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…

3

• 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

SteveS@OperonResource.com

www.OperonResource.com

19 June 2015 14

Statement of Work Templatehttp://bit.ly/2daLar8

Why is this important?

15