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We do this by utilizing years of experience in managing complex projects and by working with proven individuals and organizations that specialize in the field of medical device development, manufacturing and sales.
Our business practice is to make decisions based on forward thinking processes and the voice of our valued customers; whether a patient, clinician, corporation or client.
From developing the first prototype part to shipping first lot to stock, our company is committed to the highest quality of products and services, utilizing only GMP compliant, ISO 9001 and ISO 13485 certified facilities with best practices as the driver.
In addition to marketing our own proprietary designs and technologies, we assist well qualified inventors and startups in bringing their ideas through the medical device process. IV Medical’s expertise, experience and reach cover a wide range of disciplines:
| Design and Development | | Our design and development philosophy focuses on innovation as the driver in addressing the needs of the market and bringing value to our customers. Learn more...
When determining the viability of a new design fit, form and function and intended use need to be assessed in conjunction with how the product will be manufactured and shipped to the customer.
We believe designs must be scrutinized from all angles, starting with a well thought-out development and verification plan followed by prototypes that can withstand the test and product specifications that make sense — always maintaining focus on the manufacturing cost, validation requirements and profitability.
The products risk in the field must also be analyzed by performing an FMEA (Failure Mode and Effects Analysis) on the design. | | Manufacturing | | Our approach to a successful manufacturing process starts with a thorough understanding of the design specifications and needs of the program; especially the volume requirements and per unit cost. Only then can the scope and manufacturing specifications be written detailing the equipment requirements, features, functions, desired sequence of operation and various components required for production. Learn more...
Medical device manufacturing requires precision made parts whether plastic or rubber that begins by designing high quality molds capable of producing parts and/or finished product that can meet the specification. This is where skill and technical expertise come into play along with employing the right mold-maker, once the mold design is finalized.
Establishing the molding process or parameters by which the parts will be produced in production is the next critical phase of the manufacturing process. The molding process must be “capable” of consistently producing parts that meet the specifications called-out on the print, without sacrificing part quality. This can be a difficult and challenging process, especially in meeting the tolerances of most medical devices — unless one has a thorough understanding of plastic resins and rubber compounds along with technical skill and experience.
When the program calls for automation, having access to seasoned professionals in this field is key to designing and building equipment that can be successfully validated and maintained during production. Bigger is not necessarily better when it comes to working with companies that specialize in building automation equipment; it’s having access to experienced personnel and the latest technologies that create success.
All manufacturing processes require verification by performing metrology and testing on the parts and/or finished product being produced; especially when producing a medical device. In fact, metrology is one of the most important functions within the manufacturing process because it verifies that each part and/or finish device being produced meets the specifications. Equipment alone cannot assure a successful metrology, it requires highly skilled, well-disciplined personnel and procedures to accomplish each task.
Assessing the manufacturing risk of the program by performing an FMEA on the equipment and process is the final step before validation and going into production. This is where expertise and experience can make all the difference in creating a successful manufacturing process or one that’s riddled with problems and delays. | | Validation | | Validating the design and manufacturing process is one of the last and most important phases of the manufacturing process prior to going into production. It starts by writing a set of validation procedures that can be successfully implemented and then verified via testing. Not only must the validation procedures comply with FDA regulations and guidelines, they must be well documented and cover every aspect of the manufacturing process in producing product capable of meeting the design specifications. Learn more...
In conjunction with the validation process are the written production and maintenance procedures for running production; both are critical to long term success of the program. Procedures of this kind need to be precise and encompass the risk parameters covered in the FMEA. | | Regulatory | | When it comes to regulatory compliance there are no short cuts. IV Medical utilizes only GMP compliant, ISO 9001 and 13485 certified facilities and processes in developing, manufacturing and delivering product to our valued customers. In dealing with FDA matters, such as facility audits or seeking FDA approval to market a device, experience and knowledge matters most and IV Medical works with some of the best in this field. | | Intellectual Property | | Protecting your intellectual property can be a costly and time consuming endeavor that requires an experienced patent attorney who understands the nuances of the prosecution process, and what’s required in achieving success. Having the right patent strategy is also extremely important to this process and where experience matters most in minimizing the costs and protecting your invention. | | Contract Negotiations | | Having successfully negotiated several long-term contracts in the medical device field our company has the experience in securing contracts that make sense. Negotiating the right contract that’s fair to both parties can be extremely challenging; especially in dealing with persons skilled in the practice. A contract is all about the agreed upon intent of the parties documented in writing - this is where experience and knowledge can make all the difference. | | Business Development | | Our years of experience and access to experts and companies in the field of medical device places our company in a unique position to assist well qualified inventors and startups in moving through the medical device process and to market — perhaps IV Medical can help you. |
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