<PAGE>

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

                                   FORM 10-K/A
                                (Amendment No.2)

|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 Identification No.)
incorporation or organization)

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.


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                                Explanatory Note

      This amendment is being filed to indicate the execution of "MANAGEMENT'S
ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING."

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.


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     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 estimated useful life 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.


DAVID R. DOWSETT                                     LAWRENCE D. ELLIS
Acting Chief Executive Officer                       Chief Financial Officer

May 2, 2005


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             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.


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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.

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
May 2, 2005


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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. 2. 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.


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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(16)(17)      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.

(17)  Incorporated by reference to Form 10-K/A filed on May 2, 2005.


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                                   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 10, 2005

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


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