Dan Purvis, Founder & CEO at Velentium, joins Builder Nation's podcast host Elisa Muñoz to share his experiences as a leader in medical device engineering and the insights he has gained from his broad experience in automation, controls, and software.
This interview was brought to you by BuilderNation, the community of Hardware leaders developing world-changing products, and sponsored by ControlHub, the purchasing software for hardware companies.
In today's rapidly evolving healthcare landscape, new technologies are constantly emerging, promising better treatments, improved patient outcomes, and more cost-effective solutions. Embracing these innovations can help companies address unmet medical needs, enhance patient experiences, and create new revenue streams.
As a result, increased profitability and sustained growth can be achieved. By leveraging innovative approaches, companies can meet these requirements more efficiently and effectively, reducing the time and cost of bringing products to market.
Velentium is a prime example of a company that has been demonstrating the benefits of innovation in the medical device engineering field. Through its commitment to staying at the forefront of the latest technologies and design methodologies, Velentium has been able to develop cutting-edge solutions that meet the needs of its clients, their patients, and the healthcare providers who serve them. By blending technical expertise with a deep understanding of the industry's unique challenges, Velentium has positioned itself as a leader in this vital field.
This blog post will delve into the medical device engineering industry, the current state of the market, and the future of healthcare, with a particular focus on Velentium and its role in the industry.
The medical device engineering industry
Medical device engineering is a multidisciplinary field that involves designing, developing, testing, and manufacturing medical devices. These devices range from simple tools like thermometers and blood pressure monitors to complex machines like MRI and CT scanners.
The medical device engineering industry has been growing steadily, driven by technological advancements, increasing healthcare needs, and the aging population. This growth translates into the global medical device market, valued at USD 176.7 billion in 2020 and is expected to grow at a CAGR of 5.0% from 2021 to 2028.
This sector is experiencing several trends, including an increasing demand for connected devices, wearables, and telehealth. The need for better healthcare outcomes, cost reduction, and improved patient experience drives them. Additionally, the industry is shifting towards value-based care, where medical devices are expected to provide better outcomes at a lower cost.
Understanding the design and development process of medical devices
Medical device engineering is a complex process that requires various design and development stages to bring a product to the market. These stages include design inputs and outputs, conceptualization and feasibility studies, prototyping and testing, and regulatory compliance and approval.
- Design inputs and outputs: the first stage in the design and development process is to define the design inputs and outputs. This stage involves identifying the medical device's user needs, intended use, and performance requirements. The design inputs and outputs develop the product design specifications, which guide the rest of the development process.
- Conceptualization and feasibility studies: this stage explores different product development methods, using tools such as brainstorming, 3D models, and simulations to assess clincial feasibility therapeutic effectiveness, and market viability.
- Prototyping and testing: the design concepts turn into working prototypes in the prototyping and testing stage. Prototypes are created to test and validate the design, functionality, and safety. Testing is conducted to evaluate the device's performance under various conditions and identify potential risks or issues.
- Regulatory compliance and approval: this stage involves obtaining regulatory approval from the relevant authorities to ensure that the medical device meets all safety and performance requirements. The approval process can be complex and time-consuming, but it is essential to ensure that the medical device is safe and effective for use by patients.
Velentium is a top medical device engineering firm that designs, develops, tests, and manufactures medical devices on behalf of their clients. They have a team of experienced engineers and developers who are committed to their clients’ success, helping them create innovative and effective medical devices that meet the needs of patients and healthcare providers.
Their specialties include active implantable medical devices, systems engineering, firmware and software, cybersecurity for their products, secure development of medical devices, electrical and mechanical engineering, usability, automated test systems, and CGMP manufacturing. Velentium has become a trusted partner for medical device companies around the world.
Velentium's features and benefits include a focus on quality, reliability, cybersecurity, and safety. The company uses a rigorous development process to ensure that each medical device meets all regulatory requirements and is safe for use by patients. Velentium also has a solid commitment to customer service and works closely with its clients to ensure their needs are met at every stage of the development process.
Their expertise, end-to-end solutions, and total-solution assistance make them a preferred choice for medical device manufacturers seeking high-quality services and support. The firm offers a range of services to meet the manufacturing, design and development, testing systems, and cybersecurity of the medical device industry.
Let's take a deeper look at these features.
Velentium's ISO 13485-certified QMS and in-house design and development experts provide services such as FDA manufacturer of record, CFR 820 compliance, class 6 clean room, injection molding, and more. Velentium is preferred for pilot builds and first runs for clinical trials, on-shore manufacturing, and design for manufacturability analysis.
Design and development
In this sector, Velentium's consulting and contract design team focuses on designing and developing active medical devices, especially implantables and wearables for neuromodulation and other Class III indications. Their experts specialize in electrical and mechanical design, firmware and software development, cybersecurity, human factors, and usability. They provide end-to-end solutions and consulting services that speed up development, asking incisive questions early in the process to ensure project success.
Embedded cybersecurity is a crucial element of device design, development, regulatory approval, and business model protection. Velentium has the expertise to navigate the constraints that come with this process. They offer security solutions for various platforms, including embedded devices, smartphones, web apps, firmware, sensors, microcontrollers, and data systems. Velentium provides secure design, development, production services, micro penetration testing, vulnerability assessments, gap analysis, submissions review, fuzz testing communication mediums, postmarket surveillance, static analysis security testing (SAST), and cybersecurity training for staff.
Automated test systems
These procedures offer comprehensive testing solutions that can scale with project needs. Velentium's modular design enables easy integration with existing infrastructure, remote access, training, and support. Their services include test requirements development, design validation and verification, software quality testing, and manufacturing test systems design and development. Velentium's experts can provide better questions sooner, offer right-sized custom test solutions, and deliver total-solution assistance.
This project exemplifies dedication to a cause. Project V, a collaboration with the United States Department of Health and Human Services (HHS), was created to develop and manufacture ventilators to help meet the demand for critical care equipment during the COVID-19 pandemic. The company played a vital role in the project, providing design and development support to help bring the ventilators to the market quickly, facing an unprecedented challenge over 28 days.
The team worked tirelessly, putting in 18-hour days to build the automated test systems that allowed General Motors to manufacture 10,000 Ventec ventilators per month in response to the unprecedented challenge presented by the pandemic. Despite facing chaos and uncertainties, the team's dedication and hard work paid off when they successfully delivered the first batch of ventilators to a hospital in Chicago, ultimately saving countless lives.
Velentium invested $2.2 million of its funds to purchase materials and expand its lines of credit with suppliers, ensuring the timely procurement of necessary parts to meet the project's deadline. The team's unwavering expertise and commitment helped other companies scale up ventilator production at the Kokomo, Indiana manufacturing facility. This initiative undoubtedly saved countless lives, and Velentium's dedication to the project is a shining example of the vital role of the Medical Device Engineering industry.
The future of medical device engineering
The medical device engineering industry is poised to undergo significant changes and growth as technology advances and healthcare needs evolve. As the demand for remote patient monitoring and telemedicine increases, innovative medical devices connecting patients and providers virtually will become increasingly important.
In the coming years, we expect to see greater integration of artificial intelligence and machine learning in medical device engineering and developing devices that can improve patient outcomes while reducing healthcare costs. Regulatory agencies will continue to play a crucial role in shaping the industry, and we may see further advancements in areas like cybersecurity and data privacy.
With a steadfast commitment to quality, compliance, and customer satisfaction, Velentium works closely with clients to develop safe and effective medical devices that meet the highest standards of quality and reliability. As the industry transforms, Velentium is at the forefront of innovation, shaping the future of medical device engineering.