Global Medical Device Podcast powered by Greenlight Guru

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.Some highlights of this episode include:New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.FDA managers are trying to make sure that their teams get the training and mentorship that they need, but it is difficult and challenging.Deficiencies: What is four-part harmony? How are they written? List what was provided, what’s missing, what needs to be provided, and why is it needed?It’s not only the lead reviewer looking at a regulatory submission, but a team of people. Review the deficiencies and manage the additional information (AI) letter to ask relevant questions.To improve the speed of review and the time it takes for files, it’s important to support the reviewers and resources during that process.There’s just not enough time for FDA reviewers to read through and understand all the guidance documents put out by the FDA. Include guidance documents in files to help the reviewers and express how regulations are being followed.Recommendations for new reviewers: There’s what the regulation states, the legal definition, and then people's interpretation of the regulation, what does it mean and how does it apply?There are different risks to different devices. For most questions, there are multiple correct answers that are acceptable by FDA. As a reviewer, you feel a huge burden of wanting to make sure nothing bad happens.Memorable Quotes from Allison Komiyama:“We’re kind of dealing with a lot of new reviewers who are trying to navigate being a new reviewer and what’s actually important. We can see that reflected in some of the questions that we’re getting.” “I think the managers at FDA are doing an amazing job trying to make sure that their teams get the training and the mentorship that they need while they are there. But it’s hard.” “Sometimes that knowledge doesn’t get passed on as seamlessly as we all would want. From the industry perspective, one of the most beneficial things that we can do to improve the speed of review and improve the time that our files take to go through that process is really to support the reviewers.”“One of the things she didn’t realize when she was a new reviewer was how diligent a lot of us in industry are at keeping up on guidance and the changes in regulations because that’s my job. That’s what we do.”Links:Allison Komiyama on LinkedInAcknowledge Regulatory StrategiesRegulatory Science ForumFDA - Medical DevicesFDA - Guidance DocumentsBreakthrough Devices Program (BDP)Safer Technologies Program (STeP)510(k) Submission ProcessPremarket Approval (PMA)Emergency Use Authorization (EUA)David Pudwill (a.k.a. Mr. Regulatory) Code of Federal Regulations (CFR) Title 21Medical Device User Fee Amendments (MDUFA)Use of ISO 10993-1 Biological Evaluation of Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique insights and perspectives into why there's such a high demand right now for regulatory and quality roles and how you can find your next career opportunity with the help of a regulatory affairs recruitment solution for employers and candidates.Some highlights of this episode include:The COVID-19 pandemic affected everything, including hiring practices. Companies started to shut down progressively and put hiring people on hold. Since April-May 2020, Mitch’s firm has worked non-stop with organizations that need help placing regulatory and quality talent.COVID has caused leaders to look at things differently, if they want to continue their business. Some are uncomfortable, others view it as an opportunity to move forward, adapt, and innovate. Flexibility and autonomy are key reasons why people are interested or not. Necessity is the mother of invention: Being forced to do things in a different way, how many businesses will continue the remote workforce model or go back to a brick-and-mortar office setting?  The high demand for regulatory staff is based on several reasons, including the eventual rollout of EU MDR, unbelievable innovation and hypergrowth in digital health, population continues to age, and more medical technology startups.Career Hunters is an online, step-by-step program for professionals interested in moving their career forward. MedTech Talent Lab is a show that talks about all things talent related to medical technology and features a variety of guests.Recruiting has to change. The employer value proposition differentiates hiring opportunities. Top talent cares about organizations that help save lives or improve quality of life, rewards their talent, and offers meaningful value.     Memorable quotes from Mitch Robbins:“When this pandemic started to happen, as rapidly as it did, in March, I, as the owner of our business, like everybody else was pretty freaked out because I saw things start to shut down and shut down more and more progressively.”“We had some searches going on that a couple had just finished up and a couple that were in the final stages went on hold—just pretty much overnight.” “We have just been non-stop with organizations that need our help to place regulatory and quality talent. So, I would say that the market is on fire and demand is...greater than it’s ever been.”“Be okay being uncomfortable—meaning, especially with hiring practices, so many organizations, never in their wildest dreams thought they would hire on a remote basis, let alone build a remote workforce.”“People that are moving and adapting to what is reality are the ones that are winning. It’s okay to be uncomfortable, especially if you see a way forward to continue to innovate.”Links:Mitch Robbins on LinkedInMitch Robbins EmailThe Anthony Michael GroupThe Career HuntersEuropean Union - Medical Device Regulation (EU MDR)FDA - Classify Your Medical DevicesTony RobbinsRisk Management True Quality Virtual Summit SeriesGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program.Some highlights of this episode include:BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.STeP is for medical devices and device-led combination products that improve the safety of currently available treatments or diagnostics that target an underlying disease or condition less serious than those eligible for BDP.FDA hones in on the indication statement for breakthrough devices. A general indication statement of intended use that is not indication specific is more likely along the lines of STeP, then it is a breakthrough device.BDP designation and STeP need to be their own usually distinct q-submissions. It’s a 60-day period between submission and final designation or denial. At day 30, most get a request for more information.Some of the drawbacks of the BDP and STeP process include engagement and interactions with the FDA that do not go as expected. Consider reimbursement early on because it’s important. The Centers for Medicare and Medicaid Services (CMS) has paused the Medicare Coverage of Innovative Technology (MCIT) reimbursement for BDP designation. Memorable quotes from Isabella Schmitt:“When you have more of a general indication statement, it’s more of an intended use and not really indication specific, that’s probably more along the lines of STeP than it is a breakthrough device.”“FDA really hones in on the indication statement for a lot of breakthrough devices.”“Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.”“The FDA’s bar can get a little bit higher for your clearance or approval because you’re focusing on specific language...and you’re basically making claims that need to be proven.”Links:Isabella SchmittProxima CROBreakthrough Device Designation ReimbursementFDA - BDPFDA - STePSTeP Guidance Document510(k) Premarket NotificationPremarket Approval (PMA)De Novo Classification RequestQ-Submission GuidanceEuropean Union Medical Device Regulation (EU MDR)Emergency Use Authorization (EUA)Centers for Medicare and Medicaid Services (CMS)Medicare Coverage of Innovative Technology (MCIT)Medical Device User Fee and Modernization Act (MDUFMA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.Even if you don’t have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.Memorable quotes from Joanne LeBrun:“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we’re supposed to go live. They have a year to get more notified bodies.”“I think that notified bodies are very overwhelmed.”“While the MDR has more constituents involved, I think that it’s going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” “That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEU IVDREU MDRNotified BodiesNew Approach Notified and Designated Organizations (NANDO)ISO 13485:2016ISO 14971:2019 ISO/TR 24971:2020Medical Device Single Audit Program (MDSAP)Overview of the 510(k) ProcessAllison Komiyama from AcKnowledge Regulatory StrategiesGlobal Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun Greenlight Guru AcademyGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. Together, Mike and Jon talk about how medical device companies should approach and manage business risk, which systems and tools can help, and advice on how to review contracts and terms and conditions.Some highlights of this episode include:Are you ready to grow your company? Is it the right time for a business owner to think about the business, liability, and intellectual property? Time to engage Mike.There are consequences to a company’s distribution model and selling strategy.  Each has a different set of contracts and risks that need to be assessed and receive recommendations.Insurance is there for when you need it, even if you don’t understand it. Contractual liability is usually the biggest risk for entrepreneurs and startups.Mike often says that there are three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.Jon defines risk management as a platform with intentionally built workflows related to ISO 14971. Greenlight Guru mitigates risk for companies as they operate quality systems to manage information and handle audits.What you do and don’t do influences and represents your risk profile. Don’t make insurance an afterthought to achieve better outcomes and goals. Do everything you can to be the best company. Don’t just do the minimum, but go above and beyond to change the quality of life.Memorable quotes from Michael Cremeans:“What I’m going to do is help people map out where they’re headed. What could go wrong? Who’s going to be upset at them? What are they going to be upset about? What are the financial damages? What things should you be focused on?”“How can you figure out what they need if you haven’t asked them about their company?”“There’s three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.”“Do not sign a contract until you’ve talked to me.”Links:HylantMike Cremeans on LinkedInMike Cremeans: Risk and Insurance ConsultingFDA - Device Approvals, Denials, and ClearancesFDA - GuidancesISO 14971ISO 13485:2016Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this special 200th episode of the Global Medical Device Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall and agile methodologies for medical device product development, how they were first introduced and how they are interpreted and used today, while also dispelling common myths about the two approaches.Listen as the battle between the methodologies is finally laid to rest by Jon and Devon, with one key theme emerging: the name of your chosen methodology is not nearly as important as the defined processes you follow during product development and throughout the course of your medical device project.Some highlights of this episode include:The FDA’s Design Control Guidance for Medical Device Manufacturers is outdated and includes the waterfall design process. However, medical device manufacturers do not have to follow the waterfall approach. Industry norm? Read the entire guidance before making an incorrect assumption. The waterfall approach is one way, but the guidance offers other approaches and best practices to consider or follow. The waterfall approach was not revolutionary, but it did serve a lot of good for a lot of people. It helped companies establish infrastructure and understand how to develop medical devices in a safe and efficacious manner to meet patient needs.The term, ‘agile,’ as far as a product development methodology, didn’t exist until 2001 with the Agile Manifesto. There were huge gains in efficiency, productivity, and customer satisfaction for software companies using this shiny new approach.What does a good prototype look like? It might be a misconception that one approach is slower or faster than the other. Embrace and acknowledge the idea of continuous change and iteration. Document early, revise often.However, a certain order of operation needs to be followed for verification, validation, traceability, and flow of requirements, regulations, and other factors.Memorable quotes from this episode:“The big confusion about medical device product development is exacerbated by the infamous waterfall diagram that’s published in the FDA guidance.” Jon Speer“Incorrect impression: Well, the FDA says we have to do this, and therefore, we shall do this. They’ve given us a model. This is the way we have to do it. It doesn’t say that.”  Devon Campbell“People, they just see this waterfall approach and use it. Kind of blindly, almost.” Devon Campbell“You start seeing huge gains in efficiency and productivity and customer satisfaction for software companies where they are using this approach.” Devon CampbellLinks:FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)FDA - Quality System Regulation, Part 820 Agile ManifestoScaled Agile Framework (SAFe)Large-Scale Scrum (LeSS)Software as a Medical Device (SaMD)ISO 13485 - Medical DevicesProdct LLCDevon Campbell’s EmailDevon Campbell on LinkedInDevon Campbell on TwitterProject Medtech Podcast with Duane ManciniEasy Medical Device Podcast with Monir El AzzouziGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement.  In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.Some of the highlights of the show include:Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement. From a risk perspective, where are the trends and weak areas? Find them before someone else does and causes complaints or extra work. It is valuable to be able to look into those problem areas that need to be fixed. More medical device companies need to change their mindset by embracing quality as part of their culture, not as an obstacle or barrier. Collaborate with other departments because everyone has to own their process and procedure.Quality auditors may say there’s no choice, this has to be done. If the company has a CAPA or other options to be compliant, management will offer its buy-in. Misconceptions about internal audits include conducting internal audits on every process and procedure at least once a year, and if there’s any audit finding, you must create a CAPA. Key Tips: Make a plan/schedule, document and follow internal audit process, and realize that CAPA’s are only meant for major, risk-based, systemic issues.Memorable quotes from this episode:“We can always get better. Internal auditing is one method that, done properly, can help us improve our processes and our operations as medical device companies.” Jon Speer“I like rules. I like boundaries. I like guidelines.” Sara Adams“You can fix it and not give someone else an opportunity to find that.” Sara Adams“Your internal audits should be the toughest audits that you ever have.” Jon Speer“Being able to present options that still will take you into compliance, I think, is huge for getting management’s buy-in.” Sara AdamsLinks:Sara AdamsISO 13485:2016FDA - Medical Device Single Audit Program (MDSAP)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider when it comes to regulatory compliance and their quality system.Some highlights of this episode include:An IVD consists of the agents, instruments, and systems used for the diagnosis of disease or other health conditions, such as HIV, hepatitis, diabetes, and flu.From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken. Then, the sample is prepared and put through an IVD for analysis to determine the results of a specific test. An IVD is the equipment that analyzes the patient’s sample, not the actual patient. The IVD focuses on the fidelity and accuracy of the tested sample. There’s risk for the patient. Who’s performing the test (lab or licensed clinician), what’s being tested for (non-life threatening disease or not), and if results are inaccurate.Information has to be crystal clear because the user population could be a child, elderly person, or otherwise who takes the wrong action or misinterprets actions that could lead to death. If you have been tested for the coronavirus (COVID), how was the sample collected? How long was the swab that went up your nose? How long was it in?An IVD is a medical device and is subject to the same pre- and post-market controls. It needs a quality system and similar risk-based classification.Treat people and their data in your clinical study well. A lab developed test (LDT) and investigative device should not be perceived as a regulatory path.Memorable quotes from this episode:“That’s the key difference. There’s no patient. There is a sample.” Milton Yarberry“It clearly gives you a target population, a way they’re going to use it, a way they can misinterpret it, and all of those should become mitigations in your design.” Milton Yarberry“You can tell if you hit the right spot if the person wants to punch you.” Milton Yarberry“It’s hard to translate some of that science, that research, that clinical, that laboratory side of things into something that’s commercialized and into something that’s regulated.” Jon Speer“It’s a mindset of the manufacturer that I think is the main difference.” Milton YarberryLinks:Integrated Computer Solutions (ICS)ICS & Greenlight Guru PartnershipCenters for Disease Control and Prevention (CDC) - Waived TestsClinical Laboratory Improvement Amendments (CLIA)FDA - CLIA Waiver by Application510(k) Premarket Notification IEC Standard 6236621 CFR Part 820ISO 13485Laboratory Developed Tests (LDT)EU MDR and IVDREmergency Use Authorization (EUA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities.In this episode of the Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the difference between knowing and doing as medical device professionals and how to do what’s right for the success of your medical device.Some highlights of this episode include:People view quality differently and need to overcome pessimistic and negative perceptions. Quality is a mindset and helps companies solve business problems.Quality is knowing the right thing to do versus doing it. Some people are ignorant because quality is not their role and do not necessarily know best practices. Other people are outwardly antagonistic who know the right thing to do, but choose not to do it for a variety of reasons.  Apathetic people have an idea of what to do or have been told what to do and want to do the right thing by the patients, regulatory bodies, and investors. Quality is common sense that focuses on best practices, documentation, and performance. Rather than caring about traditional technical quality related areas, a quality system is one of the last things some companies/investors consider.Pre-revenue and pre-commercialization companies don’t need to build a quality system that has all the bells and whistles. Start with the core and add-on as needs arise.There is a right and wrong way to implement quality in any organization. Take an efficient, effective, and pragmatic approach to understand compliance and the must-haves, not the nice-to-haves. Make sure to have someone on your team to discuss and champion quality, and implement a quality system that runs the company, not the company running it. Memorable quotes from John Kapitan:“I want to do the right thing. I know I can learn because I don’t know everything and there’s probably better ways to do this. More efficient ways, more effective ways to do this.”“If quality is not your role, you’re not necessarily going to be on top of what good practice is, what best practice is for quality, and what quality requirements are from FDA or overseas. You may be ignorant of just what to do and how to do it. ”“Quality is common sense. It’s not procedures, it’s common sense. It’s how would you do this if you were going to have this device put in your own body or your family members?”“There is a right way and a wrong way to implement quality in any organization.”“It’s always about prioritizing what we spend time thinking about, what we talk about, and what we invest in.”Links:John Kapitan on LinkedInKapstone MedicalFDA - Design ControlsISO 13485 - Medical Devices Premarket Notification 510(k)Premarket Approval (PMA)Investigational Device Exemption (IDE)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?    In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic.Some of highlights of this episode include:Breathe99’s mask filters 97 and 99 percent of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.The prototype of the B1 mask offered protection with complete sealing around the mouth and nose, but allowed adequate breathing through a high-quality filter.The kickstarter for the B1 mask didn’t reach its goal, but then came an obviously serious and urgent need for high-quality respiratory protection. So, the kickstarter campaign for the B2 mask started. A total of more than $750,000 was raised.Positive Feedback—Doctors, teachers, volunteers, and other people feel safer wearing Breathe99’s B2 mask. It’s allowed them to continue doing their job.The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users’ needs and testing requirements is a long-term path that requires proper and realistic planning.Alison discusses how Greenlight has been a resource for bringing the B2 mask to market. It offers peace of mind by going step by step at an appropriate pace to navigate the design and development process.The bureaucratic and complicated regulatory process takes much longer than expected. It presents common challenges, such as checks and balances of medical devices, change orders, and regulatory approval. Medical Device Journey: Learn while you’re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, users’ needs, and why it’s important to design appropriate, safe, and effective products. Memorable quotes from Alison Lee:“We’re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can’t say we’re N95-certified yet, but those are the requirements that we’ve designed our mask around.”“We love hearing about how people feel safer wearing our mask. It’s allowed them to continue doing their job.” “That stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.” “Be aware of your scope, and you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought the regulatory process would be a lot faster.”