Interview: Barry Sands - FDA clearance success

If you've stayed up to date with our success stories, you already have an idea of what RQMIS can do for your medical device manufacturer company. In the Case Studies area of our website, you can find a summary of some of our most rewarding achievements regarding to medical devices consulting. Now a new question has arisen: how can RQMIS help to bring to market a company’s medical device by capitalizing on the synergy of its consultancy services activities while still providing punctual regulatory and quality services? Let’s review this question from the point of view of working collaboratively with the client team, while of course keeping an eye on price, having a not expensive cost and quality. I recently sat down with RQMIS consultancy President Barry Sands to explore a little more about how RQMIS operates in these cases, what the benefits for the medical device manufacturer companies might be, and what sorts of risks and costs can be expected.

Barry, first of all, thank you for your time. I want to ask you about a rumor that there’s been a recent success FDA medical device registration story at RQMIS, one in which your team worked synergistically in various areas of a company, such as regulatory and quality, that required RQMIS consultancy services. What can you tell me about that?

Sure, I think you are referring to a medical device manufacturer company called Forest Devices, and personally I think they have a really interesting story. Forest Devices is a medical device startup that began a couple of years ago with a brilliant idea: develop a portable stroke screening medical device that would work no matter the state of the patient. About 2 years ago, they were awarded the MedTech Innovator Showcase Grand Prize for their efforts! https://www.forestdevices.com/2019/09/forest-devices-voted-medtech-innovator-2019/

Wow, congratulations to Forest! So, when Forest applied to the MedTech Innovator Showcase Grand Prize, did they already have their own internal Medical Device Regulatory, Clinical and Quality team formed?

At that time, the medical device company had a staff of approximately 12 employees, and they were completely dedicated to developing a highly innovative medical device: a medical device that leverages machine learning algorithms to detect occlusions in blood vessels and other signs of cerebrovascular accident, and all housed in a single portable form factor.

Their medical device sounds intriguing! But what put them over the top to win the MedTech award?

Their medical device is driven by machine learning software and consists of a mobile unit and a specially designed cap. Emergency medical device personnel like EMTs or urgent care nurses put the cap on the patient's head, and in approximately 5 minutes it can tell whether the patient has suffered a stroke. This medical device is so innovative because the current state of clinical practice is that if the patient is conscious, the possibility of a stroke is determined based on a scoring system in a questionnaire. This is the main method used today, and the truth is that it all depends on the patient being conscious and capable of giving accurate results. https://www.forestdevices.com/...

After winning the award, what was the medical device company looking for? Medical Device consultancy?

With the aforementioned scenario, the medical device manufacturer was initially looking for strategic development and its execution. They wanted “big picture” help. The first thing they were looking for was the medical device regulatory strategy plan to be able to place their medical device in the US (by FDA submission), EU, and Canada.

Although the company already had a Medical Device Regulatory Strategy for the US FDA registration, RQMIS developed it and expanded it to other markets such as Europe and Canada. With help from RQMIS, Forest Devices (the medical device manufacturer) obtained the demanding ISO 13485 certification and the approval of the MDSAP program, with which it can expand to Europe and Canada, among other places.

When the MDSAP program audit was completed and approved, the medical device company had a brief initial discussion with the FDA about the medical device FDA submission and the requirements to be able to market them. It was at this point that Forest began taking advantage of RQMIS consultancy services for other aspects of its medical device development, including medical device regulatory affairs and quality management. Our client knew that with an ongoing project like this one, they would need a lot of help, but they didn’t want to hire separate full-time staff for each area due to costs. Plus, RQMIS could help remotely from our offices here in the US, in the EU and in UK, providing FDA submissions consultancy services and the same for Europe and Canada.

It was a busy time for Forest, to say the least. They were working on a complex medical device FDA regulatory pathway, and they needed help carrying out a phase III clinical study to submit to Health Canada. RQMIS stepped in and participated in FDA meetings where we negotiated an FDA agreement on its requirements. Finally, we designed the submission to FDA for Forest: a De Novo 510(k).

Then, as the relationship grew, the medical device manufacturer relied on RQMIS consultancy services for the writing, development, and implementation of their quality control and change control systems. Their QMS in particular was necessarily complex: it had to integrate FDA CRF 820, ISO 13485 certification, and all MDSAP program requirements.

So, I can see you were involved in many aspects of Forest’s medical device development cycle.

Yes, RQMIS consultant team members worked in the design control process, and we supported change control activities. We determined all of the medical device regulatory and quality control requirements for preclinical and clinical studies required by the FDA, EU, and Canada. RQMIS were everywhere, providing all the consultancy services needed by the client.

How was RQMIS crucial in the success of Forest Devices?

I think part of the success of this is for a medical device start-up company with limited resources to be able to hire a CRO to manage their regulatory and quality system activities, reducing the cost, and limiting the challenges of hiring quality and regulatory staff. In addition, I think it was essential for them that everything was integrated so thoroughly into RQMIS. It is key for any medical device company taking its first steps that their partner organizations dedicate time to knowing the medical device, and that both teams work together for its development. I believe that the lion’s share of success comes from working openly both internally and with our clinical advisers, designing or assisting in the design of the clinical protocols to satisfy the medical device regulatory authorities. Defining the correct indications for the use of the medical device and cultivating regulatory support are absolutely critical.

So, RQMIS provided a comprehensive consultancy service which helped the medical device manufacturer to achieve its objective without having to hire separate teams of professionals. These days it’s not always easy due to cost to find and retain the right help. Hiring internal teams means longer time and higher costs for any project and can pose outsized problems for medical device start-ups. RQMIS already has a consolidated team willing to get to know the medical device in detail and take the lead on quality and regulatory controls. But what can RQMIS offer better than other consultancy companies?

Well, as you know, RQMIS is a leading force in the medical device regulatory consulting field, with a glowing reputation among our clients and peers. RQMIS’s experts consultants with regulatory strategy development and submissions for the FDA and Europe puts us at an advantage when preparing medical device regulatory strategy documents for our client base. RQMIS has supported the development and negotiation of numerous FDA Presubmissions, 510(k)s, IDEs, and PMAs for the FDA, along with Technical Documents and Clinical Evaluation Reports for the EU. We’ve worked on a wide range of medical devices containing novel technological features. Our team has crafted FDA regulatory submissions for software-based medical devices (infusion pumps, hemodialysis devices, diagnostic devices), surgical devices, orthopedic and spinal implants (including artificial spinal discs, spinal interbody implants, and total joint prosthetics), cardiac defibrillators, ventilators, oral care devices, heart valves, drug delivery devices, wearable devices (including a diagnostic wearable patch to measure biomarkers in sweat), noninvasive diagnostic devices (including a wearable that measures cough and lung function), endoscopic imaging systems, and even devices used to disinfect other medical devices. Many of the products we’ve worked on have incorporated cutting edge technologies like machine learning and artificial intelligence, 3D printing manufacturing, and unique mechanisms of actions (the use of electron paramagnetic resonance (EPR)). 

Also, for me, the most valuable part of RQMIS is the expert consultancy team. I’m very happy to have in RQMIS an amazing combination of talented individuals. Our team includes the rare prospective of an FDA reviewer, extensive clinical and regulatory experience, and members who not only know their way around the most up-to-date medical device regulations, but can also advise based on their experience. Our team includes medical device regulatory consultants who are taking their first steps in the industry and who are eager to learn and be fully involved with new technologies. And our technical writers consultants deliver all documents with exceptional quality. At the same time, I believe that another advantage of RQMIS is its international presence. RQMIS is headquartered outside of Boston, MA, but also has permanent offices in the UK and the EU, which help us maintain a fluid relationship with the health authorities in those regions.

We, RQMIS, believe that selecting consultant teams with the right skills, operational experience, and technical expertise are key components to a successful project. By implementing a management philosophy to support our project teams and provide an intense focus on our clients’ needs, we produce results that meet only the highest quality standards. Our approach is firmly grounded in comprehensive project management and well-defined processes. We understand that comprehensive project management is key to the success of any project. Our teams are supported by involved senior management who offer a broad range of expertise throughout the life of the project.

What would you say were the challenges you encountered in the Forest project? Were there any challenges that you noticed in the course of the Forest project that were different from those of other projects? How did RQMIS solve them?

I’m glad to say that RQMIS has a history of rising to pretty serious challenges. One of the most common challenges we face is orchestrating a client’s communication with the FDA or other regulatory body. RQMIS naturally has quite a bit of experience working with medical device companies that come out of meetings with the FDA feeling frustrated or confused by the tone of the agency’s feedback. This is totally normal. It’s not easy to face FDA reviewers in high-stakes meetings when the product development cycle is already so grueling. So I think that one of the biggest challenges is just being able to get to know a product that is highly innovative, being able to have a meeting with the FDA advising that we are going to represent the client, and generating trust from both parties. I’m very proud of our track record of reaching out and clarifying the communication between FDA and our clients.

Also, as with all medical device startup companies, another perennial challenge is the budget. We’ve recently begun a program to help companies just starting in this business by generating their medical device regulatory strategy, so they have a plan to present to sponsors to obtain grants or investment capital.

One of the challenges that comes up in the course of our daily work is setting expectations for what work can be completed internally, and what work needs external help. Identifying the responsibilities of each party involved is a key starting place for us. But this challenge is relatively minor compared to the some of the others.

I’m wondering about a medical device company that is maybe just beginning in the industry and may not be ready for all the consultancy services RQMIS offers. Is it possible to reserve part of the team or only request some of the consultancy services RQMIS offers?

Yes, we meet medical device companies in that position all the time. They have a great idea and are just beginning the process of the FDA regulatory compliance. As I mentioned before, RQMIS supports these medical device companies just starting in this business by generating a Regulatory Strategy mapping out their next steps. That way they can present a medical device strategy plan to sponsors to generate grants and investments. We thrive on guiding companies step by step in their development. As they grow, RQMIS can step in to help with every phase of the path to market, including medical device postmarketing surveillance. This is part of RQMIS medical device consultancy services.

At this moment we are talking mainly about a medical device company based in the US marketing their product in the US, EU, and Canada. Can a medical device company based in any part of the word expand to the US, Canada, EU, and UK markets by teaming up with RQMIS?

Yes, we can help any medical device company in the clinical, quality, and regulatory department. I like to call it the “Path to Market” because we work with several medical device companies in this stage. Once the medical device gain its clearance and is in the market, we help the medical device company providing our consultancy services such as medical device postmarketing surveillance, breaking into new markets, and expanding their brand.

I have to admit, I’m really curious about the RQMIS consultancy service team. We’ll have to schedule another interview and talk just about the consultancy service team, its composition, and the ways in which it has been recognized. For now, though, where could a client go to learn more about what RQMIS can do for them?

Sure. Medical device companies can visit our website: www.rqmis.com and see all the consultancy services we provide. Also, readers can send any question they have to: info@rqmis.com.

Thank you very much for your time Barry, and thanks to our readers. Feel free to leave any questions here, and in the next session we will answer them.

Barry sands is a biomedical engineer with a chemical engineering concentration. He has an MBA and 24 years of experience in regulatory, clinical, and quality affairs for medical device and biotech companies. Barry has seven years of experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District. Today he is the President and founder of RQMIS, Inc., a consulting company with experience in the medical device/biotechnology industry and focused on regulatory, clinical, and quality affairs and product management. RQMIS, Inc. provides support in the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), clinical study design and management, risk management, quality system design and audits (FDA QSR and ISO 13485), and FDA negotiation and communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).