CAI’s Kneat Gx System Qualified & Released for Use

CAI

INDIANAPOLIS — CAI, a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and industrial process manufacturing industries, today confirmed its status as an official Kneat Platform Partner with the launch of its own validated Kneat Gx software instance following the initial development of a strategic partnership with Kneat Solutions in early 2022.

The Kneat Gx instance, a 21 CFR Part 11 and Annex 11 electronic records and signatures compliant SaaS validation solution, enables CAI to host work product on behalf of its clients, including reviews, approvals, and execution of protocols.

The CAI instance of Kneat Gx will provide a mechanism for Knowledge Management that is married directly to work product, by enabling tools and templates to be stored and managed in the same platform and format, where they can and should be used.

“Our Kneat Gx environment gives us the ability to serve our clients more efficiently, using industry best in class standardized off-the-shelf content while removing the geographic obstacles to collaboration within our global network of industry professionals,” states Mike Martin, CEO of CAI. He continues, “I am excited for what the future holds!”

“CAI continues to demonstrate their commitment to enhancing their client experience and results through the adoption of digital validation and through their partnership with Kneat,” commented Rick Mineo, Director of Strategic Partnerships at Kneat. “We are very pleased to partner with CAI, and we look forward to continuing to scale our solutions”

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About CAI:
Since CAI’s founding in 1996, we have delivered nearly a billion dollars in services for hundreds of clients across thousands of projects globally. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, India, Ireland, Italy, China, Singapore, United Kingdom, and Malaysia, we have built an international team of over 850 professionals providing local support from a global company. Our engineering, technical, and consulting services deliver mission critical facilities with a high level of performance and reliability. When operational readiness is critical, CAI delivers to a higher standard.

About Kneat:
Kneat, a Canadian company with operational headquarters in Limerick, Ireland, develops and markets the next generation Kneat Gx SaaS platform. Multiple business work processes can be configured on the platform from equipment to computer system validation, through to quality document management. Kneat’s software allows users to author, review, approve, execute testing online, manage any exceptions, and post approve final deliverables in a controlled FDA 21 CFR Part 11/ Eudralex Annex 11 compliant platform. Macro and micro report dashboards enable powerful oversight into all systems, projects and processes globally. Customer case studies are reporting productivity improvements in excess of 100% and a higher data integrity and compliance standard. For more information visit www.kneat.com

Media Contact:
David Shenberger
+13177219847
dwshen@cagents.com

TOMZ Corporation to Open Second Manufacturing Facility in Knightstown

TOMZ Corporation

KNIGHTSTOWN – TOMZ Corporation, a manufacturer of implantable medical devices based in Connecticut, will celebrate the opening of its second manufacturing facility in Knightstown, Indiana on Friday, August 13th. The state-of-the-art 60,000 sq. ft. facility is located near Warsaw, Indiana, also known as the “Orthopedic Capitol of the World,” allowing TOMZ to join many of its peers in orthopedics, while the accompanying 18-acre parcel allows for tremendous growth opportunity.

TOMZ Corporation’s experience in the field of medical device manufacturing spans more than three decades, with millions of medical devices in use today. TOMZ has consolidated manufacturing processes at its 150,000 sq. ft. headquarters in Berlin, Connecticut to offer shorter lead times, faster delivery, and excellent quality control. After 8 expansions of the Berlin facility, with the most recent completed in the summer of 2020, the Indiana facility will reinforce and greatly increase capacity.

With this second facility, TOMZ Corporation is looking forward to bringing a wider product range, increased volume, and additional capabilities as an instrumental partner of top medical OEMs in the medical device space.

Needless to say, there are many employment opportunities available. For mor information on TOMZ please visit their website: www.tomz.com

TOMZ Corporation is a top-tier manufacturer of implantable medical devices for the world’s leading medical OEMs, headquartered in Berlin, Connecticut. The core of their business is medical device implants, their assemblies, and accompanying surgical instruments.

CAI Announces New Leadership Team

CAI

INDIANAPOLIS – Mike Martin assumed the role as President of CAI on 1 November 2020 and will succeed Bob Chew as CEO on 1 January 2022.  Reporting to Mike Martin as of 1 January 2021 are:

  • Rich Tree – Chief Operating Officer
  • Alice Redmond – Chief Strategy Officer
  • Phil Pursifull – Chief Financial Officer
  • Jackie Karceski – Chief Technology Officer
  • Tim Howard – Chief Human Resources Officer

Robert Chew, CEO:

“CAI has delivered on our promise to meet a higher standard for our clients the past 25 years. This year clients have called on us to help them respond to the most urgent global health crisis in the past 100 years.  I am proud of the work our team is doing and am as confident as ever that under Mike’s leadership CAI will continue thrive and earn each client’s trust every day.

Our team will be driving more value for our clients by focusing on:

  • Delivering projects faster, with higher quality, and reduced costs while solving problems for our clients. 
  • Strategic focus for growth in new geographies and service / product offerings to meet the future needs of the industries we serve. 
  • World-class accounting for accuracy and integrity.
  • Digital transformation to enhance the value of our people and teams.
  • Hiring, developing, and retaining the best talent to provide the high performing teams and technical experts our clients need.”

Mike Martin, President:

“I am excited about leading CAI and look forward to working with the leadership team to drive our business in areas critical to our mission while serving our global clients.  We are investing heavily in IT systems and applications to drive efficiency throughout our organization and expand our technology enabled services.  Likewise, we continue our geographic expansion to better serve our global clients, delivering operational readiness and operational excellence solutions all around the world.”

ABOUT CAI

Since CAI was founded in 1996, we have delivered nearly a billion dollars in services for hundreds of clients across thousands of projects globally. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, Ireland, Italy, China, Singapore, and Malaysia, we have built an international team of over 600 professionals providing local support from a global company. Our engineering, technical, and consulting services are fashioned to deliver mission critical facilities with a high level of performance and reliability. When operational readiness and startup are critical, CAI delivers to a higher standard.

Indiana Again Among ‘Best States for Business’

Inside INdiana Business

INDIANAPOLIS – Chief Executive magazine’s annual “Best & Worst States for Business” survey has once again found Indiana is primed for business. For the fifth consectuvie year, the publication ranks Indiana fifth, noting a diversifying economy with a focus on innovation and technology.

The survey conducted to calculate the rankings found manufacturing is still king in Indiana, but listed ActiveCampaigneHealth and Zotec as new operations established in the state.

It also highlighted the Next Level Connections Program and its $1 billion in infrastructure, as well as Innovative Indiana Plan, the Road to One Million Plan in northeast Indiana and Indiana’s Great Southwest plan. 

It’s the 16th year of the survey, and Texas finished first for the 16th time. After Texas, the list has Florida, Nevada, Tennessee and Indiana rounding out the top five. North Carolina dropped two spots to No. 6, while Nevada gained three spots to move to No. 3.

The survey found about 52% of site-selection projects were paused across the nation by the pandemic.

“Like the stock market, a lot of site-selection projects are built on speculation, on confidence in how things will look one or two years down the road,” says Brian Corde, co-founder of Atlas Insight. “If confidence isn’t high, it slows the pace.”

The bottom five of the survey did not change from 2019, with Connecticut, New Jersey, Illinois, New York and California bringing up the rear. Click here for a full breakdown of the survey and click here for the full list of rankings. 

Hoosier Startup Details Growth Plans

Inside Indiana Business

CARMEL – A life sciences startup has announced plans to grow its central Indiana operations. The Indiana Economic Development Corp. says Carmel-based 3Oe Scientific LLC will invest $500,000 to accelerate the growth of its patented hand sanitizing system technology and create up to 30 jobs by the end of 2022.

3Oe says its aqueous ozone hand sanitizing device infuses ozone molecules into water, which kills pathogens such as viruses, bacteria and spores naturally without soaps or chemicals. The company says users place their hands into the device for a few seconds allowing all surface areas of the hands to be covered with a steady stream of aqueous ozone.

“The technology is expected to revolutionize the healthcare and public health sectors in areas of efficacy, compliance and tracking,” said Dr. Tom Foust, founder and chief executive officer of 3Oe. “As an innovation-centric tech company, we look forward to not only positively impacting our community with our products but also growing our workforce here in Indiana as we expand and scale.”

The IEDC says the company has partnered with local hospitals and schools to beta test the technology and plans to submit it for approval from the U.S. Food and Drug Administration later this year.

3Oe plans to begin hiring for the new jobs later this year. The company says the positions will to come with salaries above the state average wage.

“Thanks to innovative life sciences companies like 3Oe, Indiana ranks as one of the five most concentrated life sciences states in the U.S., contributing $77 billion to our state’s economy,” said Indiana Secretary of Commerce Jim Schellinger. “We’re excited 3Oe is developing its game-changing product here, while simultaneously investing in Indiana’s workforce and creating good jobs for Hoosiers.”

The IEDC has offered 3Oe Scientific up to $600,000 in conditional tax credits, which the company will not be eligible to claim until Hoosier workers are hired for the new jobs. 

Medical Device Company Growing in Kosciusko County

Inside Indiana Business

WARSAW – A Warsaw-based orthopedic product development company has announced plans to expand operations. Nextremity Solutions Inc. says it will invest more than $4.5 million to transform a shell building at the Warsaw Technology Park into its headquarters and create up to 111 jobs by the end of 2024. The Indiana Economic Development Corp. says the building will allow the company to consolidate its product development and manufacturing operations under one roof.

Nextremity Solutions is partnering on the project with West Hill Development, which originally developed the shell building.

“This is such an exciting time for our team at Nextremity Solutions as we expand our capabilities to create, manufacture and deliver innovative solutions to our strategic alliance partners and to other orthopedic companies,” Rod Mayer, chief executive officer of Nextremity Solutions, said in a news release. “The shell building provides the ideal location for us as we create a synergistic partnership with Lakeland Technology going forward.”

Construction is expected to be complete by April 2021 and the company plans to begin moving employees to the new facility before the end of this year. Nextremity Solutions currently employs 24 workers and says it will begin hiring for development and manufacturing positions as needs arise.

The expansion comes two months after Nextremity Solutions acquired Lakeland Technology Inc., a contract manufacturer for the medical device industry also located in Warsaw. Financial terms of the deal were not disclosed.

The IEDC has offered Nextremity Solutions up to $1.6 million in conditional tax credits and up to $100,000 in training grants, which the company will not be eligible to claim until Hoosier workers are hired for the new jobs. The Warsaw Redevelopment Commission and the Warsaw Common Council will consider additional incentives.

Indiana Advances to Stage 3 in Back on Track Indiana Plan

On Wednesday, Governor Holcomb announced that Indiana has earned the ability to move forward to stage 3 of the Back on Track Indiana plan, two days earlier than previously planned.

Cass, Lake, and Marion counties, which were hit hardest by the coronavirus, will be eligible to enter stage 3 on June 1.

Social Gatherings

Starting Sunday (May 24), social gatherings up to 100 people may take place following the CDC social distancing guidelines. Gyms and movie theaters are opening at limited capacity and playgrounds, sports fields and sports and community pools may open.  

Restaurants

Restaurant’s dining rooms will continue to operate at 50% capacity in Stage 3. In Stage 4, they can move up to 75% capacity, which is scheduled to begin June 14. 

Retail

Retail, currently operating at 50% capacity, can move up to 75% capacity in Stage 3. 

Manufacturing

If not already operating, manufacturers can open but must meet IOSHA and CDC guidelines, make provisions to maintain social distancing, and consult industry best practices.

What Limitations Will Remain?

  • Hoosiers 65 and older and those with known high-risk medical conditions should limit exposure at work and in their communities.
  • Continue remote work when possible.
  • Face coverings are recommended.
  • Nursing homes remain closed to visitors; nursing home guidance will continue to be evaluated. 

For more information on the Back on Track Indiana plan click here.

Iotron Industries Breaks Ground to Continue Worldwide Sterilization Efforts

Whitley County EDC

COLUMBIA CITY, Ind. (May 13, 2020) ­­­– Iotron Industries, a global leader in radiation processing, broke ground on their expansion project during a time when sterilization is a key priority. The expansion will add 34,000 sq. ft. to facilitate another line of sterilization capability.

“Over the last few years, due to increased market demand in the U.S. and Canada, our Indiana facility has grown to full capacity,” said Aaron Starkey, Iotron’s Vice President of U.S. Operations and Head of Business Development. “The current global pandemic has further bolstered the need to increase the supply for reliable, high scale and domestically available irradiation services.”

Construction for the expansion began earlier today with a groundbreaking ceremony led by The Hagerman Group.

“We are honored to once again handle Iotron’s construction needs in the U.S.,” said Hagerman Executive Vice President Brad Smith. “Year over year, most of our projects are with existing clients, which demonstrates the relationships and trust we build and maintain with our clients. We congratulate Iotron on this expansion project, as together we build a better future.”

Iotron Industries currently operates in a 54,000 sq. ft. facility in Park 30 and provides sterilization, bio-reduction and material modification services for the orthopedic, medical device and agricultural industries. The existing site houses Iotron’s IMPELA® brand electron-beam accelerator system, which uses no radioactive materials and is powered by standard commercial electricity.

“Whitley County is fortunate to have this unique company as a part of our diverse economy,” said Dale Buuck, Whitley County EDC president.  “On behalf of our business community, I want to congratulate the Iotron team on their past success and I’m excited to see where the future leads them.”

At the request of the Whitley County Economic Development Corporation (EDC), the Whitley County Redevelopment Commission (RDC) approved financing for Iotron’s expansion project through a bond agreement.

“The bond was a great way to incentivize Iotron’s expansion to save the company interest costs and use funds already generated by the Tax Increment Finance (TIF) district to continually improve economic development in the county,” said Jim Argerbright, Whitley County RDC president. “The use of the bond shows our flexibility as a county and alleviates the use of a tax abatement for taxpayers.”

Iotron Industries expanded its operations to the United States and Whitley County in 2011 and chose to expand in Columbia City due to the proximity to local orthopedic, medical and agriscience industries, along with being ideally situated for coast-to-coast logistics and distribution.

“With this expansion, we will create 30 to 40 new jobs during the next three years,” added Jeff Blakely, Iotron’s Corporate Vice President of Organizational Development.  “This is just the next chapter in Iotron’s 30-year history,” Blakely continued.  “Our plan moving forward is to continuously innovate, add to our already superb skill sets, position our employees for success and scale our business to meet the needs of our customers. We are extremely proud to have reached this milestone, thanks to the continued dedication of our people, our strong customer partnerships and the unwavering support from Whitley County and the State of Indiana.”

The Iotron expansion is scheduled to be completed this year.

# # #

FDA Authorizes At-Home Collection for Rutgers’ Saliva-based COVID-19 Test

Medical Device and Diagnostics Industry (MD+DI) – Amanda Pedersen

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.

To be clear, this isn’t the first test the agency has authorized with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers’ test previously had been added to FDA’s high-complexity molecular-based LDT “umbrella” emergency use authorization to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device.

Last month FDA authorized the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient’s nose with a nasal swab and saline. That authorization is for LabCorp’s COVID-19 RT-PCR test using samples patients collect themselves with LabCorp’s Pixel home collection kit.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen Hahn, MD. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

For more information about FDA-authorized COVID-19 tests and policies, check out these frequently-asked regulatory questions on the subject.

COVID-19 Resources

To safely open Indiana’s economy and remain vigilant about protecting our health and well-being, Governor Holcomb has laid out a road map to get Indiana back on track.

5 Stages to get Indiana Manufacturing Back on Track

Stage 1: Essential Employees Only (March 24 – May 3)

Stage 2: Open with Restrictions (May 4 – 23)

  • Manufacturers that have not been in operation may open following OSHA and CDC guidelines.
  • Screen employees daily; utilize face coverings according to best practices guidelines
  • Make provisions to maintain social distancing
  • Consult industry best practices
  • Provide employees, customers w/ your COVID-19 policies

Stage 3: Fully Open with Social Distancing (May 24 – June 13)

  • Open, must meet OSHA and CDC guidelines

Stage 4: Fully Open with Social Distancing (June 14 – July 3)

  • Open, must meet OSHA and CDC guidelines
  • Screen employees daily; utilize face coverings according to best practices guidelines
  • Make provisions to maintain social distancing
  • Consult industry best practices
  • Provide safety plans

Stage 5: Fully Open with Social Distancing (July 4 – Beyond)

  • Open, must meet OSHA and CDC guidelines
  • Screen employees daily
  • Provisions for employees to maintain social distancing
  • Consult industry best practices
  • Provide safety plans

More information about the Back On Track Indiana plan can be found at www.backontrack.in.gov .