WANT TO SPEED UP YOUR MEIDCAL DEVICE TIME-TO- MARKET? CONSIDER A PRE-SUBMISSION TECHNICAL FILE EVALUATION

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1 WANT TO SPEED UP YOUR MEIDCAL DEVICE TIME-TO- MARKET? CONSIDER A PRE-SUBMISSION TECHNICAL FILE EVALUATION In business there s a saying: time is money. The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realize significant cost savings and also get their products into the market faster, beating the competition and increasing their market share. For manufacturers of medical devices, the part of getting a product to market that most often is blamed for slowing the whole process down regulatory approval - may actually be one of these untapped areas for found time and money. There s no doubt about the fact that the approval process for something like a CE Marking for a medical device can sometimes bog down the process of bringing a product to market. However, I d also say that companies using a pre-submission evaluation for their technical file are realizing a quicker approval process and getting their products into the market faster, says Claire McKenna, Medical Devices Program Manager with the National Standards Authority of Ireland, a Notified Body that does medical device approvals such as CE Markings. By having some regulatory guidance before finalizing the technical file, a company can easily avoid having to wait weeks only to be told that their application contained avoidable omissions.

2 McKenna says pre-submission evaluations have become very popular over the last year-and-a-half, since the European Union strengthened the requirements for clinical evaluations of medical devices.. While the EU tightened the restrictions on companies being able to put off a clinical trial in favor of citing existing clinical data, they also were more explicit about how a medical device should be approved. Their MEDDEV Rev 3 document that was issued late in 2009 offers an excellent roadmap for how companies can work with Notified Bodies to get a product approved and by using this document as guidance, companies like NSAI have been able to help companies get their ducks in a row before formally submitting their technical file to support their application, resulting in much more definitive turn around times. MEDDEV Rev.3 contains a lot of useful information that is geared to both manufacturers of medical products and Notified Bodies like ourselves who review applications and supporting technical files, says McKenna. By following these guidelines the process of a CE Marking approval is greatly accelerated. So what are some tips can McKenna offer a company to help speed up the approval process? Aside from becoming familiar with the Rev 3 document, she says the rest revolves around being knowledgeable and open to honest critique: Know The Process: It sounds rather simple but understanding exactly what a clinical evaluation is and what the process for approval is will help you be able to better prepare and respond to questions, says McKenna.

3 We follow a five step process that is outlined in the MEDEV document. 1. Identify the scope of the clinical evaluation. Are there any design features of the new device that requires specific attention to certain populations? The more new features, the more information you ll need to provide. 2. Is there any clinical data that is used for existing devices that can be relevant to the new device and its intended use? This can be tricky because often companies will try to cite data and avoid having to stage a clinical trial. More about that later. 3. If yes to number two, then evaluate that data in terms of its suitability for establishing the safety and performance of the device. 4. If the existing data is insufficient, you ll have to generate any clinical data needed to address outstanding issues, typically through a clinical trial. Additionally, if the device is high risk (based on new technologies with little track record), creates a new clinical use for an existing device, or is implantable or a Class III device, you will need to perform a clinical trial regardless of what data is on the market. 5. Bring all the clinical data together to reach conclusions about the clinical safety and performance of the device. If there are any gaps, go

4 back to #1 and restart the process to fill in the holes. Be Honest About the Need for a Clinical Trial: As stated in step number two and three, while a company can use existing data to support the safety and performance of its new medical device, oftentimes there will be holes that need to be filled with a clinical trial. No one is thrilled at the prospect of having a clinical trial for their product because of the cost and time involved. But if you think about it, a new medical device should offer new benefits to the marketplace. To obtain these benefits there may be risks involved or the product may do things that other devices have never done, says McKenna. So while a company can follow the literature route by citing existing data in the marketplace for much of what a new device can achieve, the company should also plan on at least a limited clinical trial to fill in those gaps of existing data and new data required to certify the device. The less a company resists this idea, the quicker they can start the trial and be done with it. Use an Expert: When doing your pre-submission assessment, McKenna says you really need to have it done by someone who is an expert in the field represented by the medical device. Ask yourself Am I choosing this person to evaluate the

5 information because I know that they are an expert or because they ll give me the answers I want to hear? asks McKenna. Whomever you choose to do the evaluation they should be suitable and qualified in the particular industry the medical device is designed for. They should know how your device will be used and the methodology behind it. Choose to work with someone who is up-to-date and knowledgeable in your particular industry. Trust me, it ll get you better results and speed up the formal review of your technical files. You Want Questions: McKenna says lots of questions are good sign of a quality pre-submission evaluation. This means the technical file manager is really doing their job and looking at the technical file. To speed up the process you need to have a report that will stand up to not only the initial evaluation but will be correct even after the technical file is approved, says McKenna. What many people don t understand is the Notified Body is assuming a lot of risk by granting a CE Marking to a product. They are essentially saying yes, this device is safe to use. If it turns out that product isn t safe, the path will lead back to the auditor and the Notified Body to determine how an unsafe device ever received approval. So the more data you can show that demonstrates the tests of the product and the more you are peppered with questions during the pre-submission evaluation the better. That just means smoother sailing and faster approval when

6 the technical file is formally submitted for review and approval. McKenna says she can t say enough good things about presubmission evaluations and in the cutthroat world of medical devices, she can understand why they are catching on in popularity. I know that many companies see a Notified Body as a necessary evil, but this doesn t mean the relationship has to be antagonistic, say McKenna. By working together to assure that all of the pieces of the puzzle are there and organized, the final submission will be smoother and approval will be faster which will mean a faster time-to-market. And when that happens businesses are more profitable and innovative products get into the market to save more lives. And when that happens, it s a win-win for everyone. About NSAI The National Standards Authority of Ireland is one of the world s leading Notified Bodies, specializing in certifications and approvals associated with the manufacture of Medical Devices. This includes ISO 13485, CMDCAS, JPAL, and CE Markings. For more information visit or call