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Flexible Workforce
MassMEDIC HR Forum
Waltham, MA130 Sept 2016
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 2
Who is Operon…
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• 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)
Contents – Flexible Workforce
Agenda
1. State of the Temporary Industry
2. What’s Happening in the Med Device Sector
3. Benefits of Flexible Workforce
4. Challenges Associated with Flexible Workforce
5. Strategies to Mitigate Challenge/Risk
16 June 2015 4
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)
16 June 2015 5
Source: USA Today/AP
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
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 6
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 7
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 8
Information Technology (IT)
Office / Clerical
Manufacturing/Ind.
Field Service
Executive
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 9
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 10
Challenges of Flexible WF
16 June 2015 11
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?
ISO 13485:2016 Emphasis
16 June 2015 12
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 13
Contact Information
Steve Sawin
President & CEO
Operon
660 Suffolk Street
Lowell, MA 01854
978-937-8887
www.OperonResource.com
19 June 2015 14
Statement of Work Templatehttp://bit.ly/2daLar8
Why is this important?
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