Biomedical Sciences and Industries

Biomedical Sciences (BMS) Industries

Learning Objectives

  • Explain the background of biomedical sciences industries.

  • Describe the development of new medicine.

  • Describe the development and types of medical devices.

Contents

  • Biomedical Sciences (BMS) Industries

    • Pharmaceuticals & Biotechnology

    • Medical Technology/Devices

Biomedical Sciences/Engineering

  • Biomedical Sciences (BMS): Study of the function of cells, organs, and systems in the human body towards the understanding, diagnosis, and treatment of human diseases.

  • Biomedical Engineering (BME)/Bioengineering: Application of engineering principles to medical and biological problems towards the understanding, diagnosis, and treatment of functional impairment due to diseases and injuries.

  • As industries, BMS and BME also involve heavily in manufacturing of products related to pharmaceuticals & biotechnology and medical technology.

BMS in Singapore

  • In Singapore, the industries related to BMS are Pharmaceuticals & Biotechnology and Medical Technology (medical device).

  • Engineering plays a significant role in BMS manufacturing and design of medical devices.

  • These products and devices are highly regulated and controlled during development/design and manufacturing to ensure they are safe for human use, effective in specific treatment, and meet strict quality requirements.

Manufacturing Regulations

  • The manufacturing of medical products is regulated through laws to ensure their safety and effectiveness.

  • Regulatory agencies enforce the laws through cGMP (current Good Manufacturing Practice).

  • GMPs are guidelines for manufacturing, testing, and quality assurance to ensure medical products are safe and effective.

Design of Medical Devices

  • Regulations are in place to ensure medical devices are designed to meet requirements of performance, safety, and effectiveness.

  • The design process goes from:

    • User needs

    • Design input

    • Design process

    • Design output

    • Medical device, with review at every stage.

  • Verification: Ensuring the design output fulfils the requirements of the design input.

  • Validation: Ensuring the medical device meets user requirements.

FDA's Design Controls Requirement

  • User Needs → Design Input → Design Process → Design Output → Medical Device

  • Verification ensures design output meets design input requirements.

  • Validation ensures the medical device meets user requirements.

Biomedical Sciences Industries in Singapore

  • Pharmaceuticals & Biotechnology

  • Medical Technology (medical device)

Biomedical Manufacturing in Singapore

  • Pharmaceuticals

  • Biotechnology

  • Medical Technology (medical device)

Industries in Singapore (EDB Classification)

  • Aerospace

  • Consumer Businesses

  • Creative Industries

  • Electronics

  • Energy & Chemicals

  • Information & Communications Technology

  • Logistics & Supply Chain Management

  • Medical Technology

  • Natural Resources

  • Oil & Gas Equipment and Services

  • Pharmaceuticals & Biotechnology

  • Precision Engineering

  • Professional Services

  • Urban Solutions & Sustainability

Manufacturing Clusters in Singapore

  • Electronics

  • Precision Engineering

  • General Manufacturing

  • Biomedical Manufacturing

  • Transport Engineering

  • Chemicals

  • Manufacturing accounts for 19.2%19.2\% of Singapore’s GDP.

Biomedical Manufacturing Sector

  • Manufacturing output in 2016: $\$29.2678B, which accounts for 10.7%10.7\% of the total manufacturing output of $\$273.533B.

  • Accounts for 21%21\% of the total value added at $\$70.044B.

  • Employment number has shown a steady increase over the years.

Sectors

2005

2010

2016

2005

2010

2016

Pharmaceuticals

15,566

19,000

22,300

3,903

5,369

>6,000

Medical Technology

2,103

4,300

6,268

8,370

Total BMS

17,669

23,300

29,267

10,171

13,739

Biomedical Manufacturing Significance

  • Significant contributor to Singapore’s economy, supplying medical products to the growing global market.

  • Both industry sectors have enjoyed consistent growth, and global demand for medical products is expected to continue to grow beyond 2020.

  • Plays a major role in the Healthcare sector and the Global Economy.

The Pharmaceutical Industry

  • 2015: World total - $906 billion, United States - $416 billion, Europe - $197 billion, Emerging markets - $109 billion

  • 2016: World total - $968 billion, United States - $444 billion, Europe - $209 billion, Emerging markets - $115 billion

  • 2017: World total - $996 billion, United States - $453 billion, Europe - $214 billion, Emerging markets - $112 billion

The Medical Device Industry

  • Worldwide Sales (\% Global Sales) - 2009: Americas - 45.8%45.8\%, Western Europe - 29.5%29.5\%, Eastern Europe - 4.6%4.6\%, Asia - 17.8%17.8\%, Middle East/Africa - 2.3%2.3\%. Total Sales: $210B

  • Worldwide Sales (\% Global Sales) - 2014: Americas - 45\%,WesternEurope−, Western Europe -24\%,EasternEurope−, Eastern Europe -4\%,Asia−, Asia -24\%,MiddleEast/Africa−, Middle East/Africa -3\%.TotalSales:. Total Sales:$298B

Medical Device Industry Revenue (USD Billions)

  • 2009: $326B

  • 2010: $352B

  • 2011: $362B

  • 2012: $369B

  • 2013: $371B

  • 2014: $379B

  • 2015: $387B

  • 2016: $403B

  • 2017*: $425B

  • 2018*: $449B

  • 2019*: $473B

  • 2020*: $497B

  • 2021*: $522B

  • 2022*: $600B