Quick-change custom workholding products

Jergens Inc.’s IMTS 2018 offerings include tooling; a line of pallets, risers, receivers, and adapters; and custom design and build solutions, including:

Multi-axis 130mm self-centering vise: Part of FixturePro line of modular 5-axis workholding; reduces jaw lift, a common issue where vise jaws flex, raise up during clamping; centering adjustment, uses a screw with trapezoidal threads for increased durability; fits with the FixturePro System

Quick Loc line of pallets, cubes, rotary receivers: low-profile pallets configured in 52mm and 96mm pull stud patterns

Jergens Inc.
www.jergensinc.com
IMTS 2018 Booth #432154

Hybrid milling machine

The Lumex Advance-25 hybrid additive manufacturing (AM) machine is a powder bed metal AM platform with subtractive machining capability. It combines selective laser sintering (SLS) with high speed milling (HSM) for hybrid AM.

The Matsuura Lumex Avance-25 relies on one-machine, one-process manufacturing of complex molds and parts, creating a finished part with machined surface finish and accuracy, without causing additional variation from multiple machine set-ups and part handling. It produces complicated parts and molds through total manufacturing by digital engineering, using 3D data.

Matsuura Machinery USA Inc.
www.matsuurausa.com
IMTS 2018 Booth #338148

Ultrasonic cleaning

The 1900BT ultrasonic cleaning system is a 20-gallon, plug-and-play unit for cleaning 3D prototype parts. Its compact cleaning area is suited for ultrasonic applications where filtration is not required.

The ultrasonic cleaning process generates cavitation energy inside the bath, creating internal pressure that dissolves the parts’ support structure. With a directional spray nozzle, users spray parts directly and precisely. A programmable cycle provides complete hands-free cleaning, which can be programmed and repeated.

The magnetic drive pump system allows for agitation, where the turbulence is controlled to prevent damage. Flow and heat are adjustable to suit different materials.

Omegasonics Inc.
www.omegasonics.com
IMTS 2018 Booth #121150

Many medical devices are currently produced on a Swiss machine due to the ability to effectively turn, drill, and mill. Although the materials being used to produce medical components have, for the most part, remained the same for some time now (cobalt-chrome, 17-4PH, titanium), recent cutting tool developments are improving overall productivity related to milling applications used in the production of medical devices on Swiss machines.

1. How can manufacturers address the tight space challenges that go hand-in-hand in Swiss machines/ applications?

One solution comes from Iscar’s Multi-Master system. Shanks designed with the typical ER collet back end have been built as an integral component. The result is a highly rigid and accurate milling assembly, with extremely short gage length, excellent accuracy/repeatability, and quick-changeability.

2. What sort of accuracy/ repeatability can be expected from the Multi-Master system?

Axial accuracy is controlled to 0.0004" and radial total indicator reading (TIR) does not exceed 0.0007". This is due to a ground connection, combining a conical taper and threads which seat (or pull) the interchangeable/replaceable head into a connection designed for a slight interference fit. This is a big difference between many modular tooling systems that have to rely on a clearance fit between connections.

3. How does Iscar address milling extremely small part features on medical components?

There are two solution categories: solid carbide and indexable. Solid carbide end mills that could be categorized as micro sized have existed for years. Typically referred to as rib-processing mills, they offer a wide selection in diameter range – from 0.1mm to 6.0mm (0.0039" to 0.2360") – and varying lengths of cut to keep tiny tools working as effectively as possible. For example, a 1mm tool has eight different length options. Indexable tools are now available from Iscar with nano and micro inserts. These inserts will prove to be an excellent fit for the Swiss environment where small depths of cut are the norm and the use of a solid carbide end mill is wasteful.

4. How easy are small indexable tools to change in extremely tight spaces in Swiss machines?

One of the main strengths of the Multi-Master system is quick changeability. For example, a redundant head can be in queue. When the end of tool life is reached, the machine operator quickly switches to the new head, and the head with used inserts is taken to a bench where insert indexing is easily performed. This approach keeps the Swiss machine up and running with a much lower chance for errors.

5. What other cutting tool developments have positively impacted the ability to mill difficult medical device materials?

One of the biggest changes/impacts I’ve had recent experience with was the implementation of an end mill with a new coating, that we call IC702. The coating and substrate form an extremely hard and wear-resistant combination when compared with typical coatings. Without giving away too much information, we replaced our own product with the new technology and, without any changes to cutting parameters, the customer produced double the amount of parts.

Iscar USA
https://www.iscarusa.com

Our focus this month on the European Union (EU) is that the summer time is often a great time to think about next year’s product launch plans.

Whether you are thinking about launching your product in Europe or expanding to the EU, it’s always an interesting market.

The beauty of the EU market concept is it’s simplicity – 28 countries (Brexit is a separate discussion) representing more than 500 million wealthy consumers (by average world standards) addressable with one CE mark. The complexity of the EU market is that it remains 28 countries with different cultures, multiple languages, varied histories, and a mix of economic disciplines.

When we hear clients speaking of preparing to launch their product in Europe, it begins a series of items that require consideration of location. Unless you’re a multi-national with established channel resources in 28 countries, it’s not likely for a successful launch across Europe without addressing the following for each country:

• Product name, slogan, company/product colors: Make sure it’s not offensive when translated
• Culture: How does it fit into each country’s culture
• Languages: While relatively easy for an American company to launch in the U.K., launching elsewhere could require translating every document, marketing material into multiple languages
• Product registration: Requirements vary in each country
• Reimbursement rate: Can vary from excellent reimbursement to no reimbursement, country by country
• Channel: Know the availability of quality distributors by country
• Market penetration: Understand each country’s clinical unmet need

With all things relativelyequal from the above issues, consider these locations for U.S. companies heading to the EU:

• U.K.: No translation needed; there are ways to successfully launch a new product in the NHS
• Germany: Largest market; opportunities for special reimbursement for innovative products
• France: A core EU market
• Italy, Spain: While both of these countries has budget issues, payment issues can be handled with a qualified distributor
• Netherlands: Not a bad substitute for Italy and/or Spain; slightly smaller, however much more efficient; on pace to be the replacement country for the U.K. when it comes to healthcare in Europe

There is a lot more to the EU launch story as these are only high-level topics for consideration before you begin your European footprint. Do your homework and we are confident you will have a successful launch.

MedWorld Advisors
www.medworldadvisors.com

The MedTech MindSet is a monthly column that discusses today’s opportunities in the medical industry. Florence Joffroy-Black is a long-time medtech M&A and marketing expert with significant experience in the medtech industry and is now the CEO of MedWorld Advisors. She can be reached at florencejblack@medworldadvisors.com. Dave Sheppard is a former medical OEM Fortune 500 executive and is now a principal at MedWorld Advisors. He can be reached at davesheppard@medworld advisors.com.

Location

Skokie, Illinois

23-acre campus for

• Early stage companies
• Growing firms
• Established life sciences companies
• Related institutional research

Facility features

• Chemistry, biology laboratories
• Good manufacturing Practice (GMP)
• Nuclear magnetic resonance (NMR)
• Specialized vivarium & formulation facilities

Regional support

• +30 teaching hospitals

6 schools of medicine

• University of Chicago
• Northwestern
• University of Illinois at Chicago
• Rush
• Loyola
• Rosalind Franklin

14 community colleges

• Customized job training
• Continuing education
• Entrepreneurship training

Laboratories

• Argonne National Laboratory
• Fermi National Laboratory
• National Center for Supercomputing Applications

Workforce

• ~50% of the state’s workers are professionals, skilled technicians, craftspeople, or machine operators
• ~11.3% employed in manufacturing
• 56% with education beyond high school