MedTech Forum 2012: “S is for scrutiny, which we’re not sure about”

Erik has the distinct honor of being my first “Reblog”. In this blog posting he has done an exceptional job of capturing the political issues behind the proposed EU Medical Device Regulation. Erik is as close to the source as someone outside the Commission can be, and his knowledge is evident throughout his frequent postings–which I read and re-read each week.

His firm is offering a free on-line seminar related to the new regulations on November 14th. Make sure that you register with Marjon ahead of time.

Click on this link for information about the seminar.

medicaldeviceslegal

“S is for scrutiny, which we’re not sure about”, that would be more or less the take home message of the MedTech Forum in Brussels that I attended last week from Wednesday to Friday. This conference is an ideal moment to take stock of the EU medtech industry. No wonder that everyone was there to discuss the newly proposed medical devices and in vitro diagnostics regulations. If you want a summary report of the plenary sessions, a good picture emerges from the tweets on the hashtag #mtf2012 by @meddevlegal (that’s me), @clinicamedtech, @emdt_editor and @maxwellmedtech between 10 and 12 October 2012. The picture that emerges is that the industry welcomes the new rules in general, thinks some details must be clarified and is worried about what the proposed scrutiny procedure will look like after it has gone through the legislative procedure and the Parliament has had its way with the…

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Who’s Afraid of the Proposed European Scrutiny Process?

For those of you that are not familiar with the “Scrutiny Process”, I am referring specifically to Article 44 of the proposed EU regulations for medical devices. This process is first alluded to at the end of section 3.5 in the “Explanatory Memorandum” (i.e. – the 13 pages preceding the proposal for the regulation of medical devices).

I was looking for a video that matched up with my title and when I saw this TECHNO music video.

The US already has a pre-market approval process that we fondly refer to as the PMA process. In response to the PIP scandal, the European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) proposed a pre-market approval process as part of a press release issued on April 25, 2012. In response to this political pressure, the Commission has proposed a “Scrutiny Process” that involves preparation of a Notified Body “Summary Evaluation Report” and verification that the conformity assessment was adequate by the Coordinating Competent Authority. A similar process is outlined in MEDEV 2.11/1 rev. 2, a guidance document regarding animal tissues, and the Commission Regulation (EU) No 722/2012 of 8 August 2012. The proposed scrutiny process allows competent authorities to take a “second look” and review the findings of the Notified Body that would be issuing a CE Certificate for these high risk devices. The review process is supposed to be concluded within 60 days, but the review time limit is suspended if the Competent Authorities request additional information or product samples within the first 30 days.

In section 3.5 of the Explanatory Memorandum, the Commission states that this scrutiny process “should be the exception rather than the rule and should follow clear and transparent criteria.” The criteria for invoking the scrutiny process are defined in five points 5a) through 5e) of Article 44. The five points leave room for interpretation by Competent Authorities, and the medical device industry is concerned that the review process for Class IIb and Class III devices will be delayed by at least 60 days on a regular basis. The process could easily be delayed by as much as six months when there are requests for additional information and samples.

The “Legislative Financial Statement” (i.e. – the 19 pages immediately following the proposal for the regulation of medical devices) defines a monitoring process for the scrutiny process in the “Indicator of results and impact” (Section 1.4.4). The risk of delaying access to market for innovative devices is also identified in the “Risk(s) identified” (Section 2.2.1). Therefore, the need for a control mechanism is identified in “Control method(s) envisaged” (Section 2.2.2). This will be the responsibility of the Commission to draft a guidance document to define the control method(s). Until industry has an opportunity to review such a guidance document, executives will continue to voice their concerns and apply their own political pressure to the European Parliament.

Advice from the FDA – Come early, be loud and stay late

For the past two days, I was fortunate enough to attend a training seminar hosted by the FDA in Washington, DC. This was a “free” seminar (i.e. – travel expenses only). The session was split into two rooms. One room focused on the drug-side regulations and the other side focused on the device-side regulations. My strength is device-side. Therefore, I spent most of my time listening to the speakers on the drug-side. Throughout the training there was one common theme that was repeated by the speakers: Come Early, Be Loud, and Stay Late.

It’s much too late for me to still be awake, but I’m still recovering from motion sickness on my train ride back from DC. I feel compelled to write a blog posting, but I just don’t have the motivation for something technical tonight. Therefore, I beg you to forgive my attempt to impart philosophy rather than knowledge. Hopefully, you will find it useful. If not, at least you can enjoy the beautiful singing of Madeleine Peyroux.

“Come Early”

The speakers recommend that companies plan their submissions well in advance and talk to the appropriate FDA project manager about their plans before they start clinical studies.

“Be Loud”

The speakers recommend that companies communicate with as many people as they can at the FDA to make sure they have identified all the critical issues to address in the study design.

“Stay Late”

The speakers recommend that companies think ahead so that if (or when) things don’t go as planned, the clinical study results can be salvaged.

In simple, and more practical terms, every speaker emphasized the importance and value of consulting with the FDA instead of guessing what type of data will be needed for a submission. One of the other participants brought this up at lunch on the first day. He mentioned an example where the FDA agreed with a company on specific data that would be required for acceptance of an NDA. Then, the company did exactly what the FDA said and the FDA required more data. He then described another case where the FDA specified data and the company refused to comply—but the FDA granted approval.

This other participant and I both agreed that most companies are afraid to ask the FDA for agreement on what data is required, because the company may not like the FDA’s answer. My personal belief is that the FDA is better at identifying what data will be required than most companies, because the FDA has a broader perspective than companies do. There will always be exceptions, but my recommendation is to ask the FDA’s opinion whenever you have a question—just make sure you do your homework before you ask an inane question that is already in their guidance documents.

I believe this advice also applies to every regulatory agency in the world.

3 Ways to Fix the 510(k) Process: Self-Surveys, Scorecards and Modular Submissions

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.

A few weeks ago a posted a blog about the Triage pilot program at the FDA. I received some great comments by email and I thought I would go a little more in depth with some specific ideas for improvement of the 510(k) process. Here’s the argument for considering these three proven methods:

Self-Surveys

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.”

Modular Submissions

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.

How do you control design changes?

Of JB’s recommended artists, the Josh Abbott Band was probably my favorite. I especially liked this one. I hope every man is lucky enough to know a girl like Texas. I’m lucky enough to have married a girl that grew up in Texas. They are something special.

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 3^rd 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”:

http://linkd.in/IJtoBL

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?