Come join Hantel Technologies at Sacramento Med Tech Showcase on May 6th 2011 at Sacramento State University. For more details and registration visit their WEBSITE.

Gaining a Competitive Advantage with Strategic

Medical Device Operational Outsourcing

Hantel Technologies, Inc., May 13, 2011

In recent years, the outsourcing of medical device design and manufacturing activities to contract firms has become more and more common. This has largely been due to pressure to keep product pricing down, manage rising costs, and maintain a competitive edge in the marketplace. Consulting Engineering and Contract Manufacturing firms can streamline the product lifecycle and greatly reduce the time to market and total cost of product development. In particular, they can help companies operate efficiently and allocate resources appropriately when market conditions are difficult, such as those we face in the current economic climate. Some of the advantages offered by consulting firms include decreased time and cost of product development, increased flexibility in timing of development efforts, reduced fixed overhead and capital equipment costs, greater access to expert engineering and manufacturing resources, and increased leverage of infrastructure.

Consulting firms are uniquely structured to quickly get a project up and running thanks to several unique factors. First, contract firms that specialize in an array of medical device technologies have an outstanding depth and breadth of talent available from which to choose for each project. Thus, the right resources can be tailored to each project, bringing with them the expertise to get the work started quickly. Second, because contract firms are service oriented, the work environment rewards not only excellence in device development and manufacture but also timeliness in delivery and adherence to project budget. This not only allows projects to start quickly but also decreases the time to market, an essential factor to ensure strong company positioning in a competitive market environment.

Because contract firms already have the equipment needed to design, test, and manufacture medical devices, a client may avoid incurring substantial overhead costs involved in purchasing and maintaining machinery. Contract firms also typically have established infrastructures that can be readily leveraged, including document control and complete quality systems. Though frequently taken for granted, the time and effort involved in creating this infrastructure is substantial; utilizing the systems in place at the contract firm can greatly reduce the total project cost and reduce the time to market. These systems are tried and true; this is a great advantage for startup companies that might otherwise lose valuable time and money when a flaw in a newly established quality or document control system is discovered.

Perhaps the greatest value in a contract firm is the flexibility it provides. Projects may be started and stopped on a dime. As a result, when the project needs to be frozen due to economic constraints or the need to rethink the next steps for product development, the client does not incur the overhead costs of keeping employees and facilities running, with the exception of their own core staff. Conversely, project phases that are under enormous deadline pressure may receive the benefit of resources that can be quickly and easily added, without the expense and hassle of hiring and training new employees.

Selecting a Contract Firm

Several factors must be taken into account in order to select the contract firm that will best meet your needs. Numerous contract firms are available from which to choose. This is a testament to their utility as cost effective and time efficient organizations. Each brings unique strengths to the table, and it is therefore crucial to think critically about your product development and/or manufacturing needs before selecting a contract firm.

Questions for you to ask include:

General: What is the nature of the device? Is it complex, with multiple parts or components? Does it involve novel processes or technology? Does it require specialized expertise for difficult‐to‐perform processes such as tip forming? Does it interface with other devices or equipment? Rigorously assessing your product’s key features will help you determine whether you need a firm with specific technical expertise, or one that has more diverse expertise. Most firms will offer a fairly broad array of expertise; however some have specific areas in which their knowledge and experience is particularly deep.

Engineering: What experience do engineers at the contract firm bring to the table? Can the firm help with product conceptualization in addition to design? Can they help with design for manufacturing once the product is nearing readiness for market? What is their experience with guiding verification and validation testing? Can they rapidly produce prototypes, solid models, and CAD? Do they have the resources available to meet your needs, both in terms of expertise and in terms of project timelines? Can they add or remove engineering resources easily? Finally, what is the contract firm’s experience with similar devices? Questions like these will allow you to establish whether or not a contract firm has the engineering resources and expertise to meet your needs.

Quality and Regulatory Affairs: Do you have a quality system? A document control system? A regulatory affairs manager or consultant? If not, you will need to ensure that the contract firm has these services. Are they ISO 13485 certified? Are they registered with the FDA and with the California FDB? Have they passed all of their FDA and ISO audits? Have they passed all customer audits? Do they have strong relationships with other service providers for activities such as shipping validation, sterilization validation, biocompatibility testing, etc? Product realization from concept to production is a thrilling process, and it can be easy to overlook the fact that every step along the way must be performed with impeccable adherence to quality control systems, and that regulatory activities must be performed appropriately and in a timely manner. A good contract firm can help you with all of these services. Even if you do have your own quality and regulatory affairs systems in place, it is important for the contract firm to have their own as well, so that you know that all activities are conducted in accordance with federal and state regulation and that any potential quality issues are recognized and addressed early.

Manufacturing: What are the manufacturing and machining capabilities of the contract firm? Does the machine shop have both manual mills and lathes and CNC machining? Do they offer quick turnaround on prototype and custom parts? Is there a clean room (and what class is the clean room)? Is there a shipping and receiving system in place? Is there a supply chain system and do they provide warehousing services? Is there a regulated materials control system? Are there highly trained and skilled assembly workers who have experience with the materials used in your device?

Contract Firm Policies and Management: Does the contract firm retain any of the intellectual property for the devices it helps design and build? Does it make any of its own products that might compete with your device? Does it have a strong accounting system such that purchase orders are closely tracked and billable hours tightly controlled? Does it have a well structured management system? Is the company structured such that the departments work cross functionally and as a team to meet your needs? Selecting a Contract Firm Summary: Prospective clients must do their due diligence prior to selecting a contract firm. However, selecting the right firm can make all the difference in a successful and productive partnership.

Successful Management of the Contract Relationship

Outsourcing is not without its challenges. Regular and open communications are essential for smooth project coordination and execution. Because the contract firm and client teams are separated geographically, the casual yet critical conversations that occur throughout the day in the office place are absent between these two groups. Though taken for granted, this constant communication is essential for identifying and addressing challenges, both small and large, that invariably arise throughout the course of the product lifecycle. Something that is considered to be “common knowledge” in one location may be completely unknown to another. Hence, a more formal and regular meeting structure is highly recommended in order to ensure that all parties are kept informed and up‐to‐date regarding issues and even slight changes in project direction.

Another challenge that is magnified in the outsourcing environment is scope creep. The scope of a project will naturally expand to accommodate unforeseen challenges in design, manufacturing, test results, etc. In‐house, this creep may go unnoticed, or be more generally accepted as a normal part of product development. However, a contract firm is working under a much more specifically defined and tightly controlled timeline and budget, and is under contract to fulfill this obligation. Therefore, even a seemingly small change in design or process, or the identification of a previously unforeseen risk, may have a significant impact on the timeline and budget of the project, especially in light of the project scope as defined in the original contract. Thus, it is essential to constantly review the project status and projected activities in light of the existing contract, and update it as necessary in order to accommodate changes in scope. This allows both parties to operate with complete transparency, forces them to think more critically about changes to the project (thus contributing to project streamlining), and prevents surprises and miscommunication on the part of both parties.

Summary:

Outsourcing medical device development and manufacturing activities to an established and respected contract design and manufacturing firm can greatly reduce the time to market and total cost of development of medical devices. Outsourcing can also allow a company to gain access to engineering, manufacturing, and quality expertise that it otherwise might not have in‐house or on an as‐needed basis. Finally, outsourcing also provides the flexibility crucial for product development in a competitive market, allowing projects to start, stop, or change direction quickly. In a competitive market environment, key business decisions such as the choice to use a contract firm can greatly improve your company’s chances for success.

Hantel Technologies Customer Survey 2011





Services

We would greatly appreciate if you took a moment to rate our customer services.

Did we provide valuable engineering and product design service?

Did we provide valuable sterilization and packaging validation test services?

Did our production personnel demonstrate process understanding and product knowledge?

Did we meet our contract commitments using prompt billing methods and sufficient invoice information?

Would you recommend Hantel Technologies to other companies for design and manufacturing of Medical Devices?

Be our Guest at San Diego’s very own medical device conference & supplier showcase:


MEDevice Forum 2011 - San Diego

MEDevice Forum – San Diego
September 13th amp; 14th, 2011

San Diego Convention Center
Upper Level Ballroom
San Diego, CA

Register for FREE supplier showcase admission at – MEDeviceforum.com
ENTER PROMO CODE – BB

Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:

Topic: The use of nitinol in medical devices
Presenter: Louis Malito, NDC

Abstract: Given the alloy’s complex shape memory and super-elastic properties, nitinol is an inter-metallic compound that has found widespread use in the medical device field. Medical devices such as peripheral stents, inferior vena cava (IVC) filters, and guide wires all use nitinol’s superior strain accommodation capabilities in their application. Combined with the right post-processing techniques, nitinol can also exhibit lasting bio-compatibility. Mr. Malito will share a general overview of the unique properties of nitinol and its engineering challenges. Topics to be discussed include material applications, basic nitinol crystallography, engineering aspects, and processing techniques.

Louis Malito is a junior research and development engineer at Nitinol Devices and Components (NDC), an independent, privately held company exclusively focused on Nitinol technology. Louis is a graduate of the University of California, Davis (UCD), where he received his bachelors degree in biomedical engineering with an emphasis in medical device design. Louis served as an adviser to the UCD department of Biomedical Engineering on implementing a medical device-based curriculum. Louis has also served as Vice President of the UCD student chapter of p the Biomedical Engineering Society (BMES). His passion for science and engineering culminated in a student project his senior year (designing and prototyping a nitinol stent as a solution to pericardial effusion) – this experience steered him to explore the world of nitinol engineering.

Date: Thursday, September 29th, 2011
Time: 11:30 AM – 1:00 PM PST

The first 30 minutes will be used as a networking session, and the lecture will begin at noon.
Location: Hantel Technologies 703 Sandoval Way, Hayward, CA

Remote: Remote Access: Register to receive weblink and please check the relevant links for system requirements. Links | Join Meeting Tips | Computer Testing Tool | OR Mobile Devices/Smartphones.

RSVP: Please register on Event Brite (http://hanteltech.eventbrite.com/) for this free seminar. You are cordially invited to attend in person (lunch provided / limited number of seats), to join live via Webinar, or to view at a later date.

Best Regards, Hantel Webinar Staff

Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:

Topic: Plasma Surface modification for the life sciences industry
Presenter: Mikki Larner, Plasma Technology Systems

Abstract:
Gas plasma is a powerful method for molecular reengineering of materials to impart unique surface properties, without affecting the bulk properties. The technology is a critical tool for the life sciences industry. Applications include but are not limited to: atomic level cleaning; incorporation of functional species for diagnostic and research tools; deposition of nanometer scale thin film organic coatings to change lubricity, permeation or chemical resistance on devices; and creation of interfacial surfaces for primerless adhesion and overmolding. The effect of plasma on a material is determined by the chemistry of the reactions between the surface and the reactive species present in the process gas employed Liquids may also be introduced as vapors, expanding by many orders of magnitude the potential for unique surface alterations and coatings. The presentation will provide an overview of the diverse plasma processes applied to materials for life science applications. Discussions will include surface stability, surface validation, and a review of common study variables.

Mikki Larner is the Vice President of Sales and Marketing for Plasma Technology Systems (PTS), a Plasmatreat company. Prior to the recent acquisition, she was the PTS President and formerly the Sales Manager at 4th State, Inc. She is a graduate of the University of Florida, Gainesville, receiving a degree in marketing. She has a strong technical understanding of surface modification manufacturing practices, primarily for the life science, aerospace and electronics markets. Activities include memberships in the Surfaces in Biomaterials foundation, Society for the Advancement of Materials and Process Engineering, and the Society of Plastics Engineers Golden Gate chapter where she has held board positions since 2006. She volunteers for the Silicon Valley Engineering Council, and has advised students at San Jose State University, University of Massachusetts Lowell, and South Dakota School of Mines and Technology on plasma applications.

Date: Thursday, January 26th, 2012
Time: 11:30 AM – 1:00 PM PST

The first 30 minutes will be used as a networking session, and the lecture will begin at noon.
Location: Hantel Technologies 703 Sandoval Way, Hayward, CA

Remote: Remote Access: Register to receive weblink and please check the relevant links for system requirements. Links | Join Meeting Tips | Computer Testing Tool | OR Mobile Devices/Smartphones.

RSVP: Please register on Event Brite (http://hanteltech.eventbrite.com/) for this free seminar. You are cordially invited to attend in person (lunch provided / limited number of seats), to join live via Webinar, or to view at a later date.

Best Regards, Hantel Webinar Staff

Come join Hantel Technologies at MDM West from February 8th – 10th at the Anaheim Convention Center in booth #2176!

MDamp;M West Coupon comparatif site poker

Hantel Technologies Customer Survey 2012

* (required field)


We would greatly appreciate if you took a moment to rate our customer services.





Did we provide valuable design and engineering services?


Did we provide valuable documentation quality on regulation?


Did our production personnel demonstrate process understanding and product knowledge?


Did we meet our contract commitments using prompt billing methods and sufficient invoice information?

Would you recommend Hantel Technologies to other companies for design and manufacturing of Medical Devices?

U.S. FDA “Approved Materials” for Medical Device Use

The Center for Devices and Radiological Health (CDRH) does not maintain a list of
ingredients or materials that are certified or approved for use in medical devices. That is
because the appropriateness of a material depends on the application. That is why FDA
approves finished devices and not components or materials which could be used in varied
applications. For skin or open wound contact, only short term tests may be needed, where
as for an implant, long term in vivo tests would be recommended.
The responsibility for biocompatibility of a finished device lies with the manufacturer.
This can be accomplished in several ways, one of which is to assess or characterize all
components of a device according to the ISO 10993 standard. Some testing can be
avoided if biocompatibility data is available from the component supplier. Many
component suppliers are aware of the biocompatibility requirements that finished device
manufacturers must meet and will supply testing data to meet those needs. Use of
previously qualified components with a known safety profile can save the finished device
manufacturer time and money.

It is the responsibility of each device manufacturer or specifications developer to assure
that all ingredients and component materials are suitable for their intended purposes.
The finished medical device must be safe and effective for its intended purposes when
used according to its labeling. In this context, safety and effectiveness include many
parameters such as physical properties, chernical properties, and biological effects,
including the biocompatibility of materials that contact human tissue.

If you have reviewed ISO 10993 and the ASTM methods (F748) you should be able to
develop a rational plan for documenting the biocompatibility of your device. If you are
unsure of the minimum testing requirements contact DSMICA at:

DSMlCA@fda.hhs.gov and advise them of your device and indication for use. They will identify the correct division within the Office of Device Evaluation (ODE) for you to start a dialogue.

Published by FDA for MDamp;M Anaheim 2-8-2011 to 2-10-2011

Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:

Topic: Integrating market research into the product development process
Presenter: Barry Zakar, Intellimed Consulting

Abstract:

Integration of market research into product development is among the most important aspects of the process, yet is frequently omitted, poorly implemented or its implications misunderstood.  The effort, time and cost of good market research integration into product development is far less than the cost of the development and introduction of medical devices that do not address unmet clinical needs, or are poorly designed for their end users or clinical environment.

This presentation will define market research as it applies to product development, review the research types and sources, and discuss where and how market research makes a difference in product development, both for new products, and at various points in the product life cycle.

Market research is not an optional part of product development, but is as essential to the process as product specifications, hardware/software validation and COG determination, all of which significantly benefit from market research.  Today’s product development professionals actively seek market input and get involved in the process early on to assure the introduction of well-designed medical devices that meet customer needs and contribute to improved clinical outcomes.

Barry Zakar has over 25 years experience in the medical device industry, marketing capital medical equipment, disposables and implantables to multiple medical specialties in both the hospital and office practice market sectors. Barry has developed expertise in creating new markets for innovative medical technologies in entrepreneurial environments. As Principal at Intellimed Consulting, Barry has provided guidance in strategic marketing, clinical and reimbursement issues, and market development and tactical implementation to early-stage domestic and Australian companies.

Prior to founding Intellimed Consulting, he was a Director, Center for Business Intelligence at Edwards Lifesciences in Irvine, CA, where his primary role was the acquisition and integration of primary market research into the new product/new business identification and development process. He has also worked with AUSTRADE in assisting several dozen Australian lifesciences companies with product commercialization and entry into U.S. markets. Barry is also associated with the Sacramento Area Regional Technology Alliance (SARTA) programs: MedStart, VentureStart, CEO Forum; UC Davis, and Partnership for Innovation (PFI), a NSF grant-funded program.

Date: Thursday, March 29th, 2012
Time: 11:30 AM – 1:00 PM PST

The first 30 minutes will be used as a networking session, and the lecture will begin at noon.

Location: Hantel Technologies 703 Sandoval Way, Hayward, CA

Remote: Remote Access: Register to receive weblink and please check the relevant links for system requirements. Links | Join Meeting Tips | Computer Testing Tool | OR Mobile Devices/Smartphones.

RSVP: Please register on Event Brite (http://hanteltech.eventbrite.com/) for this free seminar. You are cordially invited to attend in person (lunch provided / limited number of seats), to join live via Webinar, or to view at a later date.

Best Regards, Hantel Webinar Staff