicable. This same strategy is used by BSI for their auditor combined checklists. Instead of checking “yes/no”, the auditor must reference a page in their audit notes where the objective evidence of conformity or nonconformity can be found. A submitter should fill in the checklist, rather than an FDA reviewer, because this forces the submitter to verify that everything required is included. Canada has a similar requirement called a “submission traceability table” for Medical Device License Applications (see Appendix A). Self-surveys also replace some of the tedious searching by a reviewer with cross-referencing work by the submitter.
Scorecards
Another tool that supplier quality uses for supplier evaluations is the Scorecard; Elsmar Cove has a few discussion threads including one with an example to download. For the purpose of the 510(k) process, I suggest developing scorecards for both the reviewer AND the submitter. The primary metrics for these scorecards would be on-time delivery and completeness of the submission for a submitter. The “on-time delivery” requires advanced planning and communication of the submission with the FDA. This is important so that the FDA has adequate time prior to submission to identify the best reviewer(s) for the submission. The completeness of the submission should be 100% of a self-survey, SmartForm or checklist is used to prepare the submission. The primary metrics for the reviewer would be on-time completion of the review and accuracy of the review. The FDA already has target turn-around timescales for decisions (i.e. – 90 days), but there are different phases of review and multiple people the are involved in the reviews. Therefore, the measurement of reviewer time should be more granular. The accuracy of the reviewers should be validated by requiring all deficiencies to be re-evaluated by a peer or superior prior to involving the company. Submission sections without any findings should also be reviewed on a sampling basis as a double check. Over time, the FDA should be able to use these scorecards to match up a reviewer with a submitter. It is critical that at least one of the parties is experienced so we don’ t have the “blind leading the blind.” For those that are offended by the concept of a required second reviewer–get over it. Radiologists are periodically graded with images that are “red herrings.”
My 3rd suggestion is to consider adopting some of the pre-market approval (PMA) processes for the 510(k) process. In particular pre-IDE meetings and modular submissions seam to be logical process improvements. There is typically one component of the submission that is a little behind the rest and holding up a submission. Under the current system, nothing is submitted or reviewed for a 510(k) unless it is complete. However, it would enable companies to get new and improved products to market faster if submissions were modular. Validation such as shelf-life and sterilization validation is rarely the cause for an “Not Substantially Equivalent” (NSE) letter, but these tests are routinely the last few reports completed for a submission. Adopting a modular submission process for 510(k) would allow companies to submit sections of the submission as they are completed. This modular approach would alleviate the time pressure on both sides, and this proposed change should result in earlier product launch dates for industry. The other component of this process is the pre-IDE Meeting. Prior to initiating a clinical study, companies will submit a plan for the study to the FDA. The intent is to obtain agreement on the validation testing that will be performed by the company–including the number of patients and the design of the Clinical. These meetings would also be valuable for 510(k) submissions where the company and the FDA need a forum to discuss what verification and validation testing will be required–especially for mixed-predicate devices and devices that are significantly different from a predicate device.
What do you think about these proposed changes to the 510(k) process?
Please share your own ideas for improving the 510(k) process–including any comments regarding the FDA‘s plans for change.
This week I pulled another song from the movie August Rush.
Thursday, Congress voted 96 to 1 for bill to increase FDA user fees. The rationale is that the FDA needs more funding in order to be strong enough to properly regulate foods, drugs and medical devices. One of the commitments linked with this new funding is to shorten the review of 510(k) submissions. To this end, OIVD has created a new program called “Triage.” The goal of this program is to accelerate the review of certain traditional 510(k) submissions to 30 days instead of 90 days.
In theory this pilot program will help some companies get their 510(k) clearance letter faster, but simultaneously the FDA will be able to concentrate resources on high-risk 510(k) submissions. This entire strategy seems to be the opposite of triage. Triage involves sorting sick patients into three categories:
1) those who are likely to live, regardless of what care they receive;
2) those who are likely to die, regardless of what care they receive; and
3) those for whom immediate care might make a positive difference in outcome.
If we apply the triage analogy to 510(k) submissions, we see three categories:
1) 510(k) submissions that are likely to be approved, regardless of how much time the FDA spends;
2) 510(k) submissions that are likely to be rejected, regardless of how much time the FDA spends; and
3) 510(k) submissions whose approval or rejection is not clear, but the FDA’s earlier involvement in the design and development process would substantially improve the review time.
The FDA’s “triage” program is intended to demonstrate improvement in the time required to approve medical devices by sorting submissions into two groups: group #1 above and group # 2/3 from above. This will make the numbers look good, but the FDA should be spending even less time on the #2 than it spends on the #1 category of submissions. The FDA should also get involved in group #3 submissions much earlier.
The types of submissions that need more FDA reviewer time are devices that are higher in risk and where special controls guidance documents and/or ISO Standards have not already been established for performance and safety testing criteria (i.e. – Category #3 above). In these cases, when a company tries to get some feedback from the FDA the company is asked to request a pre-IDE meeting. The company will not be necessarily performing a clinical trial, but this is the only vehicle the FDA has for justifying the time it spends providing feedback on proposed verification and validation testing plans. The FDA needs to develop something new that is ideally suited for 510(k) products where guidance and Standards do not exist. This would also have the effect of reducing the number of “Not Substantially Equivalent” (NSE) letters the FDA issues.
If a company is developing a device that already has an applicable special controls document or ISO Standard, then the 510(k) pathway should be well defined without the FDA’s help. Unfortunately, there is no easy mechanism for ensuring compliance with these external standards. This type of submission would benefit from software controlled submissions and/or pre-screening of submissions by 3rd party reviewers. The Turbo 510(k) software tool could lend itself to software controlled submissions, but proliferation of the Turbo 510(k) has been limited.
If a company does not submit a 510(k) with all the required elements of a guidance document the submission should not be processed. Implementation of validated software tools for each 3-letter product code would prevent incomplete submissions. At the very least, companies should be required to provide a rationale for any sections of a submission that are not applicable.
One example of a possible software solution is currently used by 3rd party auditors at BSI. BSI uses a software tool that will not allow the auditor to generate a final report unless all the required elements have been completed. The FDA could use the existing screening checklist and convert this into a similar “SmartForm”. If the submission does not have all the required elements of the checklist, the submission form could not be generated from the software. This forces the task of pre-screening reviews back upon the submitter with the aid of a validated software tool.
Disclaimer: There is no need to create the Ultimate Design Control SOP. We need medical devices that are safer and more effective.
If Adele is worthy of six Grammy Awards, she’s probably worthy of a blog link too. Rumor has it that this is my personal favorite from Adele.
In my previous blog posting, I indicated six things that medical device companies can do to improve design controls. While the last posting focused on better design team leaders (WANTED: Design Team Needs Über-Leader), this posting focuses on writing stronger procedures. I shared some of my thoughts on writing design control procedures just a few weeks ago, but my polls and LinkedIn Group discussions generated great feedback regarding design control procedures.
One of the people that responded to my poll commented that there was no option in the poll for “zero”. Design controls do not typically apply to contract manufacturers. These companies make what other companies design. Therefore, their Quality Manual will indicate that Clause 7.3 of the ISO 13485 Standard is excluded. If this describes your company, sit back and enjoy the music.
Another popular vote was “one”. If you only have one procedure for design controls, this meets the requirements. It might even be quite effective.
When I followed up to poll respondents asking how many pages their procedures were, a few people suggested “one page”. These people are subscribing to the concept of using flow charts instead of text to define the design control process. In fact, I use the following diagram to describe the design process all the time: The Waterfall Diagram!
I first saw this in the first AAMI course I took on Design Controls. This is on the FDA website somewhere too. To make this diagram effective as a procedure, we might need to include some references, such as: work instructions, forms, the US FDA guidance document for Design Controls, and Clause 7.3 of the ISO Standard.
The bulk of the remaining respondents indicated that their company has eight or more procedures related to design controls. If each of these procedures is short and specific to a single step in the Waterfall Diagram, this type of documentation structure works well. Unfortunately, many of these procedures are a bit longer.
If your company designs software, active implantable devices, or a variety of device types—it may be necessary to have more than one procedure just to address these more complex design challenges. If your company has eight lengthy procedures to design Class 1 devices that are all in the same device family, then the design process could lose some fat.
In a perfect world everyone on the design team would be well-trained and experienced. Unfortunately, we all have to learn somehow. Therefore, to improve the effectiveness of the team we create design procedures for the team to follow. As an auditor and consultant I have reviewed 100+ design control processes. One observation is that longer procedures are not followed consistently. Therefore, keep it short. Another observed I have made is that well-design forms help teams with compliance.
Therefore, if you want to rewrite your design control SOP try the following steps:
Use a flow chart or diagram to illustrate the overall process
Keep work instructions and procedures short
Spend more time revising and updating forms instead of procedures
Train the entire team on design controls and risk management
Monitor and measure team effectiveness and implement correct actions when needed
The following is a link to the guidance document on design controls from the US FDA website.
Refer to my LinkedIn polls and discussions for more ideas about design control procedures:
Last November Eucomed published a position paper titled, “A new EU regulatory framework for medical devices: Six steps guaranteeing rapid access to safe medical technology while safeguarding innovation.” While I have serious doubts that any government will ever be able to “guarantee” anything other than its own continued existence, I have an idea of how industry can help.
The position paper identified six steps. Each of these steps has a comparable action that could be taken in every medical device company. My list of six steps is:
Only the best leaders
Only one approach to design controls
Stronger internal procedures
Cross-pollination by independent reviewers
Clear communication of project status to management
Better project management skills
The most critical element to success is developing stronger design team leaders. Design teams are cross-functional teams that must comply with complex international regulations, while simultaneously the team must be creative and develop new products. This type of team is the most challenging type to manage. In order to be successful, design team leaders must be “Über-Leaders.”
The most critical skills are not technical skills, but team leadership skills. The role of a design team leader is to make sure that everyone is contributing without tromping on smaller personalities in the group. Unfortunately, there are more men in this role than women.
Why is this unfortunate? Because men suck at listening (takes one to know one).
We need a leader that will be strong but we also need someone that is in touch with the feelings of others and will use that skill to bring out the best of everyone on the team. This superwoman also needs to earn the respect of the male egos around the table. She needs to be an expert in ISO 14971, ISO 13485, Design Controls, Project Management, and managing meetings. Our beautiful heroine must also be a teacher, because some of our team members will not know everything—even if they pretend to.
The Über-Leader will always remind the team that Safety & Efficacy are paramount. As team leaders we must take the “high road” and do what’s right—even when it delays a project or fails to meet our boss’ unrealistic timetable. Superwoman must demand proof in the form of verification and validation data. It is never acceptable to go with an opinion.
She will remind us that compromise is the enemy, and we must be more creative to solve problems without taking shortcuts that jeopardize safety and efficacy. She will work harder on the project than anyone else on the team. She will keep us on schedule. She will whisper to get our attention, but she won’t be afraid to yell and kick our ass.
As Jim Croce says, “You don’t tug on Superman’s cape.” Superwoman is the only exception to this rule.
I have been directly involved in dozens of design projects throughout my career, and during the past three years I have audited 50+ Design Dossiers for CE Marking of Medical Devices. Throughout most of these design projects, I have noticed one common thread—a misunderstanding of design inputs.
ISO 13485 identifies the requirements for Design Inputs. These requirements are:
The most common error seems to be the failure to include the outputs of risk management. For those of you that have used design FMEA’s—that’s what the right-hand columns are for. When you identify suggested actions to mitigate risks with the current design, these actions should be translated into inputs for the “new and improved” model.
The second most common error seems to be failure to consider regulatory requirements. There are actually two ways this mistake is frequently made: 1) Canadian MDR’s were not considered as design inputs for a device intended for Canadian medical device licensing, and 2) an applicable ISO Standard was not considered (i.e. – “State of the Art” is Essential Requirement 2 of the Medical Device Directive or MDD).
The third most common error, and the one that drives me crazy, is confusion of design outputs and design inputs. For example: an outer diameter of 2.3 +/- 0.05 mm is not a design input for a 7 French arterial catheter. This is a design output. The user need might be that the catheter must be small enough to fit inside the femoral artery and allow interventional radiologists to navigate to a specific location to administer therapy. Validation that the new design can do this is relatively straight forward to evaluate in a pre-clinical animal model or a clinical study. The question is, “What is the design input?”
Design inputs are supposed to be objective criteria for verification that the design outputs are adequate. One example of a design input is that the catheter outer diameter must be no larger than a previous design that is an 8 French catheter. Another possible design input is that the catheter outer diameter must be less than a competitor product. In both examples, a simple measurement of the OD is all that is required to complete the verification. This also gives a design team much more freedom to develop novel products than a narrow specification of 23 +/- 0.05 mm allows for.
If you are developing a Class II medical device for a 510(k) submission to the FDA, special controls guidance documents will include design inputs. If you are developing a Class IIa, Class IIb or Class III medical device for CE marking, there is probably an ISO Standard that lists functional, performance and safety requirements for the device. Regulatory guidance documents and ISO Standards usually reference test methods and indicate acceptance criteria. When you have a test method and acceptance criteria defined, it is easier to write a verification protocol. Therefore, design teams should always strive to document design inputs that reference a test method and acceptance criteria. If this is not done, verification protocols are much more difficult to write.
In my earlier example, the outer diameter of 2.3 +/- 0.05 mm is a specification. Unfortunately, many companies would document this as an input and use the final drawing as the output. By making this mistake, “verification” is simply to measure the outer diameter to verify that it matches the drawing. This adds no value and if the specifications are incorrect the design team will not know about it.
A true verification would include a protocol that identifies the “worst-case scenario” and verifies that this still meets the design input requirements. Therefore, if the drawing indicates a dimensional tolerance of 2.3 +/- 0.05, “worst-case” is 2.35 mm. The verification process is to measure either a previous version of the product or a competitor’s catheter. The smallest previous version or competitor catheter tested must be larger than the upper limit of the design output for outer diameter of the new catheter.
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We have been discussing the best ways to control design changes at work, and I thought it might present an opportunity to have more of an interactive discussion with my readers.
During my rounds as a 3rd party auditor, I have seen quite a few design control procedures. The most complex consisted of 19 procedures (NOT recommended, but there were no nonconformities). The most simple consisted of one 4-page procedure, which I wrote, but I would never recommend being this brief. I have created a couple of polls in my LinkedIn profile for you to respond to if you would like to share your own company’s “design control stats”:
The problem I see is that most projects are not new product designs. Sometimes the projects are not even major design changes. I think most changes involve supplier changes, component specification improvements, and design for manufacturability. These changes require review and approval of changes. These changes must also be recorded and retained as a Quality Record.
My own personal preference is to always open a design project—no matter how small the change is. In order to make the process flexible, I also prefer to define how many design reviews each project will have in the design plan rather than mandating that design reviews be held in a stage-gate fashion for 100% of projects.
Most companies will have a table of requirements with columns added to indicate if the requirements are mandatory for the project or optional. For example, “risk management plan needs to be updated? Yes/No.” I like this approach, because the table of requirements makes the decision making systematic.
Sometimes a change is only to a work instruction for a step in the manufacturing process. In these cases, some companies will use a document change order process to supplement the engineering change order process.
My feeling is that more complex products (i.e. – Class IIb & Class III in EU and Class III/PMA in US) will require more stringent design controls for the change. What does your company do to control design changes?
I just wanted to thank everyone for reading my blog. It's hard to make the dry and boring worth reading about. I have also created a formal Thank You page on my personal website: http://13485cert.com/qc-is-dead/.
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Best Practices in Audit Program ManagementMarch 9, 2013
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