FDA Friday - Cristin G. Welle, PhD

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.


Finding an opportunity to work at the FDA is a fantastic way to learn the inner workings. I’d recommend that if you know anyone at FDA, send them your CV. It may wind up getting in the right hands!
— Cristin G. Welle
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Cristin graduated magna cum laude from the College of William and Mary before receiving her Ph.D. in neuroscience from the University of Pennsylvania. She joined FDA as a postdoc, and shortly thereafter began work as a Principal Investigator, focused on the safety and reliability of medical devices that interface with the nervous system. Cristin is currently an Associate Professor at the University of Colorado, Denver, in the Departments of Neurosurgery and Bioengineering. Her lab seeks to understand how invasive neural devices impact the nervous system, with the aim of informing novel device solutions for patients.

 

Tell us a little bit about your time at FDA.

I worked in the Center for Devices and Radiological Health (CDRH) as a Biologist, and my primary position was in research, within the Office of Science and Engineering Labs, where I ran the Neurological Devices Lab. However, I also served as a consulting reviewer for questions relating to animal testing, early clinical testing, electrical stimulation safety, biocompatibility and neural interfaces, and worked on 100's of files across multiple branches in the Office of Device Evaluation (ODE). I was able to become involved in a few extra projects as well, including playing a role in the Innovation Pathway, which became the Entrepreneur in Residence program, the Neurotoxicology Working Group, and the Early Feasibility Study Committee. In addition, I emphasized communication with the scientific community, worked with officials in other government agencies to promote education on FDA policies, and organized the FDA Public Workshop on Brain Computer Interface devices, resulting in the publication of a white paper.

What past experience or trait do you think helped you be a successful regulator at FDA?

My basic science training and subsequent collaborative efforts with investigators funded through the Department of Defense's Defense Advance Research Projects Agency (DARPA) gave me unique insight into the challenges that come from developing novel technology that pushes boundaries. I think this gave me a different lens through which to consider the testing protocols required for approval, particularly for early human studies. Certainly, I shared with many reviewers the ability to delve into vast amounts of scientific data and try to ascertain the most critical components. Reviewers are remarkable at digesting volumes of complex data very quickly, and I truly admired my peers for their ability to do so.

What are you up to these days?

Right now, I am an Assistant Professor at the University of Colorado, running a research lab that aims to improve the brain/electrode interface, and maximize the capabilities of modulating the brain's performance through electrical stimulation. I direct a group of 5 - 7 excellent scientists, who do the real work, to be honest! I haven't left my FDA life completely behind me though, and I have developed a comprehensive curriculum on FDA Regulatory Affairs that I teach to the university's bioengineering students. Also, I am in the process of developing a certificate program in FDA Regulatory Affairs with both coursework and an internship. So get in touch if you would like motivated, talented regulatory interns! Finally, I do dabble in some regulatory consulting, as I can't stop being interested in how Regulation and Innovation intersect!

What's something that you learned from FDA that helped you in your current position?

Regulatory decisions are extremely complex, and require integrating information from so many different sources. The ability to research an idea from many different angles, and then make a concrete decision, is highly valuable. In addition, regulators become familiar with so many different device areas. Working as a consultant reviewer stretched my boundaries of what I could understand to new limits. I use both of these abilities - pulling a central message out of diverse information sources and stretching to learn about new concepts - all the time in my current role. In addition, I've also learned quite a bit about what it takes to develop new, innovative medical devices. I'm engaged in some early stage development efforts with some collaborators, and am looking forward to putting all that FDA knowledge to use. Finally, I certainly couldn't teach the course that I teach without my FDA experience. It helps to engage the students to talk about how things 'really' work at FDA, aside from just what is printed on the website.

What do you think is a common misconception about FDA reviewers?

FDA reviewers may be more receptive to a dialogue than you think. FDA reviewers and sponsors approach the conversation with different expertise; FDA reviewers have a wide breadth of knowledge in many areas, and may be able to draw on other experiences to help shape the review of a submission, while sponsors come with a deep expertise in their particular product. Expressing healthy respect for what everyone brings to the table, but also pushing back in areas where you may have more experience than others, leads to a productive dialogue, and hopefully a satisfying solution.

What is some advice you can give to a person interested in regulatory affairs?

Finding an opportunity to work at the FDA is a fantastic way to learn the inner workings. I'd recommend that if you know anyone at FDA, send them your CV. It may wind up getting in the right hands!


More about Cristin G. Welle, PhD

For more information about Cristin, please visit the BIOElectrics Lab, or her LinkedIn page.

FDA Friday - Michael Nilo, MS

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.


In speaking with industry, both as an employee and as a consultant, there is a misconception that the FDA reviewers are intentionally obstructive or unqualified to review the submission. This is entirely untrue.
— Michael Nilo
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Michael graduated Summa cum Laude from University of Pittsburgh with a degree in Bioengineering before receiving his Masters of Science in Biomedical Engineering from University of Alabama at Birmingham. He started at FDA in 2009 where he first worked in the Office of Device Evaluation before moving to the Office of the Commissioner. After leaving FDA he worked for Biotronik as a Regulatory Specialist before starting his own consulting company, Nilo Medical Consulting Group.

 

Tell us a little bit about your time at FDA.

I started at the FDA in November 2009 as a lead reviewer in the Dental Devices Branch in the Office of the Commissioner. While I was there, I reviewed devices like dental implants, abutments, adhesive materials, and bone grafts. I also helped develop a Memorandum of Understanding between the FDA and National Institute of Health to facilitated interaction between the two agencies. This led to grant collaboration for new companies and a network of experts for panel-track PMA submissions. I also co-led (with Michael Mendelson, DDS) a project to determine the failure mode of dental hand pieces which have been shown to overheat during use causing severe burns to the patient’s mouth.

After 15 months in Dental Devices, I began to work in the Interventional Cardiovascular Devices Branch(ICDB) as a lead reviewer, splitting my time between the two branches. I moved to ICDB full time in January 2012. In ICDB, I examined pre-market submissions for cardiac medical devices, specifically devices that are inserted into the coronary arteries and the devices used in the interventional procedure. Drug eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, and embolectomy catheters are just a few of the devices that I was responsible for reviewing. I worked closely with the pediatric devices working group within the Division of Cardiovascular Devices and promoted pediatric issues within CDRH. 

My final role at the FDA was in the Office of the Commisioner, working to develop guidance for proper evaluation and reporting of age-, race-, and ethnicity-specific data within medical device clinical studies. This guidance was finalized and published just this year. 
 

What experience do you think helped you be a successful regulator at FDA?

I believe that my education and experience as a Biomedical Engineer at the University of Pittsburgh helped prepare me for the knowledge needed to review devices as well as (and more importantly) the ability to lead and participate in large, multi-disciplined teams. The other experience that helped more than I thought it would, was being a referee and umpire growing up. Having authority and being confident in my decisions in the face of disagreements was important, especially as a new reviewer.

What are you up to now?

In November 2016, I started my own consulting company, Nilo Medical Consulting Group, which is aimed at helping medical device companies navigate the regulatory process both in the US and abroad. I’ve helped with regulatory strategy, submissions, and training in large and small companies across all classes of devices. In addition to my own company, I also work closely with other excellent consulting groups like Network Partners and Vision28.

What's something that you learned from FDA that helped you in your current position?

My knowledge of the FDA processes and people is essential to my current consulting position. Recognizing the time constraints, background knowledge, and approaches of a typical reviewer, I’ve been able to (hopefully) prepare and train others to prepare submissions that make it as easy as possible for an FDA reviewer to do their job.

What do you think is a common misconception about FDA reviewers?

In speaking with industry, both as an employee and as a consultant, there is a misconception that the FDA reviewers are intentionally obstructive or unqualified to review the submission. This is entirely untrue. FDA reviewers are scientists, doctors, engineers etc. that have the protection of public health as their main interest. They look at a wide variety of devices, from companies across the globe, each with their own processes and rationales. It’s important to recognize that both FDA and industry have the same goal, and helping agencies understand your thinking is an important part of working in regulatory affairs. 

What is some advice you can give to a person interested in regulatory affairs?

Don’t be afraid to ask everyone questions. To work in regulatory, you should have a working knowledge of all aspects of a product life cycle, from research to sales. The more you know about each aspect of a work stream, the better you can help ensure that the quality system is maintained; and the better you can explain things to a regulator.


More about Michael Nilo, MS

For more information about Michael, please visit the Nilo Medical Consulting Group, or his LinkedIn page.

FDA Friday - Laura Gilmour, MS

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.

This is our last post until the new year! We're taking next week off to enjoy the holidays and spend time in the company of family and friends. Thank you for following along and being part of our community here. We'll see you in 2018!


The most common misconception about additive manufacturing for the general public is that it is only used for prototyping. In fact, the FDA recently disclosed that over 100 medical devices manufactured by additive manufacturing have been cleared to date.
— Laura Gilmour
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Laura received degrees in Bioengineering and Biomedical Engineering before working in R&D for such companies as Smith & Nephew and Abbott Vascular. She started at FDA in 2012 where she reviewed premarket applications. Laura was one of the founding members of the Additive Manufacturing Working group at FDA. She continues to support medical device manufacturers in her current role as Global Medical Business Development Manager at EOS in Austin, TX.

 

Tell us a little bit about your responsibilities at FDA.

During my time at the FDA I was in the Division of Orthopedic Devices II Branch with the main responsibilities of reviewing 510k applications for large and small joint orthopedic implants and instruments. I was also a founding member of the Additive Manufacturing Working group which continues to be led by co-founders, Matthew Di Prima and James Colburn

What experience do you think helped you be a successful regulator at FDA?

I had experience within the orthopedic device industry prior to my time at the FDA, mainly in research and development. I had working knowledge of how a medical device company approached design, development, testing, and interpreting the standards set by the FDA. I believe the experience I had from both sides helped me close any gaps in understanding with the companies whose products I reviewed because I also understood their perspective and objectives.

What are you up to now?

Today I work for EOS, the leader in industrial additive manufacturing, as the Global Medical Business Development Manager. In this role I work with medical device companies worldwide helping them implement additive manufacturing into their business.

So what's additive manufacturing? Asking for a friend...

Additive Manufacturing refers to a process by which digital 3D design data is used to build up a component in layers by depositing material. The term "3D printing" is increasingly used as a synonym for Additive Manufacturing. However, the latter is more accurate in that it describes a professional production technique which is clearly distinguished from conventional methods of material removal. Instead of milling a workpiece from solid block, for example, Additive Manufacturing builds up components layer by layer using materials which are available in fine powder form. A range of different metals, plastics and composite materials may be used.

What's something that you learned from FDA that helped you in your current position at EOS?

Because additive manufacturing is a fairly new process for medical device and instrument production, many of our customers have questions on the regulatory framework. While the guidance document, “Technical Considerations for Additive Manufactured Medical Devices” was finalized in early December 2017, my background and work as a reviewer at the FDA has given me insight into what types of questions and scope of information the FDA is asking for devices made through this manufacturing technique. It is very rewarding to be able to help our customers gain confidence and move forward with their innovative ideas through new design possibilities gained using this technology.

What do you think is a common misconception about the additive manufacturing industry?

The most common misconception about additive manufacturing for the general public is that it is only used for prototyping. In fact, the FDA recently disclosed that over 100 medical devices manufactured by additive manufacturing have been cleared to date. There are acetabular cups and revision shoulders, for example, produced by additive manufacturing that have already been implanted into patients. More and more medical device companies are using the technology for serial production.

What is some advice you can give to a person interested in regulatory affairs?

This is actually advice I would give to anyone interested in the medical device industry: Be curious. There is so much to learn about medicine and so many innovative companies and physicians creating new processes, materials, or surgical techniques. Be open to possibilities you never thought you’d find; it’s an exciting diverse field!


More about Laura Gilmour

For more information about Laura and her colleagues’ work at EOS, please visit the following link: https://www.eos.info/en

And check out this really cool video on 3D printed micro parts from EOS!

FDA Friday - Nada Hanafi, MSc, MPH

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.


FDA is not an obstacle that companies must overcome or get through. FDA’S role is to help companies have the best product; one that is safe and effective for its intended use and remains so once it is on the market.
— Nada Hanafi, MSc, MPH
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Nada began her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation in 2004 and led FDA review teams for first-of-kind devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE, and two novel neurological stent HDEs. As a Senior Science Health Advisor at CDRH, Nada led cross-Center programs for the advancement of FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. 

 

Tell us a little bit about your time at FDA.

During my tenure at FDA I had the good fortune of holding a variety of roles. I started my journey as a Lead Scientific Reviewer in the Plastic and Reconstructive Surgery Branch (PRSB) in the Office of Device Evaluation (ODE) at CDRH. After four years, I transitioned to the Office of the Center Director (OCD) and served as a Network Leader to establish consistent business practices for planning, managing, and organizing surveillance of medical devices to enhance premarket and postmarket safety. In my final role at FDA, as a Senior Science Health Advisor, I ran the development, implementation, and assessment of cross-Center and Agency policies and public health programs for the advancement of public health. I advised on projects related to strategic outreach and collaboration efforts, all while consulting and collaborating with stakeholders to ensure that premarket, postmarket, scientific, and compliance initiatives aligned with FDA’s mission.

What trait(s) do you think helped you be a successful regulator at FDA?

Team work, flexibility, and collaboration are key. In addition, keeping patient needs and improved health outcomes at the forefront of regulatory decision making is critical to being successful at FDA. I found it very worthwhile to take time at the start of each project to clearly ‘define the problem’ and determine where we wanted to go. Pre-work on goals and objectives paid dividends in the end as we developed and implemented strategies and solutions. I believe effectiveness is vital to all work products. Efficiency is good to shoot for, but ultimately, we should all strive to achieve an effective outcome for whatever it was we are trying to address.

What are you doing now?

I am currently the Chief Strategy Officer for Experien Group, a full-service medical device consulting firm based in Silicon Valley and San Diego. We offer support in regulatory affairs, quality systems, pre-clinical and clinical research, data management and reimbursement.  In my role I provide high-level strategic direction and executive oversight for the development of regulatory and clinical strategies for medical devices and combination products.  We guide and help companies at every stage in order for them to focus on executable programs throughout the total product life cycle—from early product development through post-market compliance.

What's something that you learned from FDA that helped you in your current position?

FDA is not an obstacle that companies must overcome or get through. FDA’S role is to help companies have the best product; one that is safe and effective for its intended use and remains so once it is on the market. It is best to consider FDA reviewers and management as a critical part of your team and take a more collaborative approach in your dealings with them from the very start. Partnership is key!

What do you think is a common misconception about FDA?

Industry may fear FDA and/or think that FDA wants to make things challenging for a sponsor or manufacturer. This is simply not true. FDA is there to help facilitate the journey to get a safe and effective product to market and to patients in need. I think it is important to view the interactive reviews and additional questions as a conduit to making your product the best version to truly improve health outcomes.

What do you think is a common misconception about your current industry?

A common misconception is that ‘one size fit’s all’ in navigating a regulatory path; and that is simply not the case. Companies should be open to exploring new ways and creative strategies – don’t box yourself in! I strongly recommend that medical device developers and manufactures (regardless of whether early stage startups, well established traditional device companies, or some of the emerging novel digital technologies developers), always answer a key question:

 “What is the clinical problem my device or technology is addressing?”

They should then identify their long-term goals to most effectively develop a roadmap for the total product life cycle. Keep patients as the vanguard of the mission, and consider all stakeholder's needs throughout the product development stages.

What is some advice you can give to a person interested in regulatory affairs?

If you are a curious person who enjoys solving complex challenges, developing solutions, addressing problems proactively, and enjoy a relatively fast-changing field, then don’t hesitate to explore the world of regulatory and medical devices. You won’t be disappointed. 


More about Nada Hanafi, MSc, MPH

Nada's work, both at FDA and in her current role, has a strong focus on women-specific diseases and indications. While at the Agency, she served as the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and Office of Minority Health (OMH) to evaluate research proposals and intramural grant applications.

Nada also had the opportunity of detailing as Lead International Policy Analyst at the Center for Tobacco Products (CTP) within OCD, where she helped develop an international strategic plan. She represented CTP in multilateral conferences and interagency working groups to develop regulatory partnerships and mutually beneficial information exchange for internal policy development and decision making.

For more information about Nada and her colleagues’ work at Experien Group, please visit the following link: http://experiengroup.com/team/

FDA Friday - Caroline Rhim, Ph.D.

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.


Decisions at FDA, and even those in industry, are never made in a silo and always require functional collaboration. What has been critically important in this collaboration is the fundamental reliance on scientific evidence first.
— Caroline Rhim, Ph.D.
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Dr. Rhim is currently the Executive Director of Medical Device Consulting, at NSF International, where she provides strategic and hands-on consulting services to clients looking to introduce innovative medical devices to patients. She joined NSF International after nearly 10 years in the medical device and public health sectors, including over seven years with the U.S. Food and Drug Administration. 

 

Tell us a little bit about your time at FDA.

I came to the FDA right out of graduate school, not knowing much about the Agency or appreciating the enormity of its charge in promoting and protecting public health. During my first years at FDA, I spent my time as a lead reviewer in the divisions of orthopedic and cardiovascular devices, and was responsible for the premarket review of a variety of different device types and submissions. Many times, these reviews involved coordinating a large team of experts who all weigh in on a device’s safety and effectiveness profile. More recently, I took a position as the chief of the Anterior Spine Devices Branch. In this role, I was able to lead a team of engineers and medical officers, who collectively assessed all premarket reviews for anterior spinal devices requesting US marketing clearance or approval. Additionally, there were opportunities to engage with industry counterparts as well as representatives from larger trade associations.

What past experience or trait do you think helped you be a successful reviewer and then branch chief?

Growing up, it was ingrained in me to always think about the team over myself. That collaborative nature has made the difference in considering all points of view, resolving disagreements, and keeping teams aligned to a common goal. Decisions at FDA, and even those in industry, are never made in a silo and always require functional collaboration. What has been critically important in this collaboration is the fundamental reliance on scientific evidence first.

What are you up to these days?

What some refer to as the “other side”, I now work with medical device manufacturers who are looking to get into the US market, as well as other global markets. I am using my intimate knowledge of the FDA review process to help tackle challenging regulatory scenarios and also guide clients to the most effective and efficient path to commercialization.

What's something that you learned from FDA that helped you in your current position?

Other than the regulations themselves and how reviews of submissions are conducted, I have gained an appreciation for the balance of scientific and regulatory perspective necessary for premarket review. From this, I have also learned that there are often a number of acceptable regulatory approaches, but all should have a sound scientific rationale.

What do you think is a common misconception about FDA and/or FDA reviewers?

One big misconception is that FDA wants to say “no”, which is far from the truth. There are a number of reasons that manufacturers are challenged, and these can range from an inadequate scientific rationale to an unaddressed risk to health. Other times, a particular device is questioned because FDA has evidence that points to a problem that had not come to light until recently about a certain technological feature or a certain use within a device family. Still, there are other situations where there may be a systemic issue raised by the medical community. FDA doesn’t always have the answers and very much appreciate a scientific discussion focused on how to mitigate your risks to health. If anything, FDA wants to see more devices on the market and in the hands of patients.  

What is some advice you can give to a person interested in regulatory affairs?

First, don’t be afraid to jump in. While there is merit in becoming more acquainted with the regulations and reading through regulatory affairs blogs and books, nothing can really solidify any of that knowledge without the hands-on experience. Second, talk to others for perspective. The field of regulatory affairs is so broad and the scope of what that means in different product areas (i.e., drugs, devices, food, etc.) is starkly different, too. Take time to explore each of these and reach out to people on the front line. Also consider that regulatory affairs is not only about getting something on the market, as there is a whole other regulatory world after getting that FDA stamp. Finally, think globally. Just as companies are thinking about global marketing, begin to understand that there are separate regulatory paradigms for different parts of the world. You have to be versatile across these platforms to make yourself a regulatory expert.


More about Caroline Rhim, Ph.D.

Dr. Rhim received her doctorate degree in Biomedical Engineering from Duke University, and her Bachelor and Master of Science degrees in Materials Science and Engineering from M.I.T.

Prior to joining NSF International, Caroline served as an FDA Branch Chief for the Anterior Spine Devices Branch at the Center for Devices and Radiological Health (CDRH). Caroline also led the review of premarket submissions as a lead scientific reviewer in both the Division of Orthopedic Devices and Division of Cardiovascular Devices. During her tenure at FDA, she was involved in streamlining the premarket and postmarket review process, as well as the classification efforts for posterior cervical screw systems.

For more information about Caroline and her colleagues’ work at NSF International, please visit the following link: http://www.nsf.org/services/by-industry/medical-devices/