Flexible Workforce MassMEDIC HR Forum Waltham, MA 30 Sept 2016

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Initial Audience Survey Show of hands: • How many folks are here today are from Medical Product Companies?

• How many of you have used temporary/contract labor (of any kind) in the past 12 months? • How many here have felt increased cost pressure in your companies over the past 3-5 years? • How many of you have 10% or more of your total head count as temp/contract labor? • (How many of your companies are ISO 13485 Certified?)

16 June 2015

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Who is Operon… • • • • • • • •

Outsourced Provider of Labor On-Boarding Solutions Medical Device / Healthcare Products / BioMfg’g Primary focus in manufacturing & logistics Support both OEM’s / Contract Manufacturers MassMEDIC Member/Sponsor over decade Qualified Supplier: Q-med Recognized in Forbes Magazine as a leader in staffing field. ISO 13485 Registered (BSI)

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Contents – Flexible Workforce

Agenda 1. 2. 3. 4. 5.

State of the Temporary Industry What’s Happening in the Med Device Sector Benefits of Flexible Workforce Challenges Associated with Flexible Workforce Strategies to Mitigate Challenge/Risk

16 June 2015

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State of the Industry Contingent Labor / Temporary Labor (USA Today Survey) • About 12% of all US Workers have temporary jobs! • 50% increase since the end of the Great Recession • 75% of surveyed Economists say rise in temporary jobs will be long-lasting. • Individuals sited “work” flexibility as #1 attraction to temp job. • Companies sited “cost” flexibility as #1 attraction to temp workers (JIT Workforce) Source: USA Today/AP 16 June 2015

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What’s Happening in Med Device? ‘From the White House to your house...questioning cost!’  Obama Admin challenged: • Status Quo & “good-’ol-boy” industry….to reduce cost • Lack of technology application….to reduce cost • The “cost-pass-thru culture” versus business efficiencies

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Cost pressures on healthcare providers Cost pressures on insurance providers Compounded by 2013 Med Device Excise Tax Cost pressure flow-down to the manufacturers

16 June 2015

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What’s Happening in Med Device? ‘From the White House to your house...questioning cost!’

 Result of those cost pressures?  Lean Six-Sigma (and the like)…reduce waste/incremental cost  Labor Saving (Layoffs/downsizings/flexible workforce)  Many Others…

16 June 2015

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What’s Happening in Med Device? Trends in the Contingent Labor Market

 Outsourcing  Niche Oriented Providers (small-to-mid market)     

R&D / Product Development Engineering Regulatory / Quality Clinical Management

16 June 2015

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Information Technology (IT) Office / Clerical Manufacturing/Ind. Field Service Executive

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What’s Happening in Med Device? Trends in the Contingent Labor Market

 Wage Growth (Esp. the lower end)  Minimum Wage Increases  Fight for 15  Living wage

 Employee Benefits  ACA  PSTO  Others on the horizon…

16 June 2015

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Benefits of Flexible Workforce

Benefits to the company:  Cost savings from Flexible Workforce!  Pay for what you use!  Try before you buy  Outsourcing: Better value proposition to meet requirements (cost)

16 June 2015

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Challenges of Flexible WF

Challenges to the MedTech Company:  Customer Perception  “There are temps making my medical devices?” Angst!

 Building Pressures for better risk mitigation  Company/OEM is responsible whether ‘make/buy’  If we ‘make’ it, have we properly ‘readied’ the temp workforce?  If we ‘buy’ it, have we managed risk sufficiently with our provider?

16 June 2015

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ISO 13485:2016 Emphasis

16 June 2015

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Supplier Management Using ISO 13485 to Manage Risk • If your systems auditor or notified body sees that temp labor is a significant percentage of labor on the mfg floor involved with fabricating, assembling, inspecting, testing, labeling, packaging and/or shipping the product, they may now be compelled to ask whether the temporary workers receive the same screening, qualification, training and orientation (as an example) as the company’s own full-time employees (they’ll want to see the documents/records). They will want to see evidence of sufficient supplier compliance to requirements (risk mitigation). This can be done a number of ways, including: • Redundant processes (you do what they do) • Regular audits of your providers processes and records to show compliance • Mandate ISO 13485 Registration 16 June 2015

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Contact Information

Steve Sawin Statement of Work Template http://bit.ly/2daLar8 President & CEO Operon 660 Suffolk Street Lowell, MA 01854 978-937-8887 [email protected] www.OperonResource.com

19 June 2015

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Why is this important?

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