BioTop Medical: The Right Hand of Medical Device Manufacturers
Teresa Lopes, Founder and Director The theoretical conceptualization and the real-world manifestation of a product/device in any industry are separated by multiple, objective-driven milestones that symbolize the progressive development of a device across various stages. Simply put, a medical device undergoes a journey from the initial phase of ideation, wherein it is designed to solve a realworld problem. The proof-ofconcept of the medical device then goes through an incubation period, which involves the design and development stages that transforms the idea into a physical entity. Upon manifestation, the product is verified against industry standards and benchmarks, rigorously tested, and reengineered to perfection. Ultimately, the product undergoes the final validation, where regulatory authorities (or organizations designated by them) of the corresponding region stamp the mark of approval, indicative of its safety and effective performance and thus the device’s utility in the real world.
When organizations embark on this iterative journey of medical device manufacturing, perfecting all the arts necessary to create a product often proves futile due to the ineffective mastery over the required skill sets. In other words, these manufacturers require the experience of a leader/ mentor that will guide them through this strenuous journey from quality and regulatory perspectives. In fact, BioTop Medical believes that these regulatory requirements present unique opportunities for distinction rather than standing tall as obstacles. The role played by BioTop Medical in the medical device manufacturing embodies this with “hand-on work” approach along with advice and coaching. The company helps manufacturers establish a stronghold in the industry, as they initiate medical device manufacturing ventures or as they maintain an already existing device on the market.
BioTop Medical’s core competencies address all of the different prerequisites for an organization to bring a product to market. “Our services—from a QA/RA perspective—encompass almost everything through the initial ideation to the development and eventual release of a medical device to the market. We provide services for quality management, training and coaching, auditing, GAP analysis, risk management, regulatory compliance, technical documentation, and much more,” explains Teresa Lopes, founder and director of BioTop Medical. She emphasizes that BioTop Medical excels, among other things, at the technical documentation for devices being assessed before introduction to the market. The company writes clinical evaluation reports (CER), biological safety assessment reports, and risk management files that are critical and mandatory for the technical documentation in accordance with the medical device regulatory requirements.
In tandem with the aforementioned operational expertise, the CER has become an integral part of BioTop Medical’s proficiencies.
We believe that regulations empower us to create something better
An Unbiased Comprehension of Medical Device Development
“Since 1997, when MDD was just being introduced, the medical device manufacturing sector witnessed a period of transition. Though people were aware of the new directive, they did not know how to apply it. That is where we started, with an effort to bridge this knowledge gap between manufacturers and Notified Bodies,” explains Teresa.
"Our services encompass everything from the initial ideation to the development and eventual release of a medical device"
One of the pioneers in the Netherlands to establish a stronghold in medical device QA/RA consultancy, BioTop Medical has worked alongside some of the top auditors, Notified Bodies, and subject matter experts (SMEs) since its early days in the industry. Owing to this very reason, BioTop Medical can guide clients on the importance of rules and regulations that apply to a final medical device or a process within the industry. Moreover, the company ensures to keep a check on the developments within the regulatory environment.
“I have worked in the medical device field since 1997, “I have worked in the medical device field since 1997, and the way we operate has improved parallelly with the development of standards such as ISO 13485. Adhering to these changes is more about the right way of interpreting the requirements and guidelines, and even though clients are not necessarily happy about these regulations, they have proved to be quite necessary,” details Teresa.
On a few occasions when device manufacturers complained about the regulations and the regulatory requirements their devices was subjected to, to facilitate the comprehension of their necessity, Teresa would reply: “Imagine your child was treated with the device….”
Quality Management and Regulatory Proficiency
BioTop Medical has nurtured a team of experienced and highly qualified personnel in the field of medical device realization, who are well-versed with not only the quality side of product development but also the regulatory side of the journey. The team’s collective competencies encompass everything ranging from the initial device conceptualization to market approval, post-market surveillance, and consistent support across Quality Assurance (QA) and Regulatory Affairs (RA).
The company’s strategic approach ties together the client’s current research and business requirements while devising a cost-effective avenue to facilitate regulatory compliance.
“Most companies view regulations as restrictions that stall their product development journey, despite their awareness of these requirements. We, on the other hand, believe that these regulations empower us to create something better,” details Teresa. BioTop Medical assists clients in the implementation of the required processes, all the while delivering a hands-on management structure to address the QA and RA prerequisites of clients. Through this status quo, BioTop Medical builds long-lasting relationships with clients that are forged through honesty, integrity, and knowledge.
An Integral Partner of Client Organizations
More often than not, BioTop Medical becomes an integral partner of the development phase for a client, right from the initial conceptualization of a device to the final CE marking/approval stages. The company stands tall as the right hand of project managers throughout the engagement, regardless of the complexity of the project. For example, BioTop Medical recently partnered with a company that was developing a device with multiple project dependencies, involving instruments, various reagents, and software stacks. These elements invariably required the consideration of multiple industry standards, all the while bringing together three different partners from three different organizations. Undoubtedly, coordination and collaboration were crucial to attaining success during this engagement. “There were multiple people involved, working on various aspects to bring a complex system to the market, and the coordination among all of these different but complementing entities played a crucial role in attaining success. I was tasked with advising these experts on the necessary standards to be followed while reviewing and documenting essential reports,” explains Teresa. BioTop Medical has orchestrated numerous such collaborations with clients, effectively pillaring clients’ developmental efforts through its proficiency in quality management and regulatory compliance across the European and North American marketplaces.
“One of the first clients that I had back in 1997—who, in fact, convinced me to get into this field—worked with us till last year,” prides Teresa. Rightly so, the company mentioned by Teresa has been sold twice since their first collaboration with BioTop Medical. Yet, the trust they have in Teresa’s firm has been undisputed over the years. BioTop Medical has been scripting such success stories with clients since its inception, and these stories have time and again testified the company’s proficiency in helping organizations fulfill their product or process development journey.