[vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652754875351{padding-right: 5% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/Thiết-kế-chưa-có-tên-1-1.png?id=9188) !important;}”][vc_column width=”7/12″][vc_custom_heading text=”Transitioning with Ease” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_custom_heading text=”Research to Development Mentorship” font_container=”tag:h2|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][/vc_column][vc_column width=”5/12″][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”top” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652435933262{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/2.png?id=8925) !important;}”][vc_column width=”1/2″][vc_custom_heading text=”Engineering and Documentation” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]We work together with highly qualified and experienced industrial design experts. This allows us to efficiently tackle the challenges and constraints encountered by start-up companies.[/vc_column_text][/vc_column][vc_column width=”1/2″][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652435943823{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2021/12/3.png?id=8453) !important;}”][vc_column width=”7/12″][/vc_column][vc_column width=”5/12″][vc_custom_heading text=”Attention to Detail” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]Our experience with all forms of technology licensing assignments provides the flexibility to support the licensee to complete the rest of the documentation, sufficient to launch in any market, leveraging on our prior experience working on diverse technology licensing assignments and established relationships with various academic, institutional, and hospital research organisations around the world.[/vc_column_text][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” equal_height=”yes” css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652435956806{padding-top: 90px !important;padding-right: 10% !important;padding-left: 10% !important;}”][vc_column css_animation=”fadeInUp” css=”.vc_custom_1652435965767{padding-top: 30px !important;padding-right: 10% !important;padding-bottom: 30px !important;padding-left: 10% !important;background-color: #ffffff !important;}”][vc_empty_space height=”20px”][vc_column_text]

Research to Development Mentorship


The translation of biomedical innovation into clinical usage is a lengthy and complicated process, despite the tremendous advancements in the field.

At Access-2-Healthcare, we work with some of the top MedTech commercial and engineering talent in the world. Our knowledge on the clinical workflow and required product features, as well as our deep understanding of medical usability, means that we are able to provide the precise degree of support you need. Moreover, at Access-2-Healthcare, we do nush rush things as take each projects assigned by milestone and on a monthly-retainer basis to better provide services to our valued clients.

Innovation Management Can be broadly divided to 2 sections:



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Engineering Prototyping

By providing you with a working prototype, Access-2-Healthcare can improve their chances of licensing their technology or assigning it to a spin-out company

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Technical Documentation

Documentation may be required when the technology is assigned to a MedTech start-up or an industry partner. We step in to assist you in creating documentation that is understandable for potential technology licensees, without excessive data that may slow down the licensing process.

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For the purposes of technology licensing, what qualifies as an acceptable technical file? There is a limit to how much a licensee can do with too much information. A lack of detail and granularity prevents licensees from fully comprehending the information. Access-2- A ‘JUST RIGHT’ Technical File that has the flexibility to complete a full Design History File or be changed in accordance with new indications for use and designs is provided by Accesss-2-Healthcare’s extensive experience with various academic, institutional, and hospital research organizations around the world.

Our experience with all forms of technology licensing assignments provides the flexibility to support the licensee complete the rest of the documentation sufficient to launch in any market, leveraging on our prior experience working on diverse technology licensing assignments and established relationships with various academic, institutional, and hospital research organizations around the world.

[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1647677648509{background-color: #dddddd !important;}”][vc_column][vc_custom_heading text=”What sets us apart: We go straight to the point” font_container=”tag:h4|font_size:32|text_align:center|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]We can assist you in eliminating superfluous needless information while still giving you with sufficient specs. 

Our goal is to help you keep documentation burden to an optimum – something very few would know.

If necessary, we can assist in the completion of the complete technical file and in assisting you with commercialization efforts. We use all of these factors to enable us to think creatively and develop novel ways to assist you.[/vc_column_text][/vc_column][/vc_row][vc_row full_width=”stretch_row_content_no_spaces” disable_element=”yes” leaf_row_scheme=”0″][vc_column width=”1/2″ css=”.vc_custom_1596080914941{padding-top: 30px !important;padding-right: 8% !important;padding-bottom: 30px !important;padding-left: 8% !important;background-color: #ffffff !important;}”][vc_empty_space][vc_column_text]



Engineering Prototyping is divided into three key areas

  • Industrial Design (form factor)
  • Initial prototyping (Proof of Concept)
  • Advanced prototyping (samples for performance and user testing)

To have a wider coverage of medical devices to prototype – from implants to in-vitro diagnostic kits, to active medical devices, to sensor-based monitoring devices – we are using our geographical footprint to work with some of the top talents in the medical device engineering industry.

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Gain more ideas by checking out our case study.

[/vc_column_text][/vc_column][vc_column width=”1/2″][vc_empty_space height=”40px”][vc_single_image image=”8030″ img_size=”900X550″ alignment=”center” css_animation=”fadeInUp”][/vc_column][/vc_row][vc_row full_width=”stretch_row” disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1547641390023{padding-top: 50px !important;padding-bottom: 50px !important;background-color: #ededed !important;}”][vc_column][sc_heading align=”center”]Design & Development[/sc_heading][sc_heading size=”0″ align=”center”]Product Development success from its initial concept depends on proper execution of all its stages. Our industry experts will guide you in this correct execution.[/sc_heading][vc_column_text]

Don’t be fooled – Design and Development is more than just a Design History File!

We give unerring directions on how to establish your design and development processes. For added value, we provide sound inputs to the content of your design and process documents for a safer, better product. Here’s how we help you:


  • Garbage-in, garbage-out:

We work with you to explain what exactly is design input, systematically help you collate all inter-disciplinary inputs to the design input for your product. The end result is clear, structured, and provide a solid foundation for your downstream design.


We provide in-depth, unerring consulting in design planning, design input, design output, design transfer, organisating design reviews, integrating risk management processes and validation/verification.

  • Review the content, level of detail, and correctness of the design documents to ensure it fulfills all applicable regulatory requirements (ISO13485, FDA CFR Part 21 Section 820) and the quality of its contents for a safer, better product.
  • Integrate your risk management processes according to ISO14971 – establish the risk management feedback loop with your design, and go further by ensuring the risk controls translates to the necessary design changes.


We provide consultation and mentorship to adapt your product design and its related risk mitigation plans for the process and for manufacturing.

  • Initial small-volume manufacturing to scale-up
  • Design of production line/processes to manufacture, assemble and test
  • Define your process validation planning, gage R&R, validation protocols and maintenance, statistical process control planning.

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  • User Needs, Design Requirements, Design Specifications Matrix
  • Risk Management
  • Design Reviews
  • Development Plans





In-Sourcing simply means having the start-up take on as much of the research, development, prototyping and manufacturing effort as feasible. This may seem counter intuitive and daunting in today’s highly connected and outsourced environment, however doing so allows you to truly develop understanding and awareness of your core technology and hence the ability to be nimble and react to unexpected situations in a start-up which will be inevitable and plenty.

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Integrate our in-depth understanding of healthcare processes into the design idea and form.

Our Industrial Design professionals evaluate the product’s qualities based on their applicability for the target market. In a world-class start-up environment, our professionals originating from the EU, have years of hands-on expertise in developing complicated, unique medical devices, and they are familiar with the difficulties and limits of a high-tech start-up.

In addition to ergonomics, our specialists may appraise product design based on its overall look and other physical aspects depending on market compatibility. We properly suggest superior prototype designs, saving time and resources on unnecessary design cycles.

We are able to “get it right” more quickly, thus saving both time and money by reducing the number of design revisions.

The end result is a design that works

[/vc_column_text][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJmYWRlLWluLXNsb3clMjB3b3clMjBtb3ZlVXAlMjBhbmltYXRlZCUyMiUyMHN0eWxlJTNEJTIydmlzaWJpbGl0eSUzQSUyMHZpc2libGUlM0IlMjBhbmltYXRpb24tZGVsYXklM0ElMjA2MDBtcyUzQiUyMGFuaW1hdGlvbi1uYW1lJTNBJTIwbW92ZVVwJTNCJTIyJTIwZGF0YS13b3ctZGVsYXklM0QlMjI2MDBtcyUyMiUzRSUwQSU1QnNwX2Vhc3lhY2NvcmRpb24lMjBpZCUzRCUyMjY1NDklMjIlNUQlM0MlMkZkaXYlM0U=[/vc_raw_html][/vc_column][vc_column width=”1/3″][vc_column_text]



The Engineering companies we are working with have the necessary experience to manage and iterate for you. Not just 3D printing, in many cases we will be hand-crafting the prototype as required, supported by local manufacturing for components; tight tolerances and quality control. 

The key advantage we have is that we have a formidable equipment list that can manage various active medical devices (one of the most challenging to prototype because of the involvement of mechanical, electronics and software components). We have established prototyping outfits in Thailand and China that can turn around any proof of concept for a reasonable price.

After an acceptable form factor is found, and proof of concept is attained, there may be several pathways:

  • Adjust or change the form factor (including its size and use case)
  • Change of materials to work towards commonly used materials.
  • Optimization of Assembly or Production Methods

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This is the stage where the design iteration matures and design for manufacturing is considered. Discover our manufacturing services – its set up to scale up!

There are two critical considerations


We offer consulting services to help examine your product’s compliance to IEC62366 and human factors engineering 

We can perform gap analysis for you to identify the right resources and facilities to perform product usability testing, particularly to identify and mitigate any associated risks.


We help you identify the relevant standards and regulatory requirements based on these factors in this prototyping phase to streamline the design and development processes – from the technology used, to the assembly of its various parts

The final objective is to develop the medical device that would meet medical device usability and clinical design considerations for:

– Usability Tests (HFE and IEC62366)

– Animal Studies

– First-in-Human Trials

[/vc_column_text][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1647838288514{background-color: #dddddd !important;}”][vc_column][vc_custom_heading text=”What sets us apart: Our experts” font_container=”tag:h4|font_size:32|text_align:center|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]We work together with highly qualified and experienced industrial design experts. This allows us to efficiently tackle the challenges and constraints encountered by start-up companies, especially in design validation, which is a key stage in a commercialization process. [/vc_column_text][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″][vc_column][vc_empty_space height=”50px”][vc_column_text css_animation=”fadeInUp”]



[/vc_column_text][vc_tta_accordion c_icon=”triangle” active_section=”0″ css_animation=”fadeInUp” collapsible_all=”true”][vc_tta_section title=”Prototyping Facility” tab_id=”1596525909951-f7ae1071-6acc”][vc_column_text]We operate out of a local facility quipped with quality equipment typical of a medical device start-up laboratory.

This allows us to quickly take idea to prototype, sometimes within a single day.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Laboratory Outfitting” tab_id=”1596525909951-8ce35b3d-df41″][vc_column_text]

If you have a facility space available, we provide services to outfit a laboratory to suit your operations.

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Eventually, your start-up will grow to require production of units. Mostly, it will be low volumes for the first years. If by now you have insourced development and prototyping, you would have already developed the processes for building the devices hence it would be easy and natural to scale up and insource initial productions. We are able to provide support in the form of setting up audit/certification support, line setup, process development and production controls and documentation.


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Our Partners in these solutions include The MedTech Lab, and Rexadvance

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Research to Development Mentorship

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Investment Referral

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Medical Technology Design & Development

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Quality Systems Consulting

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Clinical site support

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Manufacturing scale up and set up

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Supplier Control Support

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Go-To-Market Strategy Services

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Full Suite Regulatory Services

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Business Due Diligence

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Licensing holding

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Regional Sales / Tech Service Hub