History of Medical Device Manufacturing

Southmedic’s medical manufacturing division specializes in certified cleanroom injection molding and clean room assembly. Our certified class 100,000 clean room, houses modern injection molding machines ranging from 35 to 300 tons. Our design team provides state of the art 3D solid modeling capabilities. The approach we take guarantees our medical customers both rapid delivery and cost effective tooling.

Emphasizing customer service, our medical manufacturing team provides the technical support and knowledge that is essential to all our customers.

Southmedic has more than 2 decades of medical device development, manufacturing and business growth:

2008 – 2009

  1. Acquired assets of Personna Medical Blade and Scalpel Division
  2. Celebrated 25th year in business
  3. Additions of ERP System and One Piece Flow to assembly line
  4. Winner of WXN Top 100
  5. Winner of Profit Top 100 Women Entrepreneurs
  6. Platinum Prime Status with Tri-anim Health Services
  7. Ernst & Young Entrepreneur of the Year Finalist
  8. Grace Medical Leader in International Sales – Canadian Distribution
  9. CME and NRC of Canada Award for New Technologies, Ontario Region

2006 – 2007

  1. Registered by SGS for certification to: ISO 13485:2003, MDD 93/42/EEC Annex II (European Medical Device Directive), CMDCAS (Health Canada’s Medical Device Conformity Assessment System)
  2. Lee McDonald (owner and CEO) honoured with the Canadian Women Entrepreneur “Lifetime Achievement Award”
  3. Launched 3 medical devices (OxyMask, OxyPlus and OxyKid 24-90%) worldwide

2001 – 2005

  1. Building expanded to more than double its size (60,000 sq. ft.)
  2. Received certification from notified body to IS0 13485: 2003, CMDCAS (Health Canada’s Medical Device Conformity Assessment System), MDD 93/42/EEC Annex II (European Medical Device Directive), International Distributor of the year – Kirwan 2004, NAFTA Distributor of the year – Gyrus 2004, Outstanding Sales Performance of the year – Microline International Distributor of the year
  3. Medical device (OxyArm) was launched worldwide
  4. Southmedic acquired Ultrafem contract

1996 – 2000

  1. Received ISO 9001 certification
  2. Built a certified class 100,000 injection molding clean room
  3. Acquired in-house 3D solid design capabilities to compliment our tooling facility
  4. Southmedic, with an average growth rate of 60% per year for the past 5 years is accepted as a member of Innovative Alliance, an organization recognizing Innovative Growth Firm
  5. Lee McDonald honoured with the Canadian Women Entrepreneur of the Year Award.
  6. Southmedic expanded exports to more than 45 countries worldwide
  7. Purchased assets of M-Des Industries to further expand manufacturing capabilities and expertise
  8. Expanded to 30,000 sq. ft. and grew to a staff of 55
  9. Established Corporate Advisory Board
  10. R & D commenced for Southmedic’s innovative medical device, the OxyArm™

1991 – 1995

  1. Expanded to a 4,000 sq ft. facility to accommodate the manufacturing of a drug closure system for world distribution
  2. Purchased assets of Ericana Industries and expanded our medical manufacturing facility and capabilities to include in-house tooling and molding
  3. Founded the Canadian Specialty Distribution Division to market specialty products to the operating room marketplace
  4. Purchased a 14,000 sq ft. building on Alliance Boulevard
  5. Southmedic staff expanded to 20.

1986 – 1990

  1. Launched the Aerosol T, medical device
  2. Moved to our new 2,000 sq. ft. office
  3. Expanded staff to four employees.

1983 – 1985

  • Incorporated in Hamilton, Ontario to introduce the Anaeslock – a patented vaporizer interlock system
  • Established distribution to 20 countries worldwide
  • Designed and launched the Vapofil – a revolutionary vaporizer filling device
  • Moved to Barrie, Ontario