<PAGE>

                UNITED STATES SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549

                                   FORM 10-K/A
                                (Amendment No. 1)

|X|   ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
      ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2004

                                       OR

|_|   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
      EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ to
      ____________ .

                         Commission file number: 0-25852

                           THE MED-DESIGN CORPORATION
             (Exact name of registrant as specified in its charter)

Delaware                                                              23-2771475
(State or other jurisdiction of                                 (I.R.S. Employer
incorporation or organization)                               Identification No.)

2810 Bunsen Avenue, Ventura, CA                                            93003
(Address of principal executive offices)                              (Zip Code)

       Registrant's telephone number, including area code: (805) 339-0375

           Securities registered pursuant to Section 12(b) of the Act:

   Title of each class              Name of each exchange on which registered
           None                                       None

           Securities registered pursuant to Section 12(g) of the Act:

                     Common Stock, par value $0.01 per share
                                (Title of Class)

Indicate by check mark whether the registrant: (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes |X| No |_|

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in the definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K |X|.

Indicate by check mark whether the registrant is an accelerated filer (as
defined in Exchange Act Rule 12b-2). Yes |X| No |_|

The aggregate market value of voting stock held by non-affiliates of the
Registrant (computed by reference to the last reported sale price of such stock
on June 30, 2004) was $10,768,403. The number of shares of Registrant's common
stock outstanding as of April 23, 2005 was 16,622,690.


<PAGE>

                                Explanatory Note

      In Release No. 34-50754, The Securities and Exchange Commission issued an
exemptive order providing a 45-day extension for the filing of management's
annual report on internal control over financial reporting and the independent
registered public accountants' attestation by eligible companies. We elected to
utilize this extension period, and are filing this amendment to our Annual
Report on Form 10-K, filed on March 31, 2005 to include Management's Annual
Report on Internal Control over Financial Reporting and the Report of
Independent Registered Public Accounting Firm in Item 9A. We are also providing
information responsive to the disclosure requirements of Part III of Form 10-K.

ITEM 9A. CONTROLS AND PROCEDURES

(a)   Evaluation of Disclosure Controls and Procedures

      Our management, with the participation of our Acting Chief Executive
Officer and Chief Financial Officer, evaluated the effectiveness of our
disclosure controls and procedures as of the end of the period covered by this
report. Disclosure controls and procedures are defined in SEC regulations as
controls and other procedures of an issuer that are designed to ensure that
information required to be disclosed by the issuer in the reports that it files
or submits under the Securities Exchange Act of 1934, as amended, is recorded,
summarized and reported within the time periods specified in the SEC's rules and
forms. Disclosure controls and procedures include, without limitation, controls
and procedures designed to ensure that information required to be disclosed by
an issuer in the reports that it files or submits under the Securities Exchange
Act of 1934, as amended, is accumulated and communicated to the issuer's
management, including its principal executive and principal financial officers,
or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure. Due to the material weakness in
internal control discussed in Management's Annual Report on Internal Control
Over Financial Reporting on the following page of this report, the Acting Chief
Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures were not effective as of December 31, 2004.

      As noted in Management's Annual Report on Internal Control Over Financial
Reporting, the material weakness related to misapplication of Statement of
Financial Accounting Standards No. 144, "Accounting for the Impairment of
Long-Lived Assets," in connection with our evaluation of the recoverability of
acquired license rights. Management is reviewing its processes for evaluation of
acquired assets and application of the relevant accounting principles.

(b)   Management's Annual Report on Internal Control Over Financial Reporting

      Our management's annual report on internal control over financial
reporting is set forth on the following page of this report and is incorporated
by reference herein.

(c)   Change in Internal Control over Financial Reporting

      No change in our internal control over financial reporting occurred during
our fourth fiscal quarter that has materially affected, or is reasonably likely
to materially affect, our internal control over financial reporting.


                                       2
<PAGE>

     MANAGEMENT'S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

      Management of The Med-Design Corporation is responsible for establishing
and maintaining adequate internal control over financial reporting. Internal
control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally
accepted accounting principles. A company's internal control over financial
reporting includes those policies and procedures that pertain to the maintenance
of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; provide reasonable
assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company are being made
only in accordance with authorizations of management and directors of the
company; and provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's
assets that could have a material effect on the financial statements.

      Because of its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also, projections of any
evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the
degree of compliance with the policies or procedures may deteriorate.

      Management evaluated the Company's internal control over financial
reporting as of December 31, 2004. In making this assessment, management used
the framework established in Internal Control-Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based
on this assessment, management has concluded that the Company's internal control
over financial reporting was not effective as of December 31, 2004 because of
the material weakness outlined below.

      A material weakness is a control deficiency, or combination of control
deficiencies, that results in more than a remote likelihood that a material
misstatement of the financial statements would not be prevented or detected.
Management has identified the following material weakness in connection with its
assessment of the effectiveness of the Company's internal control over financial
reporting as of December 31, 2004:

      The Company lacked effective controls over the processes and procedures
involved in the application of Statement of Financial Accounting Standards No.
144, "Accounting for the Impairment of Long-Lived Assets" ("FAS 144") in
connection with the Company's evaluation of the recoverability of acquired
license rights. Specifically, in applying the impairment test for a long lived
asset to be held and used, namely the acquired license rights, the Company
analyzed future cash flows over a period that was less than the estimated useful
life of the asset. Paragraph 18 of FAS 144 requires that the impairment test be
based on all cashflows expected to result from the use and eventual disposition
of the asset. The misapplication was identified by the Company's independent
registered public accountants as part of the year-end audit. As a result, the
Company recorded adjustments in the consolidated financial statements for the
year ended December 31, 2004 to reverse a previously recorded impairment charge.
The adjustment related to the fourth quarter of 2004 and did not affect prior
periods.

      The Company's independent auditors, BDO Seidman, LLP, have audited
management's assessment of the Company's internal control over financial
reporting. Their opinions on management's assessment and the effectiveness of
the Company's internal control over financial reporting appear on the following
page of this report.



------------------------------            ------------------------------
Acting Chief Executive Officer            Chief Financial Officer

May 2, 2005


                                       3
<PAGE>

             Report of Independent Registered Public Accounting Firm

Board of Directors
The Med-Design Corporation
Ventura, California

We have audited management's assessment, included in the accompanying
Management's Report on Internal Control over Financial Reporting, that The
Med-Design Corporation did not maintain effective internal control over
financial reporting as of December 31, 2004, based on criteria established in
Internal Control--Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). The Med-Design Corporation's
management is responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness of internal
control over financial reporting. Our responsibility is to express an opinion on
management's assessment and an opinion on the effectiveness of the company's
internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, evaluating management's assessment, testing and evaluating
the design and operating effectiveness of internal control, and performing such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.

A company's internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company's internal control over
financial reporting includes those policies and procedures that (1) pertain to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's
assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting
may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.

A material weakness is a control deficiency, or combination of control
deficiencies, that results in more than a remote likelihood that a material
misstatement of the annual or interim financial statements of the Company will
not be prevented or detected. The following material weakness was identified and
included in management's assessment:

The Company's controls over the review of financial reporting did not operate
effectively. This material weakness could have affected the Company's ability to
prepare annual or interim financial statements in accordance with GAAP and
resulted in the misapplication of Statement of Financial Accounting Standards
No. 144, "Accounting for the Impairment of Long-Lived Assets" ("SFAS 144"), in
connection with the Company's evaluation of the recoverability of acquired
license rights in the fourth quarter of 2004. In applying the impairment test
for this asset, the Company analyzed future cash flows over a period that was
less than the estimated useful life of the asset. SFAS 144 requires that the
impairment test be based on all cash flows expected to result from the use and
eventual disposition of the asset. Undiscounted cash flows for the estimated
useful life of the asset were greater than its carrying amount. Thus no
impairment had occurred. This caused the Company to reverse a previously
recorded impairment charge. This adjustment related to the fourth quarter of
2004 and did not affect prior periods.

This material weakness was considered in determining the nature, timing and
extent of audit tests applied in our audit of the 2004 consolidated financial
statements, and this report does not affect our report dated March 29, 2005 on
those consolidated financial statements.


                                       4
<PAGE>

In our opinion, management's assessment that The Med-Design Corporation did not
maintain effective internal control over financial reporting as of December 31,
2004, is fairly stated, in all material respects, based on criteria established
in Internal Control--Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). Also, in our opinion, because
of the effect of the material weakness described above on the achievement of the
objectives of the control criteria, The Med-Design Corporation has not
maintained effective internal control over financial reporting as of December
31, 2004, based on criteria established in Internal Control--Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO).

We have also audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), the consolidated balance sheet of
The Med-Design Corporation as of December 31, 2004 and the related consolidated
statements of operations, changes in stockholders' equity and comprehensive
loss, and cash flows for the year then ended, and our report dated March 29,
2005 expressed an unqualified opinion.

/s/ BDO Seidman, LLP

Los Angeles, California
April 27, 2005


                                       5
<PAGE>

PART III

ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

Name                             Age     Position(s)
----                             ---     -----------
Vincent J. Papa (1)(2)           55      Chairman of the Board
Joseph N.  Bongiovanni, III      60      Vice President, Secretary and Director
Ralph Balzano (3)                68      Director
Paul D. Castignani (1)(4)        59      Director
D. Walter Cohen (2)(3)           78      Director
James M. Donegan (4)             54      Director
Stephen E. Smith, Jr. (3)        47      Director
Pasquale L. Vallone (1)(2)       77      Director
Gilbert M.  White (2)(3)         67      Director
David R. Dowsett                 51      Acting Chief Executive Officer
Lawrence D.  Ellis               54      Vice President, Chief Financial Officer

----------
(1) Member of the Audit Committee of the Board of Directors

(2)   Member of the Compensation Committee of the Board of Directors

(3)   Member of the Nominating Committee of the Board of Directors

(4)   Member of the Investment Committee of the Board of Directors

      Vincent J. Papa has served as Chairman of the Board since August 2004 and
has served as a director since 1998. Mr. Papa has served as Senior Vice
President and Secretary of Energy Merchants Corporation since 1999. From 1995 to
1999, Mr. Papa was a Managing Director and General Counsel for P.M.G. Capital
Corp., a wholly-owned affiliate of the Pennsylvania Merchant Group.

      Joseph N. Bongiovanni, III, has served as a director of Med-Design and our
Vice President and Secretary since 1994. Since 1978, Mr. Bongiovanni has been
the senior partner of the law firm of Bongiovanni & Berger.

      Ralph Balzano has served as a director of Med-Design since January 2001.
Mr. Balzano has been an independent systems consultant since January 2001 for
Balzano LLC. He served as Chief Information Officer for the South Manhattan
Network of New York Hospital Corporation from 1998 to 2000. Mr. Balzano served
as Chief Information Officer for the City of New York and Commissioner of the
Department of Information Technology & Telecommunications from 1994 to 1998.

      Paul D. Castignani has served as a director of Med-Design since July 2002.
Mr. Castignani has been an independent consultant since October 2003. From 1987
to 2003, Mr. Castignani held various positions at Eagle National Bank, most
recently as Senior Vice President and Chief Financial Officer.

      D. Walter Cohen, D.D.S. has served as a director of Med-Design since July
2002. Dr. Cohen is a practicing dentist with Louis Rose D.D.S. & Associates,
where he has practiced since September 2003. From 1993 to 2003, Dr. Cohen was a
Professor of Periodontics at the Medical College of Pennsylvania. He is also a
former professor and dean of the School of Dental Medicine at the University of
Pennsylvania. Dr. Cohen has authored or co-authored numerous books and articles
on various medical topics. He is a member of the Institute of Medicine of the
National Academy of Sciences. Dr. Cohen was also a member of the Board of
Directors of Atrix Laboratories, Inc. until November 2004.


                                       6
<PAGE>

      James M. Donegan has served as a director of Med-Design since 1995. Mr.
Donegan was our Chairman of the Board from 1995 until August 2004 and our Chief
Executive Officer and President from 1995 until October 2004. From 1991 to 1995,
Mr. Donegan held various positions at Chase Manhattan Bank, including marketing
executive for the Structured Investment Division and most recently as the
Managing Director of Chase Futures Management, Inc.

      Stephen E. Smith has served as a director of Med-Design since September
2003. Mr. Smith has been involved in the Kennedy family financial investment and
real estate development business for the past 20 years. He is also a Founding
Partner of K.S.S. Realty Partners and is responsible for investor relations,
capital raising and investment strategy. Mr. Smith founded and is Chairman of
Social Media, a media company, and Kennedy Smith Sammaweera, a real estate
investment and development business specializing in developing technology
related to real estate.

      Pasquale L. Vallone has served as a director of Med-Design since 1998. Mr.
Vallone has been a consultant for U.S. Aviation Underwriters, Inc. since July
1997. Mr. Vallone served in the underwriting and technical areas at U.S.
Aviation Underwriters for fifty years until his retirement as a Senior Vice
President in June 1997.

      Gilbert M. White has served as a director of Med-Design since 1994 and
served as an Executive Vice President of Med-Design from 1995 until January
1998. Mr. White is currently an independent insurance consultant. From 1984
until joining Med-Design in 1995, Mr. White was Senior Vice President of Rollins
Hudig Hall, a multinational insurance firm, where he designed, marketed and
serviced complex insurance programs for large national and international
clients.

      David R. Dowsett has served as our acting Chief Executive Officer since
October 2004. He served as our Vice President and Chief Operating Officer from
June 2002 until October 2004. From 1997 to May 2002, Mr. Dowsett served in a
number of capacities at Becton, Dickinson and Company, most recently as
Worldwide Director in the Infusion Therapy Systems business. Between 1980 and
1997, Mr. Dowsett held various sales, marketing and business development
positions at C.R. Bard, a company engaged in the development, manufacturing and
supply of healthcare products.

      Lawrence D. Ellis has served as our Vice President and Chief Financial
Officer since 1997. From 1991 to 1995, Mr. Ellis served as Controller for
Phonotics, Inc., a company engaged in the research and development and
manufacturing of fiber optic test equipment. In addition, Mr. Ellis has six
years of public accounting experience with Ernst & Young, LLP.

Code of Conduct

      We have adopted a Code of Conduct that applies to our employees including
our acting chief executive officer, chief financial officer, all other officers
and our directors. Our Code of Conduct is posted on the Investor Relations
section of our website at www.med-design.com and may be obtained free of charge
by sending a written request to The Med-Design Corporation, Attention: Investor
Relations, 2810 Bunsen Avenue, Ventura, California, 93003. We intend to satisfy
the disclosure requirements regarding any amendment to, or waiver from, a
provision of our Code of Conduct by disclosing such matters in the Investor
Relations section of our website.

Audit Committee Financial Expert

      Our Board of Directors has determined that Paul Castignani, a member of
our Audit Committee, is an audit committee financial expert as defined in
Securities and Exchange Commission regulations. Mr. Castignani is independent
within the meaning of the rules of the Nasdaq Stock Market, Inc.

Audit Committee

      We have a standing Audit Committee that, among other things, was
established by the Board of Directors for the purpose of overseeing our
accounting and financial reporting processes and audits of our financial


                                       7
<PAGE>

statements. The members of our Audit Committee are Messrs. Paul D. Castignani,
Vincent J. Papa and Pasquale L. Vallone. Mr. Castignani is the Chairman of our
Audit Committee.

Section 16(a) Beneficial Ownership Reporting Compliance

      Section 16(a) of the Securities Exchange Act of 1934, as amended, requires
our directors and executive officers, and persons who own more than ten percent
of our common stock, to file reports of ownership of our securities and changes
in ownership with the Securities and Exchange Commission. To our knowledge,
based solely on a review of the copies of such reports furnished to us and
representations of these persons that no other reports were required, during the
year ended December 31, 2004, all of our directors, executive officers and
greater than 10% stockholders complied with all Section 16(a) filing
requirements.

ITEM 11. EXECUTIVE COMPENSATION

Summary Compensation Table

      The following table sets forth for the years ended December 31, 2004, 2003
and 2002, information regarding compensation we paid to our Chief Executive
Officer and the other most highly paid executive officers whose total annual
salary and bonus exceeded $100,000 for the year ended December 31, 2004.

                           Summary Compensation Table

<TABLE>
<CAPTION>
                                                      Annual Compensation                   Long-Term Compensation
                                                      -------------------                   ----------------------
                                                                                                    Awards
                                                                                                    ------
                                                                                          Restricted
                                                                         Other Annual        Stock          Securities
Name and Principal Position            Year    Salary ($)    Bonus($)   Compensation($)     Awards($)    Underlying Options
---------------------------            ----    ----------    --------   ---------------     ---------    ------------------
<S>                                    <C>      <C>           <C>          <C>                 <C>            <C>
James M. Donegan                       2004     354,000           --       753,738(1)          --                  --
  Former Chairman, Chief Executive     2003     354,000           --       753,738(1)          --              20,000
  Officer and President                2002     354,000       50,000       753,738(1)          --             200,000

                                       2004     218,400                         --             --                  --
David R. Dowsett(2)                    2003     210,000           --        40,000(3)          --              37,500
  Acting Chief Executive Officer,      2002     115,272           --        40,000(3)          --             300,000

Lawrence D. Ellis                      2004     174,720           --            --             --                  --
  Vice President and                   2003     168,000           --            --             --                  --
  Chief Financial Officer              2002     168,000       30,000            --             --              89,000

Joseph N. Bongiovanni, III             2004     166,400           --            --             --                  --
  Vice President and Secretary         2003     160,000           --            --             --                  --
                                       2002     160,000       30,000            --             --              67,000
</TABLE>

----------
(1)   Represents 59,702 shares of common stock for 2004, 2003 and 2002 awarded
      to Mr. Donegan as compensation for past service. In 2000, our Compensation
      Committee, after consultation with outside professional compensation
      consultants, determined that Mr. Donegan had been under-compensated since
      our inception and authorized an award of approximately 59,701 shares of
      common stock per year for the following four years as compensation for
      past service, or an aggregate of 238,806 shares.

(2)   Mr. Dowsett was initially employed by us as our Chief Operating Officer
      and Vice President on June 1, 2002.

(3)   Represents payments for relocation for Mr. Dowsett.


                                       8
<PAGE>

Stock Options

      No stock options were granted to executive officers in 2004.

Fiscal Year-End Values

      The following table summarizes the value of vested and unvested options
for the persons named in the Summary Compensation Table at December 31, 2004.
Year-end values are based upon a price of $1.30 per share, which was the closing
price of a share of our common stock on December 31, 2004 as reported on the
Nasdaq National Market. No options were exercised by the named executive
officers in 2004.

Aggregate Option Exercises in Last Fiscal Year and Fiscal Year-End Option Values

<TABLE>
<CAPTION>
                                                         Number Of Securities
                                                        Underlying Unexercised         Value Of Unexercised
                                                                Options                In-The-Money Options
                                                          At Fiscal Year-End            At Fiscal Year-End
                                                          ------------------            ------------------
                               Shares
                              Acquired      Value
            Name             On Exercise   Realized   Exercisable   Unexercisable   Exercisable   Unexercisable
            ----             -----------   --------   -----------   -------------   -----------   -------------
<S>                               <C>      <C>          <C>            <C>            <C>            <C>
James M. Donegan                  --       $    --      525,800        525,800        $ 39,000       $    --

David R. Dowsett                  --            --      150,000        187,500              --            --

Lawrence D. Ellis                 --            --      129,200         67,000              --            --

Joseph N. Bongiovanni, III        --            --      222,000         45,000              --            --
</TABLE>

Compensation of Directors

      Non-employee directors receive $1,000 per board of directors meeting
attended and annually receive options to purchase 9,000 shares of our common
stock, with an exercise price equal to the closing market price on the date of
grant, as compensation for services on our board of directors. Non-employee
directors also receive $1,000 for each in-person committee meeting attended and
$1,000 for every three telephonic committee meetings attended. No other
directors receive cash or other compensation for services on our board of
directors or any board committee. All directors are entitled to reimbursement
for reasonable expenses incurred in the performance of their duties as board
members.

Employment Agreements

      On June 1, 2002, we entered into a four-year employment agreement with
David Dowsett, our current Acting Chief Executive Officer, which agreement was
effective as of May 15, 2002. The agreement provides for an annual base salary
of $210,000, a stock option grant covering 300,000 shares and an automobile
allowance of $800 per month. The stock option was issued in two tranches, as to
187,500 shares on May 15, 2002 at an exercise price of $11.70 per share and as
to 112,500 shares on July 26, 2002 at an exercise price of $6.51 per share. Of
the shares underlying the May 15, 2002 grant representing 187,500 shares, 50,000
shares vested on October 15, 2002, 25,000 shares vested on May 15, 2003, 37,500
shares vested on May 15, 2004 and 37,500 shares will vest on each of May 15,
2005 and 2006. Of the shares underlying the July 26, 2002 grant representing
112,500 shares, all will vest on July 26, 2009. The options expire July 26,
2012. Vesting may be accelerated as to one-third, two-thirds and all unvested
underlying shares if our earnings per share reaches specified levels.

      On October 17, 2003, we extended our employment agreement with Mr. Dowsett
to May 15, 2007. The extension does not affect his annual base salary but
provided Mr. Dowsett with a stock option grant of 37,500 shares of common stock,
which was made on October 17, 2003. The stock option has an exercise price of
$4.14 per share, vested in full on October 17, 2004 and expires on October 17,
2013.


                                       9
<PAGE>

      On October 10, 2002, we entered into a three-year employment agreement
with Lawrence D. Ellis, our Vice President and Chief Financial Officer. The
agreement provides for an annual base salary of $168,000, the grant of a stock
option to purchase 89,000 shares of common stock and an automobile allowance of
$850 per month. The stock option has an exercise price of $3.25 per share and
expires October 10, 2012. Of the shares underlying the option, 22,000 shares
vested immediately and the remaining shares will vest October 10, 2007. Vesting
may be accelerated as to one-third, two-thirds and all unvested underlying
shares if the market price of our common stock reaches specified levels.

      On October 10, 2002 we entered into a three-year employment agreement with
Joseph N. Bongiovanni, our Vice President and Corporate Secretary. The agreement
provides for a base salary of $160,000, the grant of a stock option for 67,000
shares of common stock and an automobile allowance of $850 per month. The stock
option has an exercise price of $3.25 per share and expires October 10, 2012. Of
the shares underlying the option, 22,000 shares vested immediately and the
remaining shares will vest October 10, 2007. Vesting may be accelerated as to
one-third, two-thirds and all unvested underlying shares if the market price of
our common stock reaches specified levels.

Separation of Employment Agreement with James A. Donegan

      James M. Donegan resigned as our President and Chief Executive Officer on
October 14, 2004. In connection with his resignation, we entered into a
Separation of Employment Agreement and General Release with Mr. Donegan,
effective as of October 14, 2004 (the "Agreement"). In connection with the
execution of the Agreement, most of the provisions of Mr. Donegan's employment
agreement, including the compensatory provisions therein (which provided, among
other things, for one-year's severance to Mr. Donegan if he was terminated
without cause), terminated. The employment agreement was to expire in October
2005.

      Pursuant to the Agreement, Mr. Donegan will continue to serve as one of
our directors and will make himself available, on a part-time basis, for
consultation with us, reporting directly to our Board of Directors or its
committees.

      Under the Agreement, we are paying Mr. Donegan aggregate severance of
$497,275.16. Of that amount, $346,303.98 is being paid in bi-weekly installments
from October 14, 2004 through November 15, 2005 (the "Initial Severance
Period"), and the remaining $150,971.18 will be paid in bi-weekly installments
from November 15, 2005 through November 14, 2006 (the "Second Severance
Period"). During the Initial Severance Period, Mr. Donegan will make himself
available for consultation at reasonable times via telephone up to five hours
per month. During the Second Severance Period, Mr. Donegan will make himself
available for consultation at reasonable times via telephone up to three hours
per month. Mr. Donegan may, but is not required to, provide additional
consultation at no additional cost to us, other than the reimbursement of his
expenses in connection therewith.

      In addition, we are providing medical, life and disability coverage to Mr.
Donegan during the Initial Severance Period on the same terms as are available
to other senior executives under our medical, life and disability plans. In the
event such coverage is no longer available, we will pay any premiums that may be
required to continue Mr. Donegan's coverage pursuant to the Consolidated Omnibus
Budget Reconciliation Act ("COBRA") through the end of the Initial Severance
Period. The estimated cost of this benefit is $13,200.

      In addition, options held by Mr. Donegan to purchase 120,000 shares of our
common stock at an exercise price of $3.25 per share became fully vested on the
effective date of the Agreement. Prior to the Agreement, such options would have
vested in 2007 or 2008, subject to earlier vesting if the price of our common
stock reached specified levels. We also granted to Mr. Donegan fully vested
options to purchase an additional 30,000 shares of our common stock at an
exercise price of $0.92 per share, which was the last reported sale price per
share on the Nasdaq National Market on October 14, 2004. The options expire in
October 2014. In the event of a merger in connection with which options of our
executive officers and/or other directors are repriced, we will reprice all
options held by Mr. Donegan.

      We also agreed that, as required by law, Mr. Donegan will receive a pro
rata contribution to his account in our 401(k) plan for the period in which he
was employed during 2004. In addition, Mr. Donegan received all benefits accrued
or earned as of the date of the Agreement, including accrued and unused vacation
time.


                                       10
<PAGE>

      We also paid $2,500 per month to cover Mr. Donegan's rent at his corporate
residence in California until April 30, 2005, the date of termination of the
lease for such residence.

      As consideration for the benefits described above, Mr. Donegan provided a
general release from any claims against us and any individual or organization
related to us. Mr. Donegan also agreed to certain nondisclosure, nonsolicitation
and noncompetition covenants.

Compensation Committee Interlocks and Insider Participation

      Gilbert M. White served on our Compensation Committee during 2004. Mr.
White served as our Executive Vice President from June 1995 to January 1998.


                                       11
<PAGE>

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS

      The following table sets forth as of April 10, 2005 (unless otherwise
indicated) information with respect to the beneficial ownership of our common
stock (i) by each person known to us to own beneficially five percent or more of
our outstanding common stock (the only voting class outstanding), (ii) by each
director, (iii) by each of the officers named in the Summary Compensation Table
included in this report and (iv) by all executive officers and directors as a
group.

<TABLE>
<CAPTION>
                                                                        Number of Shares         Percent of Class
                    Name and Address                                 Beneficially Owned (1)     Beneficially Owned
                    -----------------                                ----------------------     ------------------
<S>                                                                       <C>                          <C>
Vincent J. Papa ................................................            118,000(2)                    *

Joseph N. Bongiovanni, III .....................................            232,000(3)                  1.4%

Ralph Balzano ..................................................             75,333(4)                    *

Paul D. Castignani .............................................             56,624(5)                    *

D. Walter Cohen ................................................             46,544(6)                    *

James M. Donegan ...............................................          1,224,273(7)                  9.4%

Stephen E. Smith, Jr ...........................................             17,794(8)                    *

Pasquale L. Vallone ............................................            210,026(9)                  1.2%

Gilbert M. White ...............................................            205,634(10)                 1.2%

David R. Dowsett ...............................................            165,100(11)                   *

Lawrence D. Ellis ..............................................            138,200(12)                   *

State of Wisconsin Investment Board ............................          2,347,500(13)                14.0%

Evan Sturza ....................................................          1,002,500(14)                 6.0%

Adage Capital Partners LP. .....................................          1,726,893(15)                10.3%

Pioneer Global Asset Management S.p.A. .........................          1,563,000(16)                 9.3%

All current Directors and Officers as a Group (12 persons) .....          2,579,588(17)                14.2%
</TABLE>

----------

=*Less than one percent (1%)

(1)   Beneficial ownership is determined in accordance with the rules of the
      Securities and Exchange Commission and generally includes voting or
      investment power with respect to securities. Shares of common stock
      subject to options, warrants and convertible notes currently exercisable
      or convertible, or exercisable or convertible within 60 days of April 10,
      2005, are deemed outstanding for computing the percentage ownership of the
      person holding such securities but are not deemed outstanding for
      computing the percentage ownership of any other person. Except as
      indicated by footnote, and subject to community property laws where
      applicable, the person named in the table has sole voting and investment
      power with respect to all shares of common stock shown as beneficially
      owned by such person.

(2)   Includes options to purchase 86,000 shares of common stock.


                                       12
<PAGE>

(3)   Includes options to purchase 219,000 shares of common stock.

(4)   Includes options to purchase 75,333 shares of common stock.

(5)   Includes options to purchase 52,544 shares of common stock.

(6)   Includes options to purchase 27,544 shares of common stock and warrants to
      purchase 18,000 shares of common stock.

(7)   Includes 1,600 shares of common stock held by Mr. Donegan as custodian for
      his son, and 525,800 shares underlying options. The address of Mr. Donegan
      is The Med-Design Corporation, 2810 Bunsen Avenue, Ventura, California
      93003.

(8)   Includes options to purchase 17,794 shares of common stock.

(9)   Includes options to purchase 61,000 shares of common stock.

(10)  Includes 1,400 shares of common stock held by Mr. White's spouse and
      options to purchase 50,000 shares of common stock.

(11)  Includes options to purchase 150,000 shares of common stock.

(12)  Includes options to purchase 112,200 shares of common stock and warrants
      to purchase 16,000 shares of common stock.

(13)  The information in this table is as of December 31, 2004. The principal
      business address of the State of Wisconsin Investment Board is P.O. Box
      7842, Madison, Wisconsin, 53707. The information in the table and this
      note is based on the Schedule 13G/A filed with Securities and Exchange
      Commission on February 8, 2005 by the State of Wisconsin Investment Board.

(14)  The information in this table is as of December 31, 2004. The principal
      business address of Evan Sturza is 1370 Avenue of the Americas, 27th
      Floor, New York, New York, 10019. The information in this table and note
      is based on the Schedule 13G filed with the Securities and Exchange
      Commission on October 1, 2004 by Evan Sturza.

(15)  The shares listed include shares underlying warrants to purchase 335,998
      shares of common stock. Adage Capital Partners, L.P., a Delaware limited
      partnership ("Adage"), shares voting and investment power as to the shares
      listed with Adage Capital Partners GP, L.L.C., a Delaware limited
      liability company ("Adage GP"), Adage Capital Advisors, L.L.C., a Delaware
      limited liability company ("Adage Advisors"), Robert Atchinson and Phillip
      Gross. Adage GP is the general partner of Adage, Adage Advisors is the
      managing member of Adage GP and Messrs. Atchinson and Gross are the
      managing members of Adage Advisors. The principal business address of
      Adage, Adage GP, Adage Advisors, Mr. Atchinson and Mr. Gross is 200
      Clarendon Street, Boston, Massachusetts, 02116. The information in the
      table and this note is based on the Schedule 13G/A filed with the
      Securities and Exchange Commission on February 14, 2005 by Adage GP and
      Messrs. Atchinson and Gross.

(16)  The information in this table is as of December 31, 2004. The principal
      business address of Pioneer Global Asset Management S.p.A. is 60 State
      Street, 19th Floor, Boston, Massachusetts, 02109. The information in this
      table and note is based on the Schedule 13G filed with the Securities and
      Exchange Commission on August 20, 2004 by Pioneer Global Asset Management.

(17)  Includes options and warrants to purchase 3,670,076 shares of common
      stock.


                                       13
<PAGE>

Equity Compensation Plan Information

      The following table provides information as of December 31, 2004 with
respect to compensation plans under which equity compensation is authorized, as
well as individual compensatory arrangements

<TABLE>
<CAPTION>
----------------------------------------------------------------------------------------------------------------------------
                                                                                                       Number of securities
                                                                                                     remaining available for
                                                                                 Weighted-average     future issuance under
                                                      Number of securities to   exercise price of      equity compensation
                                                      be issued upon exercise      outstanding           plans (excluding
                                                      of outstanding options,   options, warrants    securities reflected in
                                                        warrants and rights         and rights             column (a))
                       Plan category                            (a)                    (b)                     (c)
----------------------------------------------------------------------------------------------------------------------------
<S>                                                          <C>                      <C>                    <C>
Equity compensation plans approved by security               3,670,076(1)             $7.59                  24,822
holders
----------------------------------------------------------------------------------------------------------------------------
Equity compensation plans not approved by security
holders                                                             --                   --                      --
----------------------------------------------------------------------------------------------------------------------------
Total                                                        3,670,076               $ 7.59                  24,822
----------------------------------------------------------------------------------------------------------------------------
</TABLE>

(1)   Includes warrants to issue 1,565,532 shares of common stock issued to
      employees, consultants and shareholders of Med-Design.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

      Joseph N. Bongiovanni, III, the senior partner of the law firm of
Bongiovanni & Berger, is a director, Vice President and Corporate Counsel of
Med-Design. During the fiscal years ended December 31, 2004 and 2003,
Bongiovanni & Berger received $18,335 and $22,717, respectively, for legal
services billed to Med-Design and for use of office space and other office
related expenses.

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

      The following table shows the fees that we incurred in 2004 for audit
services provided by BDO Seidman LLP, the independent public accounting firm
that audited our 2004 consolidated financial statements, and the fees that we
incurred in 2003 for audit and other services provided by PricewaterhouseCoopers
LLP Pwc, the independent public accounting firm that audited our 2003
consolidated financial statements.

AUDITOR FEES

                                                            2004          2003

Audit Fees (1):                                          $ 253,081     $ 181,569
Audit Related Fees (2):                                                    4,832
Tax Fees (3):                                                             25,000
All Other Fees:                                                 --            --
                                                         ---------     ---------
Total:                                                   $ 253,081     $ 211,606
                                                         =========     =========

(1)   Audit fees represent fees for services rendered for the audit of our
      financial statements and review of our quarterly financial statements.

(2)   Audit-related fees represent fees for other assurance and related services
      that are reasonably related to the performance of the audit or review of
      our financial statements.

(3)   For fiscal 2003, tax fees related to the preparation of federal,
      state and local returns and tax compliance provided by Pwc.


                                       14
<PAGE>

PART IV

ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K

(a)   Documents filed as part of this Report:

1. Financial Statements. The following financial statements and notes thereto of
Med-Design were incorporated by reference into Item 8 of the initial Form 10-K
filed by Med-Design with the Securities and Exchange Commission on March 31,
2005:

<TABLE>
<CAPTION>
                                                                                                      Page
                                                                                                      ----
<S>                                                                                                    <C>
      Reports of Independent Registered Public Accounting Firms                                        F-2
      Consolidated Balance Sheets as of December 31, 2004 and 2003                                     F-4
      Consolidated Statements of Operations for the years ended December 31, 2004, 2003 and 2002       F-5
      Consolidated Statements of Stockholders' Equity and Comprehensive Loss for the years ended
        December 31, 2004, 2003 and 2002                                                               F-6
      Consolidated Statements of Cash Flows for the years ended December 31, 2004, 2003 and 2002       F-7
      Notes to Consolidated Financial Statements                                                       F-8
</TABLE>

2. All schedules are omitted because they are inapplicable, or not required, or
the information is shown in the financial statements or notes thereto.

3. List of Exhibits. The following is a list of exhibits filed as part of this
Amendment No. 1. Where so indicated by footnote, exhibits which were previously
filed are incorporated by reference.

EXHIBIT
NUMBER                            DESCRIPTION
------                            -----------

3.1(1)      Certificate of Incorporation of Med-Design.

3.2(8)      Certificate of Amendment to Certificate of Incorporation of
            Med-Design

3.3(1)      Bylaws of Med-Design.

4.1(1)      Specimen of Common Stock Certificate of Med-Design.

10.1(4)     Amended and Restated Non-Qualified Stock Option Plan.

10.2(2)     Lease Agreement dated June 15, 1995 between Moen Development and MDC
            Research Ltd. and guaranteed by Med-Design.

10.3(16)    Renewal Lease Agreement dated November 1, 2003, Moen Development and
            MDC Research Ltd.

10.4(9)     Asset Purchase Agreement dated April 1, 2004 between Med-Design and
            Luther Needlesafe Product, Inc.

10.5(4)     Licensing and Option Agreement dated December 11, 1998 with Becton,
            Dickinson and Company.

10.6(4)     Equity agreement dated December 11, 1998 with Becton, Dickinson and
            Company.

10.7(5)     Addendum to License Agreement dated December 11, 1999 with Becton,
            Dickinson and Company.

10.8(5)     Second Addendum to License Agreement dated January 25, 2000 with
            Becton, Dickinson and Company.

10.9(6)     Warrant Agreement dated April 25, 2000 between Med-Design and
            Lawrence Ellis.*

10.10(6)    Licensing Agreement dated May 11, 2000 with Becton, Dickinson and
            Company.

10.11(7)    2001 Equity Compensation Plan.

10.12(16)   Separation of Employment Agreement dated October 10, 2004 between
            Med-Design and James Donegan.


                                       15
<PAGE>

10.13(10)   Employment Agreement dated October 10, 2002 between Med-Design and
            Joseph Bongiovanni.

10.14(10)   Employment Agreement dated October 10, 2002 between Med-Design and
            Lawrence D. Ellis.

10.15(11)   Employment Agreement dated May 15, 2002 between Med-Design and David
            Dowsett

10.16(11)   Employment Agreement extension dated October 17, 2003 between
            Med-Design and David Dowsett

10.17(12)   Developing and Licensing Agreement for Safety "Seldinger" Needle
            Device between Med-Design and Enpath Medical, Inc. dated as of
            August 25, 2000) the "Enpath Agreement").

10.18(13)   Addendum Number One to the Enpath Agreement.

10.19(14)   Addendum Number Two to the Enpath Agreement.

10.20(16)   Plastics Engineering & Development Incorporated Manufacturing
            Agreement dated as of May 22, 2003.

10.21(16)   New Alliance of Independent Medical Distributors, Inc. Exclusive
            Master Sales & Distribution Agreement dated as of November 1, 2003
            Agreement.

21.1(16)    List of Subsidiaries of Med-Design

23.1        Consent of BDO Seidman, LLP**

23.2(16)    Consent of PricewaterhouseCoopers LLP

31.1        Certificate of the Chief Executive Officer required by Rule 15d -
            14(a).**

31.2        Certificate of the Chief Financial Officer required by Rule 15d -
            14(a).**

32.1(16)    Certificate of the Chief Executive Officer required by Rule 15d -
            14(b).

32.2(16)    Certificate of the Chief Financial Officer required by Rule 15d -
            14(b).

99.1(16)    Experts

*     Constitutes management contract or compensatory plan or arrangement
      required to be filed as an exhibit to this Form 10-K

**    Filed herewith

(1) Incorporated by reference to Form SB-2 filed April 7, 1995 and Amendment
Nos. 1, 2 and 3 thereto (File No. 33-901014).

(2) Incorporated by reference to Form 10-KSB filed on March 29, 1996.

(3) Incorporated by reference to Form 10-KSB filed on March 31, 1998.

(4) Incorporated by reference to Form 10-KSB filed on March 31, 1999.

(5) Incorporated by reference to Form 10-KSB filed on March 7, 2000.

(6) Incorporated by reference to Form 10-K filed March 23, 2001.

(7) Incorporated by reference to Schedule 14A filed on June 28, 2001.

(8) Incorporated by reference to Form 10-K filed on April 1, 2002.

(9) Incorporated by reference to Form 8-K filed on April 15, 2004.

(10) Incorporated by reference to Form 10-K filed on March 28, 2003.

(11) Incorporated by reference to Form 10-K filed on March 12, 2004.

(12) Incorporated by reference to Form 10-K filed on March 31, 2005.

(13) Incorporated by reference to Exhibit 10.1 to Form 8-K filed by Enpath
Medical, Inc. on September 19, 2000.

(14) Incorporated by reference to Exhibit 10.1 to Form S-3 filed by Enpath
Medical, Inc. on October 16, 2001.

(15) Incorporated by reference to Form 8-K filed on January 3, 2005.

(16) Incorporated by reference to Form 10-K filed on March 31, 2005.


                                       16
<PAGE>

                                   SIGNATURES

      Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.

                                                THE MED-DESIGN CORPORATION
Dated:  May 2, 2005

                                                By:  JOSEPH N. BONGIOVANNI, III
                                                -------------------------------
                                                Joseph N. Bongiovanni, III
                                                Vice President and Secretary


                                       17